42746 Patient Reported Outcomes in the Phase 3 THRIVE-AA1 Trial with CTP-543 (Deuruxolitinib) in Adult Patients with Moderate to Severe Alopecia Areata

Background: Introduction Alopecia areata (AA) is a serious autoimmune disease, characterized by patchy or complete hair loss on the scalp and/or body. THRIVE‐AA1 is a double‐blind, placebo‐controlled Phase 3 trial with CTP‐543, an oral JAK1/JAK2 Inhibitor for treatment of AA. Material and Methods Eligible AA patients were 18‐65 years with 2:50% scalp hair loss and current AA episode >6 months and <10 years. The primary efficacy endpoint of Severity of Alopecia Tool (SALT) score <20 was achieved. A key secondary endpoint was the percent of responders who reported satisfaction on the hair Satisfaction Patient Reported Outcome (SPRO) scale (5‐point scale ranging from “very dissatisfied (5)” to “very satisfied (1)”) at Week 24. Results 706 patients were randomized: placebo (PBO)=140, CTP‐543 8 mg BID=351 or 12 mg BID=215. For the SPRO, 42% and 53% of the 8 mg BID and 12 mg BID groups, respectively, reported being “satisfied” or “very satisfied” with their scalp hair at Week 24 compared to 5% for PBO (p<0.0001). Patients on both CTP‐543 doses were significantly different from placebo at Week 24 for satisfaction with both thickness (p<0.001) and evenness (p <0.001) of scalp hair coverage. In addition, both doses of CTP‐543 were significantly different from placebo at Week 24 with regard to patient global impression of severity (p<0.001) and global impression of improvement (p<0.0001). Discussion Patient satisfaction and patient impressions of severity and improvement of scalp hair were significantly higher for both doses of CTP‐543 compared to placebo.