Risk of Infection in Patients With Inflammatory Bowel Disease Treated With Interleukin-Targeting Agents: A Systematic Review and Meta-Analysis

Konstantinos Ouranos; Hira Saleem; Stephanos Vassilopoulos; Athanasios Vassilopoulos; Evangelia K Mylona; Fadi Shehadeh; Markos Kalligeros; Bincy P Abraham; Eleftherios Mylonakis

doi:10.1093/ibd/izae031

Risk of Infection in Patients With Inflammatory Bowel Disease Treated With Interleukin-Targeting Agents: A Systematic Review and Meta-Analysis

Inflamm Bowel Dis. 2024 Mar 1:izae031. doi: 10.1093/ibd/izae031. Online ahead of print.

Affiliations

¹ Department of Medicine, Houston Methodist Research Institute, Houston, TX, USA.
² Department of Medicine, Rhode Island Hospital, Warren Alpert Medical School of Brown University, Providence, RI, USA.
³ Department of Electrical and Computer Engineering, School of Electrical and Computer Engineering, National Technical University of Athens, Athens, Greece.
⁴ Division of Gastroenterology and Hepatology, Department of Medicine, Lynda K. and David M. Underwood Center for Digestive Disorders, Houston Methodist Hospital, Houston, TX, USA.
⁵ Department of Medicine, Weill Cornell Medicine, New York, NY, USA.

PMID: 38427714
DOI: 10.1093/ibd/izae031

Abstract

Background: Patients with inflammatory bowel disease (IBD) are at increased risk of infection. The aim of this study was to assess the cumulative incidence and risk of infection in patients with IBD treated with interleukin (IL)-targeting agents.

Methods: We searched PubMed, EMBASE, and Web of Science for randomized controlled trials including patients with IBD receiving IL-targeting agents compared with patients receiving placebo or treatment that only differed from the intervention arm in the absence of an IL-targeting agent. The primary outcome of interest was the relative risk (RR) of any-grade and severe infection during the induction phase.

Results: There was no difference in risk of any-grade (RR, 0.98; 95% confidence interval [CI], 0.89-1.09) or severe (RR, 0.64; 95% CI, 0.38-1.10) infection in patients receiving any IL-targeting agent compared with the control group. During the maintenance period, the cumulative incidence of any-grade infection in patients receiving IL-12/23p40-targeting agents (mean follow-up 29 weeks) was 34.82% (95% CI, 26.78%-43.32%), while the cumulative incidence of severe infection was 3.07% (95% CI, 0.93%-6.21%). The cumulative incidence of any-grade infection in patients receiving IL-23p19-targeting agents (mean follow-up 40.9 weeks) was 32.16% (95% CI, 20.63%-44.88%), while the cumulative incidence of severe infection was 1.75% (95% CI, 0.60%-3.36%). During the maintenance phase of the included studies, the incidence of infection was 30.66% (95% CI, 22.12%-39.90%) for any-grade and 1.59% (95% CI, 0.76%-2.63%) for severe infection in patients in the control group.

Conclusions: There was no difference in risk of infection between patients with IBD who received IL-targeting agents compared with the control group. Case registries and randomized controlled trials reporting the safety of IL inhibitors should provide detailed information about the risk of specific infectious complications in patients with IBD receiving IL-targeting agents.

Keywords: infection; interleukin inhibitor; randomized controlled trial.

Plain language summary

Patients with inflammatory bowel disease treated with interleukin-targeting agents are not more likely to develop any-grade or severe infection compared with patients with inflammatory bowel disease receiving placebo or treatment that only differs in the absence of an interleukin-targeting agent.