Abstract

Abstract Background Ustekinumab and vedolizumab represent both valid therapeutic options in patients with Crohn’s Disease following anti-TNF failure. Comparison data regarding safety and efficacy between these drugs are indirect, and reports conflicting results. The aim of the study was to assess the safety and efficacy profile of ustekinumab and vedolizumab in patients with Crohn’s Disease who failed prior anti-TNF treatment, including studies that applied propensity score matching to reduce confounding bias. Methods We identified 52 reports that compared ustekinumab and vedolizumab after a propensity score match analysis, of which 14 were assessed for eligibility, and finally 8 retrospective studies were included. The main outcomes considered were clinical steroid-free remission at 14±4, 24±4, and 52±weeks, drug discontinuation rate, adverse events, serious infections, and hospitalisation during the first year of treatment. Results A total of 3,185 patients were treated with ustekinumab (n=1,906, 59.8%) or vedolizumab (n=1,279, 40.2%). Steroid-free clinical remission was not significantly different between ustekinumab and vedolizumab at 12±4 weeks (OR 1.14, 95CI 0.76-1.72), at 24±4 weeks (OR 0.92, 95CI 0.56-1.51, p=0.73), and at 52±4 weeks (1.07, 95CI 0.73-1.56, p=0.75). Risk of adverse events was not different between the two drugs (OR 0.65, CI95 0.30-1.41, p=0.28). In patients receiving ustekinumab, the rate of infection (OR:0.52, CI95 0.30-0.91, p=0.02) and the need of hospitalisation at 1-year (OR:0.68, CI95 0.57-0.81, p<0.0001) appeared to be lower. Conclusion Ustekinumab and vedolizumab do not significantly differ in inducing and maintaining clinical steroid-free remission, while ustekinumab was associated with a lower risk of serious infections and hospitalisation during the first year of treatment.

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