AbbVie Seeks FDA Nod After 55% Achieve SALT ≤20 at Week 24 in Alopecia Trials
AbbVie sought FDA approval of upadacitinib in alopecia areata after phase 3 trials showed 45–55% of patients reached SALT ≤20 at week 24. Complete scalp regrowth (SALT = 0) occurred in up to 22.5% at week 24 and 37% at week 52, and safety remained consistent through 52 weeks.
1. Application Submission
AbbVie submitted an application to the FDA for upadacitinib (RINVOQ) 15 mg and 30 mg tablets to treat adults and adolescents with severe alopecia areata, based on positive outcomes from the phase 3 UP-AA clinical program.
2. Trial Design & Enrollment
The UP-AA program comprised two replicate, double-blind, placebo-controlled studies (Period A) over 24 weeks, followed by a blinded 28-week extension (Period B), randomizing 1,399 participants with a mean baseline SALT score of 84, including 51% with near-total scalp hair loss.
3. Efficacy Outcomes
At week 24, 45–55% of patients achieved substantial hair coverage (SALT ≤20) and 13–20% achieved complete regrowth (SALT = 0). Response rates improved through week 52 to 55–64% for SALT ≤20 and 26.6–37.0% for SALT = 0 across both dosage groups.
4. Safety Profile
The safety profile of both 15 mg and 30 mg doses through week 52 mirrored the 24-week data, with no new adverse signals and tolerability consistent with previous findings.