Baricitinib effects hair regrowth in severe Alopecia Areata: NEJM

Alopecia areata is a known autoimmune condition characterized by rapid hair loss in the scalp, eyebrows, and eyelashes, for which treatments are limited. Baricitinib, an oral selective is known to cure the hair loss, reversible inhibitor of Janus kinases 1 and 2, may interrupt cytokine signaling implicated in the pathogenesis of alopecia areata.

Two clinical trials by Dr Brett King, M.D., Ph.D and team revealed that in patients with severe alopecia areata, oral baricitinib was very effective in treating with respect to hair regrowth at 36 weeks. Study findings are published in The New England Journal of Medicine.

Study included two randomized, placebo-controlled, phase 3 trials (BRAVE-AA1 and BRAVE-AA2) involving adults with severe alopecia areata with a Severity of Alopecia Tool (SALT) score of 50 or higher (range, 0 [no scalp hair loss] to 100 [complete scalp hair loss]). Patients were randomly assigned in a 3:2:2 ratio to receive once-daily baricitinib at a dose of 4 mg, baricitinib at a dose of 2 mg, or placebo. The primary outcome was a SALT score of 20 or less at week 36.

The results of the study were

• A total of 654 patients in the BRAVE-AA1 trial and 546 in the BRAVE-AA2 trial. The estimated percentage of patients with a SALT score of 20 or less at week 36 was 38.8% with 4-mg baricitinib, 22.8% with 2-mg baricitinib, and 6.2% with placebo in BRAVE-AA1 and 35.9%, 19.4%, and 3.3%, respectively, in BRAVE-AA2.

• In BRAVE-AA1, the difference between 4-mg baricitinib and placebo was 32.6 percentage points, and the difference between 2-mg baricitinib and placebo was 16.6 percentage points for each dose vs. placebo).

• In BRAVE-AA2, the corresponding values were 32.6 percentage points and 16.1 percentage points for each dose vs. placebo.

• Secondary outcomes for baricitinib at a dose of 4 mg but not at a dose of 2 mg generally favored baricitinib over placebo.

• Acne, elevated levels of creatine kinase, and increased levels of low- and high-density lipoprotein cholesterol were more common with baricitinib than with placebo.

Dr King, and team concluded that "In two phase 3 trials involving patients with severe alopecia areata, oral baricitinib was superior to placebo with respect to hair regrowth at 36 weeks. Longer trials are required to assess the efficacy and safety of baricitinib for alopecia areata."

Reference: 10.1056/NEJMoa2110343