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Opportunistic Infections in Patients with Inflammatory Bowel Disease Treated with Advanced Therapies: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

BACKGROUND & AIM
Advanced therapies for inflammatory bowel disease (IBD) could potentially lead to a state of immunosuppression with an increased risk of opportunistic infections (OIs). We aimed to update on the incidence of OIs among adult IBD patients in randomized controlled trials (RCTs) of approved biologics and small-molecule drugs (SMDs). Also, we aim to describe OIs definitions utilized in RCTs, to ultimately propose a standardized definition.


METHODS
Electronic databases were searched from January 1, 1990, until April 16, 2022. Our primary outcome was incidence rate of overall OIs among IBD patients exposed and unexposed to biologics or SMDs. We also described specific OIs reported in included trials, as well as definitions of OIs within studies when provided.


RESULTS
90 studies were included. The incidence rate of reported OIs were 0.42 and 0.21 per 100 person-years in patients exposed to advanced therapies and placebo, respectively. This was highest for anti-TNFs (0.83 per 100 person-years) and JAK inhibitors (0.55 per 100 person-years) and lowest for anti-integrins and ozanimod. On meta-analysis, no increased risk of OIs was observed. None of the studies provided a detailed definition of OIs, or a comprehensive list of infections considered as OIs.


CONCLUSION
Different mechanisms of action may have specific OIs profiles. In the absence of a uniform definition of OIs, these estimates are less reliable. We propose a definition to be used in future studies to help standardized reporting. When using this definition, we saw significant differences in incidence rates of OIs across mechanisms of action.