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<p>Nemolizumab, a monoclonal antibody targeting the IL-31 receptor α subunit, has emerged as a potential therapeutic option for atopic dermatitis (AD). This meta-analysis aimed to comprehensively evaluate the efficacy and safety of nemolizumab compared with placebo in patients with AD. A systematic search was performed in Europe PMC, Medline, Scopus, and the Cochrane Library, covering all studies published up to October 8th, 2025. Only randomized controlled trials (RCTs) comparing nemolizumab with placebo in patients with AD were included. Data were synthesized using a random-effects model, and outcomes were expressed as odds ratios (ORs) and mean differences (MDs). Six RCTs comprising 2,470 participants were included. Nemolizumab significantly improved clinical and patient-reported outcomes, including IGA success (OR 1.71; 95%CI 1.40–2.09), EASI reduction (MD -12.46%; 95%CI -16.93, -7.99), and SCORAD improvement (MD -9.01; 95%CI -11.42, -6.61). Pruritus-related outcomes also favored nemolizumab, with greater VAS reduction (MD -26.30%; 95%CI -28.96, -23.65) and a higher rate of ≥ 4-point reduction in pruritus VAS (OR 3.32; 95%CI 2.68–4.12). Nemolizumab improved DLQI (MD -2.40; 95%CI -3.00, -1.80) and reduced the need for rescue medications (OR 0.49; 95%CI 0.25–0.93). No significant differences were observed in TEAEs, serious AEs, or treatment discontinuations. Nemolizumab demonstrates superior efficacy and comparable safety to placebo for managing atopic dermatitis, supporting its role as a promising biologic therapy in AD management.</p>

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Efficacy, safety, and quality-of-life outcomes with nemolizumab in atopic dermatitis: a meta-analysis of randomized controlled trials

  • 期刊论文

  • 发表日期：

    2026年7月20日

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  • Medisiana Sukses Soenoe,
  • Sukses Hadi

摘要

Nemolizumab, a monoclonal antibody targeting the IL-31 receptor α subunit, has emerged as a potential therapeutic option for atopic dermatitis (AD). This meta-analysis aimed to comprehensively evaluate the efficacy and safety of nemolizumab compared with placebo in patients with AD. A systematic search was performed in Europe PMC, Medline, Scopus, and the Cochrane Library, covering all studies published up to October 8th, 2025. Only randomized controlled trials (RCTs) comparing nemolizumab with placebo in patients with AD were included. Data were synthesized using a random-effects model, and outcomes were expressed as odds ratios (ORs) and mean differences (MDs). Six RCTs comprising 2,470 participants were included. Nemolizumab significantly improved clinical and patient-reported outcomes, including IGA success (OR 1.71; 95%CI 1.40–2.09), EASI reduction (MD -12.46%; 95%CI -16.93, -7.99), and SCORAD improvement (MD -9.01; 95%CI -11.42, -6.61). Pruritus-related outcomes also favored nemolizumab, with greater VAS reduction (MD -26.30%; 95%CI -28.96, -23.65) and a higher rate of ≥ 4-point reduction in pruritus VAS (OR 3.32; 95%CI 2.68–4.12). Nemolizumab improved DLQI (MD -2.40; 95%CI -3.00, -1.80) and reduced the need for rescue medications (OR 0.49; 95%CI 0.25–0.93). No significant differences were observed in TEAEs, serious AEs, or treatment discontinuations. Nemolizumab demonstrates superior efficacy and comparable safety to placebo for managing atopic dermatitis, supporting its role as a promising biologic therapy in AD management.