A Hospital-Based Retrospective Study to Compare the Clinical and Endoscopic Effectiveness of Vedolizumab (VDZ) and Infliximab (IFX) in Biologic-Naïve Patients with Ulcerative Colitis at a Tertiary Care Centre

Background: The symptoms of ulcerative colitis (UC), a chronic inflammatory bowel illness, include tenesmus, hematochezia, and stomach pain. Globally, the incidence of UC has been increasing, especially in recently industrialized countries. Anti-TNF medications have significantly changed how moderate-to-severe UC is treated. In a retrospective, real-world, single-center study with a 52-week follow-up (FU), we assessed the efficacy of IFX and VDZ in two nearly identical cohorts of biologic-naïve patients with moderate-to-severe UC. Material and Methods: This was a hospital-based retrospective comparative observational study conducted at our tertiary care teaching hospital between January 2021 and December 2025. Data was obtained from hospital medical records department and pharmacy databases. The study duration was 6 months, including protocol approval, data collection, analysis, and report preparation. Participants were divided into two groups: Those receiving Vedolizumab (VDZ) were included in Group 1, while those getting Infliximab (IFX) were included in Group 2. Adult patients with ulcerative colitis who were not exposed to advanced therapies (biologics or small molecules) and who had at least the induction doses of VDZ or IFX administered intravenously (IV) in accordance with the standard induction protocol at 0, 2, and 6 weeks, followed by maintenance every 8 weeks. A 300 mg dose of VDZ and a 5 mg/kg dose of IFX were given. Patients who stopped therapy before week 52 because of primary non-response, subsequent loss of response, adverse events, or the requirement for surgery were included in the mean follow-up calculation. Results: We included 30 patients on IFX, 30 on VDZ, and 60 biologic-naïve patients based on the inclusion and exclusion criteria. Before the propensity score was applied, the mean age at diagnosis was higher in the VDZ than in the IFX group (mean age 48.5 vs. 36.8, p=0.001), but the propensity score analysis did not support this. At the end of follow-up (FU), 76.6% and 30% of patients on VDZ and IFX, respectively, achieved the primary end goal of clinical response (CR) (p<0.05*; OR:6.725; 95% CI 2.346–16.253). Additionally, the VDZ group had a greater response rate (80% vs. 53.3% for IFX, p<0.05*). There was a significant difference (p<0.05*) in the percentage of main non-response between the IFX group (30%) and the VDZ group (10%). The secondary response loss was comparable (p>0.05). Conclusion: For the majority of the predetermined goals (CR, persistence in therapy, clinical response at the end of induction, steroid-free remission, and requirement for optimization), VDZ outperformed IFX as a first-line treatment in biologic-naïve patients with UC in this retrospective real-life study.

Keywords: Ulcerative colitis (UC), infliximab (IFX), vedolizumab (VDZ), Partial mayo score (PMS), Clinical Response (CR).