Title : Efficacy of deuruxolitinib in patients with severe alopecia areata by baseline nail involvement: Pooled post hoc analysis of the THRIVE-AA1 and THRIVE-AA2 phase 3 trials
Abstract:
Introduction: Alopecia areata (AA) is an inflammatory autoimmune disorder resulting in nonscarring hair loss of the scalp or other areas of the body. Some patients with AA present with nail changes, including pitting and trachyonychia. Nail involvement occurs more frequently in patients with severe forms of AA. Deuruxolitinib, a Janus kinase 1/2 inhibitor is approved for adults with severe AA. This pooled post hoc analysis evaluated the efficacy of deuruxolitinib in patients with AA with or without nail involvement at baseline in the THRIVE-AA1 (NCT04518995) and THRIVE-AA2 (NCT04797650) Phase 3 trials.
Methods: Adults aged 18 to 65 years with a diagnosis of AA and ≥50% scalp hair loss were treated with deuruxolitinib 8 mg twice daily (BID) or placebo for 24 weeks. Nail involvement was determined by the rater’s “yes” or “no” response to the question, “Is there nail involvement?” Scalp hair loss was assessed by Severity of Alopecia Tool (SALT) scores at Week 24. Efficacy was based on patients who achieved a SALT score ≤20 or ≤10 at Week 24.
Results: Among the patients receiving deuruxolitinib 8 mg BID (n = 600) and placebo (n = 267), the mean age was approximately 39 years and approximately 64% were female and 74% were White. At baseline, 233/600 (38.8%) patients receiving deuruxolitinib 8 mg BID and 103/600 (38.6%) patients treated with placebo had nail involvement. Of the patients with baseline nail involvement, 64/217 (29.5%) patients receiving deuruxolitinib 8 mg BID and 0/95 patients treated with placebo achieved a SALT score ≤20 at Week 24 (P <0.0001 vs placebo). For patients without baseline nail involvement, 104/330 (31.5%) and 2/151 (1.3%) patients treated with deuruxolitinib 8 mg BID and placebo, respectively, achieved a SALT score ≤20 at Week 24 (P <0.0001 vs placebo). Additionally, among patients with baseline nail involvement, 45/217 (20.7%) patients receiving deuruxolitinib 8 mg BID and 0/95 patients treated with placebo achieved a SALT score ≤10 at Week 24 (P <0.0001 vs placebo). For those without baseline nail involvement, 76/330 (23.0%) and 0/151 patients treated with deuruxolitinib 8 mg BID and placebo, respectively, achieved a SALT score ≤10 at Week 24 (P <0.0001 vs placebo). There was no significant difference in the percentage of patients receiving deuruxolitinib 8 mg BID with vs without nail involvement at baseline who achieved a SALT score ≤20 (P = 0.9224) or ≤10 (P = 0.9004) at Week 24.
Conclusion: Similar proportions of patients with and without baseline nail involvement achieved a SALT score ≤20 or ≤10 at Week 24 with deuruxolitinib, demonstrating that baseline nail involvement does not impact the efficacy of deuruxolitinib.