Effectiveness of golimumab in patients with ulcerative colitis: results of a real-life study in Switzerland.

Background: Tumor necrosis factor (TNF) inhibitors have improved treatment of ulcerative colitis (UC), but loss of response remains a frequent problem. The anti-TNF agent, golimumab, was approved in Switzerland for the treatment of UC in 2014. This study aims to summarize the experience of golimumab in a real-world setting in Switzerland. Methods: We analyzed real-world data from 1769 UC patients from the Swiss Inflammatory Bowel Disease Cohort (SIBDC) study and performed a chart review of golimumab-treated patients. We extracted the partial Mayo score at t₀ (baseline), t₁ (2–16 weeks), t₂ (17–35 weeks), and t₃ (36–89 weeks). The primary endpoint was clinical response at t₁, defined as marked improvement in partial Mayo score and objective parameters. Clinical remission was defined as resolution of symptoms and normalization of objective parameters. Results: Our chart review included 103 UC patients with golimumab treatment (5.8% of all SIBDC UC patients); only 16 (15.5%) were anti-TNF naïve. Sixty-three patients remained on golimumab (61.2%) after 180 days, 51 (44.7%) after 365 days, and 34 (33%) after 630 days after the start of treatment. Upon golimumab treatment, the partial Mayo score decreased from 4 [interquartile range (IQR): 2–6] at t₀ to 2 (IQR: 0–4) at t₁, 1 (IQR: 0–3.5) at t₂, and 1 (IQR: 0–3) at t₃ (p < 0.001 for all comparisons with t₀). The primary endpoint, clinical response at t₁, could be evaluated in 52 patients and was met in 15 individuals (28.8%). Clinical remission at t₁ was observed in 8 out of 52 patients (15.4%). Golimumab was generally well tolerated, one patient developed meningitis. The most frequent reasons to stop treatment were primary and secondary non-response. Conclusion: Golimumab was used in 5.8% of Swiss UC patients, mainly in biologic-experienced individuals. Golimumab treatment was associated with a sustained reduction of symptoms and clinical response in approximately 30% of patients. [ClinicalTrials.gov identifier: NCT00488631] [ABSTRACT FROM AUTHOR]