Nemolizumab in moderate-to-severe atopic dermatitis: Randomized, phase II, long-term extension study

Publication date: Available online 10 May 2018
Source:Journal of Allergy and Clinical Immunology
Author(s): Kenji Kabashima, Masutaka Furue, Jon M. Hanifin, Grazyna Pulka, Andreas Wollenberg, Ryszard Galus, Takafumi Etoh, Ryosuke Mihara, Miwa Nakano, Thomas Ruzicka
BackgroundNemolizumab, an anti–interleukin-31 receptor A monoclonal antibody, improved pruritus, dermatitis, and sleep in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical treatments in a phase II, 12-week, randomized, double-blind, placebo-controlled study (Part A) (NCT01986933).ObjectiveTo assess long-term efficacy and safety of nemolizumab injected subcutaneously every 4 weeks (Q4W) or every 8 weeks (Q8W) in a 52-week double-blind extension (Part B).MethodsDuring Part B, patients continued previous nemolizumab dose (0.1, 0.5, or 2.0 mg/kg Q4W or 2.0 mg/kg Q8W). Part B endpoints included percentage improvement from baseline in pruritus visual analogue scale (VAS) and dermatitis scores (including Eczema Area and Severity Index [EASI]).ResultsOverall, 216/264 patients completed Part A and 191 entered Part B; 131 completed Part B. In 153 patients randomized to nemolizumab in Part A, improvement from baseline in pruritus VAS was maintained/increased from Week 12 to 64, with greatest improvement in the 0.5-mg/kg Q4W group (percentage change from baseline at Week 64: −73.0, −89.6, −74.7, and −79.1 in the 0.1-, 0.5-, and 2.0-mg/kg Q4W and 2.0-mg/kg Q8W groups, respectively). Improvement from baseline in dermatitis scores was also maintained/increased to Week 64 (percent change in EASI score: −68.5, −75.8, −78.9, and −69.3 in the 0.1-, 0.5-, and 2.0-mg/kg Q4W and 2.0-mg/kg Q8W groups, respectively). Over 64 weeks, 83–89% had ≥1 adverse event, with no new safety concerns identified.ConclusionNemolizumab for up to 64 weeks was efficacious and, overall, well tolerated in patients with moderate-to-severe atopic dermatitis inadequately controlled by topical therapy.



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