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.

Keywords: Crohn’s Disease; biologics; comparison; meta-analysis; ustekinumab; vedolizumab.

Figure 1

PRISMA flow chart of the literature search and selection process.

Figure 2

(A) Risk of bias summary: review of authors’ judgment about each risk of bias item for each included study, and (B) Risk of bias graph: review of authors’ judgment about each risk of bias item presented as percentages across all included studies.

Figure 3

(A) Forest plot showing odd ratios and (B) funnel plot for 52 weeks (w) steroid-free remission (SF). (C) Forest plot showing odds ratios and (D) funnel plot for 12w-SF remission. (E) Forest plot showing odds ratios and (F) funnel plot for 24 w-SF remission in ustekinumab (UST) and vedolizumab (VDZ).

Figure 4

(A) Forest plot showing odds ratios and (B) funnel plot for 1-year drug discontinuation in ustekinumab (UST) and vedolizumab (VDZ).

Figure 5

(A) Forest plot showing odd ratios and (B) funnel plot for adverse events. (C) Forest plot showing odds ratios and (D) funnel plot for 1-year severe infection. (E) Forest plot showing odds ratios and (F) funnel plot for 1-year hospitalization in ustekinumab (UST) and vedolizumab (VDZ).