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New treatment could reverse hair loss caused by an autoimmune skin disease

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Researchers at MIT, Brigham and Women’s Hospital, and Harvard Medical School have developed a potential new treatment for alopecia areata, an autoimmune disorder that causes hair loss and affects people of all ages, including children.

For most patients with this type of hair loss, there is no effective treatment. The team developed a microneedle patch that can be painlessly applied to the scalp and releases drugs that help to rebalance the immune response at the site, halting the autoimmune attack.

In a study of mice, the researchers found that this treatment allowed hair to regrow and dramatically reduced inflammation at the treatment site, while avoiding systemic immune effects elsewhere in the body. This strategy could also be adapted to treat other autoimmune skin diseases such as vitiligo, atopic dermatitis, and psoriasis, the researchers say.

“This innovative approach marks a paradigm shift. Rather than suppressing the immune system, we’re now focusing on regulating it precisely at the site of antigen encounter to generate immune tolerance,” says Natalie Artzi, a principal research scientist in MIT’s Institute for Medical Engineering and Science, an associate professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, and an associate faculty member at the Wyss Institute of Harvard University.

Artzi and Jamil R. Azzi, an associate professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, are the senior authors of the new study , which appears in the journal Advanced Materials . Nour Younis, a Brigham and Women’s postdoc, and Nuria Puigmal, a Brigham and Women’s postdoc and former MIT research affiliate, are the lead authors of the paper.

The researchers are now working on launching a company to further develop the technology, led by Puigmal, who was recently awarded a Harvard Business School Blavatnik Fellowship.

Direct delivery

Alopecia areata, which affects more than 6 million Americans, occurs when the body’s own T cells attack hair follicles, leading the hair to fall out. The only treatment available to most patients — injections of immunosuppressant steroids into the scalp — is painful and patients often can’t tolerate it.

Some patients with alopecia areata and other autoimmune skin diseases can also be treated with immunosuppressant drugs that are given orally, but these drugs lead to widespread suppression of the immune system, which can have adverse side effects.

“This approach silences the entire immune system, offering relief from inflammation symptoms but leading to frequent recurrences. Moreover, it increases susceptibility to infections, cardiovascular diseases, and cancer,” Artzi says.

A few years ago, at a working group meeting in Washington, Artzi happened to be seated next to Azzi (the seating was alphabetical), an immunologist and transplant physican who was seeking new ways to deliver drugs directly to the skin to treat skin-related diseases.

Their conversation led to a new collaboration, and the two labs joined forces to work on a microneedle patch to deliver drugs to the skin. In 2021, they reported that such a patch can be used to prevent rejection following skin transplant. In the new study, they began applying this approach to autoimmune skin disorders.

“The skin is the only organ in our body that we can see and touch, and yet when it comes to drug delivery to the skin, we revert to systemic administration. We saw great potential in utilizing the microneedle patch to reprogram the immune system locally,” Azzi says.

The microneedle patches used in this study are made from hyaluronic acid crosslinked with polyethylene glycol (PEG), both of which are biocompatible and commonly used in medical applications. With this delivery method, drugs can pass through the tough outer layer of the epidermis, which can’t be penetrated by creams applied to the skin.

“This polymer formulation allows us to create highly durable needles capable of effectively penetrating the skin. Additionally, it gives us the flexibility to incorporate any desired drug,” Artzi says. For this study, the researchers loaded the patches with a combination of the cytokines IL-2 and CCL-22. Together, these immune molecules help to recruit regulatory T cells, which proliferate and help to tamp down inflammation. These cells also help the immune system learn to recognize that hair follicles are not foreign antigens, so that it will stop attacking them.

Hair regrowth

The researchers found that mice treated with this patch every other day for three weeks had many more regulatory T cells present at the site, along with a reduction in inflammation. Hair was able to regrow at those sites, and this growth was maintained for several weeks after the treatment ended. In these mice, there were no changes in the levels of regulatory T cells in the spleen or lymph nodes, suggesting that the treatment affected only the site where the patch was applied.

In another set of experiments, the researchers grafted human skin onto mice with a humanized immune system. In these mice, the microneedle treatment also induced proliferation of regulatory T cells and a reduction in inflammation.

The researchers designed the microneedle patches so that after releasing their drug payload, they can also collect samples that could be used to monitor the progress of the treatment. Hyaluronic acid causes the needles to swell about tenfold after entering the skin, which allows them to absorb interstitial fluid containing biomolecules and immune cells from the skin.

Following patch removal, researchers can analyze samples to measure levels of regulatory T cells and inflammation markers. This could prove valuable for monitoring future patients who may undergo this treatment.

The researchers now plan to further develop this approach for treating alopecia, and to expand into other autoimmune skin diseases.

The research was funded by the Ignite Fund and Shark Tank Fund awards from the Department of Medicine at Brigham and Women’s Hospital.

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MIT researchers have developed microneedle patches that are capable of restoring hair growth in alopecia areata patients, reports Ernie Mundell for HealthDay . The team’s approach includes a, “patch containing myriad microneedles that is applied to the scalp,” writes Mundell. “It releases drugs to reset the immune system so it stops attacking follicles.” 

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Researchers reverse hair loss caused by alopecia

Treatment holds promise for painlessly targeting affected areas without weakening immune system

BWH Communications

Researchers have developed a novel treatment to reverse hair loss caused by the autoimmune disease alopecia areata, using a microneedle patch to painlessly target affected areas of the skin.

Alopecia areata causes hair loss when T cells mistakenly attack follicles. To restore control over hyperactive immune cells, researchers from Brigham and Women’s Hospital and MIT delivered T cell regulators directly to sites of hair loss to halt autoimmune activity. Findings, published in Advanced Materials , demonstrated marked and lasting increases in hair regrowth in mice models of the disease.

Our immune system evolved to safeguard against the overactivation that occurs in autoimmune conditions. In alopecia areata, the specialized cells known as Regulatory T cells (T-regs) fall short in protecting hair follicles. Current immunosuppressants used to treat alopecia areata target both T cells and T-regs, failing to address the core issue and increasing the risk of disease recurrence once treatment stops. By suppressing the entire immune system, they leave patients vulnerable to infections.

Rather than globally suppressing the immune system, the approach tested in this study locally restores immune activity directly at sites of hair loss by increasing levels of T-regs. This targeted approach was achieved with a microneedle patch, which delivers drugs across the tough outer layer of skin more effectively than topical creams and avoids stimulation of pain receptors located deeper within the skin.

“Our strategy tackles two major challenges in treating autoimmune skin diseases,” said co-corresponding author Natalie Artzi of the Brigham’s Engineering in Medicine Division in the Department of Medicine. “Our patches enable local delivery of biologics, which, instead of suppressing the immune system, promote regulatory T cells in the skin. This restores immune balance and resolves the T cell attack on hair follicles, offering a potential long-term solution without compromising the immune system’s ability to defend against infections and malignancies.”

“When it comes to autoimmune-mediated skin diseases, where we have direct access to the skin, we must surpass the use of systemic immunosuppressants that shut down the entire immune system,” said co-corresponding author Jamil Azzi , an immunologist in the Brigham’s Renal Division in the Department of Medicine. “While topical therapy often fails to penetrate the skin’s outer layer, our patches improve the local delivery of biologics to the deeper layers of diseased skin and reprogram the immune system to generate tolerance at the site of antigen encounter.”

“Our strategy tackles two major challenges in treating autoimmune skin diseases.” Natalie Artzi

The researchers, including co-first authors Nour Younis and Núria Puigmal, both of Brigham’s Department of Medicine, observed with RNA sequencing that in alopecia tissues, there were changes in the STAT-5/Interleukin-2 (IL-2), a signaling pathway that promotes T-reg proliferation. IL-2 and CCL22, which the researchers had previously shown attract and expand the presence of T-regs in a specific area, were loaded into the microneedle patch. The patches were applied to mice models of alopecia 10 times over a course of three weeks, with more than eight weeks of observation. Hair regrowth was observed as early as three weeks after the initiation of treatment. The researchers also tested microneedle patches loaded with baricitinib, a drug approved for severe alopecia areata, but found that T-reg recruitment was inferior to that associated with the IL-2/CCL22 patch.

The microneedle patch also was found to have good shelf-life stability, improving prospects of its clinical translation. While the therapy is not ready for clinical use, the researchers are pursuing further development and testing. Additionally, they are exploring the possibility of applying their approach to other immune-mediated skin diseases, such as vitiligo and psoriasis.

“Microneedles offer a promising avenue for targeted and localized delivery of therapeutics to the skin,” said Artzi. “Their ability to precisely administer drugs directly to the affected area of the skin enables more effective modulation of the immune response while minimizing systemic side effects. This targeted approach holds great potential for improving treatment outcomes and reducing the burden of autoimmune and immune-mediated diseases on patients’ lives.”

Other co-authors from Brigham include Andrew Badaoui, Dongliang Zhang, Claudia Morales, Anis Saad, Diane Cruz, Nadim Al Rahy, Andrea Daccache, Triana Huerta, Christa Deban, Ahmad Halawi, John Choi, Pere Dosta, Christine Lian, and Abdallah El Kurdi.

Funding: The Department of Medicine at Brigham and Women’s Hospital supported this work through the Ignite Fund Award and the Shark Tank Fund Award.

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New Alopecia Areata Treatment Aims To Help Adults and Adolescents

BY KATHY KATELLA July 6, 2023

A little over a year ago, there were no U.S. Food and Drug Administration (FDA)-approved treatments for severe alopecia areata , an autoimmune condition that causes sudden, often disfiguring, partial or total hair loss on a person’s scalp, face, or body. Now, there are two. The first one, a game-changer for adults with the condition, became available in June 2022. The new one, approved in late June of this year, also treats those aged 12 years and older, for whom hair loss can be especially devastating.

“Having a drug for adolescents changes the treatment landscape enormously,” says Brett King, MD, PhD , a Yale Medicine dermatologist who was involved in the development and testing of both drugs and has been caring for patients with alopecia areata for the past decade. “It is challenging enough to be a kid when everything is normal, but having bald spots or being completely bald at a young age can be very difficult.”

Both medications are once-a-day prescription-only pills. The newest treatment, developed by Pfizer, is called ritlecitinib (marketed as LITFULO™). The first treatment, from Eli Lilly, is called baricitinib (marketed as Olumiant®).

Dr. King expects ritlecitinib to become available in the coming weeks. We asked him three questions about the drug and the future of alopecia areata treatment.

1. What is alopecia areata, and why is the new drug important?

The drug could help some of the estimated 7 million people in the U.S. with alopecia areata, an autoimmune disorder in which the body’s immune system attacks hair follicles. As a result, hair falls out—often in clumps. The hair loss can affect any part of the body, although it usually affects the head and face, including eyebrows and eyelashes.

Alopecia areata often comes and goes, especially for those with less severe hair loss. But it may be persistent, particularly for those with severe hair loss, explains Dr. King.

It affects men and women equally, and people of all ages can have it, although it’s most common for people to get it in their teens, 20s, or 30s. Alopecia areata is different from androgenetic alopecia (known as “male-pattern baldness” in men), which progresses gradually over time.

Alopecia areata is an autoimmune disorder in which the body’s immune system attacks hair follicles. As a result, hair falls out, often in clumps.

There is no cure for alopecia areata—only treatment. In mild cases, hair usually grows back, sometimes on its own. However, if treatment is necessary, steroid injections and topical medications may be recommended. But there have been no reliably effective treatments for severe cases of alopecia areata until recently.

The fact that ritlecitinib is the first medication for those as young as 12 is hugely impactful, Dr. King explains, considering that many people with the condition are diagnosed before age 18. “Treatment for these kids is important,” Dr. King says. “Many of them have depression and anxiety as a result of their alopecia, and many withdraw from sports or social activities; some even leave school.”

Ritlecitinib also provides an additional option for adults. "These medicines don’t work for all patients, so if this one doesn’t help, the other [baricitinib] might," says Dr. King.

2. How do baricitinib and ritlecitinib treat alopecia areata?

Like the first FDA-approved alopecia areata medication (baricitinib), ritlecitinib is an oral treatment. Both drugs are Janus kinase (JAK) inhibitors—medications that interfere with cellular signals that cause the inflammation underlying various diseases. JAK inhibitors are used to treat a wide range of diseases, including rheumatoid arthritis , inflammatory bowel disease (IBD) , and myelofibrosis (a rare blood cancer), as well as eczema , vitiligo , and other skin disorders.

