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Fda approves second yale-researched treatment for alopecia areata.

A side by side comparison of the same patient before and after treatment.

A side by side comparison of the same patient before and after treatment.

Just a year after the U.S. Food and Drug Administration (FDA) approved the first treatment for severe alopecia areata, the federal agency has approved a second treatment for the disfiguring skin disease — both the result of pioneering research by the same Yale dermatologist.

On June 23, the FDA announced its approval for the use of ritlecitinib — a Janus kinase (JAK) inhibitor — to treat alopecia areata in both adolescents and adults. The medicine, taken orally, goes by the product name Litfulo.

Alopecia areata is an autoimmune disease characterized by sudden, often disfiguring, loss of hair. It is the second most common cause of hair loss, affecting up to 7 million people in the United States.

Dr. Brett King , an associate professor of dermatology at Yale School of Medicine, worked with pharmaceutical company Pfizer to conduct a series of clinical trials with ritlecitinib. He worked with Eli Lilly and Company on clinical trials for the earlier medicine — baricitinib (which goes by the product name Olumiant), approved as a treatment for patients with severe alopecia areata in June 2022 .

King’s groundbreaking work with JAK inhibitors, which were originally designed to treat rheumatoid arthritis and myelofibrosis (a rare blood cancer), has shown significant potential to treat an array of intractable skin diseases, including eczema, erosive lichen planus, vitiligo, granuloma annulare, and sarcoidosis.

King spoke with Yale News about this latest FDA approval.

How does FDA approval for ritlecitinib change the treatment landscape for people with alopecia areata?

Brett King: Ritlecitinib [Litfulo] changes the treatment landscape for people with alopecia areata enormously. Last year, history was made when baricitinib [Olumiant] was FDA approved for the treatment of adults with severe alopecia areata. But alopecia areata affects people of all ages and, indeed, it commonly affects children of all ages. Ritlecitinib is approved in patients ages 12 years and older.

Childhood and adolescence are such vulnerable times, and children and adolescents have so much to do and learn and become during these years. It is challenging enough to be a kid, but when alopecia areata happens and suddenly one has big bald spots or is completely bald and missing eyebrows, the normal trajectory of that kid’s life, and the family’s life, too, can be derailed. Kids withdraw from sports and other social activities, and even from school. Extreme sadness and anxiety are common. It is awful. There is a way out of the darkness, however, and that is to regrow the hair that was lost, to restore the person as they had been prior to alopecia areata.

Normalcy is so important for everybody, but especially when we are developing. So it is easy to understand what a monumental breakthrough it is to have a medicine, ritlecitinib, approved for adolescents. Ritlecitinib restores normalcy and will make life better — literally will change life — for so many people.

When can patients in the U.S. expect ritlecitinib to be available for use?

King: Hopefully in the days or weeks ahead.

You have been at the center of two FDA approvals for major treatments of alopecia areata in two years. Has that sunk in yet — and how does that make you feel?

King: These new medicines for alopecia areata are historic, and I feel super fortunate to be a part of their development. Being a doctor is amazing because I get to share in the lives of others, hopefully making those lives better. It happens one person at a time, though. To have played a central role in the development of treatments for alopecia areata and other diseases — treatments that doctors around the world will give to thousands and thousands (or even millions) of people to make their lives better — is really incredible. We are all a part of something bigger than ourselves, and for me this experience highlights that as well as the possibility that we can change the world.

What are you working on next?

King: The next horizon is approval of these and other treatments for younger patients. Remember, alopecia areata is not uncommon in pre-adolescents. Also, JAK inhibitors do not work for everybody with alopecia areata, and so work needs to be done both to understand why that is and to develop treatments other than JAK inhibitors. The goal is for everybody to be able to have effective treatment. We have come so, so far but we still have a ways to go. It’s exciting.

  • New Alopecia Areata treatment aims to help adults and adolescents
  • FDA approves alopecia areata treatment with roots at Yale
  • New trials for alopecia areata treatment are a success

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Researchers reverse hair loss caused by alopecia

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

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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 treatment could reverse hair loss caused by an autoimmune skin disease

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A colorized microscopic view shows the cone-shaped microneedles laid on out a grid, in yellow, on a purple surface.

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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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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

Elizabeth Gamillo

Correspondent

An image of four alopecia patients showing their before and after hair growth after taking the drug baricitinib.

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

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.

New Alopecia Areata Treatment Aims To Help Adults and Adolescents

BY KATHY KATELLA July 6, 2023

woman holding brush with hair on it, representing hair loss from alopecia areata

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

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.

Brett King, MD, PhD

“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.

More news from Yale Medicine

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New treatment could reverse hair loss caused by autoimmune skin disease alopecia areata

by Anne Trafton, Massachusetts Institute of Technology

New treatment could reverse hair loss caused by autoimmune skin disease alopecia areata

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 has 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 was published 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.

New treatment could reverse hair loss caused by autoimmune skin disease alopecia areata

"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.

This story is republished courtesy of MIT News ( web.mit.edu/newsoffice/ ), a popular site that covers news about MIT research, innovation and teaching.

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COMMENTS

  1. FDA approves second Yale-researched treatment for alopecia areata

    Just a year after the U.S. Food and Drug Administration (FDA) approved the first treatment for severe alopecia areata, the federal agency has approved a second treatment for the disfiguring skin disease — both the result of pioneering research by the same Yale dermatologist.

  2. Researchers reverse hair loss caused by alopecia — Harvard ...

    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.

  3. New treatment could reverse hair loss caused by an autoimmune ...

    Researchers developed a potential new treatment for alopecia areata, an autoimmune disorder that causes hair loss. The microneedle patch delivers immune-regulating molecules that can teach T cells not to attack hair follicles, helping hair regrow.

  4. FDA Approves First Drug to Treat Hair Loss Caused By Alopecia

    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.

  5. New Alopecia Areata Treatment Aims To Help Adults and ...

    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.

  6. New treatment could reverse hair loss caused by autoimmune ...

    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...