Abstract
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Introduction: Deuruxolitinib, a Janus kinase 1/2 inhibitor is approved in the US for adults with severe alopecia areata. This Phase 2 study (NCT04784533) assessed the effect of deuruxolitinib dose reduction or discontinuation on scalp hair regrowth in patients with severe alopecia areata.
Methods: In Part A, Period 1 (PAP1), patients aged 18 to 65 years with AA and ≥50% scalp hair loss were randomized to deuruxolitinib 8 mg (DRX8) or 12 mg (DRX12) twice daily for 24 weeks. The results for the DRX8 group are presented herein. In Part A, Period 2 (PAP2), patients achieving a response (Severity of Alopecia Tool [SALT] score ≤20 in PAP1) were rerandomized to a lower deuruxolitinib dose or placebo (DRX8-deuruxolitinib 4 mg [DRX4], or DRX8-placebo) for up to 24 weeks or loss of maintenance (LOM; defined as SALT score >20). Patients with LOM entered Part B and received their original deuruxolitinib dose from PAP1 for 24 weeks. Scalp hair loss was assessed by SALT at baseline and every 4 weeks. Safety included treatment-emergent adverse events (TEAEs).
Results: In PAP1, response was achieved by 36/163 (22.1%) patients receiving DRX8 at Week 24. By the end of PAP2, LOM criteria were met by 5/18 (27.8%; DRX8-DRX4) patients in the dose-reduction group, and 15/18 (83.3%; DRX8-placebo) patients in the treatment-discontinuation group. Patients discontinuing treatment met LOM criteria faster compared with those who underwent dose reduction. In Part B, patients who underwent deuruxolitinib retreatment after dose reduction (n = 5) experienced faster scalp hair regrowth vs those who discontinued treatment (n = 13). Most TEAEs were mild or moderate in severity.
Conclusion: Following hair regrowth with deuruxolitinib, dose reduction or discontinuation resulted in loss of treatment response. Scalp hair regrowth was restored in most patients retreated with deuruxolitinib.
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