Baricitinib Shows Promise in Restoring Up to 80% Hair Growth for Severe Alopecia Areata, Nears Approval in EU

On May 21, Eli Lilly and Company and Incyte Corporation announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) supported the marketing authorization of their JAK inhibitor baricitinib (brand name: Olumiant) for the treatment of adult patients with severe alopecia areata. The European Union is expected to make a final decision within 1-2 months. The press release noted that if approved, baricitinib will become the first JAK inhibitor used to treat severe alopecia areata. Baricitinib received Priority Review designation from the U.S. FDA in February this year, and Eli Lilly expects to receive regulatory decisions from the U.S., EU, and Japan by the end of this year.

Alopecia Areata: The Second Most Common Type of Hair Loss WorldwideAlopecia areata is the second most common type of hair loss worldwide, with approximately 147 million patients globally and about 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.

Baricitinib is a once-daily oral JAK inhibitor that has been approved in more than 75 countries and regions for the treatment of rheumatoid arthritis, and in over 50 countries and regions for the treatment of moderate to severe atopic dermatitis.

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

The positive opinion of the CHMP is based on the results of two Phase 3 clinical trials, BRAVE-AA1 and BRAVE-AA2, conducted in 1200 patients with severe alopecia areata. The trial results showed that after 36 weeks of treatment, approximately one-third of patients receiving a 4 mg dose of baricitinib achieved over 80% scalp hair coverage in both clinical trials (BRAVE-AA1=35.2%, BRAVE-AA2=32.5%), compared to 5.3% (BRAVE-AA1) and 2.6% (BRAVE-AA2) in the placebo groups.

At the same time, about one-third of the patients achieved complete regrowth of eyebrows or eyelashes or had no obvious loss. In terms of safety, no new safety signals were found. Most treatment-related adverse events were mild or severe.

"Alopecia areata is a frequently misunderstood autoimmune disease that can cause unpredictable hair loss, and in severe cases, lead to the loss of all hair. This condition brings significant psychosocial burden and can affect people of any ethnicity and age group. Many patients experience hair loss in their 20s," said Professor Bianca Maria Piraccini, head of the Dermatology Department at the University of Bologna. He is very pleased to see the potential of this oral therapy to help patients with severe alopecia areata.

In addition to baricitinib, Pfizer's JAK3/TEC inhibitor ritlecitinib, Concert Pharmaceuticals' JAK1/2 inhibitor CTP-543, Zelgen Pharma's JAK inhibitor jaktinib, and Reistone Biopharma's JAK1 inhibitor SHR0302 have also achieved positive results in clinical trials and are in the late stages of clinical development. It is hoped that these JAK inhibitors will progress smoothly in clinical trials and soon bring new treatment options for patients with alopecia areata.

References:

[1] CHMP Recommends Approval of Lilly and Incyte's OLUMIANT® (baricitinib) as the First and Only Centrally-Authorized Treatment for Adults with Severe Alopecia Areata (AA). Retrieved May 20, 2022, from https://www.prnewswire.com/news-releases/chmp-recommends-approval-of-lilly-and-incytes-olumiant-baricitinib-as-the-first-and-only-centrally-authorized-treatment-for-adults-with-severe-alopecia-areata-aa-301551999.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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