Comparison of the Safety and Efficacy of Ustekinumab and Vedolizumab in Patients with Crohn's Disease: A Systematic Review and Meta-Analysis of Propensity Score Matched Cohort Studies.

Abstract

Background: Ustekinumab and vedolizumab represent both valid therapeutic options in patients with Crohn's Disease. Data comparing the safety and efficacy of these drugs are indirect, with conflicting results reported. We aim to conduct a systematic review and metanalysis to assess the safety and effectiveness profile of ustekinumab and vedolizumab in patients with Crohn's Disease, including only studies that applied propensity scores to reduce confounding bias. Methods: We identified 59 reports that compared ustekinumab and vedolizumab after a propensity score match analysis, of which 16 were assessed for eligibility, and finally, ten retrospective studies were included. The main outcomes considered were clinical steroid-free remission at 14 ± 4, 24 ± 4, and 52 ± 4 weeks, drug discontinuation rate, adverse events, serious infections, and hospitalization during the first year of treatment. Results: A total of 4398 patients were treated with ustekinumab (n = 2774, 63.1%) or vedolizumab (1624, 36.9%). Steroid-free clinical remission was not significantly different between ustekinumab and vedolizumab at 12 ± 4 weeks (OR 1.31, 95%CI 0.88-1.94, p = 0.180), at 24 ± 4 weeks (OR 1.18, 95%CI 0.79-1.75, p = 0.420), and at 52 ± 4 weeks (1.35, 95%CI 0.91-2.01, p = 0.140). In patients receiving ustekinumab, the rate of adverse events (OR 0.54, 95%CI 0.35-0.83, p = 0.005), infection (OR 0.61, 95%CI 0.47-0.80, p < 0.001) and the need of hospitalization at 1-year (OR 0.68, 95%CI 0.58-0.80, p < 0.001) 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 hospitalization during the first year of treatment.