Nearly 40% of Severe Alopecia Areata Patients Achieve ≥80% Scalp Hair Coverage with Baricitinib at 52 Weeks in Phase 3 Trials

Recently, Eli Lilly and Company and Incyte jointly announced positive long-term results from the pivotal Phase 3 clinical trial of the JAK inhibitor baricitinib (brand name: Olumiant) for the treatment of patients with severe alopecia areata. Among patients receiving a 4 mg dose of baricitinib, approximately 40% achieved over 80% scalp hair coverage after 52 weeks of treatment. This therapy received Priority Review designation from the U.S. FDA in February this year. Eli Lilly anticipates regulatory decisions from the U.S., EU, and Japan by 2022. The press release notes that it has the potential to become the first approved treatment for this condition.

Alopecia Areata: The Second Most Common Type of Hair Loss WorldwideAlopecia areata is the second most common type of hair loss globally, with approximately 147 million patients worldwide and around 4 million in China. It is an autoimmune disease where the immune system attacks hair follicles, causing partial or complete hair loss on the scalp, face, or other parts of the body. Alopecia areata often begins in childhood, and it can affect individuals of any age, gender, or ethnicity. Currently, there is no FDA-approved treatment for this condition.

Baricitinib is an oral JAK inhibitor that has already received FDA approval for the treatment of rheumatoid arthritis. In 2020, it received FDA Breakthrough Therapy designation for the treatment of alopecia areata. Previously, Eli Lilly announced that it had met the primary endpoints in two Phase 3 clinical trials, BRAVE-AA1 and BRAVE-AA2, significantly improving scalp hair regrowth in patients with severe alopecia areata after 36 weeks of treatment.

▲The manifestations of a patient with severe alopecia before treatment and after 8 months of treatment with baricitinib (Image source: Reference [2])

At baseline, patients receiving treatment had 85.5% hair loss, with 69.4% and 57.9% experiencing significant eyebrow and eyelash loss, respectively. The average age of the patients was 37.6 years, and they began experiencing hair loss around the age of 25, with symptoms lasting an average of 12.2 years.

After 52 weeks of treatment with 4 mg baricitinib, 39% (n=201/515) of patients experienced significant hair regrowth, with scalp hair coverage reaching over 80%. Of these patients, nearly three-quarters (74.1%, n=149/201) achieved scalp hair coverage of over 90%. Moreover, over 40% of patients experienced complete regrowth or no significant loss of eyebrows and eyelashes.

"Whether losing all hair, experiencing localized alopecia, or losing eyebrows or eyelashes, this autoimmune disease affects people of all ages and can have serious consequences," said Dr. Brett King, Professor of Dermatology at Yale School of Medicine. "In 2022, baricitinib may become the first approved drug for treating adult patients with alopecia areata. The trial results showing that nearly 40% of patients who had at least 50% hair loss at baseline achieved complete or near-complete hair regrowth were outstanding."

References:

[1] 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. Retrieved March 26, 2022, from https://www.prnewswire.com/news-releases/nearly-40-of-adults-with-alopecia-areata-taking-olumiant-4-mg-saw-at-least-80-scalp-hair-coverage-at-52-weeks-in-lillys-pivotal-phase-3-studies-301510503.html

[2] Olamiju et al., (2019). Treatment of severe alopecia areata with baricitinib. JAAD case reports, DOI:https://doi.org/10.1016/j.jdcr.2019.07.005

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