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

• 椛島, 健治

• Furue, Masutaka

• Hanifin, Jon M.

• Pulka, Grazyna

• Wollenberg, Andreas

• Galus, Ryszard

• Etoh, Takafumi

• Mihara, Ryosuke

• Nakano, Miwa

• Ruzicka, Thomas

抄録

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.

収録刊行物

• Journal of Allergy and Clinical Immunology

  Journal of Allergy and Clinical Immunology 142 (4), 1121-1130, 2018-10

  Elsevier BV

キーワード

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

詳細情報

• CRID: 1050282813190335616
• NII論文ID: 120006601464
• ISSN: 00916749
• ISSN: 10976825
• HANDLE: 2433/240654
• 本文言語コード: en
• 資料種別: journal article
• データソース種別:
  • IRDB
  • CiNii Articles