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

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.

Trial registration: ClinicalTrials.gov NCT04518995 and NCT04797650 NCT03898479, NCT05041803 NCT04797650.

Keywords: Alopecia areata; Janus kinase (JAK) inhibitor; Phase 3; Severity of Alopecia Tool (SALT); THRIVE-AA2; deuruxolitinib.