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.
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.
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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