Upadacitinib shows efficacy in severe alopecia areata phase 3 trials

Two parallel phase 3 randomized clinical trials, UP-AA1 and UP-AA2, have demonstrated that upadacitinib, an oral selective Janus kinase (JAK) inhibitor, is effective in treating severe alopecia areata. The studies involved 1,399 adults and adolescents, aged 12 to 64, who experienced extensive scalp hair loss.

In the UP-AA1 trial, 45.2% of patients on a 15-mg dose and 55.0% on a 30-mg dose achieved a Severity of Alopecia Tool (SALT) score of 20 or less by week 24, compared to 1.5% in the placebo group. The UP-AA2 trial showed similar efficacy, with 44.6% and 54.3% of the 15-mg and 30-mg groups reaching the endpoint, respectively, versus 3.4% for placebo.

Beyond scalp coverage, participants reported improvements in eyebrow and eyelash regrowth, as well as enhanced quality-of-life measures. The trials also included 118 adolescents, addressing a significant unmet clinical need as systemic options for this age group are currently limited. Common adverse events reported included acne and upper respiratory tract infections.