Clinical effectiveness and safety of vedolizumab versus infliximab in biologic-naïve patients with ulcerative colitis: A comparative real-world multicentric observational study
Year: 2025
Type: article
Study design: Observational Study
Abstract: 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.
Authors: Sandro da Costa Ferreira, Rogério Serafim Parra, Ligia Yukie Sassaki, José Miguel Luz Parente, Munique Kurtz de Mello, Liliana Andrade Chebli, Rafael Luís Luporini, Antonio José Tiburcio Alves Junior, Fernando Jorge Firmino Nóbrega, Bruno César da Silva, Eron Fábio Miranda, Abel Botelho Quaresma, Guilherme Mattioli Nicollelli, Rodrigo Galhardi Gasparini, Renata de Medeiros Dutra, Juarez Roberto de Oliveira Vasconcelos, Katia da Conceição da Silva, Daniéla Oliveira Magro, Marcello Rabello Imbrizi, Cristiane Kibune Nagasako, Omar Féres, Luiz Ernesto de Almeida Troncon, Paulo Gustavo Kotze, Júlio Maria Fonseca Chebli
Institutions: Universidade de São Paulo, Universidade Estadual Paulista (Unesp), Universidade Federal do Piauí, Universidade Federal de Juiz de Fora, Universidade Federal de São Carlos, Pontifícia Universidade Católica do Paraná, Universidade do Oeste de Santa Catarina, Universidade Federal do Paraná, Universidade Estadual de Campinas (UNICAMP)
Language: English
Topic: Inflammatory Bowel Disease
Subfield: Genetics
Domain: Life Sciences
Open Access status: hybrid
Estimated APC paid: $3,074
OpenAlex ID: W4415628710