Upadacitinib Hits Phase 3 Alopecia Goals in 1,399 Patients as 55% Regrow Scalp Hair
Updated
Updated · Physician's Weekly · Aug 6
Upadacitinib Hits Phase 3 Alopecia Goals in 1,399 Patients as 55% Regrow Scalp Hair
2 articles · Updated · Physician's Weekly · Aug 6
Summary
Two global phase 3 trials showed upadacitinib beat placebo at 24 weeks in severe alopecia areata, with 44.6%-45.2% of patients on 15 mg and 54.3%-55.0% on 30 mg reaching SALT 20 or less versus 1.5%-3.4%.
The studies enrolled 1,399 patients aged 12-64 with heavy baseline disease burden—mean SALT 83.9—and also met key secondary endpoints including complete scalp regrowth, eyebrow and eyelash improvement, patient-reported improvement and quality-of-life gains.
Safety was consistent with upadacitinib's established profile: serious adverse events occurred in 1.6% on 15 mg, 2.3% on 30 mg and 0.4% on placebo, with no new safety signals reported.
Researchers said the results address an unmet need in a field where many patients do not improve on current options and only ritlecitinib is approved for adolescents; a third study is tracking long-term outcomes and dose adjustments through week 52.