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. 2025 Apr 28:16:1538563.
doi: 10.3389/fphar.2025.1538563. eCollection 2025.

Incidence of infection associated with eculizumab: a meta-analysis of 9 randomized controlled trials

Aidou Jiang  1 , Ying Liu  1 , Chunyan Wei  1 , Guirong Xiao  1
Affiliations

Incidence of infection associated with eculizumab: a meta-analysis of 9 randomized controlled trials

Aidou Jiang et al. Front Pharmacol. .

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.

Keywords: bacteremia; eculizumab; infection; meta-analysis; urinary tract infection.

PubMed Disclaimer

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flow diagram: randomized controlled trials included and excluded from this meta-analysis. RCTs, randomized controlled trials.
FIGURE 2
FIGURE 2
Forest plot with meta-analysis of the overall risk of infection.
See this image and copyright information in PMC

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