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Efficacy and safety of deuruxolitinib, an oral selective Janus kinase 1/2 inhibitor, in adults with alopecia areata: Results from the THRIVE-AA2 Phase 3, randomized, double-blind, controlled trial

Tsianakas A, Passeron T, Magnolo N, Blume-Peytavi U, Kelly V, Day I, Serrao R, Guttman-Yassky E, Sticherling M, Csernus AE, Moreno-Arrones OM, Hamilton C, Cassella J (2025)

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Publication Type: Journal article

Publication year: 2025

Journal

DOI: 10.1016/j.jaad.2025.11.070

Abstract

Background Alopecia areata (AA) is an autoimmune disease resulting in patchy or complete hair loss. Objective We report safety and efficacy results of deuruxolitinib, a selective Janus kinase 1/2 inhibitor, in adults with severe chronic AA. Methods We conducted a randomized, double-blind, placebo-controlled, multicenter trial (NCT04797650). Patients aged 18 to 65 years with a Severity of Alopecia Tool (SALT) score ≥50 and an AA episode lasting ≥6 months at screening were randomized 1:2:1 to deuruxolitinib 12 mg twice daily (BID), 8 mg BID, or placebo between June 10 and December 13, 2021. The primary endpoint was the percentage of patients achieving a SALT score ≤20 (SALT20) at Week 24. Results Of 517 patients randomized, 515 received ≥1 dose of study drug. At Week 24, 33.0%, 38.3%, and 0.8% of patients receiving deuruxolitinib 8 mg BID, 12 mg BID, and placebo, respectively, achieved SALT20 ( P < .0001 vs placebo for both doses). Deuruxolitinib was well tolerated, and most study drug–related treatment-emergent adverse events were mild or moderate in severity. Limitations Long-term efficacy and safety or durability of treatment response were not assessed; further study is required. Conclusion Efficacy and safety analyses support deuruxolitinib as a treatment option in adults with AA.

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APA:

Tsianakas, A., Passeron, T., Magnolo, N., Blume-Peytavi, U., Kelly, V., Day, I.,... Cassella, J. (2025). Efficacy and safety of deuruxolitinib, an oral selective Janus kinase 1/2 inhibitor, in adults with alopecia areata: Results from the THRIVE-AA2 Phase 3, randomized, double-blind, controlled trial. Journal of the American Academy of Dermatology. https://doi.org/10.1016/j.jaad.2025.11.070

MLA:

Tsianakas, Athanasios, et al. "Efficacy and safety of deuruxolitinib, an oral selective Janus kinase 1/2 inhibitor, in adults with alopecia areata: Results from the THRIVE-AA2 Phase 3, randomized, double-blind, controlled trial." Journal of the American Academy of Dermatology (2025).

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