Dose optimization of deuruxolitinib in adults with alopecia areata: A phase 2 randomized trial.

BACKGROUND: The autoimmune disorder alopecia areata (AA) results in patchy or complete hair loss. OBJECTIVE: To evaluate the efficacy and safety of the Janus kinase 1/2 inhibitor deuruxolitinib dosed 8 mg twice daily (BID) or 16 mg once daily (QD) in adults with severe AA. METHODS: In this phase 2 study (NCT03811912), patients were randomized to deuruxolitinib 8 mg BID or 16 mg QD. Primary endpoint was relative change from baseline in Severity of Alopecia Tool (SALT) score at Week 24. Safety included treatment-emergent adverse events (TEAEs). RESULTS: The study included 57 patients (mean age, 40.1 years; 66.7% female). At Week 24, the mean relative change from baseline in SALT score was greater with deuruxolitinib 8 mg BID (46.4 [90% confidence interval [CI], 34.3-58.4]) vs 16 mg QD (18.0 [90% CI, 7.6-28.4]) and a greater proportion of patients receiving deuruxolitinib 8 mg BID vs 16 mg QD achieved SALT score ≤20 and ≤10. TEAEs were mild or moderate in severity. LIMITATIONS: This study had a small sample size. Larger studies will further evaluate the efficacy and safety of deuruxolitinib. CONCLUSION: Deuruxolitinib 8 mg BID was associated with greater improvements in scalp hair regrowth vs deuruxolitinib 16 mg QD.