Two parallel phase 3 replicate RCTs (UP-AA1 and UP-AA2) evaluated once-daily oral upadacitinib 15 mg or 30 mg vs. placebo over 24 weeks in 1,399 adults and adolescents (ages 12–<64) with severe alopecia areata (SALT score ≥50).
At week 24, SALT ≤20 was achieved by ~45% of patients on 15 mg and ~55% on 30 mg upadacitinib, versus only 1.5–3.4% on placebo. Serious adverse events occurred in 1.6% (15 mg), 2.3% (30 mg), and 0.4% (placebo) of patients; no new safety signals were identified.
- 24-week placebo-controlled period is relatively short for a chronic, relapsing disease; long-term durability beyond 52 weeks is unknown. - Open-label extension design (period B) limits blinded comparative data beyond week 24. - Upper age cap of 64 years limits generalizability to older adults.
Upadacitinib 15 mg or 30 mg daily produces meaningful scalp hair regrowth in adults and adolescents with severe AA, with a safety profile consistent with its other approved uses. Clinicians treating adolescents should note this is one of very few systemic options with Phase 3 data in patients as young as 12.
