NAAF’s Industry Partners support NAAF’s mission-driven work and programs, and meet regularly with NAAF leadership to learn about the needs of the AA community and collaborate to achieve common goals.

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Media reports of two newly approved drugs for treating alopecia areata brought good news to many people living with the disease. After years of being told there were no treatment options, there’s now hope. However, most news stories about new drugs or indications (uses) usually focus on the researchers and clinical trial results. Rarely do they mention the thousands of clinical trial volunteers — like Maureen McGettigan. Maureen, a 61-year-old from the Philadelphia, PA, area, has lived with alopecia areata since she was 16. Without volunteers like her, there could be no approvals by the U.S. Food & Drug Administration (FDA).

Given how crucial clinical trial volunteers are, how can you or someone you know who has alopecia areata find a study and be part of the very important clinical trial community?

Three stages before drugs are FDA-approved

Maureen, who is also a NAAF board member, encourages people to consider entering a clinical trial if the opportunity arises. She said it took quite a while before there was an alopecia areata drug trial in her area, but when a phase 3 trial became available, she jumped at the chance to participate. “I thought, literally, what do I have to lose? I’d had alopecia areata for such a long time, it’s worth a shot,” she said. “If my hair grows back, that’s fabulous. If not, then I gave it a shot.” If there had been a local phase 2 trial, Maureen said she would have volunteered for that one.

There are three stages of clinical trials before a drug is approved. When one phase is successful, researchers can move on to the next. However, trials can be stopped at any time in any phase if the researchers find dangers to the volunteers or there’s no apparent benefit to the drug. (Information on the differences between the clinical stages follows below the article. In addition, NAAF has a webinar, Patient Guide to Clinical Trials and Drug Development: Phases and Terminology Explained, which goes into more detail.)

Like many clinical trial volunteers, Maureen pointed out that while she hoped she’d benefit from taking the study drug, there was another reason. “The clinical trial is an opportunity to help myself but also to help our community to advance the science,” she explained. She added that having yet one more patient enrolled in the study would help provide more data for the scientists.

Benefits of being a clinical trial volunteer 

In addition to having access to a possibly new medication, clinical trial volunteers have other advantages through their participation, such as having someone keeping a close eye on their health. This includes regular contact with research nurses, along with blood tests and other medical tests, depending on the drug and its potential side effects.

Of course, there may be some disadvantages to participating in a clinical trial as well. If it’s a trial that compares a new drug with a placebo (an inactive medication), there is a chance you may not get the study drug at first. But Maryanne Senna, MD, Director of the Lahey Hair Loss Center of Excellence and Research Unit at Beth Israel Lahey Health and member of NAAF’s Scientific & Medical Advisory Task Force, pointed out that some studies have what is called cross-over portions. “This is where patients who were first randomized to placebo eventually get treated with the active therapy. This is worth asking if you are considering participating in a clinical trial.”

The advantages of regular contact and tests could become a disadvantage if the clinic visits become too frequent or inconvenient for you, though, so you have to consider how much of your time is needed. Finally, you could experience side effects, or the study drug may not work.

In Maureen’s case, although she hasn’t had full hair regrowth since she entered the trial, she said she’s happy anyway. “My lashes and eyebrows have come back!” she explained. “I have more hair than I did two and a half years ago. I’m not wearing my false eyelashes anymore and I can put the makeup on my eyebrows to expand them a little bit.”

But why be in a trial if there already are approved treatments?

Many in the alopecia areata community welcomed the FDA approval for Olumiant and LITFULO over the past year. Still, research continues into pediatric use of these drugs, and other medications. Expanding the number of available treatments is essential because not all drugs work for or are appropriate for everyone.

According to Dr. Senna, response rates, where patients see good results, hover around 40% in most clinical trials when the researchers look at about a year’s worth of data. “This means that many people with alopecia areata still have less than clinically meaningful results. I believe that these first FDA approvals in alopecia areata are the tip of the iceberg,” she said. “As we learn more about alopecia areata and continue to study emerging therapies, we will hopefully increase these response rates and have improved patient outcomes.” In addition, more treatments may become available for children as well.

