Comparative effectiveness of infliximab vs vedolizumab as first-line biologic therapy in moderate-to-severe ulcerative colitis: A prospective, multicenter, real-world study.

BACKGROUND

In real-world clinical settings, direct comparative evidence on the effectiveness of infliximab vs vedolizumab for biologic-naïve patients with moderate-to-severe ulcerative colitis remains limited.

METHODS

This prospective, multicenter, real-world study enrolled patients with moderate-to-severe ulcerative colitis who were biologic-naïve and began using infliximab or vedolizumab from January 2023 to November 2024. To reduce confounding, inverse probability of treatment weighting was applied. The primary outcome was a composite of 14-week clinical remission and 52-week endoscopic remission. The secondary endpoints encompassed clinical response/remission, endoscopic response/remission, and clinical steroid-free remission at weeks 14 and 30; clinical remission, endoscopic remission, and clinical steroid-free remission at week 52; and the therapeutic continuation rate and adverse events rate across the complete observation period.

RESULTS

In total, 251 eligible patients were enrolled. After inverse probability of treatment weighting, vedolizumab was significantly superior to infliximab for the composite endpoint (60.18% vs 39.52%; P = .003). Significantly greater proportions of patients in the vedolizumab group attained clinical remission (84.80% vs 66.49%; P = .003), steroid‑free clinical remission (75.87% vs 59.57%; P = .015), endoscopic response (70.43% vs 52.44%; P = .008), and endoscopic remission (70.43% vs 52.44%; P = .008) at week 14 relative to the infliximab group. Effectiveness endpoints were comparable between groups at week 30. At week 52, vedolizumab remained significantly superior in clinical remission (78.39% vs 57.38%; P = .003), clinical steroid-free remission (75.96% vs 53.39%; P = .002), and endoscopic remission (66.03% vs 51.12%; P = .042). The rate of adverse events did not differ significantly between the vedolizumab and infliximab groups (5.47% vs 7.57%; P = .56).

CONCLUSIONS

Among patients with moderate-to-severe ulcerative colitis who have not been treated with biologics before, vedolizumab-first therapy showed superior short- and long-term effectiveness vs infliximab-first therapy, with comparable safety profiles. Vedolizumab could serve as the initial biologic agent for moderate‑to‑severe ulcerative colitis.NCT06962020; Selection and Efficacy-Inducing Factors of First-Line Biologic Agents in Moderate-to-Severe Ulcerative Colitis; https://clinicaltrials.gov/study/NCT06962020.