PATIENTS with severe alopecia areata treated with upadacitinib achieved greater hair regrowth at Week 24 versus placebo.
Upadacitinib in Severe Alopecia Areata
New subgroup data from the UP-AA Phase III clinical program suggest that upadacitinib was effective in both adolescents and adults with severe alopecia areata. Across Study 1 and Study 2, both the 15 mg and 30 mg doses led to higher response rates than placebo at Week 24, with no new safety signals identified.
Alopecia areata is an autoimmune disease that causes non-scarring hair loss affecting the scalp and other body sites, and in some cases can progress to total-body hair loss. The condition can have a substantial effect on quality of life, making meaningful hair regrowth and improvement in visible areas such as the eyebrows and eyelashes particularly important outcomes.
Hair Regrowth Outcomes at Week 24
At Week 24, a greater proportion of adolescents and adults receiving upadacitinib achieved a Severity of Alopecia Tool score of 20 or less compared with placebo in both studies. Among adolescents, response rates for SALT≤20 were 56.0% and 56.5% with upadacitinib 15 mg in Study 1 and Study 2, respectively, and 84.6% and 76.2% with upadacitinib 30 mg. In adults, the corresponding response rates were 44.1% and 43.6% with the 15 mg dose, and 51.8% and 52.6% with the 30 mg dose.
By comparison, placebo response rates for SALT≤20 were low in both age groups. In adolescents, rates were 0% in Study 1 and 10.0% in Study 2. In adults, placebo rates were 1.6% and 3.0%.
The analysis also showed that a greater proportion of adolescents and adults receiving either dose of upadacitinib achieved deeper levels of response, including SALT≤10 and complete scalp hair regrowth defined as SALT=0, compared with placebo.
Eyebrow, Eyelash, and Quality-of-Life Improvements
Beyond scalp hair regrowth, improvements were also seen in eyebrow and eyelash regrowth in both adolescents and adults treated with upadacitinib. Quality-of-life measures also improved versus placebo, supporting the broader clinical relevance of treatment benefit in a disease that can carry a considerable psychosocial burden.
These findings are notable because visible hair loss beyond the scalp can further affect daily functioning and self-perception. The consistency of benefit across scalp hair, eyebrow and eyelash regrowth, and quality of life suggests a broad treatment effect across clinically meaningful domains.
Safety Findings Remained Consistent
Safety findings were generally consistent with the known profile of upadacitinib. No serious treatment-emergent adverse events were reported in adolescents receiving upadacitinib, while such events were reported in 3.0% or fewer adults. Treatment-emergent adverse events leading to discontinuation occurred in one of 95 adolescents and 12 of 1,022 adults receiving treatment.
No deaths were reported in either age group. Overall, the investigators concluded that upadacitinib demonstrated high efficacy in adolescents and adults with severe alopecia areata, with no new safety signals identified in either study.
Reference
Gooderham M et al. Efficacy and Safety of Upadacitinib in Adolescents and Adults with Severe Alopecia Areata: A Subgroup Analysis of the UP-AA Phase 3 Clinical Program. Abstract 76957. AAD Annual Meeting, 27-31 March, 2026.
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