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Real-world effectiveness and safety of golimumab in ulcerative colitis: multicenter experience from Chile
Paulina Núñez1, Rodrigo Quera2, Karin Herrera3
1Inflammatory Bowel Disease Program, Digestive Disease Center, Clinica de la Universidad de los Andes, Santiago, Chile; Inflammatory Bowel Disease Program, Hospital San Juan de Dios, Santiago, Chile; Universidad de Chile, Facultad de Medicina Occidente, Santiago, Chile.
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.
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Inflammatory Bowel Disease II: Ulcerative Colitis
Inflammatory Bowel Disease I: Ulcerative Colitis
Inflammatory bowel disease, or IBD, encompasses a group of disorders characterized by chronic inflammation or ulceration of the gastrointestinal tract.
Risk Factors
The exact cause of IBD remains unclear, although it is believed to be due to a mix of genetic, environmental, microbial, and immune factors. Genetic factors are significant in determining susceptibility to IBD, with family history being a critical risk factor. Individuals with a first-degree relative who has IBD are at...