Clinical effectiveness and safety of vedolizumab versus infliximab in biologic-naïve patients with ulcerative colitis: A comparative real-world multicentric observational study

• Main Author: da Costa Ferreira, Sandro
• Publication Date: 2025
• Other Authors: Parra, Rogério Serafim, Sassaki, Ligia Yukie [UNESP], Parente, José Miguel Luz, de Mello, Munique Kurtz, Chebli, Liliana Andrade, Luporini, Rafael Luís, Alves Junior, Antonio José Tiburcio, Firmino Nóbrega, Fernando Jorge, da Silva, Bruno César, Miranda, Eron Fábio, Quaresma, Abel Botelho, Nicollelli, Guilherme Mattioli, Gasparini, Rodrigo Galhardi, Dutra, Renata de Medeiros [UNESP], Vasconcelos, Juarez Roberto de Oliveira, da Silva, Katia da Conceição, Magro, Daniéla Oliveira, Imbrizi, Marcello Rabello, Nagasako, Cristiane Kibune, Féres, Omar, Troncon, Luiz Ernesto de Almeida, Kotze, Paulo Gustavo, Chebli, Júlio Maria Fonseca
• Format: Article
• Language: eng; spa
• Source: Repositório Institucional da UNESP
• Download full: http://dx.doi.org/10.1016/j.gastrohep.2025.502396; https://hdl.handle.net/11449/301334
• topic: Inflammatory bowel disease; Infliximab; Ulcerative colitis; Vedolizumab

Objective: Vedolizumab (VDZ) and infliximab (IFX) are first-line therapies for moderate-to-severe ulcerative colitis (UC). Despite their widespread use, there are no direct comparative studies, and real-world data, particularly in Latin America, are limited. This study compared the effectiveness and safety of VDZ and IFX in biologic-naïve UC patients. Methods: This retrospective cohort study included patients with moderate-to-severe UC (Mayo score 6–12, endoscopic sub-score ≥2) treated with VDZ or IFX. Primary endpoints were clinical remission (partial Mayo score ≤2), endoscopic remission (Mayo sub-score = 0), and steroid-free clinical remission at week 52. Secondary endpoints included clinical response, endoscopic response, biological therapy optimization, adverse events (AEs), hospitalizations, and biochemical remission at week 52. Propensity score adjustment (1/PS) was used to adjust for potential confounders. Results: A total of 297 UC patients (156 IFX, 141 VDZ) were analyzed. Clinical remission at week 52 was 82.3% for VDZ and 77.6% for IFX (p = 0.11), while endoscopic remission was higher in VDZ patients (47.4% vs. 33.1%, p = 0.03). Steroid-free clinical remission rates were similar between groups (p = 0.98). Endoscopic response at week 52 favored VDZ (78.4% vs. 62.7%, p < 0.001), and VDZ had higher treatment persistence (80.8% vs. 61.8%, p < 0.001). AEs and hospitalizations were more frequent in IFX patients (p < 0.001). Conclusions: Both VDZ and IFX are effective in biologic-naïve UC patients, however VDZ demonstrated superior endoscopic outcomes, higher treatment persistence, and a better safety profile, supporting its use as a first-line therapy.