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

Abstract

Nemolizumab, an anti-IL-31 receptor AmAb, improved pruritus, dermatitis, and sleep in adults with moderate-to-severe atopic dermatitis that was inadequately controlled by topical treatments in a phase II, 12-week, randomized, double-blind, placebo-controlled study (part A; NCT01986933). We sought to assess the long-term efficacy and safety of nemolizumab injected subcutaneously every 4weeks (Q4W) or every 8weeks (Q8W) in a 52-week, double-blind extension (part B). During part B, patients continued the previous nemolizumab dose (0.1, 0.5, or 2.0mg/kg Q4W or 2.0mg/kg Q8W). Part B end points included percentage improvement from baseline in pruritus visual analog scale and dermatitis scores (including the Eczema Area and Severity Index). Overall, 216 of 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 visual analog scale score was maintained/increased from weeks 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 (percentage change in Eczema Area and Severity Index 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 64weeks, 83% to 89% had 1 or more adverse events, with no new safety concerns identified. Nemolizumab for up to 64weeks was efficacious and overall well tolerated in patients with moderate-to-severe atopic dermatitis inadequately controlled by topical therapy.