Rapid improvement of itch with nemolizumab in atopic dermatitis and prurigo nodularis phase 3 studies

作者：Sonja Ständer, Sarina B. Elmariah, Shawn G. Kwatra, Gil Yosipovitch, Andrew Pink, Soo Yeon Cheong, Xiaoxiao Chen, Zarif K. Jabbar‐Lopez, Liliana Ulianov, Christophe Piketty, Jonathan I. Silverberg · 发表于：Journal of the European Academy of Dermatology and Venereology · 年份：2025 · DOI：10.1111/jdv.70250 · 被引用次数：6 · 研究领域：Dermatology and Skin Diseases、Psoriasis: Treatment and Pathogenesis、Mast cells and histamine

BACKGROUND/OBJECTIVES: Itch is the most burdensome symptom in atopic dermatitis (AD) and prurigo nodularis (PN) and is associated with significant psychological distress, sleep deprivation and impaired quality of life. Achieving rapid control of itch is expected to minimize symptomatology and disease burden. Nemolizumab, which targets the interleukin 31 (IL-31) pathway, rapidly relieved itch in Phase 2 trials; thus, a post hoc analysis of four pivotal randomized controlled clinical trials of nemolizumab in AD and PN was performed to further evaluate the improvement of itch over the first 14 days of therapy. METHODS: Data from ARCADIA 1 and 2 in AD (N = 1728) and OLYMPIA 1 and 2 in PN (N = 560) were analysed. Patients reported itch intensity and sleep disturbance daily. Differences in the proportion of itch and sleep responders (patients with ≥4-point improvement from baseline in peak pruritus numerical rating scale [PP-NRS] or sleep disturbance [SD-NRS] score) between nemolizumab and placebo groups were calculated. RESULTS: Nemolizumab rapidly reduced itch in AD (ARCADIA 1 and 2), with a difference versus placebo in PP-NRS responders apparent by Day 2 (pooled data: 10.7% vs. 2.9%; 95% CI: 5.6-10.1; p < 0.0001) that steadily increased through Day 14. Nemolizumab also reduced itch rapidly in PN (OLYMPIA 1 and 2); a difference versus placebo occurred by Day 2 (pooled data: 17.2% vs. 3.7%; 95% CI: 6.8-16.7; p < 0.0001). Early improvement (Day 2) was also observed in sleep in nemo...