Title : Efficacy of deuruxolitinib in patients with severe alopecia areata by baseline eyelash involvement: Pooled post hoc analysis of the THRIVE-AA1 and THRIVE-AA2 Phase 3 trials
Abstract:
Introduction: Alopecia areata (AA), an autoimmune disorder characterized by nonscarring scalp hair loss, may affect other areas of the body. Eyelash involvement has been reported in patients with AA and eyelash hair loss has been associated with reduced quality of life. The Janus kinase 1/2 inhibitor deuruxolitinib is indicated for the treatment of adults with severe AA. This pooled post hoc analysis examined the efficacy of deuruxolitinib in patients with AA with or without baseline eyelash involvement in THRIVE-AA1 (NCT04518995) and THRIVE-AA2 (NCT04797650).
Methods: In the two trials, patients 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. Eyelash involvement was determined by the rater’s “yes” or “no” response to the question, “Is there eyelash involvement?” Scalp hair loss was assessed in patients with and without baseline eyelash 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.
Results: Patients in the pooled population (deuruxolitinib 8 mg BID [n=600]; placebo [n=267]) had a mean age of approximately 39 years, approximately one-third were male, and approximately 74% were White. In the pooled population, 421/600 (70.2%) and 182/267 (68.2%) patients receiving deuruxolitinib 8 mg BID or placebo, respectively, had baseline eyelash involvement. At Week 24, among patients with baseline eyelash involvement, a significantly higher percentage of patients receiving deuruxolitinib 8 mg BID achieved a SALT score ≤20 vs placebo (26.9% [105/391] vs 0% [0/170]; P <0.0001). Similarly, among patients without baseline eyelash involvement, a significantly higher percentage of patients receiving deuruxolitinib 8 mg BID achieved a SALT score ≤20 vs placebo (39.3% [57/145] vs 2.8% [2/72]; P <0.0001). Additionally, among patients with baseline eyelash involvement, a significantly greater percentage of patients receiving deuruxolitinib 8 mg vs placebo achieved a SALT score ≤10 at Week 24 (18.7% [73/391] vs 0% [0/170]; P <0.0001). Among those without baseline eyelash involvement, 30.3% (44/145) vs 0% (0/72) of patients receiving deuruxolitinib 8 mg or placebo achieved a SALT score ≤10 at Week 24 (P <0.0001). There was no significant difference in the percentage of patients receiving deuruxolitinib 8 mg BID with vs without eyelash involvement at baseline who achieved a SALT score ≤20 (P = 0.7965) or ≤10 (P = 0.4423) at Week 24.
Conclusion: Significantly greater proportions of patients receiving deuruxolitinib 8 mg BID achieved SALT scores of ≤20 and ≤10 at Week 24 versus placebo-treated patients, regardless of baseline eyelash involvement, indicating that this baseline characteristic does not affect the efficacy of deuruxolitinib.