Nemolizumab plus topical agents in patients with atopic dermatitis (AD) and moderate-to-severe pruritus provide improvement in pruritus and signs of AD for up to 68 weeks: Results from two phase III, long-term studies
British Journal of Dermatology Dec 26, 2021
Kabashima K, Matsumura T, Komazaki H, et al. - In patients with atopic dermatitis (AD) and inadequately controlled moderate-to-severe pruritus, use of nemolizumab 60 mg (a humanized monoclonal antibody against interleukin-31 receptor A) every 4 weeks (Q4W) with concomitant topical treatments resulted in a continuous improvement in pruritus, signs of AD, and quality of life (QoL) for up to 68 weeks, with a favourable safety profile.
Using two long-term phase III studies (in which nemolizumab 60 mg Q4W was given subcutaneously, concomitantly with topical treatments), experts assessed long-term effectiveness as well as safety of nemolizumab in patients aged ≥ 13 years with AD and inadequately controlled moderate-to-severe pruritus.
In Study-JP01, patients were administered double-blind nemolizumab or placebo for 16 weeks, followed by a 52-week extension in which all patients received nemolizumab (nemolizumab/nemolizumab and placebo/nemolizumab groups); Study-JP02 patients had nemolizumab for 52 weeks.
From treatment initiation to week 68, clinically meaningful improvements were evident in the pruritus visual analogue scale (66% decrease) and Eczema Area and Severity Index (78% decrease) in the nemolizumab/nemolizumab group.
Following receipt of the first nemolizumab dose, improvement occurred in QoL indicators; improvements were maintained during the follow-up.
Long-term safety profile consistent with previous studies was obtained, with no unexpected late-onset adverse events.
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