Nemolizumab in patients with moderate-to-severe atopic dermatitis : randomized, phase II, long-term extension study
| Autor: | Miwa Nakano, Grazyna Pulka, Masutaka Furue, Thomas Ruzicka, Kenji Kabashima, Ryosuke Mihara, Andreas Wollenberg, Ryszard Galus, Takafumi Etoh, Jon M. Hanifin |
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| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
Monoclonal antibody medicine.medical_specialty Nemolizumab nemolizumab Visual analogue scale Immunology IL-31 Antibodies Monoclonal Humanized Eczema Area and Severity Index Dermatitis Atopic 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Double-Blind Method Internal medicine Anti-Allergic Agents Humans Immunology and Allergy Medicine SCORAD Adverse effect Body surface area medicine.diagnostic_test atopic dermatitis business.industry Atopic dermatitis Dermatology Life Quality Index pruritus medicine.disease Treatment Outcome 030104 developmental biology IL-31 receptor Sleep business |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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