Maintenance of hair regrowth following dose reduction or discontinuation of deuruxolitinib in patients with severe alopecia areata: A phase 2 randomized study

Title : Maintenance of hair regrowth following dose reduction or discontinuation of deuruxolitinib in patients with severe alopecia areata: A phase 2 randomized study

Abstract:

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.

Biography:

Kizito Kyeremateng, BSc, PharmD, is a Director of Medical Affairs in Dermatology with extensive experience in pharmaceutical medical affairs. He leads medical strategy at Sun Pharma, advancing evidence-based approaches to acne, alopecia areata, and other skin diseases. His research includes peer-reviewed publications on acne, clascoterone, alopecia areata, and deuruxolitinib, contributing to the understanding of disease pathophysiology and treatment. Dr. Kyeremateng earned his PharmD from Idaho State University and remains actively engaged in clinical research, scientific publications, and medical communications.