Anti-IL-5 treatment reduces infection-related adverse events: A meta-analysis of phase 3 clinical trials.

Abstract

Background: Though multiple meta-analyses have evaluated the efficacy and safety of anti-IL5 monoclonal antibody therapy, few studies have made detailed, specific assessments of adverse events and infectious diseases (ID) adverse events.

Objective: To conduct a meta-analysis to evaluate the effect of anti-IL5 therapy on ID adverse events.

Methods: A meta-analysis was undertaken using 27 randomized, placebo-controlled phase 3 clinical trials. Detailed information on ID events was extracted, as well as study demographics. ID events were recorded as serious events and non-serious events as they appeared in the clinical trial record in clinicaltrials.gov. ID events were then classified into clinical and microbiologic groups.

Results: Anti IL-5 therapy significantly reduced serious bacterial infections [RR = 0.808, 95% CI = 0.667 - 0.978] and pneumonias [RR = 0.806, 95% CI = 0.650 - 0.998]. Anti-IL5 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 C.difficile infection (p=0.025). Non-serious gastroenteritis was increased in those on anti-IL5 therapy [RR = 1.754, 95% CI = 1.087 - 2.830].

Conclusions: Anti-IL5 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-IL5 therapy, these effects may translate into substantial decreases in healthcare utilization.