Anti-IL-5 Treatment Reduces Infection-Related Adverse Events: A Meta-Analysis of Phase 3 Clinical Trials.

Abstract

Although multiple meta-analyses have evaluated the efficacy and safety of anti-IL-5 mAb therapy, few studies have made detailed, specific assessments of adverse events and infectious disease (ID) adverse events. To conduct a meta-analysis to evaluate the effect of anti-IL-5 therapy on ID adverse events. We undertook a meta-analysis using 27 randomized, placebo-controlled phase 3 clinical trials. Detailed information on ID events was extracted, as well as study demographics. We recorded ID events as serious events and non-serious events as they appeared in the clinical trial record in ClinicalTrials.gov. The ID events were then classified into clinical and microbiologic groups. Anti-IL-5 therapy significantly reduced serious bacterial infections (relative risk [RR] = 0.808; 95% CI, 0.667-0.978) and pneumonia (RR = 0.806; 95% CI, 0.650-0.998). Anti-IL-5 therapy also significantly reduced influenza infection (RR = 0.817; 95% CI, 0.674-0.991), sinusitis (RR = 0.807; 95% CI, 0.685-0.951), non-serious lower respiratory tract infections (RR = 0.787; 95% CI, 0.656-0.943), and Clostridium difficile infection (P = .025). Non-serious gastroenteritis was increased in patients receiving anti-IL-5 therapy (RR = 1.754; 95% CI, 1.087-2.830). Anti-IL-5 therapy significantly reduces adverse events categorized as serious bacterial infections, pneumonia, influenza, non-serious lower respiratory tract infections, and C difficile infection. In the population of patients receiving anti-IL-5 therapy, these effects may translate into substantial decreases in health care use.