Two-year effectiveness and safety of golimumab in ulcerative colitis: An IG-IBD study

Background: Few data exist regarding the long-term effectiveness of golimumab in ulcerative colitis. No data have been reported on real-world continuous clinical response. Objective: This study aimed to describe the long-term outcomes in a large cohort of patients on golimumab who had ulcerative colitis. Methods: Consecutive patients with active ulcerative colitis, started on golimumab, were enrolled and prospectively followed up. The primary end point was to evaluate the long-term persistence on golimumab therapy. Results: A total of 173 patients with ulcerative colitis were studied. Of these, 79.2% were steroid dependent, and 46.3% were naïve to anti-tumour necrosis factor alpha agents. The median duration of golimumab therapy was 52 weeks (range 4-142 weeks). The cumulative probability of maintaining golimumab treatment was 47.3% and 22.5% at 54 and 108 weeks, respectively. Biological-naïve status (odds ratio (OR) = 3.02, 95% confidence interval (CI) 1.44-6.29, p = 0.003) and being able to discontinue steroids at week 8 (OR = 3.32, 95% CI 1.34-8.30, p = 0.010) and week 14 (OR = 2.94, 95% CI 1.08-8.02, p = 0.036) were associated with longer persistence on therapy. At week 54, 65/124 (52.4%) post-induction responders were in continuous clinical response. A continuous clinical response was associated with a lower likelihood of golimumab discontinuation throughout the subsequent year of therapy (p < 0.01). Overall, 40 (23.1%) patients were in clinical remission at the last follow-up visit. Twenty-six adverse events were recorded, leading to golimumab withdrawal in 9.2% of patients. Conclusions: Biological-naïve status and not requiring steroids at weeks 8 and 14 seem to be associated with a longer persistence on golimumab therapy in ulcerative colitis.