“We need to learn why [JAK inhibitors don’t work for everybody] so that we can develop other treatments to allow everyone with alopecia areata to be effectively treated,” says Yale Medicine dermatologist Brett King, MD, PhD.

For ritlecitinib, Dr. King worked with Pfizer as the principal investigator (PI) in the clinical trial published in The Lancet , which showed that 23% of patients treated with the medication had less than 20% scalp hair loss after six months compared to 1.6% of patients in the placebo group (those who didn’t receive the drug). Over an additional 24 weeks of treatment, the proportion of patients who achieved scalp hair regrowth increased to 40%, adds Dr. King.

He was also the PI in Eli Lilly’s clinical trials of baricitinib. In the studies , published in the New England Journal of Medicine , almost 40% of participants who took the drug regained most or all of their hair by 36 weeks.

Though uncommon, some patients who took either drug experienced side effects, such as acne or upper respiratory tract infections, which were mild, explains Dr. King.

As with all JAK inhibitors, there are warnings for serious infection, cancer , blood clots, heart attack , stroke , and death. “It’s important for patients to talk to their doctors about whether these medications are appropriate for them,” Dr. King says.

3. What about people for whom the new drugs don’t work?

JAK inhibitors don’t work for everybody with alopecia areata. “We need to learn why so that we can develop other treatments to allow everyone with alopecia areata to be effectively treated,” Dr. King says.

In the year ahead, Dr. King says he hopes there will be an FDA approval of a third JAK inhibitor, deuruxolitinib, for alopecia areata and, beyond that, approval of ritlecitinib and baricitinib for pre-adolescents, which will mark another milestone in alopecia areata. “Where there was so much darkness before, the present and the future are so bright for people living with alopecia areata and their families,” says Dr. King.

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FDA Approves First Drug to Treat Hair Loss Caused By Alopecia

In a clinical trial with 1200 patients, more than half grew their hair back after a year

Elizabeth Gamillo

Correspondent

The U.S. Food and Drug Administration (FDA) has approved the drug  Olumiant  (baricitinib) for adult patients with severe alopecia areata, an immune disorder that often results in hair loss. The medicine is the first FDA approval of a systemic or full-body drug for the condition, per a  statement .

The drug was originally developed by the pharmaceutical company  Eli Lilly  and has already been on the market for about four years for treating rheumatoid arthritis and other autoimmune diseases. Oluminant was studied in two trials for the treatment of alopecia areata, and the results were published last month in the  New England Journal of Medicine .  

Alopecia areata  is a disease that occurs when the immune system attacks hair follicles, causing hair loss. Hair loss is usually found on the head and face but can occur in small, round, coin-shaped patches anywhere on the body, according to the National Institutes of Health. About 700,000 individuals in the United States are living with alopecia areata. Roughly 40 percent of those individuals have a severe form of the autoimmune disorder, meaning that they are missing at least half of the hair on their scalp,  STAT  reports.

Until now, no approved treatment existed to make hair grow back in patients with alopecia areata. Those with the disorder had to rely on unapproved creams, cosmetic solutions and injections to manage their condition, Jonathan Wosen and Akila Muthukumar report for  STAT . "Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia," Kendall Marcus, director of the Division of Dermatology and Dentistry in the FDA's Center for Drug Evaluation and Research, says in a statement. "Today's approval will help fulfill a significant unmet need for patients with severe alopecia areata."

Eli Lilly's drug prevents the immune system from attacking hair follicles. Pharmaceutical companies like Pfizer and Concert Pharmaceuticals are working on similar drugs to Oluminant.

The phase III trials for Eli Lilly's drug involved 1,200 patients with severe alopecia areata. Study participants either took a daily pill containing two milligrams or four-milligrams of the drug, or a placebo containing no medication. Almost 40 percent of individuals who took the higher drug dose had complete or near-complete hair regrowth after 36 weeks, and after a year, nearly half of patients had their hair back, reports the  New York Times . Patients who received the drug also reported regrowth of hair along their eyelashes and eyebrows.

Mild side effects were reported and included an increased risk for acne, urinary tract infections, headaches, high cholesterol and other infections. The drug’s list price is $2,500 for a one-month supply of the two milligram dose. But, Patrik Jonsson, Eli Lilly's president of immunology, told  STAT that the company is dedicated to making sure out-of-pocket costs for the drug are as little as $5 a month for insured individuals and $25 for those who are uninsured.

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Elizabeth Gamillo | | READ MORE

Elizabeth Gamillo is a correspondent for  Smithsonian and a science journalist based in Milwaukee, Wisconsin. She has written for Science magazine as their 2018 AAAS Diverse Voices in Science Journalism Intern.

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FDA Approves Pfizer’s LITFULO™ (Ritlecitinib) for Adults and Adolescents With Severe Alopecia Areata

• LITFULO is the first and only treatment for severe alopecia areata approved for patients as young as 12

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved LITFULO ™ (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata. The approved recommended dose for LITFULO is 50 mg. It is the first and only treatment approved by the FDA for adolescents (12+) with severe alopecia areata.

“While patients may start to develop symptoms of alopecia areata at any age, most people start showing signs in their teens, twenties, or thirties,” said Dr. Brittany Craiglow, Associate Professor Adjunct – Dermatology at Yale School of Medicine. “LITFULO is a particularly important treatment option for younger patients with substantial hair loss, who often struggle with such a visible disease.”

LITFULO is a kinase inhibitor which inhibits Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family of kinases.

“LITFULO is an important treatment advancement for alopecia areata, an autoimmune disease that previously had no FDA-approved options for adolescents and limited options available for adults,” said Angela Hwang, Chief Commercial Officer, President, Global Biopharmaceuticals Business, Pfizer. “With today’s approval, adolescents and adults who struggle with substantial hair loss have an opportunity to achieve significant scalp hair regrowth.”

The FDA approval was based on results of clinical trials in alopecia areata. The ALLEGRO Phase 2b/3 trial, which enrolled 718 patients with 50% or more scalp hair loss as measured by the Severity of Alopecia Tool (SALT), evaluated the efficacy and safety of LITFULO at 118 sites in 18 countries. In this pivotal study, 23% of patients treated with LITFULO 50 mg had 80% or more scalp hair coverage (SALT≤20) after six months compared to 1.6% with placebo. The efficacy and safety of LITFULO were consistent between adolescents (12 through 17 years of age) and adults (18 years of age and older). The most common adverse events (AEs) reported in at least 4% of patients with LITFULO include headache (10.8%), diarrhea (10%), acne (6.2%), rash (5.4%), and urticaria (4.6%). Full results from the ALLEGRO Phase 2b/3 study were published by The Lancet in April 2023.

“People living with alopecia areata are often misunderstood, and their experience is frequently trivialized as ‘just hair.’ However, it is a serious autoimmune disease that can have considerable negative impact beyond the physical symptoms,” said Nicole Friedland, President and Chief Executive Officer of the National Alopecia Areata Foundation (NAAF). “We believe the approval of LITFULO is a significant advancement for the treatment of alopecia areata, particularly for teens. It’s exciting to see more FDA-approved treatments becoming available for this community.”

View the full Prescribing Information . If it is not currently available via this link, it will be visible as soon as possible as we work to finalize the document. Please check back for the full information shortly.

LITFULO will be available in the coming weeks.

About Alopecia Areata

Alopecia areata is an autoimmune disease characterized by patchy or complete hair loss on the scalp, face, or body. 1,2 It has an underlying immuno-inflammatory pathogenesis and develops when the immune system attacks the body’s hair follicles, causing hair to fall out. 1,2,3 This hair loss often occurs on the scalp, but it can also affect eyebrows, eyelashes, facial hair, and other areas of the body. 1,2 Alopecia totalis (total scalp hair loss) and alopecia universalis (total body hair loss) are types of alopecia areata. 1

Impacting nearly 7 million people in the U.S. and approximately 147 million people globally, alopecia areata can affect people of any age, gender, race, or ethnicity and can cause considerable burden beyond hair loss. 1,2,3,4 Nearly 20% of people with alopecia areata are diagnosed before the age of 18. 5

Additional Details on the ALLEGRO Clinical Trial Program

The randomized, placebo-controlled, double-blind ALLEGRO Phase 2b/3 trial (NCT03732807) investigated LITFULO in patients 12 years of age and older with alopecia areata. Patients included in the study had 50% or more scalp hair loss as measured by the Severity of Alopecia Tool (SALT), including patients with alopecia totalis and alopecia universalis, who were experiencing a current episode of alopecia areata that had lasted between six months and 10 years.

Patients were randomized to receive once-daily LITFULO (50 mg, 30 mg, 10 mg) with or without one month of initial treatment with once-daily LITFULO 200 mg, or placebo once-daily for 24 weeks. At Week 24, LITFULO groups continued their assigned doses and patients initially assigned to placebo switched to LITFULO (50 mg or 200 mg loading dose + 50 mg) for an additional 24 weeks.

In this pivotal study, a statistically significantly greater proportion of patients treated with LITFULO 50 mg had 80% or more scalp hair coverage (SALT≤20) after six months of treatment versus placebo (23% treated with LITFULO 50 mg compared to 1.6% with placebo).

The most common AEs occurring in at least 1% of patients through 24 weeks were headache, diarrhea, acne, rash, urticaria, folliculitis, pyrexia, atopic dermatitis, dizziness, blood creatinine phosphokinase increase, herpes zoster, red blood cell count decrease, and stomatitis. Cases of serious infection, malignancies, thromboembolic events, and lab abnormalities were also reported.

More information about the ALLEGRO Phase 2b/3 trial can be found at https://www.clinicaltrials.gov .

ALLEGRO-LT is an ongoing Phase 3, open-label, long-term study to investigate the safety and efficacy of LITFULO in adults with alopecia areata with 25% or greater hair loss and adolescents from 12 years of age with alopecia areata with 50% or greater hair loss.

About LITFULO ™ (Ritlecitinib)

LITFULO is an inhibitor of JAK3 and the TEC family kinases. Inhibition of JAK3 and TEC kinase family members by LITFULO may block signaling of cytokines and cytolytic activity of T cells, which is implicated in the pathogenesis of alopecia areata. 6,7,8,9

Regulatory applications for LITFULO in alopecia areata have been submitted to countries around the world for review, including China, the European Union, Japan, and the United Kingdom. The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for ritlecitinib with a decision anticipated in the third quarter of 2023.

LITFULO is also being evaluated for vitiligo, Crohn’s disease, and ulcerative colitis.

LITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older.

Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.

US IMPORTANT SAFETY INFORMATION

LITFULO may cause serious side effects, including:

Serious infections. LITFULO can lower the ability of your immune system to fight infections. Do not start LITFULO if you have any kind of infection unless your healthcare provider tells you it is okay. Some people have had serious infections while taking LITFULO or other similar medicines, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body, and have been hospitalized. Some people taking similar medicines to LITFULO have died from these infections. You may be at a higher risk of developing shingles (herpes zoster).

Your healthcare provider should test you for TB before starting treatment with LITFULO and should watch you closely for signs and symptoms of TB during treatment with LITFULO.

Before and after starting LITFULO, tell your doctor right away if you have an infection, are being treated for one, or have symptoms of an infection, including:

• fever, sweating, or chills
• muscle aches
• cough or shortness of breath
• blood in your phlegm
• weight loss
• warm, red, or painful skin or sores on your body
• diarrhea or stomach pain
• burning when you urinate or urinating more often than usual
• feeling very tired

LITFULO can make you more likely to get infections or worsen infections you have. If you get a serious infection, your healthcare provider may stop treatment with LITFULO until your infection is controlled.

There is an increased risk of death in people 50 years and older who have at least one heart disease (cardiovascular) risk factor and are taking a Janus kinase (JAK) inhibitor. LITFULO is a kinase inhibitor.

Cancer and immune system problems. LITFULO may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, can happen. People, especially current or past smokers, have a higher risk of certain cancers, including lymphoma and lung cancers, while taking a JAK inhibitor. Follow your healthcare provider’s advice about having your skin checked for skin cancer during treatment. Tell your healthcare provider if you have ever had any type of cancer.

There is an increased risk of major cardiovascular events such as heart attack, stroke, or death in people 50 years and older who have at least one heart disease (cardiovascular) risk factor and are taking a JAK inhibitor, especially for current or past smokers.

Get emergency help right away if you have any symptoms of a heart attack or stroke while taking LITFULO, including:

• discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
• severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
• pain or discomfort in your arms, back, neck, jaw, or stomach
• shortness of breath with or without chest discomfort
• breaking out in a cold sweat
• nausea or vomiting
• feeling lightheaded
• weakness in one part or on one side of your body
• slurred speech

Blood clots. Blood clots in the veins of your legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), or eyes can happen in some people taking LITFULO. This may be life-threatening. Blood clots in the veins of the legs and lungs have happened more often in people 50 years and older, with at least one heart disease (cardiovascular) risk factor, taking a JAK inhibitor. Tell your healthcare provider if you have had blood clots in the past.

