Title : Efficacy of deuruxolitinib in patients with severe alopecia areata by baseline eyebrow involvement: Pooled post hoc analysis of the THRIVE-AA1 and THRIVE-AA2 phase 3 trials
Abstract:
Introduction: Alopecia areata (AA) is an autoimmune disorder characterized by nonscarring scalp hair loss, with or without involvement of other hair-bearing areas of the body. Eyebrow involvement has been reported in AA with varying prevalence; patients with AA have indicated that eyebrow involvement is as important as scalp hair loss. The Janus kinase 1/2 inhibitor deuruxolitinib is approved for the treatment of adults with severe AA. This pooled post hoc analysis examined the efficacy of deuruxolitinib in patients with or without baseline eyebrow involvement in THRIVE-AA1 (NCT04518995) and THRIVE-AA2 (NCT04797650).
Methods: Adults 18 to 65 years of age with a diagnosis of AA and ≥50% scalp hair loss received deuruxolitinib 8 mg twice daily (BID) or placebo for 24 weeks. Eyebrow involvement was determined by the rater’s “yes” or “no” response to the question, “Is there eyebrow involvement?” Scalp hair loss was assessed in patients with and without baseline eyebrow involvement using Severity of Alopecia Tool (SALT) scores at Week 24. Proportions of patients achieving SALT scores ≤20 or ≤10 at Week 24 were compared between treatment groups by baseline eyebrow involvement.
Results: For patients receiving deuruxolitinib 8 mg BID (n = 600) and placebo (n = 267), the mean age was 38.6 and 39.0 years, respectively; 35.8% and 34.8% were male; and 73.8% and 74.2% were White. In the pooled population, a comparable percentage of patients receiving deuruxolitinib 8 mg BID (431/600 [71.8%]) and placebo (197/267 [73.8%]) had baseline eyebrow involvement. At Week 24, among patients with baseline eyebrow involvement, a significantly higher percentage of patients receiving deuruxolitinib 8 mg BID achieved a SALT score ≤20 vs placebo (26.9% [109/405] vs 0% [0/184]; P <0.0001). Similarly, among patients without baseline eyebrow involvement, a significantly higher percentage of patients receiving deuruxolitinib 8 mg BID achieved a SALT score ≤20 vs placebo (45.6% [47/103] vs 4.2% [2/48]; P <0.0001). Further, among patients with baseline eyebrow involvement, 18.8% (76/405) of patients receiving deuruxolitinib 8 mg achieved a SALT score ≤10 at Week 24, compared with 0% (0/184) of patients receiving placebo (P <0.0001). Among those without baseline eyebrow involvement, 36.9% (38/103) of patients receiving deuruxolitinib 8 mg achieved a SALT score ≤10 at Week 24, compared with 0% (0/48) of patients receiving placebo (P <0.0001). There was no significant difference in the percentage of patients receiving deuruxolitinib 8 mg BID with vs without eyebrow involvement at baseline who achieved a SALT score ≤20 (P = 0.4084) or ≤10 (P = 0.1680) at Week 24.
Conclusion: In patients with and without baseline eyebrow involvement, a significantly greater proportion of patients receiving deuruxolitinib 8 mg BID achieved SALT scores ≤20 and ≤10 at Week 24, compared with patients who received placebo, indicating that baseline eyebrow involvement does not affect the efficacy of deuruxolitinib.