Upadacitinib improves scalp hair regrowth in two alopecia areata trials

Two parallel phase 3 UP-AA randomized trials evaluated oral upadacitinib in nearly 1,400 adults and adolescents older than 12 years with severe alopecia areata. Participants had a mean baseline Severity of Alopecia Tool (SALT) score of 83.9 and received upadacitinib 15 mg, 30 mg or placebo daily. The reported efficacy endpoint was a SALT score ≤20 at week 24, corresponding to hair coverage on at least 80% of the scalp.

Response rates in the two trials were 45.2% and 44.6% with 15 mg, and 55.0% and 54.3% with 30 mg, versus 1.5% and 3.4% with placebo. Both doses were significantly more effective than placebo. Serious adverse events were reported in 1.6%, 2.3% and 0.4% of the 15-mg, 30-mg and placebo groups, respectively. Reported adverse events also included upper respiratory tract infection, acne and elevated creatine phosphokinase levels.

The results suggest substantial short-term hair regrowth benefits, but the source provides no longer-term efficacy or safety outcomes. No trials directly compare upadacitinib with ritlecitinib, which Norway's Decision Forum approved for restricted use in severe alopecia areata in 2025. Differences between study populations and designs prevent reliable comparative conclusions. High treatment costs remain an access concern, according to the specialist commentary accompanying this journal report; Norwegian approval of upadacitinib for this indication is described as prospective.