How to find a trial

If volunteering for an alopecia areata clinical trial interests you, speak with your dermatologist. There may be a trial that is not local but close enough that you’re willing to travel. NAAF has a downloadable worksheet to help you discuss the issue with your doctor and a guide that explains how to use the U.S. government’s clinical trials website.  NAAF also posts information about active alopecia areata clinical trials on its website.

Researchers vet and prepare their clinical trial volunteers carefully because they want the trial to be as fair and accurate as possible – and safe for the volunteers. Before trial admission, the volunteers are carefully screened to ensure they are likely to complete the trial (to minimize drop-outs) and don’t have any health issues that could affect how the study drug works.

Part of the screening looks for inclusion and exclusion criteria. Inclusion criteria may include things like:

• Having the condition the drug is meant for
• Being in a particular demographic or geographic area
• Being in a specific age group

Exclusion criteria can include things like:

• Not being able to give informed consent
• Undergoing treatment for an unrelated disease
• Not being in the trial’s target age group

“Participating in a trial doesn’t hurt and you’re helping the next generation,” Maureen said. There’s the hope that when other 16-year-old girls lose their hair there will be options, and they don’t have to go through all the challenges and the pain and the suffering that that many of us did.”

Dr. Senna agreed. “Some current treatments are less effective for people who have had alopecia areata for a long time. That is understandably disappointing. But it doesn’t always have to be this way,” she says. “Now is our moment!  We are at the tip of the iceberg in understanding this condition and the best treatments for it. As physicians, patients, and advocates, we must keep this wonderful momentum. To continue to move our knowledge forward – and that includes developing treatments for patients who have had the disease for a longer time – clinical trials in alopecia areata are critical.”

Clinical Trial Phases Explained:

Phase 1 is like a fact-finding mission. A small group of up to 100 clinical trial volunteers take the new drug for a few months so researchers can look at the drug’s safety and dose levels. Most often, the volunteers are healthy, although in some cases, they may have the disease or condition the drug is meant to treat. About 70% of these studies move on to phase 2 trials.

Phase 2 trials need volunteers with the disease or condition. The researchers now observe up to several hundred people, how they react to the drug, and whether they have side effects. This phase can last from several months to a couple of years.  Only about one-third of phase 2 trials move on to phase 3.

Phase 3 trials take the longest and need the most volunteers, up to 3000 and sometimes more. This is when researchers are looking more closely at the safety data. Because there are more volunteers and the study goes for an extended period, the researchers may find more uncommon side effects or some that only occur after someone takes the drug for longer. About one-quarter of drugs move on to apply for FDA approval after a phase 3 trial.

The post Alopecia Areata Research Depends on Clinical Trial Volunteers appeared first on National Alopecia Areata Foundation | NAAF.

The post FDA Approves LITFULO™ (Ritlecitinib) for Adults and Children ages 12+ with Severe Alopecia Areata appeared first on National Alopecia Areata Foundation | NAAF.

Asian Americans seem to have highest prevalence

This past March, the online issue of JAMA Dermatology published an article reviewing the prevalence — the proportion of a population affected — of alopecia areata (AA), alopecia totalis (AT), and alopecia universalis (AU) among patients of Asian, Black, Hispanic/Latino, and white descent.

The researchers found that AA was more common among women (67% of cases) and that most adults with AA were between the ages of 30 and 49. But they also found a difference in racial and ethnic groups. They found while AT and AU were pretty even across all groups:

– 414 of every 100,000 patients with AA were Asian American
– 314 of every 100,000 were of multiple races
– 226 of every 100,000 were Black Americans
– 122 of every 100,000 were Hispanic
– 168 of every 100,000 were white

An earlier study, from 2022, published in the British Journal of Dermatology and looking at patients with AA prevalence in the United Kingdom, reported similar findings. The authors wrote, “People of nonwhite ethnicity were more likely to present with AA, especially those of Asian ethnicity.”

