Clinical Report: Upadacitinib may improve scalp hair regrowth
Overview
In two phase 3 randomized trials involving 1,399 adults and adolescents with severe alopecia areata, upadacitinib increased the proportion achieving a SALT score of 20 or less at week 24 compared with placebo. Hair regrowth outcomes, including eyebrow and eyelash responses, favored both doses; no new safety signals were identified during the 24-week treatment period.
Background
Severe alopecia areata can involve extensive scalp hair loss, with eyebrow and eyelash involvement also assessed in these trials. The Severity of Alopecia Tool (SALT) score measures scalp hair loss; a score of 50 or higher was required for trial entry, and a score of 20 or less represented no more than 20% scalp hair loss. Upadacitinib is an oral Janus kinase 1 inhibitor. The trials evaluated its efficacy and safety against placebo in patients aged 12 to under 64 years.
Data Highlights
| Outcome at week 24 | Upadacitinib 15 mg | Upadacitinib 30 mg | Placebo |
|---|---|---|---|
| SALT score ≤20, UP-AA1 | 45% | 55% | 2% |
| SALT score ≤20, UP-AA2 | 45% | 54% | 3% |
| SALT score ≤10, across trials | 35%–36% | 46%–47% | About 1% |
| Complete scalp hair regrowth (SALT score 0), across trials | 13%–14% | 20%–23% | 0%–1% |
| Moderately or much better patient-reported disease status | 65%–68% | About 75% | 7%–8% |
| Treatment-emergent adverse events | 63% | 67% | 57% |
| Serious adverse events | 2% | 2% | Less than 1% |
Key Findings
- The two global, double-blind, placebo-controlled phase 3 trials enrolled 1,399 patients, including 118 adolescents, with severe alopecia areata and baseline SALT scores of at least 50.
- At week 24, SALT scores of 20 or less were achieved by 45% and 55% of patients receiving 15 mg and 30 mg, respectively, in UP-AA1, compared with 2% receiving placebo; corresponding UP-AA2 rates were 45%, 54%, and 3%.
- Differences between each upadacitinib dose and placebo for the primary endpoint were statistically significant by week 8. The 30-mg dose had higher response rates than the 15-mg dose for most endpoints, but formal statistical comparisons between doses were not conducted.
- Across the trials, eyebrow and eyelash response rates at week 24 were higher with upadacitinib than placebo. Among patients with substantial baseline eyebrow loss, clinically meaningful eyebrow improvement occurred in 41%–42% with 15 mg and 59%–62% with 30 mg, versus 1%–3% with placebo; eyelash response rates were 43%–44%, 59%–61%, and 4%–6%, respectively.
- Patients receiving upadacitinib also reported improvements in disease-related symptoms, interference with daily activities, and emotional and functional quality-of-life measures. Adolescents showed greater treatment effects than the overall population, although the subgroup included only 118 patients.
- Common adverse events included acne, nasopharyngitis, upper respiratory tract infections, and elevated blood creatine phosphokinase. No deaths or new safety signals were reported during the 24-week treatment period.
Clinical Implications
The trial authors concluded that upadacitinib may be an effective therapeutic option for adults and adolescents with severe alopecia areata. The 24-week placebo-controlled period limits conclusions about longer-term efficacy and safety; the authors noted that longer-term follow-up is needed to assess response durability and safety over extended treatment.
Conclusion
In UP-AA1 and UP-AA2, upadacitinib improved scalp hair regrowth outcomes compared with placebo over 24 weeks, with additional eyebrow and eyelash responses. Longer-term follow-up is needed to characterize durability and extended safety.
Related Resources & Content
- Mostaghimi A, et al., JAMA Dermatology, year not specified — Upadacitinib for Severe Alopecia Areata in Adults and Adolescents: Two Phase 3 UP-AA Randomized Clinical Trials
- JAMA Dermatology, 2026 — Delphi Consensus Statement on Treatment of Severe Alopecia Areata in US Adults
- MDSpire News, year not specified — Baricitinib Aids Eyebrow, Eyelash Regrowth in Alopecia Areata
- MDSpire News, year not specified — Deuruxolitinib Shows Promise for Alopecia
- JAMA Oncology — Upadacitinib for Immune Checkpoint Inhibitor–Related Dermatitis: A Nonrandomized Clinical Trial
- MDSpire News — Baricitinib Effective for Teen Alopecia
- Upadacitinib for Severe Alopecia Areata in Adults and Adolescents: Two Phase 3 UP-AA Randomized Clinical Trials
- Delphi Consensus Statement on Treatment of Severe Alopecia Areata in US Adults
- S3 guideline diagnostics and therapy in alopecia areata - Part 2: Therapy, psychosocial and cosmetic support - PubMed
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