Real-World Effectiveness and Safety of Golimumab in Patients with Ulcerative Colitis: A Retrospective Cohort Study

<b>Background/Objectives:</b> Golimumab has proven efficacy in inducing and maintaining remission in moderate-to-severe ulcerative colitis (UC). This study evaluated the short-term and long-term effectiveness and safety of golimumab for the treatment of patients with active UC in Brazil. <b>Methods:</b> This observational, multicenter, retrospective, cohort study included patients with moderate-to-severe UC treated with golimumab. The primary outcome was corticosteroids-free clinical remission at weeks 24 and 54, defined as a partial Mayo score (PMS) of 0 or 1, without the need for corticosteroids (CS,) in continued treatment with golimumab. Secondary outcomes were clinical response, defined as a reduction in PMS of 50% or 3 points, and endoscopic remission, defined as a Mayo endoscopic subscore of 0. We also evaluated persistence with golimumab during follow-up. <b>Results:</b> Seventy-three patients were enrolled in the study. The rates of CS-free remission at weeks 24 and 54 were 43.8% and 63%, respectively. Clinical response was achieved in 50.7% and 71.2% of patients at weeks 24 and 48, respectively. Among patients undergoing endoscopic evaluation, CS-free endoscopic remission was observed in 80.8% of patients at week 24 and in 84.4% at week 54. The cumulative probability of retaining golimumab was 86.1% (95% CI 78-94) at 54 weeks. Adverse events leading to golimumab discontinuation occurred in three patients (4.1%). <b>Conclusions:</b> Golimumab was effective and safe as induction and maintenance therapy in patients with moderate-to-severe ulcerative colitis, leading to a high rate of persistence with golimumab maintenance after 1 year of follow-up.

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Journal
Journal of Clinical Medicine
Published
2025-09-26
DOI
https://doi.org/10.3390/jcm14196827
Primary Topic
Inflammatory Bowel Disease
Type
article
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article

Real-World Effectiveness and Safety of Golimumab in Patients with Ulcerative Colitis: A Retrospective Cohort Study

Renata de Sá Brito Fróes, Alexandre Venâncio, Carlos Henrique Marques dos Santos, Bruno César da Silva et al.
Journal of Clinical Medicine
Inflammatory Bowel Disease
article

Real-World Effectiveness and Safety of Golimumab in Patients with Ulcerative Colitis: A Retrospective Cohort Study

Renata de Sá Brito Fróes, Alexandre Venâncio, Carlos Henrique Marques dos Santos, Bruno César da Silva, Carlos Taxonera, Antônio José Tibúrcio Alves, Carlos Frederico Pereira Porto Alegre Rosa, Bianca Loyo Pona Schiavetti da Silva, Francisco Guilherme Cancela e Penna, Eduardo Federighi Baisi Chagas, Rodrigo Galhardi Gasparini, Cristina Flores, Caio César Furtado Freire, Rogério Serafim Parra, Hélio Rzetelna, Mikaell Alexandre Gouvêa Faria, Adriana Ribas Andrade, Sandro da Costa Ferreira, Richard Borba Magalhães
article en

Abstract

<b>Background/Objectives:</b> Golimumab has proven efficacy in inducing and maintaining remission in moderate-to-severe ulcerative colitis (UC). This study evaluated the short-term and long-term effectiveness and safety of golimumab for the treatment of patients with active UC in Brazil. <b>Methods:</b> This observational, multicenter, retrospective, cohort study included patients with moderate-to-severe UC treated with golimumab. The primary outcome was corticosteroids-free clinical remission at weeks 24 and 54, defined as a partial Mayo score (PMS) of 0 or 1, without the need for corticosteroids (CS,) in continued treatment with golimumab. Secondary outcomes were clinical response, defined as a reduction in PMS of 50% or 3 points, and endoscopic remission, defined as a Mayo endoscopic subscore of 0. We also evaluated persistence with golimumab during follow-up. <b>Results:</b> Seventy-three patients were enrolled in the study. The rates of CS-free remission at weeks 24 and 54 were 43.8% and 63%, respectively. Clinical response was achieved in 50.7% and 71.2% of patients at weeks 24 and 48, respectively. Among patients undergoing endoscopic evaluation, CS-free endoscopic remission was observed in 80.8% of patients at week 24 and in 84.4% at week 54. The cumulative probability of retaining golimumab was 86.1% (95% CI 78-94) at 54 weeks. Adverse events leading to golimumab discontinuation occurred in three patients (4.1%). <b>Conclusions:</b> Golimumab was effective and safe as induction and maintenance therapy in patients with moderate-to-severe ulcerative colitis, leading to a high rate of persistence with golimumab maintenance after 1 year of follow-up.

Journal of Clinical MedicineVol. 14(19)
Universidade Federal de Mato Grosso do Sul (BR), Universidade do Estado da Bahia (BR), Universidade de Ribeirão Preto (BR), Faculdade de Medicina de São José do Rio Preto (BR), Faculdade de Medicina de Marília (BR), Universidade Católica de Santos (BR), Hospital Clínico San Carlos (ES), D’Or Institute for Research and Education (BR), Nanomed (Brazil) (BR), Universidade de Marília (BR), Hospital São Rafael (BR), Hospital das Clínicas da Universidade Federal de Minas Gerais (BR), Universidade Metropolitana de Santos (BR), Faculdade de Medicina de Jundiaí (BR), Hospital Ana Nery (BR), Clinics Hospital of Ribeirão Preto (BR), Ordem dos Médicos (PT), Hospital Geral de Fortaleza (BR), Pontifícia Universidade Católica de Campinas (BR)
Openalex Percentile: Top 72%
Inflammatory Bowel Disease
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