Abstract
BACKGROUND AND AIMS: Eculizumab is expected to lead to increased susceptibility to infection. We performed a meta-analysis of data from randomized controlled trials (RCTs) to determine the risk of infection in eculizumab-treated patients. METHODS: We searched PubMed, EMBASE, Web of Science and ClinicalTrials.gov (up to 8 Oct 2024) to identify published RCTs that focused on the occurrence of infection in patients treated with eculizumab regardless of the indications of the patients. Relative risks and 95% confidence intervals (95% CIs) were calculated via the random effects model. (PROSPERO Code No. CRD42024562470). RESULTS: Nine RCTs including 691 patients were eligible. Compared with the control (placebo or standard of care), eculizumab did not significantly increase the overall risk of infection (RR = 1.07; 95% CI, 0.89-1.28; I (2) = 44%), regardless of whether the infection was a general infection (RR = 1.07; 95% CI, 0.86-1.34; I (2) = 39%) or a serious infection (RR = 1.05; 95% CI, 0.75-1.47; I (2) = 11%). Analyses of subgroups revealed that eculizumab significantly increased the risk of general urinary system infection (RR = 1.33; 95% CI, 1.00-1.77; I (2) = 46%) and severe bacteremia (RR = 2.31; 95% CI, 1.04-5.13; I (2) = 0%). CONCLUSION: Compared with placebo or standard of care, although eculizumab did not significantly increase the overall risk of infection, it was associated with 33% and 131% increases in the risk of general urinary system infection and severe bacteremia, respectively. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42024562470.