Type of publication:
Systematic Review
Author(s):
Bharadwaj H.; Perros I.; Biggs D.; *Butterworth J.; Gohar F.; Mallen C.; Sokhal B.S.;
Citation:
United European Gastroenterology Journal. Conference: The 33rd United European Gastroenterology Week, UEGW 2025. Berlin Germany. 13(Supplement_8) (pp 466), 2025. Date of Publication: 01 Oct 2025.
Abstract:
Introduction: Biological therapies have improved remission rates in Ulcerative colitis (UC) and are superior to standard treatment. This systematic review and meta-analysis of randomised controlled trials (RCTs) aimed to estimate the risk of major adverse cerebrovascular and cardiovascular events (MACCE) in adult UC patients receiving biologics. Aims & Methods: MEDLINE, EMBASE and Cochrane were searched to identify RCTs that investigated the risk of MACCE in UC induction and maintenance trials. Data were pooled and analysed using random effects modelling with 95% confidence intervals (CIs). This study followed the Preferred Reporting items for Systematic Reviews and Meta-Analyses. Result(s): 31 studies were retrieved from inception to November 2024. 54 RCTs were included, describing 29 induction and 25 maintenance phases. A total of 26,114 patients were included, with 17,271 (66.1%) receiving biologic agents or small molecules. The risk of MACCEs was not higher in induction (OR=0.62, 95%CI:0.32,1.18, P=0.14) or maintenance trials (OR=0.57, 95%CI:0.28,1.18, P=0.13) compared to placebo or active comparators. No drug agent, drug class or trial duration incurred a higher risk of MACCEs. Overall, those treated with biologic agents and small molecules had a lower MACCE risk (OR=0.60, 95%CI:0.37,0.97, P<0.05). Heterogeneity for all outcomes and subgroups was low (I2=0.00%, P=1.00). Conclusion(s): Biologics were not associated with risk of MACCE. Longer follow- up studies with real-world data are required to confirm these findings outside the RCT setting.
DOI: 10.1002/ueg2.70032
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