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

Kenji Kabashima, Masutaka Furue, Jon M. Hanifin, Grazyna Pulka, Andreas Wollenberg, Ryszard Galus, Takafumi Etoh, Ryosuke Mihara, Miwa Nakano, Thomas Ruzicka

Research output: Contribution to journalArticle

69 Scopus citations

Abstract

Background: Nemolizumab, an anti–IL-31 receptor A mAb, 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). Objective: We sought to assess the 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). Methods: During part B, patients continued the previous nemolizumab dose (0.1, 0.5, or 2.0 mg/kg Q4W or 2.0 mg/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). Results: 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 64 weeks, 83% to 89% had 1 or more adverse events, with no new safety concerns identified. Conclusion: Nemolizumab for up to 64 weeks was efficacious and overall well tolerated in patients with moderate-to-severe atopic dermatitis inadequately controlled by topical therapy.

Original languageEnglish (US)
Pages (from-to)1121-1130.e7
JournalJournal of Allergy and Clinical Immunology
Volume142
Issue number4
DOIs
StatePublished - Oct 2018

Keywords

  • IL-31
  • IL-31 receptor
  • Monoclonal antibody
  • atopic dermatitis
  • nemolizumab
  • pruritus

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

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    Kabashima, K., Furue, M., Hanifin, J. M., Pulka, G., Wollenberg, A., Galus, R., Etoh, T., Mihara, R., Nakano, M., & Ruzicka, T. (2018). Nemolizumab in patients with moderate-to-severe atopic dermatitis: Randomized, phase II, long-term extension study. Journal of Allergy and Clinical Immunology, 142(4), 1121-1130.e7. https://doi.org/10.1016/j.jaci.2018.03.018