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

TL;DR

This study shows that golimumab is effective and safe for treating moderate-to-severe ulcerative colitis in Brazil, with many patients achieving remission and staying on the drug for over a year.

Contribution

The study provides real-world evidence of golimumab's effectiveness and safety in a Brazilian UC patient cohort over short and long terms.

Findings

63% of patients achieved corticosteroid-free remission at 54 weeks.

86.1% of patients remained on golimumab after 54 weeks.

Only 4.1% of patients discontinued golimumab due to adverse events.

Abstract

Background/Objectives: 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. Methods: 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. Results: 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%). Conclusions: 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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