Title : Efficacy of deuruxolitinib in patients with severe alopecia areata by baseline alopecia areata episode duration: Pooled analysis of the THRIVE-AA1 and THRIVE-AA2 phase 3 trials
Abstract:
Introduction: Alopecia areata (AA) is a common cause of nonscarring hair loss, and the duration of AA is inversely correlated with hair regrowth. Deuruxolitinib is approved in the US for adults with severe AA. This pooled post hoc analysis examined scalp hair regrowth with deuruxolitinib by baseline duration of AA episode in the Phase 3 trials THRIVE-AA1 (NCT04518995) and THRIVE-AA2 (NCT04797650).
Methods: Patients 18 to 65 years of age with AA and ≥50% scalp hair loss received deuruxolitinib 8 mg twice daily (BID) or placebo for up to 24 weeks. Scalp hair loss was assessed in patients using Severity of Alopecia Tool (SALT). The percentage of patients achieving SALT scores ≤20 or ≤10 at Week 24 was assessed in the pooled population by baseline duration of AA episode <4 and ≥4 years.
Results: Patients receiving deuruxolitinib 8 mg BID (n=600) or placebo (n=267) had a mean baseline duration of AA episode of 3.7 and 3.9 years, respectively. The percentage of patients achieving SALT scores ≤20 and ≤10 at Week 24 was significantly higher with deuruxolitinib 8 mg BID vs placebo regardless of baseline AA duration (P<0.0001 for all). The percentage of patients with a baseline duration of AA episode <4 years achieving SALT scores ≤20 and ≤10 with deuruxolitinib 8 mg BID was significantly greater than those with a baseline AA duration ≥4 years (P=0.0024 and P=0.0236, respectively) at Week 24.
Conclusion: A significantly higher proportion of patients receiving deuruxolitinib achieved clinically meaningful scalp hair regrowth by Week 24 vs placebo-treated patients regardless of the baseline duration of their AA episode. Further, a significantly higher proportion of patients with a shorter vs longer baseline AA duration achieved ≥80% and ≥90% scalp hair regrowth by Week 24 with deuruxolitinib.