There are some limitations to studies like this because the information depends on people self-reporting their racial or ethnic background and many people may have AA but be undiagnosed. Because of this, there still may be some confusion about actual numbers. For example, a 2020 study found that Black people had a higher prevalence than Asians, but both groups still had higher rates compared with white people.

The importance of the findings

Gone are the days when it’s assumed that one medical condition affects all people the same way. Knowing that certain diseases, like AA, affect groups differently can help researchers identify possible causes that may not have been considered before. For example, are there genetic, social, or environmental issues that haven’t been found yet? If researchers could zero in on these, the information could lead to a better understanding of the disease, which could possibly lead to prevention measures or better treatments.

Recognition and diagnosis of AA may also be improved if doctors know to consider the disease in certain populations. Skin conditions look different according to skin color. For example, a rash may look red or pink on someone with white skin, but it may only appear darker on a Black person’s skin. This can lead to healthcare professionals not recognizing dermatologic problems in people with different skin colors.

Earlier recognition and diagnosis of AA could lead to more aggressive – and hopefully effective — treatment options for patients.

And finally, knowing who may be at higher risk of developing AA can help healthcare professionals provide awareness and support within those communities. They could address health inequities or disparities, helping those who are affected get the help they need in a timely manner.

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Results from a clinical trial for a new treatment for alopecia areata were published in the medical journal The Lancet on 4/13/23. The publication reports on the evaluation of ritlecitinib, an experimental medication developed by Pfizer.

The late-stage clinical trial (Phase 2b-3) evaluated how safe and effective ritlecitinib was among 718 patients who have alopecia areata with 50% or more scalp hair loss. The international trial  took place in 18 countries, including the U.S. and Canada. Participants in the trial included adults and adolescents, ages 12 and up. The study examined the effectiveness of ritlecitinib at different doses and dosing patterns in achieving hair regrowth.

The researchers found that after 24 weeks, participants who took 30 mg or 50 mg of ritlecitinib daily experienced significant hair regrowth compared to patients who took a placebo. Between 14% and 31% of patients in the different treatment groups reached the study endpoint, which was 20% or less scalp hair loss. In addition, the percentage of patients achieving or exceeding the study endpoint increased as treatment continued to 48 weeks.

Ritlecitinib is an oral medication and a member of a class of drugs known as JAK inhibitors. These drugs block cellular signals thought to interfere with the immune attack on hair follicles that occurs with alopecia areata. Ritlecitinib is an inhibitor of JAK3 and the TEC kinase family.

Based on the trial results, the study authors concluded that ritlecitinib has an acceptable safety profile and is effective in treating alopecia areata. The drug is currently under review by the U.S. Food and Drug Administration (FDA) and a decision is expected during the second quarter of 2023.

Dr. Brett King, the study’s lead author, is a member of NAAF’s Board of Directors. Other study authors include two NAAF Research Advisory Council members, Dr. Jerry Shapiro and Dr. Natasha Mesinkovska.

Learn more:

An infographic summary of the study results from The Lancet is available here.

Read a plain language summary of the ritlecitinib clinical trial results.

A video abstract of the study from The Lancet is available here.

In addition, a text summary of The Lancet research publication is available here.

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As we come to the close of 2022, we look upon these past 12 months as among the most pivotal in the history of both the National Alopecia Areata Foundation and the community we serve.

2022 was the year our research efforts came to fruition with the first FDA-approved treatment for alopecia areata. Read the story of how it happened. This special Treatment Development Program Impact Report celebrates 12 years of NAAF research efforts which our community helped make possible.

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The post FDA Accepts Filing of New Drug Application (NDA) appeared first on National Alopecia Areata Foundation | NAAF.

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