Alopecia areata is an autoimmune disease in which the body’s defense system attacks hair roots, causing sudden bald patches on the scalp, face, or body. Until recently, doctors had no medicine approved to stop the attacks and help hair grow back.
A large Yale-led clinical trial has now shown that baricitinib, a pill already used for rheumatoid arthritis, can calm the immune reaction. After thirty-six weeks, roughly one out of three people who took the higher dose had enough new growth to cover most of their scalp, while only a few people taking a dummy pill improved.
Because of these results, on 13 June 2022 the US Food and Drug Administration gave full approval for baricitinib (brand name Olumiant) as the first systemic treatment for adults with severe alopecia areata. Specialists say the decision should make the drug easier to access through health insurance and give patients and doctors new confidence that the therapy is both effective and reasonably safe when doctors monitor it for infection risks.
Researchers will keep tracking volunteers to learn how well the benefits last and to watch for long-term side effects, but the finding already marks a turning point: people with hard-to-treat hair loss now have an evidence-based option that can restore confidence as well as hair.
Two Phase 3 Trials of Baricitinib for Alopecia Areata (New England Journal of Medicine, online 26 March 2022; print 5 May 2022).
Oral baricitinib outperformed placebo in two multicenter trials of more than 1,200 adults with severe alopecia areata, with about one-third achieving near-complete scalp coverage in 36 weeks.
FDA approves alopecia areata treatment with roots at Yale (Yale News, 13 June 2022)
Explains the FDA decision, the research journey led by dermatologist Brett King, and what approval means for patient access.
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