672 - Nemolizumab monotherapy improves itch, sleep disturbance, and skin lesions in patients with moderate-to-severe prurigo nodularis: Pooled analyses from OLYMPIA 1 and OLYMPIA 2 phase 3 studies

Abstract Introduction Nemolizumab demonstrated clinically and statistically significant improvements in itch, sleep disturbance, and skin lesions in adults with moderate-to-severe prurigo nodularis (PN) in two phase 3 pivotal studies (OLYMPIA 1 NCT045016661 and OLYMPIA 2 NCT045016792). Objectives To report pooled efficacy and safety from two phase 3 studies of nemolizumab in the treatment of PN. Materials 0.0001), an Investigator’s Global Assessment score of 0/1 clear/almost clear skin with ≥2-point reduction from baseline was achieved in 31.9% of nemolizumab- vs 9.1% of placebo-treated patients (P0.0001) at Week 16, itch-free/nearly itch-free state (defined as PP-NRS2) was achieved in 34.6% of nemolizumab- vs 5.9% of placebo-treated patients (P0.0001) and a ≥4-point improvement from baseline in weekly average Sleep Disturbance NRS was achieved in 50.9% of nemolizumab- vs 16.0% of placebo-treated patients (P0.0001). Treatment-emergent adverse events (TEAEs) were reported in 66.5% of patients (nemolizumab) and 59.1% (placebo). Of these patients, the majority in each treatment group experienced that were considered mild or moderate in severity. Conclusion Nemolizumab monotherapy administered Q4W was well-tolerated and led to rapid and sustained clinically meaningful improvements in itch intensity and sleep disturbance along with improvement in skin lesions. Pooled results were consistent with those observed in individual pivotal phase 3 studies.2,3