Baricitinib Produces Significant Hair Regrowth in Adults With Severe Alopecia Areata

Treatment with baricitinib (Olumiant; Eli Lilly and Incyte ) was found to produce significant hair regrowth on the scalp, eyelashes, and eyebrows of adults with severe alopecia areata (AA). Further, approximately 75% of individuals administered baricitinib 4 mg experienced 90% scalp coverage at 52 weeks, according to the study, the results of which were presented at the American Academy of Dermatology (AAD) Annual Meeting.

"Whether people with alopecia areata suffer loss of all the hair on their body or bald spots and missing eyebrows or eyelashes, this autoimmune disease can be devastating. The disease affects people of all ages," said study lead author Brett King, MD, PhD, FAAD, associate professor of dermatology at Yale School of Medicine, in a press release. "In 2022, Olumiant could become the first medicine ever approved to treat adults with alopecia areata. It's remarkable that nearly 40% of patients on Olumiant 4 mg, all of whom started out with at least 50% scalp hair loss, experienced full or nearly full scalp hair coverage, and similar improvements were achieved among those patients with significant eyebrows or eyelashes involvement."

The double-blind, placebo-controlled, phase 3 trials randomized 1200 patients with severe AA to receive once-daily baricitinib 4 mg, baricitinib 2 mg, or placebo. Patients randomized to baricitinib were administered the same treatment for 52 weeks while placebo non-responders were switched to baricitinib at 36 weeks. In the BRAVE studies, 51.7% of patients were white (n=620/1200), 36.3% were Asian (n=435/1200), and 8.2% were Black (n=98/1200).

At baseline of a pooled 52-week analysis, patients had a mean Severity of Alopecia Tool (SALT) score of 85.5 (85.5% scalp hair loss, or 14.5% scalp hair coverage), with severe AA defined as having a SALT score ≥50 (≥50% scalp hair loss).

At baseline, 69.4% of those enrolled had significant eyebrow hair loss and 57.9% had significant eyelash hair loss as defined by Clinician-Reported Outcome (ClinRO) scores ≥2. The average age of these patients was 37.6 years, with hair loss beginning at approximately 25 years of age and a mean of 12.2 years since symptom onset.

Among those administered baricitinib 4 mg, 2 of 5 (39.0%, n=201/515) experienced significant scalp hair regrowth, defined as a SALT score ≤20, or 80% or more scalp hair coverage. Approximately 3 of 4 of these same patients (74.1%, n=149/201) also experienced a SALT score ≤10, or 90% hair coverage, at 52 weeks.

More than 2 of 5 patients with ClinRO baseline scores ≥2 (eyebrow: 44.1%, n=154/349; eyelash: 45.3%, n=139/307) experienced full regrowth or regrowth with minimal gaps in eyebrow and eyelash hair.

Among those administered baricitinib 2 mg, more than 1 of 5 (22.6%, n=77/340) experienced significant scalp hair regrowth and 2 of 3 (67.5%, n=52/77) experienced 90% or more hair coverage at 52 weeks. The study also showed that more than 1 in 5 and 1 in 4 individuals, respectively (eyebrow: 22.9%, n=55/240; eyelash: 25.5%, n=51/200), experienced full regrowth or regrowth with minimal gaps in eyebrow and eyelash hair.

In terms of adverse events (AEs) for the 4 mg and 2 mg doses of baricitinib, there were no new safety signals reported. Incidence rates of frequently reported AEs up to 52 weeks (median 56 weeks exposure) were consistent with the 36-week, placebo-controlled period. These AEs included upper respiratory tract infection, headache, acne, urinary tract infection, and increases in muscle-related blood markers.

The FDA granted baricitinib with priority review designation in February for severe AA as a potential first-in-disease medicine, with a regulatory decision expected in the United States in 2022. The drug has been approved in the United States and more than 75 other countries for moderate to severe rheumatoid arthritis and is approved in more than 50 countries, including the European Union and Japan, for adults with moderate to severe atopic dermatitis who are candidates for systemic therapy.

"Olumiant's long-term efficacy data reveal significant regrowth of scalp, eyelash and eyebrow hair and we're delighted by what these results can mean for patients. Our alopecia areata safety data adds further evidence to one of the largest and longest sets of safety data in the JAK inhibitor class, including nine years and 19,000 patient years across our program," said Lotus Mallbris, MD, PhD, vice president of global immunology development and medical affairs at Lilly, in a press release. "We're excited Olumiant may be a potential first-in-disease medicine approved this year for adults with severe alopecia areata."

Reference

Nearly 40% of Adults with Alopecia Areata Taking OLUMIANT® 4-mg Saw at Least 80% Scalp Hair Coverage at 52 Weeks in Lilly's Pivotal Phase 3 Studies. Eli Lilly. [news release]. Accessed March 28, 2022. https://investor.lilly.com/news-releases/news-release-details/nearly-40-adults-alopecia-areata-taking-olumiantr-4-mg-saw-least