Upadacitinib (Rinvoq, AbbVie) performed well in severe alopecia areata (AA), according to topline data from the first of two pivotal studies of the Phase 3 UP-AA clinical program.
The study evaluated the safety and efficacy of upadacitinib 15mg and 30mg, taken once daily, in adult and adolescent patients with severe alopecia areata (AA) characterized by a mean baseline Severity of Alopecia Tool (SALT) score of 83.8 (approximately 16% scalp hair coverage). Both doses of upadacitinib achieved the primary endpoint, with 44.6% and 54.3% of patients treated with upadacitinib 15mg and 30mg, respectively, reaching 80% or more scalp hair coverage (SALT score ≤ 20) at week 24, compared to 3.4% of patients receiving placebo, AbbVie reports.
Most Patients Met Endpoints
Fully 36% and 47.1% of patients treated with upadacitinib 15mg and 30mg, respectively, reached 90% or more scalp hair coverage (SALT ≤ 10), compared to 1.4% of patients receiving placebo at week 24, the study showed. Additional key secondary endpoints that were met included the percentage of subjects with improvements in eyebrows and eyelashes, as well as the percentage of subjects with complete scalp hair coverage (SALT = 0) with both doses of upadacitinib at week 24.
“The sudden and often unpredictable hair loss people living with AA experience can profoundly impact their self-esteem and mental well-being,” says Arash Mostaghimi, MD, MPA, MPH, Associate Professor of Dermatology and Vice Chair of Clinical Trials and Innovation at Brigham & Women’s Hospital at Harvard Medical School in Boston, MA. “There is a pressing need for more treatments that help enable the regrowth of scalp and non-scalp hair. I am encouraged by these results that demonstrate the potential of upadacitinib to be an important new treatment option.”
Safety Profile Generally Consistent
The safety profile of both doses of upadacitinib in the 24-week, placebo-controlled period (Period A) 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 15mg and 30mg groups, respectively, and none in the placebo group. Discontinuations due to treatment-emergent adverse events (TEAEs) occurred in 0.7% and 1.4% of subjects in the upadacitinib 15mg and 30mg groups, respectively, and none in the placebo group.
The most common TEAEs observed were acne, nasopharyngitis, and upper respiratory tract infection. Serious infections were reported infrequently, with 0.7% in the upadacitinib 15mg group and 1.0% in the upadacitinib 30mg group, and none in the placebo group. There were no adjudicated Major Adverse Cardiac Events (MACE), malignancies, or deaths reported. One adjudicated venous thromboembolism was reported in the upadacitinib 15mg group in a patient with multiple risk factors.
The use of upadacitinib in AA is not approved, and its safety and efficacy have not been evaluated by regulatory authorities. The Janus kinase (JAK) inhibitor is U.S. Food and Drug Administration (FDA)-approved to treat rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, non-radiographic axial spondyloarthritis, polyarticular juvenile idiopathic arthritis, and giant cell arteritis.