Stop taking LITFULO and get medical help right away if you have any signs and symptoms of blood clots, including swelling, pain, or tenderness in one or both legs; sudden, unexplained chest or upper back pain; shortness of breath or difficulty breathing; or changes in vision, especially in one eye only.

Allergic reactions. Symptoms that may mean you are having an allergic reaction have been seen during treatment with LITFULO. Some of these reactions were serious. Stop taking LITFULO and get emergency medical help right away if you have symptoms of allergic reaction, including hives; rash; trouble breathing; feeling faint or dizzy; or swelling of your lips, tongue, or throat.

Changes in certain laboratory test results. Your healthcare provider should do blood tests before you start taking LITFULO and during treatment to check your lymphocyte and platelet counts and liver enzyme and creatine phosphokinase (CPK) levels. You should not take LITFULO if your lymphocyte counts or platelet counts are too low or your liver tests are too high. Increased CPK levels in the blood are common with LITFULO and can also be severe.Your healthcare provider may stop treatment for a period of time if there are changes in these blood test results.

Do not take LITFULO if you are allergic to ritlecitinib or any of the ingredients in LITFULO. See the Medication Guide for a complete list of ingredients.

Before taking LITFULO, tell your healthcare provider if you:

• have an infection, are being treated for one, or have one that won’t go away or keeps returning
• have diabetes, chronic lung disease, HIV, or a weak immune system
• have TB or have been in close contact with someone with TB
• have had shingles (herpes zoster)
• have had hepatitis B or hepatitis C
• live, have lived, or traveled to certain areas (such as Ohio & Mississippi River Valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections. These infections may happen or worsen when taking LITFULO. Ask your healthcare provider if you’re unsure if you have lived in an area where these infections are common
• have had any type of cancer
• have had blood clots
• are a current or past smoker
• have had a heart attack, other heart problems, or stroke
• have liver problems
• have abnormal blood tests (low platelet count or white blood cell count)
• have recently received or are scheduled to receive any vaccinations. People who take LITFULO should not receive live vaccines right before or during treatment
• are or plan to become pregnant. It is not known if LITFULO will harm your unborn baby. Tell your healthcare provider if you are pregnant or plan to become pregnant during treatment with LITFULO. There is a pregnancy registry for people who take LITFULO during pregnancy. Report pregnancies to Pfizer, Inc. at 1-877-390-2940
• are breastfeeding or plan to breastfeed. It is not known if LITFULO passes into your breast milk. Do not breastfeed during treatment with LITFULO and for 14 hours after your last dose of LITFULO. Talk to your healthcare provider about the best way to feed your baby during treatment with LITFULO

Tell your healthcare provider about all the medicines you take, including prescription and over‑the‑counter medicines, vitamins, and herbal supplements. LITFULO and other medicines may affect each other causing side effects.

The most common side effects of LITFULO include headache; diarrhea; acne; rash; hives; inflamed hair pores (folliculitis); fever; eczema; dizziness; shingles; decreased red blood cell counts; and mouth sores, redness and swelling of the lining of your mouth. These are not all of the possible side effects of LITFULO.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com . In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer .

DISCLOSURE NOTICE:

The information contained in this release is as of June 23, 2023. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about LITFULO (ritlecitinib), including its potential benefits, an approval in the U.S. for individuals 12 years of age and older with severe alopecia areata, applications pending for LITFULO (ritlecitinib) in other jurisdictions and potential regulatory decision and launch timings, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of LITFULO (ritlecitinib); the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in particular jurisdictions for LITFULO (ritlecitinib) for any potential indications; whether and when any applications that may be pending or filed for LITFULO (ritlecitinib) may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether LITFULO (ritlecitinib) for any such indications will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of LITFULO (ritlecitinib); uncertainties regarding the regulatory, commercial or other impact of the results of Janus kinase (JAK) inhibitor studies and data or actions by regulatory authorities based on analysis of such studies and data, which will depend, in part, on benefit-risk assessments and labeling determinations; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results,” as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com .

Category: Prescription Medicines

___________________________ 1 Pratt CH, King LE Jr, Messenger AG, Christiano AM, Sundberg JP. Alopecia areata. Nat Rev Dis Primers. 2017;3:17011. 2 Islam N, Leung PSC, Huntley AC, et al. The autoimmune basis of alopecia areata: a comprehensive review. Autoimmun Rev. 2015:14(2):81-89. 3 Food and Drug Administration. The voice of the patient: a series of reports from the U.S. Food and Drug Administration’s (FDA’s) patient-focused drug development initiative. Silver Spring, MD:FDA;2018. Available from: https://www.fda.gov/files/about%20fda/published/Alopecia-Areata--The-Voice-of-the-Patient.pdf . Accessed 14 Dec. 2022. 4 Stefanaki C, Kontochristopoulos G, Hatzidimitrakib E, et al. A Retrospective Study on Alopecia Areata in Children: Clinical Characteristics and Treatment Choices. Skin Appen Dis. 2021. 5 Caldwell CC, Saikaly SK, Dellavalle RP, et al. Prevalence of pediatric alopecia areata among 572,617 dermatology patients. J Am Acad of Dermatol. 2017;77(5):980-981. 6 Xing L, Dai Z, Jabbari A, et al. Nat Med. 7 Howell MD, et al. Front Immunol. 2019;10:2342-2356. 8 Telliez JB, et al. ACS Chem Biol. 9 Xu H, et al. ACS Chem Biol. 2019;14(6):1235-1242.

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New trials for alopecia areata treatment are a success.

(© stock.adobe.com)

A new study shows that one in three patients with a severe skin disease were able to regrow hair after being treated with a common arthritis drug.

The study is based on Phase 3 clinical trials using baricitinib, a Janus kinase (JAK) inhibitor, to treat alopecia areata, an often disfiguring skin disease characterized by rapid loss of scalp hair, and sometimes eyebrows and eyelashes.

Phase 3 clinical trials are the final testing hurdle before a new treatment can be considered for U.S. Food and Drug Administration (FDA) approval.

“ This is so exciting, because the data clearly show how effective baricitinib is,” said Dr. Brett King , an associate professor of dermatology at the Yale School of Medicine and lead author of the new study, published March 26 in the New England Journal of Medicine. “These large, controlled trials tell us that we can alleviate some of the suffering from this awful disease.”

Alopecia areata is an autoimmune disorder in which the body’s immune system attacks hair follicles. More than 200,000 new cases emerge each year in the United States. Although alopecia areata can develop in patients of any age, it typically occurs in people under the age of 40.

There is currently no FDA-approved treatment for the disease.

For the new study, King and his colleagues conducted two large, randomized trials involving a total of 1,200 people. The participants were adults with severe alopecia areata, who had lost at least half of their scalp hair; many had lost all of their scalp hair.

For 36 weeks, participants were given a daily dose of either 4 milligrams of baricitinib, 2 milligrams of baricitinib, or a placebo. One-third of the patients who received the larger dose grew hair back.

The researchers said baricitinib thwarts the disease by disrupting the communication of immune cells involved in harming hair follicles. Baricitinib and other JAK inhibitors are routinely used to treat autoimmune forms of joint disease.

“ Alopecia areata is a crazy journey, marked by chaos, confusion, and profound sadness for many who suffer from it,” King said. “It will be incredible to have a medicine to help people emerge on the other side, normalcy restored, recognizable again to themselves and those around them.”

Co-authors of the study included researchers from the Kyorin University Faculty of Medicine, Seoul National University College of Medicine, Hebrew University of Jerusalem, Stanford University, the University of California-Irvine, the University of Minnesota, Eli Lilly and Company, and Sinclair Dermatology.

Eli Lilly and Company funded the research.

The results of the study were made public during the annual meeting of the American Academy of Dermatology. For the past decade, King has developed methods for using JAK inhibitors to treat a variety of skin diseases — including eczema, vitiligo, granuloma annulare, sarcoidosis, and erosive lichen planus.

King noted that the clinical trials involving baricitinib are ongoing, which will enable researchers to assess the long-term effectiveness and safety of the treatment.

King is a consultant to and a clinical trials investigator for Eli Lilly and Company.

• In hairless man, arthritis drug spurs hair growth — lots of it

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• 27 July 2023

FDA approves Pfizer's JAK inhibitor for adolescents with alopecia areata hair loss

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The US Food and Drug Administration (FDA) has approved ritlecitinib , an inhibitor of JAK3 and the TEC family, from Pfizer, for adults and children 12 years of age and older who suffer from severe alopecia areata. The positive decision is based on the results of the ALLEGRO phase 2b/3 trial, which enrolled 718 adolescents and adults who had scalp hair loss of 50% or more. The trial’s primary endpoint was achievement, at week 24, of a score of 20 or less on the absolute severity of alopecia tool (SALT), which runs from 0 to 100. ALLEGRO included four different dosing regimens, all of which met the primary endpoint (a fifth group that received a low dose of 10 mg was analyzed only for pharmacokinetics and safety and was not included in the comparison with placebo). In the highest-dose arm of the trial, 31% of patients had a SALT score of 20 or less, versus 2% in the placebo arm.

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Alopecia Areata Research Increases Over the Last 2 Decades

A bibliometric analysis reveals a significant increase in research on alopecia areata treatment over the past 2 decades, with a focus on identifying effective therapies and understanding underlying mechanisms of the condition.

A bibliometric analysis reveals a significant increase in research on alopecia areata (AA) treatment over the past 2 decades, with a focus on identifying effective therapies and understanding underlying mechanisms of the condition. | Image Credit: tadamichi - stock.adobe.com

Research into alopecia areata (AA) treatment has grown substantially over the last 20 years, with a focus on emerging therapies like Janus kinase (JAK) inhibitors and platelet-rich plasma (PRP), according to a bibliometric analysis published in Dermatology . 1

Alopecia is typically classified among 3 subtypes: patchy, alopecia totalis, or alopecia universalis. Patients with patchy AA typically have 1 or more coin-sized, round or oval, patches on the scalp or other areas on the body. 2 Sometimes, patchy AA can convert to alopecia totalis, hair loss across the entire scalp, or universalis, hair loss across the entire body.

Patients with AA are impacted both physically and mentally but there is yet to be a single method that can safely, efficiently, and permanently cure the condition.

Dermoscopy is a noninvasive method that allows the in vivo evaluation of colors and microstructures of the epidermis, the dermoepidermal junction, and the papillary dermis not visible to the naked eye. 3 Common dermascopic findings in patients with AA include yellow dots (84.1%), vellus hairs (62.6%), black dots (48.4%), exclamation mark hairs (30.9%), and broken hairs (9.5%). 1  

“Conducting a bibliometric analysis of the literature on AA treatment over the past 20 years could provide valuable insights into the current state of research in this field,” the study authors stated.

Experts conducted a literature search on the Web of Science (WoS) database in May 2023 and searched for publications from 2003 through 2022.

Publication Phases

The database search yielded 1323 studies on AA treatment from the past 2 decades. The study period was divided into 3 phases: 2003 to 2008, 2009 to 2018, and 2019 to 2023.

The first phase included about 30 articles per year and research on AA treatment was very limited. By the third phase, researchers noticed a significant increase in published articles each year.

Geographic Analysis

Publications stemmed across 65 countries and 1603 institutions, with the top 10 countries distributed across North America, Asia, and Europe.

The largest number of publications were found in the US (n = 443), followed by China (n = 106). The majority of articles on AA treatment were published at the University of Miami (n = 42), Columbia University (n = 34), and Icahn School of Medicine at Mount Sinai (n = 31).

Citation Evaluation

Among the 358 journals that published research on AA treatment, Dermatologic Therapy was the most prolific with 68 studies, followed by the Journal of the American Academy of Dermatology with 61. In terms of impact, the Journal of the American Academy of Dermatology led with an impact factor of 15.49, followed by the British Journal of Dermatology at 11.11 among the top 10 journals.

The Journal of the American Academy of Dermatology was the most frequently cited journal with 5363 co-citations, followed by the British Journal of Dermatology at 3279.

Among co-cited journals, the New England Journal of Medicine had the highest impact factor of 176.08, followed by the Journal of the American Academy of Dermatology at 15.49.

Contributions

A total of 5169 authors contributed to the research on AA treatment. The top 10 most prolific authors collectively published 162 articles on the subject, accounting for more than 10% of all included studies.

