Comparative Efficacy and Safety of Anti-Interleukin-5 Therapies and Placebo in Patients with Uncontrolled Eosinophilic Asthma:

  • ANDO Koichi
    Department of Medicine, Division of Respiratory Medicine and Allergology, Showa University School of Medicine Showa University Dental Hospital Medical Clinic
  • TANAKA Akihiko
    Department of Medicine, Division of Respiratory Medicine and Allergology, Showa University School of Medicine
  • KUSUMOTO Sojiro
    Department of Medicine, Division of Respiratory Medicine and Allergology, Showa University School of Medicine
  • YAMAOKA Toshimitsu
    Institute of Molecular Oncology, Showa University
  • OHMORI Tohru
    Institute of Molecular Oncology, Showa University
  • OHNISHI Tsukasa
    Department of Medicine, Division of Respiratory Medicine and Allergology, Showa University School of Medicine
  • INOUE Shin
    Showa University Dental Hospital Medical Clinic
  • SAGARA Hironori
    Department of Medicine, Division of Respiratory Medicine and Allergology, Showa University School of Medicine

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  • A Systematic Review and Meta-analysis of Phase 3 Trials

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The overall efficacy and safety of anti-interleukin (IL)-5 therapies at currently recommended dosages and administration remain to be fully characterized. The present study was a meta-analysis of Phase 3 trials of the efficacy and safety of anti-IL-5 therapies at the currently recommended dosages and administration compared with placebo in patients with uncontrolled eosinophilic asthma. This meta-analysis complied with the PRISMA guidelines. The primary efficacy outcome was asthma exacerbation rate, and the primary safety outcomes included the incidence rates of all adverse events, asthma worsening, and injection site reactions. A subgroup analysis was also performed according to the type of anti-IL-5 agent. Pooled estimates are presented as rate ratios or relative risks (RRs) with 95% confidence intervals (CIs). Analyses included intention-to-treat cases. Six randomized controlled trials of anti-IL-5 therapies met the inclusion criteria. The overall rate ratio for asthma exacerbation was 0.54 (95% CI 0.47-0.61). The RRs (95% CIs) for the incidence of all adverse events, asthma worsening, and injection site reactions compared with placebo were 0.93 (0.89-0.96), 0.63 (0.56-0.72), and 1.59 (0.95-2.65), respectively. The subgroup analysis revealed that the incidence of injection site reactions was significantly higher among mepolizumab- than placebo-treated patients, with an RR of 2.56 (95% CI 1.15-5.68). These results suggest that anti-IL-5 therapies at the currently recommended dosages and administration are effective and generally well tolerated in patients with uncontrolled eosinophilic asthma. However, the occurrence of injection site reactions warrants specific attention, especially concerning mepolizumab administration.

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