• Jonathan I Silverberg, Andreas Pinter, Grazyna Pulka, Yves Poulin, Jean-David Bouaziz, Andreas Wollenberg, Dédée F Murrell, Andrew Alexis, Lisa Lindsey, Faiz Ahmad, Christophe Piketty, and Alan Clucas.
• Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Ill. Electronic address: jonathanisilverberg@gmail.com.
• J. Allergy Clin. Immunol. 2020 Jan 1; 145 (1): 173-182.

BackgroundNemolizumab targets the IL-31 receptor α subunit involved in atopic dermatitis (AD) pathogenesis.ObjectiveWe sought to evaluate a new dosing strategy of nemolizumab in patients with AD.MethodsWe performed a 24-week, randomized, double-blind, multicenter study of nemolizumab (10, 30, and 90 mg) subcutaneous injections every 4 weeks versus placebo, with topical corticosteroids in adults with moderate-to-severe AD, severe pruritus, and inadequate control with topical treatment (n = 226). The Eczema Area and Severity Index (EASI), the peak pruritus (PP) numeric rating scale (NRS), and the Investigator's Global Assessment (IGA) were assessed. Standard safety assessments were performed.ResultsNemolizumab improved EASI, IGA, and/or NRS-itch scores, with the 30-mg dose being most effective. Nemolizumab (30 mg) reduced EASI scores versus placebo at week 24 (-68.8% vs -52.1%, P = .016); significant differences were observed by week 8 (P ≤ .01). With significant improvement (P = .028) as early as week 4, IGA 0/1 rates were higher for 30 mg of nemolizumab versus placebo at week 16 (33.3% vs 12.3%, P = .008) but not week 24 because of an increased placebo/topical corticosteroid effect (36.8% vs 21.1%, P = .06). PP-NRS scores were improved for 30 mg of nemolizumab versus placebo at week 16 (-68.6% vs -34.3%, P < .0001) and week 24 (-67.3% vs -35.8%, P < .0001), with a difference by week 1 (P < .001). NRS response rates (≥4-point decrease) were greater for 30 mg of nemolizumab versus placebo at week 16 (P ≤ .001) and week 24 (P ≤ .01). Nemolizumab was safe and well tolerated. The most common adverse events were nasopharyngitis and upper respiratory tract infection.ConclusionsNemolizumab resulted in rapid and sustained improvements in cutaneous signs of inflammation and pruritus in patients with AD, with maximal efficacy observed at 30 mg. Nemolizumab had an acceptable safety profile.Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.

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