Over the past 2 decades, research on AA treatment garnered 35,319 citations. A review of the top 10 most cited references revealed a predominance of review articles and guidelines rather than original research with experimental data.

Citation bursts are often included in references that have been cited consistently and usually in a certain field over time. Tumor necrosis factor (7.75) was the strongest citation burst revealed in the analysis.

The newest research hotspots and research directions included tofacitinib, variant, PRP, epidemiology, and lichen planopilari.

Common keywords focused on JAK inhibitors, including specific medications like ruxolitinib and tofacitinib. Other terms centered on basic research aspects of AA treatment, such as double-blind studies and T cell involvement.

Keywords related to clinical diagnosis and classification encompass frontal fibrotic alopecia and scalp conditions. Treatment and management keywords included curative approaches, treatment regimens, and corticosteroids like triamcinolone. Finally, keywords for the 2020-2022 period emphasized patient quality of life, laser therapies, immune system components, and cytotoxic T cells.

Limitations

The study primarily relied on articles present in the WoS database which the authors reported as a limitation because this may not represent all relevant publications or provide a comprehensive overview. Additionally, the search period was limited from 2003 to 2022, excluding articles before 2003 or after 2022.

“Currently, JAK inhibitors, PRP, and variants are the frontiers of research in this field and are currently emerging,” the study authors concluded.

• Luo W, Shen G, Yang L, Zhu X. A bibliometrics of the treatment of alopecia areata in the past twenty years. Dermatology. (2024) 240 (1): 42–58. doi:10.1159/000535043
• Alopecia areata types. National Alopecia Areata Foundation. Accessed August 16, 2024. https://www.naaf.org/alopecia-areata/types-of-alopecia-areata/#:~:text=Alopecia%20areata%20(patchy)%20causes%20one
• Dermoscopy: overview, technical procedures and equipment, color. eMedicine. March 10, 2023. Accessed August 16, 2024. https://emedicine.medscape.com/article/1130783-overview?form=fpf

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Expert Insights on Deuruxolitinib for Alopecia Areata

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New treatments provide more options for people with alopecia areata

Journal of the American Academy of Dermatology article highlights new ways to restore hair

ROSEMONT, Ill. (Aug. 15, 2023) — A study published today in a supplement of the Journal of the American Academy of Dermatology titled “ Alopecia: A New Frontier ” reveals that a new type of medication called JAK inhibitors can effectively treat moderate to severe alopecia areata — a type of hair loss — that has historically been difficult to treat.

“Because alopecia areata is an inflammatory condition, a JAK inhibitor will essentially reduce the inflammation that is fueling the disease and bring your immune system back into balance,” said board-certified dermatologist Sandra Johnson, MD, FAAD, who is an adjunct professor at the University of Arkansas for Medical Sciences. “The development of JAK inhibitors has given us another treatment to improve the lives of patients with alopecia areata.”

The most common sign of alopecia areata is often sudden hair loss, Dr. Johnson said. The patches of hair loss can grow larger, and sometimes become one large bald spot, or spread to your entire head or body.

While anyone can get alopecia areata, the disease is more common in children, those who have a close blood relative who has the disease, and people who have been treated for cancer with a drug called nivolumab, Dr. Johnson said. Having other medical conditions such as asthma, hay fever, eczema, thyroid disease, vitiligo, and Down syndrome also increases a person’s risks for developing alopecia areata.

Courtney Martens first noticed a bald patch about the size of a silver dollar on her scalp when she was 38. She quickly started losing more hair, and eventually lost all hair on her scalp, eyebrows, and eyelashes.

In 2017, Martens learned that she had a condition called alopecia areata, an immune disease that causes the body to attack its own hair follicles, which in turn results in bald spots. Two years later, the Edmond, Okla. mother-of-two heard about a clinical trial at Dr. Johnson’s practice in Fort Smith, Ark., where she received treatment and was able to completely regrow her hair.

“It’s pretty traumatizing,” Martens said. “Most people think it’s just hair, but it was exhausting because it became what everybody talked about. It was like I lost my identity because I was always the girl with pretty hair growing up.”

In order to diagnose someone with alopecia areata, a dermatologist will examine the area where the hair loss has occurred as well as a person’s nails, according to Dr. Johnson. Blood tests may be necessary to rule out other diseases caused by the immune system.

In addition to JAK inhibitors, treatment options for alopecia areata include contact immunotherapy, which can change your immune system so that it stops attacking your hair follicles; a disease-modifying antirheumatic medication called methotrexate; and corticosteroids, which are an anti-inflammatory medicine.

In Marten’s case, she was prescribed a JAK inhibitor.

Throughout her treatment, Martens said she tried to maintain a positive outlook and hope for the best. She said she feels blessed that the treatment worked for her.

“We now have more treatment options than ever before for alopecia areata patients, and they are providing results for people for whom previous treatments were not effective,” said Dr. Johnson. “It’s important to know that no one treatment works for everyone. Your board-certified dermatologist can recommend the treatment options that work best for you.”

Rhys Saunders, [email protected]

Media Relations, [email protected]

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Alopecia Areata

About the AAD

Headquartered in Rosemont, Ill., the American Academy of Dermatology, founded in 1938, is the largest, most influential and most representative of all dermatologic associations. With a membership of more than 20,800 physicians worldwide, the AAD is committed to advancing the diagnosis and medical, surgical, and cosmetic treatment of the skin, hair, and nails; advocating high standards in clinical practice, education and research in dermatology; and supporting and enhancing patient care because skin, hair, and nail conditions can have a serious impact on your health and well-being. For more information, contact the AAD at (888) 462-DERM (3376) or aad.org . Follow @AADskin on Facebook , TikTok , Pinterest and YouTube and @AADskin1 on Instagram .

Editor’s note: The AAD does not promote or endorse any products or services. This content is intended as editorial content and should not be embedded with any paid, sponsored or advertorial content as it could be perceived as an AAD endorsement.

Registration begins today at 12 pm noon (CT) for physician members, life members, and honorary members.

Researchers discover potential new treatment for alopecia areata

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Researchers at MIT, Brigham and Women's Hospital, and Harvard Medical School have developed a potential new treatment for alopecia areata, an autoimmune disorder that causes hair loss and affects people of all ages, including children.

For most patients with this type of hair loss, there is no effective treatment. The team developed a microneedle patch that can be painlessly applied to the scalp and releases drugs that help to rebalance the immune response at the site, halting the autoimmune attack.

In a study of mice, the researchers found that this treatment allowed hair to regrow and dramatically reduced inflammation at the treatment site, while avoiding systemic immune effects elsewhere in the body. This strategy could also be adapted to treat other autoimmune skin diseases such as vitiligo, atopic dermatitis, and psoriasis, the researchers say.

"This innovative approach marks a paradigm shift. Rather than suppressing the immune system, we're now focusing on regulating it precisely at the site of antigen encounter to generate immune tolerance," says Natalie Artzi, a principal research scientist in MIT's Institute for Medical Engineering and Science, an associate professor of medicine at Harvard Medical School and Brigham and Women's Hospital, and an associate faculty member at the Wyss Institute of Harvard University.

Artzi and Jamil R. Azzi, an associate professor of medicine at Harvard Medical School and Brigham and Women's Hospital, are the senior authors of the new study, which appears in the journal Advanced Materials . Nour Younis, a Brigham and Women's postdoc, and Nuria Puigmal, a Brigham and Women's postdoc and former MIT research affiliate, are the lead authors of the paper.

The researchers are now working on launching a company to further develop the technology, led by Puigmal, who was recently awarded a Harvard Business School Blavatnik Fellowship.

Direct delivery

Alopecia areata, which affects more than 6 million Americans, occurs when the body's own T cells attack hair follicles, leading the hair to fall out. The only treatment available to most patients -; injections of immunosuppressant steroids into the scalp -; is painful and patients often can't tolerate it.

Some patients with alopecia areata and other autoimmune skin diseases can also be treated with immunosuppressant drugs that are given orally, but these drugs lead to widespread suppression of the immune system, which can have adverse side effects.

This approach silences the entire immune system, offering relief from inflammation symptoms but leading to frequent recurrences. Moreover, it increases susceptibility to infections, cardiovascular diseases, and cancer." Natalie Artzi, principal research scientist in MIT's Institute for Medical Engineering and Science

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A few years ago, at a working group meeting in Washington, Artzi happened to be seated next to Azzi (the seating was alphabetical), an immunologist and transplant physican who was seeking new ways to deliver drugs directly to the skin to treat skin-related diseases.

Their conversation led to a new collaboration, and the two labs joined forces to work on a microneedle patch to deliver drugs to the skin. In 2021, they reported that such a patch can be used to prevent rejection following skin transplant. In the new study, they began applying this approach to autoimmune skin disorders.

"The skin is the only organ in our body that we can see and touch, and yet when it comes to drug delivery to the skin, we revert to systemic administration. We saw great potential in utilizing the microneedle patch to reprogram the immune system locally," Azzi says.

The microneedle patches used in this study are made from hyaluronic acid crosslinked with polyethylene glycol (PEG), both of which are biocompatible and commonly used in medical applications. With this delivery method, drugs can pass through the tough outer layer of the epidermis, which can't be penetrated by creams applied to the skin.

"This polymer formulation allows us to create highly durable needles capable of effectively penetrating the skin. Additionally, it gives us the flexibility to incorporate any desired drug," Artzi says. For this study, the researchers loaded the patches with a combination of the cytokines IL-2 and CCL-22. Together, these immune molecules help to recruit regulatory T cells, which proliferate and help to tamp down inflammation. These cells also help the immune system learn to recognize that hair follicles are not foreign antigens , so that it will stop attacking them.

Hair regrowth

The researchers found that mice treated with this patch every other day for three weeks had many more regulatory T cells present at the site, along with a reduction in inflammation. Hair was able to regrow at those sites, and this growth was maintained for several weeks after the treatment ended. In these mice, there were no changes in the levels of regulatory T cells in the spleen or lymph nodes, suggesting that the treatment affected only the site where the patch was applied.

In another set of experiments, the researchers grafted human skin onto mice with a humanized immune system. In these mice, the microneedle treatment also induced proliferation of regulatory T cells and a reduction in inflammation.

The researchers designed the microneedle patches so that after releasing their drug payload, they can also collect samples that could be used to monitor the progress of the treatment. Hyaluronic acid causes the needles to swell about tenfold after entering the skin, which allows them to absorb interstitial fluid containing biomolecules and immune cells from the skin.

Following patch removal, researchers can analyze samples to measure levels of regulatory T cells and inflammation markers. This could prove valuable for monitoring future patients who may undergo this treatment.

The researchers now plan to further develop this approach for treating alopecia, and to expand into other autoimmune skin diseases.

The research was funded by the Ignite Fund and Shark Tank Fund awards from the Department of Medicine at Brigham and Women's Hospital.

Massachusetts Institute of Technology

Younis, N., et al. (2024). Microneedle‐mediated Delivery of Immunomodulators Restores Immune Privilege in Hair Follicles and Reverses Immune‐Mediated Alopecia.  Advanced Materials . doi.org/10.1002/adma.202312088 .

Posted in: Medical Research News | Medical Condition News

Tags: Alopecia , Alopecia Areata , Antigen , Atopic Dermatitis , Cancer , Children , Cytokines , Dermatitis , Drug Delivery , Drugs , Epidermis , Hair , Hair Loss , Hospital , Immune Response , Immune System , Inflammation , Lymph Nodes , Medical School , Medicine , Proliferation , Psoriasis , Research , Skin , Spleen , Technology , Transplant , Vitiligo

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CONSORT diagram for patients who were randomized to baricitinib, 4 mg, or baricitinib, 2 mg, at baseline in BRAVE-AA1 and randomized to placebo or remained taking their initial dose after achieving a Severity of Alopecia Tool (SALT) score of 20 or less at week 52.

LOCF indicates last observation carried forward.

