AbbVie reports results from Phase 3 UP-AA clinical program

AbbVie (ABBV) announced positive topline results from the first of two pivotal studies of the Phase 3 UP-AA clinical program evaluating the safety and efficacy of upadacitinib, or RINVOQ, in adult and adolescent patients with severe alopecia areata, or AA, with a mean baseline SALT score of 83.8. In Study 2, both doses of upadacitinib achieved the primary endpoint, with 44.6% and 54.3% of patients treated with upadacitinib 15 mg and 30 mg, respectively, reaching 80% or more scalp hair coverage at week 24, compared to 3.4% of patients receiving placebo. 36.0% and 47.1% of patients treated with upadacitinib 15 mg and 30 mg, respectively, reached 90% or more scalp hair coverage, compared to 1.4% of patients receiving placebo at week 24. Additional key secondary endpoints that were met included percentage of subjects with improvements in eyebrows and eyelashes, as well as the percentage of subjects with complete scalp hair coverage with both doses of upadacitinib at week 24. The safety profile of both doses of upadacitinib in the 24-week, placebo-controlled period was generally consistent with that observed in approved indications. Treatment-emergent serious adverse events occurred in 1.4% and 2.8% of patients in the upadacitinib 15 mg and 30 mg groups, respectively, and none in the placebo group.1 Discontinuations due to treatment-emergent adverse events occurred in 0.7% and 1.4% of subjects in the upadacitinib 15 mg and 30 mg groups, respectively, and none in the placebo group. Use of upadacitinib in AA is not approved and its safety and efficacy have not been evaluated by regulatory authorities.