Real-world effectiveness and safety of golimumab in ulcerative colitis: multicenter experience from Chile.

Abstract

Objectives: Evidence on golimumab for ulcerative colitis (UC) is scarce in Latin America. We aimed to assess the real-world effectiveness and safety of golimumab in a multicenter Chilean cohort.

Materials and methods: We conducted a retrospective, observational study including adult patients with moderate-to-severe UC treated with golimumab under the Chilean government coverage program (July 2019-August 2023). Clinical, biomarker, endoscopic, and histological outcomes were evaluated at weeks 16 and 52. Dose optimization strategies and adverse events (AEs) were recorded.

Results: Seventy-nine patients were included (69.6% women; median disease duration 8 years). Most were anti-TNF naïve (94%). At week 16.81% achieved symptomatic remission, 77% biomarker remission, 35% endoscopic remission, and 38% histological remission. At week 52, 43 patients remained on treatment; of these, 93% achieved symptomatic remission, 98% biomarker remission, 63% endoscopic remission, and 42% histological remission. Dose optimization was required in 62% of patients, and early optimization was associated with higher remission stability. Kaplan-Meier analysis showed 75% clinical remission at 24 months. Adverse events were infrequent, with no colectomies reported.

Conclusions: In this first Chilean and Latin American multicenter real-world study, golimumab proved effective and safe for moderate UC, achieving high rates of clinical and biomarker remission, particularly with early dose optimization. Despite newer biologics and small molecules, golimumab remains a valid therapeutic option in regions with limited access.