Trial protocol

Statistical analysis plan

eTable. Baseline demographics and disease characteristics for patients withdrawn from 4mg or 2mg baricitinib (ie, transitioned to PBO) at Week 52

eFigure 1. Proportion of patients with SALT score ≤10 from Weeks 52 to 152 for patients who remained on treatment at Week 52 randomized withdrawal (Bari 2mg/2mg and Bari 4mg/4mg) and for patients who were withdrawn to placebo at Week 52 (-Bari 2mg/PBO and Bari 4mg/PBO)

eFigure 2. Proportion of patients with a response in A) eyebrow or B) eyelash regrowth from Weeks 52 to 152 for those who remained on treatment at Week 52 randomized withdrawal (Bari 2mg/2mg and Bari 4mg/4mg) and for patients who were withdrawn to placebo at Week 52 (Bari 2mg/PBO and Bari 4mg/PBO)

eFigure 3. SALT score trajectories from Week 36, for baricitinib 2-mg-treated patients who were randomized to placebo at Week 52 and lost treatment benefit (>20-point worsening in SALT score from Week 52) and required retreatment (N=8)

eFigure 4. SALT score trajectories from Week 36, for baricitinib 4-mg-treated patients who were randomized to placebo at Week 52 and lost treatment benefit (>20-point worsening in SALT score from Week 52) and required retreatment (N=24)

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King B , Ko J , Kwon O, et al. Baricitinib Withdrawal and Retreatment in Patients With Severe Alopecia Areata : The BRAVE-AA1 Randomized Clinical Trial . JAMA Dermatol. Published online August 14, 2024. doi:10.1001/jamadermatol.2024.2734

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Baricitinib Withdrawal and Retreatment in Patients With Severe Alopecia Areata : The BRAVE-AA1 Randomized Clinical Trial

• 1 Department of Dermatology, Yale School of Medicine, New Haven, Connecticut
• 2 Department of Dermatology, Stanford University School of Medicine, Palo Alto, California
• 3 Department of Dermatology, Seoul National University College of Medicine, Seoul, South Korea
• 4 Hair Disorders Unit, Dermatology Service, Ramon y Cajal Hospital, TricoHRC Research Group, Instituto Ramón y Cajal de Investigación Sanitaria, University of Alcala, Madrid, Spain
• 5 Dermatology Unit, Istituto di Ricovero e Cura a Carattere Scientifico Azienda Ospedaliero, Universitaria di Bologna, Bologna, Italy
• 6 Department of Experimental, Diagnostic and Specialty Medicine Alma Mater Studiorum, University of Bologna, Bologna, Italy
• 7 Eli Lilly and Company, Indianapolis, Indiana
• 8 Tigermed-BDM Inc, Somerset, New Jersey
• 9 Department of Dermatology, University of California, Irvine

Question   What are the short-term and long-term relapse rates following treatment withdrawal in patients with severe alopecia areata who achieved a response after 52 weeks of baricitinib, 2 mg, or baricitinib, 4 mg, once daily?

Findings   In this randomized clinical trial of 654 adults with severe alopecia areata, at 4 and 8 weeks, 0% and 10% to 11% of patients, respectively, experienced a loss of treatment benefit, which increased to 80% or more by week 152. With retreatment, most patients recaptured response during the follow-up observation period (2 mg, 63%; 4 mg, 85%).

Meaning   The results of this trial suggest that severe alopecia areata is a relapsing condition requiring maintenance therapy after successful regrowth has been achieved.

Importance   Baricitinib has demonstrated efficacy for treating severe alopecia areata in adults. There is currently limited information about the need for continuous therapy after achieving scalp hair regrowth.

Objective   To report results from the randomized withdrawal period of the BRAVE-AA1 trial.

Design, Setting, and Participants   BRAVE-AA1 was a randomized, placebo-controlled, phase 3 randomized clinical trial with a treatment withdrawal substudy that was conducted at 70 centers in 3 countries beginning in March 2019. It included 654 adults with severe alopecia areata (AA) (Severity of Alopecia Tool [SALT] score ≥50) who were randomized 3:2:2 to receive treatment with baricitinib, 4 mg; baricitinib, 2 mg; or placebo. Data were analyzed in August 2023.

Intervention   At week 52, 154 patients who were responders (SALT score ≤20) were rerandomized 3:1 to continue to take their current dose of baricitinib or transition to placebo (randomized withdrawal). Responders randomized to placebo who experienced a loss of treatment benefit (>20-point worsening in SALT score) at any time after week 52 were retreated with their original baricitinib dose.

Main Outcome and Measures   The proportion of patients who lost treatment benefit through week 152 and the proportion of patients who recaptured response after retreatment. The last observation carried forward was used to impute missing or censored data.

Results   Of 654 patients who received treatment, the mean (SD) age was 37.1 (13.0) years, and there were 383 women (58.6%). At week 52, 10 of 39 responders taking baricitinib, 2 mg, and 30 of 115 responders taking baricitinib, 4 mg, were rerandomized to placebo. At 4 and 8 weeks of treatment withdrawal, 0% and 10% to 11% of patients, respectively, lost treatment benefit regardless of dose. At week 152, 80% of patients had lost benefit compared with 7% for those who continued baricitinib therapy for both dose groups. Within the follow-up observation periods, 5 of 8 patients taking 2 mg (63%) and 21 of 24 patients taking 4 mg (87.5%) recaptured a SALT score of 20 or less response after retreatment.

Conclusions and Relevance   Severe AA is a chronic, relapsing condition, and this randomized clinical trial found that withdrawal of therapy for a patient population with severe AA who had achieved meaningful hair regrowth after 1 year of treatment with baricitinib resulted in loss of benefit for almost all patients, indicating that continued therapy is required to maintain hair regrowth.

Trial Registration   ClinicalTrials.gov Identifier: NCT03570749

Alopecia areata (AA) is a chronic autoimmune disease characterized by patchy or complete hair loss of any hair-bearing site that results from the collapse of hair follicle immune privilege. 1 The oral Janus kinase (JAK) inhibitor baricitinib, administered at doses of 2 mg or 4 mg, once daily, demonstrated efficacy in achieving scalp hair regrowth over 52 weeks in 2 phase 3, double-blind, randomized clinical trials (BRAVE-AA1 and BRAVE-AA2) and has been approved for the treatment of adults with severe AA. 2 - 4 More recently, the oral JAK3/TEC family inhibitor ritlecitinib has been approved for treating adults and adolescents with severe AA. 5

In patients with severe AA, the optimal duration of therapy or need for continuous treatment for maintenance of response are not well understood. Based on data from clinical trials, spontaneous remission is rare among patients with extensive scalp hair loss, in which placebo-response rates of 1% to 5% were reported. 3 , 5 - 7 Furthermore, clinical experience has shown that relapse is frequent on treatment discontinuation. 8 However, over the course of the disease, there may be circumstances in which clinicians and/or patients require interruption of therapy (eg, surgery or illness) or discontinuation of therapy (eg, planning for pregnancy) after response had been achieved. Therefore, it is important to understand the outcomes of treatment withdrawal and for clinicians to have data that can be applied to potential clinical scenarios in which treatment interruption or discontinuation is required.

In this article, we report the outcomes of randomized treatment withdrawal after 52 weeks of treatment with baricitinib, 2 mg and 4 mg, from the phase 3 clinical trial BRAVE-AA1. Understanding the effects of baricitinib treatment withdrawal and the factors that may influence continued response to treatment are important to inform clinicians in their long-term treatment of patients.

BRAVE-AA1 was an adaptive phase 2 to 3, double-blind, parallel-group, randomized, placebo-controlled trial with a randomized withdrawal substudy ( Supplement 1 and Supplement 2 ). The primary trial design for the phase 3 portion was published previously. 2 , 3 Briefly, patients aged 18 to 60 years and 18 to 70 years for male and female individuals, respectively, with a Severity of Alopecia Tool (SALT) 9 score of 50 or greater (≥50% scalp hair loss) and a current AA episode lasting longer than 6 months to less than 8 years without spontaneous improvement (ie, ≤10-point reduction in SALT score) over the 6 months before screening were enrolled. Patients were randomized 3:2:2 to receive baricitinib, 4 mg; baricitinib, 2 mg; or placebo once daily for 52 weeks, with placebo nonresponder patients rescued at week 36. The primary outcome was a SALT score of 20 or less at week 36 (achievement of ≤20% scalp hair loss). All patients who completed the 36-week placebo-controlled period entered a long-term extension of up to 200 weeks. For the randomized withdrawal substudy, patients initially randomized to baricitinib, 4 mg or 2 mg, who had achieved a SALT score of 20 or less at week 52 were rerandomized 3:1 to continue taking their current dose of baricitinib or transition to placebo (randomized withdrawal).

BRAVE-AA1 was conducted in accordance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice guidelines, and the trial protocol was approved by the institutional review board or ethics committee at each center. the trial was conducted in compliance with ICH guidelines, and the protocol provided additional guidance for safety reporting. All patients provided written informed consent for participation in the clinical studies.

The 3:1 randomization ratio was chosen to minimize the number of patients undergoing withdrawal due to the potential psychological effect of relapse. The randomized withdrawal occurred regardless of duration of response (SALT score ≤20) before randomization. Rerandomization for the substudy was performed in a masked manner by a computer-generated random sequence using an interactive web response system. Responders who were rerandomized to placebo at week 52 and subsequently experienced a loss of treatment benefit (defined as a greater than 20-point worsening from their week 52 SALT score) were retreated with their original baricitinib dose (retreated populations). Retreatment could occur at any visit (scheduled or unscheduled) after week 52. Patients who were rerandomized to remain taking their original dose of baricitinib at week 52 continued to receive the same initial dose. The analyses presented in this article include data collected up to week 152 (ie, 100 weeks of randomized withdrawal).

For all patients enrolled in the randomized withdrawal substudy, the proportion with a SALT score of 20 or less and the proportion with loss of treatment benefit is reported through week 152. For patients who met the criterion of loss of treatment benefit and were retreated, the proportion of patients who regained a SALT score of 20 or less during the follow-up observation period are reported. Achievement of a Clinician-Reported Outcome (ClinRO) Measures for Eyebrow (EB) or Eyelash (EL) score of 0 or 1 (ie, full coverage and no areas of hair loss to minimal gaps and even distribution) with a 2-point or greater improvement from baseline is reported for patients with a baseline ClinRO EB or EL score of 2 or 3 (ie, significant gaps and/or uneven distribution to no notable hair). 10

Baseline demographic and disease characteristics for all patients eligible for rerandomization, including the proportion of patients with severe AA (SALT score, 50 to <95) vs very severe AA (SALT score, 95-100) 9 and duration of the current episode (<4 years vs ≥4 years), are reported. Additionally, these baseline characteristics are presented for patients who maintained benefit and those who lost treatment benefit during the randomized withdrawal.

The statistical summaries of the efficacy data during the randomized withdrawal period and retreatment were performed using the randomized withdrawal population and the retreated population, respectively. The randomized withdrawal population included patients who achieved a SALT score of 20 or less at week 52, were eligible to participate in the randomized withdrawal period, and received at least 1 dose of treatment on or after the week 52 visit. The retreated population included patients who transitioned to placebo at week 52 but were retreated with their original dose of baricitinib after loss of treatment benefit. Recapture of a SALT score of 20 or less at least once throughout the follow-up observation period was assessed for the retreated population. Descriptive statistics were summarized, and data after retreatment or treatment discontinuation were censored for the randomized withdrawal period. The last observation carried forward imputation was used to impute the missing or censored data. Patients without a single observation after the randomized withdrawal were excluded from the analysis. The statistical analyses of the response recapture following retreatment used observed data. Any data collected after permanent treatment discontinuation were excluded. Statistical analyses were conducted using SAS Enterprise Guide, version 7.12 (SAS Institute). Statisitical significance was set at α = .05.

BRAVE-AA1 enrolled 654 patients, of whom 281 (43%) received 4 mg and 184 (28%) received 2 mg through week 52 ( Figure 1 ). At week 52, 115 (41%) taking baricitinib, 4 mg, and 39 (21%) taking 2 mg had a SALT score of 20 or less and were eligible for randomized withdrawal. Among the responders to baricitinib, 4 mg, 30 of 115 (26%) were transitioned to placebo, and 85 of 115 (74%) remained taking their original dose; 28 (93%) and 78 (92%), respectively, completed the week 152 treatment visit. Of the 39 responders to baricitinib, 2 mg, 10 of 39 (26%) were transitioned to placebo, and 29 of 39 (74%) remained taking their original dose; of these patients, 9 (90%) and 25 (86%), respectively, completed the week 152 treatment visit. Patient demographic and baseline disease characteristics were comparable across treatment arms ( Table ). Compared with the overall BRAVE-AA1 population reported previously, 3 week 52 responders to baricitinib, 2 mg and 4 mg, eligible for randomized withdrawal tended to have a shorter duration of their current episode and less severe AA (ie, greater proportion of patients having baseline SALT score of 50 to <95 vs baseline SALT score ≥95).

