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Upadacitinib Delivers 80% Scalp Coverage in 50% of Severe Alopecia Areata Cases Across Two Phase 3 Trials

Upadacitinib Delivers 80% Scalp Coverage in 50% of Severe Alopecia Areata Cases Across Two Phase 3 Trials

Phase 3 data demonstrate clinically meaningful regrowth with upadacitinib in severe alopecia areata. Dose-response and extension-phase durability remain key open questions before approval.

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Observational cohorts show JAK inhibitors can lose efficacy upon discontinuation, suggesting maintenance strategies will be needed. Regulatory filings are expected; FDA review will hinge on sustained benefit and malignancy-infection signals observed in the rheumatoid arthritis program.

⚡ Prediction

FDA: Upadacitinib alopecia areata supplemental NDA decision by December 2026 if 52-week extension shows <15% relapse off-therapy.

Sources (2)

  • [1]
    Primary Source(https://jamanetwork.com/journals/jamadermatology/article-abstract/2823456)
  • [2]
    Supporting Source(https://www.nejm.org/doi/full/10.1056/NEJMoa2118025)