Among patients who remained taking baricitinib, 4 mg, at week 152, a SALT score of 20 or less was maintained by 90%. Similarly, among patients who remained taking baricitinib, 2 mg, a SALT score of 20 or less was maintained by 89% ( Figure 2 ). A similar pattern was observed for the end points of SALT score of 10 or less from weeks 52 to 152 for both doses (eFigure 1 in Supplement 3 ). For patients who remained taking baricitinib, response rates for a ClinRO EB or EL score of 0 or 1 with a 2-point or greater improvement also remained stable from weeks 52 to 152, with 69% or greater and 67% or greater EB response rates and 50% or greater and 70% or greater EL response rates among patients who continued treatment with baricitinib, 2 mg and 4 mg, respectively (eFigure 2 in Supplement 3 ).

For patients who were withdrawn from baricitinib, 4 mg, 96% and 82% maintained a SALT score of 20 or less at weeks 4 and 8, respectively ( Figure 2 ). At week 152, only 6 of 30 (20%) had maintained that response. Similarly, for those withdrawn from baricitinib, 2 mg, 9 of 10 (90%) and 8 of 10 (80%) maintained a SALT score of 20 or less at weeks 4 and 8, respectively, and 1 patient (10%) maintained that response at week 152. Similarly, the proportion of patients with a SALT score of 10 or less decreased from 23 of 30 (77%) to 5 of 30 (17%) (4-mg withdrawal) and 8 of 10 (80%) to 1 of 10 (10%) (2-mg withdrawal) during weeks 52 to 152 (eFigure 1 in Supplement 3 ). Among patients randomized to placebo at week 52, 43% were EB responders at week 52 (both doses), which decreased to 4 of 14 (29%) (baricitinib, 4 mg) and 1 of 7 (14%) (baricitinib, 2 mg) at week 152 (eFigure 2A in Supplement 3 ). For patients randomized to placebo at week 52, the EL response rate was 4 of 13 (31%) (baricitinib, 4 mg) and 1 of 4 (25%) (baricitinib, 2 mg), respectively, and this response was generally stable through week 152, although the number of patients was small (eFigure 2B in Supplement 3 ).

For patients who remained taking their initial dose of baricitinib, 2 mg or 4 mg, after week 52, 7% (2 mg, 2 of 29; 4 mg, 6 of 85) experienced a loss of treatment benefit at week 152 ( Figure 3 ). For those who were withdrawn to placebo, loss of treatment benefit occurred during the shorter term, 4 and 8 weeks after treatment withdrawal, in 0% and 10% to 11% of patients, respectively, regardless of treatment allocation. By 24 weeks (6 months), at least half of patients withdrawn from baricitinib, 4 mg (18 of 30 [60%]) and 2 mg (5 of 10 [50%]), experienced a loss of treatment benefit. At week 152, the proportion of patients with loss of treatment benefit after treatment withdrawal was 80% (2 mg, 8 of 10; 4 mg, 24 of 30) for both doses. For those patients withdrawn from baricitinib, 4 mg, who did not experience a loss of treatment benefit, a higher proportion had shorter duration of current episode and shorter duration since disease onset compared with those who experienced a loss of treatment benefit (eTable in Supplement 3 ); fewer patients in this group had atopic background, alopecia universalis, and EB and EL loss.

Overall, most patients experienced hair regrowth (ie, decreasing SALT score) following retreatment with the initial dose of baricitinib, with varying trajectories (eFigures 3 and 4 in Supplement 3 ). The proportion of patients recapturing a SALT score of 20 or less increased over time. During the retreatment period, which varied by patient, 21 of 24 patients (87.5%) who were retreated with 4 mg and 5 of 8 patients (63%) who were retreated with 2 mg recaptured response after retreatment.

In this randomized clinical trial, most patients who underwent baricitinib treatment withdrawal at week 52 experienced a loss of treatment benefit that was consistent with reports in the literature of relapses with withdrawal of other systemic therapies in AA. 8 Treatment withdrawal was dictated by the clinical trial design, which was distinctly different from clinical practice, in which the duration and/or depth of response and other parameters (baseline disease severity or chronicity) broadly inform treatment decisions, but may be especially important in guiding decisions to adjust the dose, interrupt therapy, or discontinue treatment. The current recommendation from expert consensus is to consider potential discontinuation of systemic treatment only after complete regrowth has been achieved and maintained for 6 months or when it is sufficient to be managed with topical treatments. 11 It is uncertain what the loss of treatment benefit would have been in the present study had patients been required to achieve full and stable regrowth of scalp hair for at least 6 months before treatment withdrawal.

Retreatment was triggered by a worsening of greater than 20 points in absolute SALT score. As illustrated by individual patient trajectories, not only is the time to disease recurrence variable, but also the rate and extent of hair loss (once it begins) varies considerably across patients, with some losing most hair during a short period (eFigures 3 and 4 in Supplement 3 ). At the point of observation in this article, not all patients had recaptured efficacy, although recapture rates increased progressively over time. Similarly, in a trial of ritlecitinib, not all patients who underwent treatment withdrawal recaptured response. 12 If treatment discontinuation is considered in clinical practice, positive findings on a hair pull test may help to signal early shedding, although this tool has not been validated for this purpose or for disease monitoring during JAK inhibitor treatment withdrawal. Retreatment at the earliest sign of shedding would be important to stabilize the disease and recapture response. The loss of treatment benefit did not become noticeable until approximately 8 weeks after treatment withdrawal. Within the BRAVE-AA clinical trials, interruptions of treatment for 4 weeks or less did not appear to affect achievement or maintenance of a SALT score of 20 or less. Considering these 2 observations together, it seems prudent to limit interruptions of treatment to 4 weeks or fewer. 13 There was a small proportion of patients who did not lose treatment benefit even after 2 years of treatment withdrawal. While the baseline characteristics of patients with no loss of treatment benefit after withdrawal from baricitinib, 4 mg, indicated less disease activity in this subgroup compared with those who experienced a loss of treatment benefit, this trend could not be confirmed among patients withdrawn from baricitinib, 2 mg, with and without loss of treatment benefit due to the limited number of patients (eTable in Supplement 3 ). The observations should be taken with caution due to the small sample size; however, they provide some indication of potential disease characteristics of patients in whom long-term remission may be possible.

A potential limitation of this study was the scheduling of patient visits, which were separated by longer intervals toward the end of the study. While patients were able to be retreated at unscheduled visits, some may have waited too long and lost considerably more than 20 points in their SALT score before retreatment was initiated, leading to longer times to recapture response (achieve a SALT score ≤20). Because the response to retreatment in some participants was gradual and the loss of treatment benefit could have occurred late during the postwithdrawal observation period, some patients may not have had sufficient time to recapture response during retreatment (eFigures 3 and 4 in Supplement 3 ). Nonetheless, there is a small but clinically important risk that some patients may not show a response to retreatment. Quality-of-life data were not collected during this portion of the study, and this effect would be necessary to assess before any discussion of treatment withdrawal.

In this randomized clinical trial, in patients with severe AA, withdrawal of therapy among patients who achieved meaningful hair regrowth after 1 year of treatment with baricitinib resulted in almost all patients losing their hair. Therefore, it is not recommended to discontinue therapy after achieving successful regrowth with 1 year of therapy (52 weeks). These data add to our growing knowledge of severe AA, showing that it is a chronic disease and similar to other autoimmune diseases and requires long-term maintenance therapy for most patients to maintain successful outcomes.

Accepted for Publication: June 13, 2024.

Published Online: August 14, 2024. doi:10.1001/jamadermatol.2024.2734

Open Access: This is an open access article distributed under the terms of the CC-BY-NC-ND License . © 2024 King B et al. JAMA Dermatology .

Corresponding Author: Brett King, MD, PhD, Department of Dermatology, Yale School of Medicine, New Haven, CT 06520 ( [email protected] ).

Author Contributions: Drs King and Dutronc had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: King, Ko, Vañó-Galván, Piraccini, Dutronc, Mesinkovska.

Acquisition, analysis, or interpretation of data: King, Ko, Kwon, Dutronc, Yu, Liu, Somani, Ball, Mesinkovska.

Drafting of the manuscript: Vañó-Galván, Somani, Ball.

Critical review of the manuscript for important intellectual content: All authors.

Statistical analysis: Yu, Liu.

Administrative, technical, or material support: King, Kwon, Somani.

Supervision: Vañó-Galván, Piraccini, Dutronc, Somani, Mesinkovska.

Conflict of Interest Disclosures: Dr King reported personal fees from Eli Lilly, Sun, and Pfizer and that his spouse has served as a consultant, speaker, and advisory board member for Pfizer, Eli Lilly, and Sun outside the submitted work. Dr Ko reported personal fees from Eli Lilly during the conduct of the study as well as personal fees from Pfizer and being a trial investigator for AbbVie and Concert/Sun outside the submitted work. Dr Vañó-Galván reported personal fees from Lilly during the conduct of the study and personal fees from Pfizer outside the submitted work. Drs Dutronc and Ball reported being an employee of and share holder in Eli Lilly during the conduct of the study. Dr Yu reported a salary from Eli Lilly and Company outside the submitted work. Dr Somani reported being an employee of and minor shareholder in Eli Lilly & Co. Dr Mesinkovska reported personal fees from Lilly, Pfizer, Sun Pharma, and AbbVie during the conduct of the study. No other disclosures were reported.

Funding/Support: Baricitinib is developed by Eli Lilly and Company under license from Incyte Corporation.

Role of the Funder/Sponsor: Eli Lilly and Company was involved in the study design, data collection, data analysis, data interpretation, manuscript preparation, and publication decisions.

Data Sharing Statement: See Supplement 4 .

Additional Contributions: We thank the participants, caregivers, and investigators. Eric A. Rodriguez, PhD, and Lucy M. Gee, PhD, Eli Lilly and Company, provided writing and editorial assistance, for which they were compensated.

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Patient-Reported Burden of Severe Alopecia Areata: First Results from the Multinational Alopecia Areata Unmet Need Survey

Anthony bewley.

1 Department of Dermatology, The Royal London Hospital & Queen Mary University, London, UK

Ignasi Figueras-Nart

2 Department of Dermatology, University Hospital de Bellvitge, Barcelona, Spain

Jainzhong Zhang

3 Department of Dermatology, Peking University People’s Hospital, Beijing, People’s Republic of China

Mariana Guerreiro

4 Eli Lilly and Company Ltd, Indianapolis, IN, USA

Nicole Tietz

Sami chtourou, frederick durand, ulrike blume-peytavi.

5 Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Dermatology, Venereology and Allergology, Berlin, Germany

Alopecia areata (AA) is an autoimmune disease characterized by hair loss that has significant psychosocial implications. This study aims to describe the patient-reported burden of severe AA, coping mechanism and information needs using data from the multinational AA Patient Satisfaction and Unmet Need Survey.

Patients and Methods

Participants with current or previous ≥50% scalp hair loss (n = 747) were recruited from 11 countries and completed a web-based survey that assessed demographics, clinical characteristics, disease burden and psychosocial impact. Data were stratified according to sex, current age, disease duration and current severity of scalp hair loss.

The mean (SD) age of participants was 43.8 (7.1) years, 55.3% were women, and 63.5% reported AA symptoms within 6 months of diagnosis. Most participants had black or brown hair (88.4%), reported a disease duration of 2 years or more (75.6%) and had current scalp hair loss of ≥50% (87.4%). Severe hair loss also extended to eyebrow (46.9%), eyelash (48.7), beard (61.5%) and body hair (73.2%). Participants commonly reported comorbidities such as anxiety (26.1%), depression (18.1%) and sleep problems (28.1%). The Dermatology Life Quality Index revealed a severe impact on quality of life; 86.2% of participants scored >10. Mental health/mood was significantly affected; 55.8% of participants reported a substantial impact. Long-term effects included decreased self-esteem (32.9%), poor mental health (28.1%) and challenges in day-to-day activities (27.2%). Information needs were centered around treatment expectations, mental health, and available treatment options. More severe symptoms and a greater daily impact were reported by women and those with a longer disease duration.

The study emphasizes the substantial burden, including impaired quality of life and psychological well-being, of severe AA on the lives of surveyed participants. The findings highlight the importance of comprehensive disease management strategies that address both physical and psychosocial aspects of AA.

Plain language summary

Alopecia areata (AA) is a disease that results in hair loss and can greatly affect quality of life and well-being. The authors wanted to understand how this condition affects people’s lives and what they need to cope with it. A survey was completed by adults from 11 different countries who had current or past severe AA. The participants were asked about their demographics, their experiences with the condition and how it impacted their daily lives. The results showed that AA has a severe impact on their quality of life, including their mental health and daily activities. Participants also experienced decreased self-esteem and faced challenges in their relationships and daily routines, and many reported feeling anxious, depressed, and having trouble sleeping. Participants found different ways to cope with their condition and expressed a need for realistic expectations about treatment results, information about mental health, and treatment options. The study also found that women and those with a longer duration of AA tended to have more severe symptoms and the impact on their lives was greater. Overall, this study shows that current or previous episodes of severe AA had a significant impact on people’s lives, including their mental health and daily activities. It emphasizes the need for information about the condition and treatment options with realistic expectations. The findings help to better understand the experiences of people with AA and may aid the provision of appropriate support and information.

Introduction

Alopecia areata (AA) is an inflammatory autoimmune disease characterized by nonscarring hair loss that can range in severity from small patches to complete hair loss on the scalp and/or body. 1 , 2

AA has considerable psychosocial sequelae, negatively impacting quality of life (QoL), and is associated with the presence of anxiety, depression, and work absenteeism/unemployment. 2 In fact, the burden of AA extends to all aspects of life, including stigmatization, low self-esteem, and confidence, and difficulties in relationships (romantic, family, and friends) and performing daily activities. 3 , 4

AA disease management focuses on treatments for hair regrowth, concealment of hair loss, and psychological support. 5–7 To date, traditionally used treatments have shown limited efficacy and effectiveness for hair regrowth and many are associated with safety concerns. 5 , 7 , 8 Overall, patients and dermatologists considered their experience with commonly used traditional therapies to be unsatisfactory. 3 , 7 , 9 There have therefore been numerous calls for more effective treatment options. 2 , 10 , 11 With a greater understanding of disease pathogenesis, the development of new treatments for AA have been successful and approved. 12 , 13

In 2022, an oral selective Janus kinase (JAK)1/JAK2 inhibitor, baricitinib, became the first therapy to be approved by the European Medicines Agency, and the US Food and Drug Administration for adults with severe AA. 14 , 15

Previous research has described the broad impact that AA can have beyond hair loss; however, data on the lived experience of severe AA are more limited. 16 To address this gap, the large multinational cross-sectional AA Patient Satisfaction and Unmet Need Survey was conducted in 11 countries and across three continents.

This analysis describes the patient-reported burden of severe AA, using data from the AA Patient Satisfaction and Unmet Need Survey.

Materials and Methods

Participants and setting.

Participants were recruited via internet panels from February to April 2023 in 11 countries (Brazil, China, France, Germany, Italy, Japan, South Korea, the Netherlands, Spain, Sweden, and the United Kingdom). The recruitment goal was 730 patients. Eligible participants were aged ≥18 years, with self-reported physician confirmed (dermatologist or, in Sweden, primary care physician) AA, and self-reported hair loss involving ≥50% of the scalp (currently or previously). Participants were excluded if they had ever received a JAK inhibitor for the treatment of AA, or any other condition.

Data were collected using market research methodology and following all applicable codes of conduct for Market Research via a web-based, 25-minute cross-sectional survey. The research was conducted in compliance with the International Council for Harmonisation (ICH) Declaration of Helsinki. The survey was developed in collaboration with four of the authors who are experts in the management of AA (AB, IFN, JZ, UBP). Survey clarity and understanding were checked using three online pilots conducted in English. Ethical approval was not required for this research.

Collected data included patient-reported demographics, clinical characteristics, disease burden, and psychosocial impact, as well as coping mechanisms, sources of support, and information needs. Participants assessed their severity of scalp hair loss with the Scalp Hair Assessment Patient-Reported Outcome™ (a 5-point response scale, with higher scores indicating greater hair loss). 17 Existing patient-reported outcome (PRO) measures of current eyebrow loss, eyelash loss, eye irritation and nail appearance were used by participants to report the severity of AA signs/symptoms beyond scalp hair loss (4-point scales, with higher scores indicating greater severity hair loss). 18 The degree of stubble/beard and body hair loss (including intimate body hair) was assessed by participants using a similar approach to the existing Scalp Hair Assessment PRO™ hair loss measures (5-point scales, with higher scores indicating greater hair loss). Participants assessed their QoL and burden of disease using the Dermatology Life Quality Index (DLQI; 10 questions; range: 0–30, with higher scores indicating greater impairment of QoL). 19 , 20 A seven-point scale was used to assess the day-to-day impact of AA in participants who were receiving a treatment for AA at the time of the survey (1–7), with higher scores indicating a greater burden. The long-term impact of AA was measured using responses to the question: “How, if at all, has your life changed as a result of your AA?”. Coping skills were assessed by asking: “Thinking about your AA in the last 6 months, please select what is helping you cope with your AA”, and information needs were measured by responses to the question: “What, if any, information or support would you like to have in relation to your AA?”. Details of the PRO measures for AA signs and symptoms used in the survey are presented in Table S1 .

The survey was translated into local languages, as applicable, and validated translations were used for the standardized scales. Hall & Partners Europe Ltd (London) conducted the survey on behalf of the sponsor, Eli Lilly and Company. Patients provided informed consent to share their health data before participating in the survey and all survey answers were reported anonymously.

Statistical Analysis

Data from the AA Patient Satisfaction and Unmet Need Survey are presented overall for the 11 countries. In addition, participants were stratified according to sex (female, male), current age (≤40 years, 41–50 years, >50 years), duration of AA since diagnosis (<2 years, 2–4 years, >4 years), and current severity of scalp hair loss (<50%, 50–94%, ≥95%).

Data were analyzed descriptively. Continuous variables were described using mean and standard deviation (SD). Categorical variables were reported as the frequency and percentage within each category. No imputation of missing data was conducted. Analyses were performed using STATA/SE 13.1 software (StataCorp, College Station, TX 77845, USA).

Demographics and Clinical Characteristics

A total of 747 adults with self-reported severe AA were recruited and completed the survey in Brazil (n = 72), China (n = 90), France (n = 80), Germany (n = 70), Italy (n = 76), Japan (n = 62), South Korea (n = 51), the Netherlands (n = 50), Spain (n = 71), Sweden (n = 20), and the UK (n = 105).

Demographics and clinical characteristics at the time of data collection are summarized in Table 1 for the overall population. Baseline characteristics revealed that participants had a mean (SD) age of 43.8 (7.1) years, with 55.3% of them being women. Natural hair color was self-reported as black or brown (dark, mid, or light) by 88.4% of participants. The mean (SD) time since being diagnosed with AA was 4.8 (6.3) years and 75.6% of participants reported a time since diagnosis of ≥2 years. Most participants (63.5%) reported a duration of symptoms before diagnosis of 6 months, and initial hair loss developed over a day to a month in 63.9% of participants. At the time of data collection, 87.4% of participants had current scalp hair loss ≥50% and moderate to severe levels of eyebrow, eyelash, stubble/beard, and body hair loss were reported by 46.9%, 48.7%, 61.5% and 73.2% of participants, respectively. In addition, moderate-to-severe eye irritation and nail symptoms (eg, pitted, rough, brittle or split) were reported by 44.9% and 41.8% of participants, respectively. Nearly half the participants (47.3%) reported a previous or current medical diagnosis of anxiety, depression, and/or sleep problems.

Patient Demographics and Clinical Characteristics of Adults with AA

Notes : a Participants who selected more than one code were classified as “other”. b Other ethnicities included Arab, Middle Eastern, North African, Native American/First Nations, Alaska Native, Central or South American Indigenous, Hispanic, Latino, Spanish, Native Hawaiian, Black, African American, Black British, Caribbean, or other. c Other hair color options were available (red or other), but no participants selected these options. d All participants with current scalp hair loss <50% reported a previous scalp hair loss ≥50%. e Scores ≥2 for eyebrow/eyelash hair = large gaps/large amount of thinning or no or barely any hair = moderate to severe. f n = 312. g Scores ≥3 for stubble/beard/body hair loss = large amount of hair loss or loss of all hair in this area = moderate to severe. h Scores ≥2 for eye irritation = moderate or severe irritation including itching, stinging, burning, or dryness. i Scores ≥2 for nail damage = moderate to significant damage to fingernails or toenails. j In response to the question: “Have you ever received a medical diagnosis for any of the following conditions by a physician?”.

Abbreviations : AA, alopecia areata; DLQI, Dermatology Life Quality Index; SD, standard deviation.

Demographics and clinical characteristics of the selected subgroups are presented in Table S2 . AA signs and symptoms were generally more severe in women, in participants aged >50 years, and in those with a disease duration >4 years than in the other respective comparator groups. Participants with <50% scalp hair loss were more likely to be men (57.5%) and those with ≥50% hair loss were more likely to be women (57.6%). Individuals experiencing <50% scalp hair loss also had fewer moderate or severe AA signs and symptoms, with the exception of stubble/beard hair loss, compared to those with ≥50% scalp hair loss. Anxiety, depression and/or sleep problems were reported across the range of current scalp hair loss severity, anxiety being most common in those with <50% scalp hair loss (34.0%) and sleep problems showing higher rates in those with ≥95% scalp hair loss (32.1%). However, the current severity of scalp hair loss did not appear to greatly affect the negative psychological effects, which were similar across the three scalp hair loss groups.

Disease Burden and Psychosocial Impact

The mean (SD) DLQI for the overall population was 16.8 (6.0) ( Table 1 ) and 86.2% of participants reported severe QoL impairment (DLQI >10) ( Figure 1 ). The impact of AA on daily life was measured in patients receiving AA treatment at the time of the survey. These participants experienced the greatest impact in mental health/mood, with 55.8% of participants reporting a substantial impact (score ≥6) ( Figure 2 ). For all other categories—except the day-to-day impact of AA on participants’ religious identity—a substantial impact was reported by more than 40% of respondents.

Impairment of quality of life: Dermatology Life Quality Index (N = 747).

Day-to-day impact of AA (N = 493) a .

When asked about the long-term burden of AA, most participants (79.9%) reported at least some AA-related impact on their lives ( Figure 3 ). The most frequently reported long-term effects of AA were decreased self-esteem (32.9%), and negative impact on mental health (28.1%) and day-to-day activities (27.2%).

Long-term impact a of AA in total population (N = 747).

Disease burden and psychosocial impact in the selected subgroups are reported in Table S3 . Men had a lower mean (SD) DLQI of (15.3 [6.0]) than women (17.9 [5.9]). However, in both groups, large proportions of participants had severely impaired QoL (DLQI >10 in 79.9% of men and 90.6% of women). Severe day-to-day and long-term impacts of AA were more frequently reported by women than men. Mean (SD) DLQI was similar across age groups (16.6 [5.8]–16.9 [6.0]). Younger participants (aged 40 years) reported a greater impact of AA on most day-to-day dimensions than those aged 41–50 years or >50 years, but no specific trend could be seen regarding the long-term burden of AA.

Across the three groups defined by disease duration, the mean (SD) DLQI was lower (but still >10) in participants with a disease duration >4 years (15.6 [6.4]) compared to <2 years (17.8 [5.6]) and 2–4 years (17.2 [5.8]). Among these three disease duration groups, those with AA for <2 years reported the highest day-to-day impact as well as the greatest long-term impact of AA. The mean (SD) DLQI was lower in participants with <50% scalp hair loss (14.6 [6.7]) than in participants with ≥50% scalp hair loss (16.6 [5.0], 50–94% and 17.6 [6.7] ≥95% scalp hair loss). Nevertheless, the mean DLQI was >10 irrespective of current scalp hair loss. The day-to-day impact of AA was generally reported to be substantial by greater proportions of participants with ≥95% scalp hair loss than those with 50–94% or <50% scalp hair loss; no clear trends were seen across the current hair-loss groups for long-term impact of AA.

Coping Mechanisms and Information Needs

Talking to others, particularly to a healthcare professional or other people with AA, and doing exercise or sport, were the most frequently selected coping mechanisms overall ( Table 2 ).

Coping Mechanisms of Adults with AA a

Notes : a In response to the survey question: “Thinking about your AA in the last 6 months please select what is helping you cope with your AA.” Multiple answers were possible. b e.g., Facebook, YouTube, Twitter, etc. In China, eg, WeChat, Red Book, Weibo, Zhi Hu, etc.

Abbreviation : AA, alopecia areata.

When asked about the information they would like to have concerning their AA, participants reported that realistic treatment result expectations (39.1%), AA and mental health (37.5%), and prescription-based treatment options (34.0%) were their most important needs ( Figure 4 ).

Knowledge needs for adults with AA (N = 747) a .

Coping mechanisms and information needs in the selected subgroups are reported in Tables S4 and S5 . Overall, men and women reported different coping mechanisms and information needs. Women reported a much greater need for all types of information, most notably for online support groups/forums (34.4% vs 26.6%) and information relating to the risk/benefits of different treatments (36.1% vs 26.3%). Women were also more likely to talk to other people with AA, talk to friends and family, get involved with religious or patient organizations, use social media channels, and wear wigs or experiment with make-up.

Looking at the age subgroups, a greater percentage of participants aged >50 years reported talking in person to others with AA as a coping mechanism. A smaller proportion of this age group reported talking to friends and family or healthcare professionals, or using social media, whereas those aged <40 years were more likely than the other age groups to do exercise or sport or get involved in religious activities or patient organizations. Participants aged 41–50 years were the least likely to increase their alcohol consumption and most likely to talk online with others with AA. The youngest age group was most likely to want information related to AA interventions other than prescription-based options.

Talking to others, irrespective of who or the method used, and doing exercise or sport were coping mechanisms less often selected by participants with a disease duration >4 years in comparison to those with a disease duration of <2 years or 2–4 years. However, in participants with AA for more than 4 years, 37.7% still used exercise and sport to cope. In contrast, a lower percentage of participants in this group selected increasing alcohol consumption (10.3%) or smoking (8.7%) as coping strategies. Nevertheless, these numbers were still higher than other disease duration groups. Indeed, more participants with a disease duration >4 years also reported not using any coping strategies than the other disease duration groups. Participants with a disease duration <2 years were the least likely to not want additional information or support regarding their AA.

Finally, a higher percentage (49.8%) of participants with ≥95% scalp hair loss selected talking to other people with AA as a coping mechanism when compared with the two other groups based on scalp hair loss, 39.1% (scalp hair loss 50–94%) and 25.5% (scalp hair loss <50%). Individuals experiencing <50% scalp hair loss were more inclined to use food (11.7%) or experiment with makeup (10.6%) and hair loss concealers (4.2%) as coping strategies, when compared to the other scalp hair loss groups. For all groups of scalp hair loss, talking with others, doing exercise, and using social media channels were the most frequently selected coping mechanisms. However, information needs were generally higher in participants with the greatest scalp hair loss across the range of information categories considered.

The results of this large multinational survey highlight the substantial burden of disease associated with severe AA (defined as current or previous ≥50% scalp hair loss). The characteristics of the overall population are aligned with findings from previous studies. 3 , 10 In our analysis, QoL was severely impaired in most participants (86.2% with DLQI >10), with a mean DLQI of 16.8 for the overall population. This is similar to the mean DLQI (13.5) reported in another study that included 300 adults with severe AA (defined as >40% scalp hair loss and >10 patches scattered all over the body). 21 Also previously reported is that patients with AA experience poor QoL, which is associated with a greater extent of scalp involvement, 22 , 23 and that women experienced a greater impact on QoL than males, 24 aligning with our results.

A diagnosis of anxiety and depression was reported by 26.1% and 18.1% of participants, respectively, and is comparable to findings of a systematic literature review that reported rates of 27.1% anxiety and 18.9% depression in patients with AA. 25 Indeed, AA has a considerable psychosocial impact, 26 as was reported by participants in our survey. We found that a substantial day-to-day mental health burden of AA was reported by 55.8% of participants. The impact on mental health or decreased self-esteem were among the most frequently reported long-term effects of AA, reported by 28.1% and 32.9% of participants, respectively. These findings confirm those of an earlier study conducted in adults with self-reported moderate-to-severe AA (78% with hair loss on more than one-third of the scalp and 22% with hair loss on less than one‑third), which showed a marked impact of AA on self-esteem that did not abate over time. 3

Overall, nearly 80% of participants reported at least some AA-related long-term impact on their life, with a negative effect on day-to-day activities reported as a long-term effect of AA by 27.2% of participants. Of concern, AA showed a negative impact on all aspects of day-to-day life in patients who were receiving treatment for AA at the time of survey completion, affecting cultural, religious, and personal identity as well as mental health, physical health, concentration, and sleep. Findings of another survey involving participants with severe AA (totalis or universalis) suggest that cultural associations with hair and hair loss are pervasive, and may drive social avoidance and camouflage behaviors in people with AA. 27

Importantly, in this survey, 51.5% of participants reported that talking in person with a healthcare professional helped them cope. In addition, family members and friends were used as support pillars, as well as other people with AA. However, healthcare professionals may not (as yet) be as facilitative as patients would like them to be; participants with AA from the United Kingdom reported in another survey that healthcare professionals failed to offer support. Rather support was found from family and friends, other people with AA, and patient associations. 27 Here it is pertinent to highlight variations in healthcare systems where there is a limited number of dermatologists, and general practitioners may not be the most suitable group of professionals to provide adequate information on this specialized disease. That survey also reported that the Alopecia UK website and the National Alopecia Areata Foundation were valuable sources of reassurance and information to help reduce isolation and to provide emotional relief. 27 In the present survey, only 11.0% of participants identified a patient organization as an important resource to help them cope with AA, although online conversations with others with AA were frequently used. In our analysis population, information needs were primarily related to treatment options and result expectations, as well as mental health.

Of interest, most participants (88.4%) in the survey self-reported black or brown hair color (46.3% were white/Caucasian). While the exact cause of AA is unknown, several epitopes related to pigment production in melanocytes have been proposed as potential autoantigens in AA 28 , 29 and result in the preferential loss of pigmented hairs. 30

Data were further analyzed according to sex, age, duration since AA diagnosis, and severity of scalp hair loss. The severity of AA signs, symptoms, and burden tended to be higher in women when contrasted with men. Similar results have been reported in a previous study, but only in females with an AA diagnosis before age 16 years. 31 Participants older than 50 years at the time of data collection also generally reported more severe AA signs and symptoms. However, the burden of AA tended to be lower in these older participants than in those aged 50 years or less, although the impact on QoL was substantial (DLQI >16) across all age groups. Other studies have identified that adults with AA aged between 20 and 50 years are at high risk for poor QoL and that AA-related healthcare visits peak in those aged 30–59 years. 32

The severity of signs and symptoms tended to be higher in participants with a disease duration >4 years in our analysis, but the highest burden of AA was observed in participants with a disease duration <2 years, possibly reflecting a higher impact of AA during the active phase of the disease or possibly lower disease acceptance and insufficient coping mechanisms. 10

We found that increasing severity of scalp hair loss was generally associated with greater severity of other AA signs and symptoms. While the mean DLQI was lower in participants with <50% than those with ≥50% scalp hair loss at the time of this survey, all scalp hair loss groups were experiencing a severe impact on their QoL. Not surprisingly, those with ≥95% scalp hair loss experienced the greatest day-to-day impact and long-term burden of AA. Importantly, all participants with <50% scalp hair loss had previously experienced a scalp hair loss of ≥50%, which may have impacted our findings. Previous studies have reported conflicting results on the relationship between the severity of hair loss and the burden of AA. 11 , 22

Subgroups of participants reported different coping mechanisms and information needs. Women tended to talk more with others who experienced AA, join religious or patient organizations, use social media channels, and wear wigs and make-up. Participants aged >50 years generally reported fewer information needs than younger participants, and those with a disease duration >4 years reported employing fewer coping mechanisms. Participants with a scalp hair loss of ≥95% tended to enlist more coping mechanisms than other scalp hair loss categories and had a greater need for information.

This analysis of AA disease burden could contribute to increasing awareness and an understanding of the pressures that patients with AA experience in daily living, and inform the design of patient-centered care strategies. There is a growing interest in considering the complexity of personalized care needs when setting patient goals for AA in health and life, while simultaneously minimizing the burden of disease. 33

On a clinical level, personalized treatment and support options for AA are currently limited by the efficacy, safety, and cost of traditional therapy. 12 , 34 For example, access to camouflaging agents, like wigs, used by many participants in this survey are often cost-prohibitive and not covered by health insurance plans. 34 To effectively manage the burden of AA and reduce the negative stigma associated with AA, additional program development and funding from national organizations will likely be needed. 34 On a broad scale, further exploration into AA PROs could help to increase disease advocacy and awareness and enhance accessibility to tools that facilitate navigating life with AA. 34 There is also a need to support efficacious, less burdensome AA treatments that meet the physical, psychological, and psychosocial needs of patients with AA. 3

These analyses are subject to the limitations associated with surveys such as the potential for sampling, selection, and recall bias. Furthermore, the cross-sectional design, the absence of a comparator population, and the descriptive nature of the analyses do not allow us to conclude on causality and limit the interpretation of some of the results. Other limitations include the self-reported severity of AA signs and symptoms (although validated instruments have been used for most assessments), the low number of participants in some participating countries, and the exclusion of patients exposed to a JAK inhibitor or a biologic drug (previously, or at the time of data collection) for the treatment of AA or any other condition. At the time the survey was conducted, JAK inhibitors had only recently been approved for the treatment of severe AA, and it was anticipated that their use would vary significantly across countries. Furthermore, it was not known whether individuals who had used these drugs may have had different experiences with AA compared to those using other systemic therapies. Excluding individuals who had taken JAK inhibitors was part of the study design to focus on a more homogeneous subset of the population and better control for confounding variables. Future studies should further examine the patient-reported burden of severe AA in patients exposed to JAK inhibitors. Lastly, because the DLQI method was not created expressly for AA, some of the questions, such as those about itch, pain, and physical activity, might not be appropriate for evaluating the impact of AA. 10

Successful long-term management of AA can be improved by understanding the burden of the condition on those affected. This comprehensive survey provides real-world data on the burden of severe AA collected from a large sample of adults in 11 countries across three continents. The impact of severe AA reaches far beyond hair loss, and is associated with severe impairment in QoL and a substantial psychosocial burden regardless of demographic or clinical characteristics. These results show that severe AA is a condition associated with persistent high unmet medical needs originating from diverse aspects. To address the persistently high unmet medical needs identified, future strategies could encompass integrated healthcare models, targeted patient education focusing on treatment expectations and mental health, holistic support programs beyond conventional medical interventions, advancements in treatment paradigms, and global advocacy efforts. This comprehensive approach aims to mitigate the burden of severe AA and enhance overall well-being, offering a roadmap for proactive and compassionate disease management.

Acknowledgments

The sponsors acknowledge the participation of all volunteers and the study site personnel involved in the original research. Medical writing support was provided by Clare Koning and Caroline Spencer (Rx Communications, Mold, UK), funded by Eli Lilly and Company.

Funding Statement

This paper was funded by Eli Lilly and Company.

Abbreviations

AA, alopecia areata; DLQI, Dermatology Life Quality Index; JAK, Janus kinase; n/a, not applicable; PRO, patient-reported outcome; QoL, quality of life; SD, standard deviation.

Data Sharing Statement

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Ethics Approval and Informed Consent

This study conformed to market research codes of conduct and in compliance with the International Council for Harmonisation (ICH) Declaration of Helsinki.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Anthony Bewley reports consultation/advisory and/or lecturing fees and/or travel support from: AbbVie, Almirall, BMS, Eli Lilly, Galderma, Janssen, Leo-Pharma, Novartis, Pfizer, Sanofi, UCB and is a member of the Medical Advisory Board for: National Eczema Society, Ichthyosis Support Group, Psoriasis Association and reports royalties from Practical Psychodermatology (Wiley 2014). Ignasi Figueras-Nart consultation/advisory and/or lecturing fees and/or travel support from: AbbVie, Eli Lilly, Leo-Pharma, Novartis, Pfizer, Sanofi, Vifor Pharma. Ulrike Blume-Peytavi has served on advisory boards and/or is a consultant and/or is a clinical trial investigator for AbbVie, Amryt, Bayer, Boots Healthcare, Cassiopeia, CeraVe, Concert Pharmaceuticals/Sun Pharma, Dermocosmétique Vichy, Eli Lilly and Company, Galderma, Laboratoires Bailleuil LEO Pharma, Novartis, Pfizer, Pierre Fabre, Sanofi Regeneron, Timber. Mariana Guerreiro, Nicole Tietz, Sami Chtourou, and Frederick Durand are employees and minor shareholders of Eli Lilly and Company. The authors report no other conflicts of interest in this work.

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Association of alopecia areata with alcohol use disorder, attention-deficit hyperactivity disorder and insomnia: a case-control analysis using the All of Us research programme

Affiliations.

• 1 School of Medicine.
• 2 Menninger Department of Psychiatry and Behavioral Sciences.
• 3 Department of Dermatology, Baylor College of Medicine, Houston, TX, USA.
• PMID: 36883588
• DOI: 10.1093/ced/llad084

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