DOP71 Low occurrence of colectomy with long-term (up to 4 years) golimumab treatment in patients with moderate-to-severe active Ulcerative Colitis: Data from the PURSUIT maintenance and long-term extension studies

Abstract Background In a previous real-world study of long-term (up to 4 years) treatment with golimumab (GLM) in ulcerative colitis (UC), patients reported a low overall colectomy incidence (5.8%).1 This analysis evaluates the incidence of colectomy among patients with moderate-to-severe active UC in the PURSUIT-maintenance (-M)2 and long-term extension (-LTE)3 studies. Methods Eligible PURSUIT-M trial participants completed a 6-week GLM induction trial without requiring colectomy.4,5 Responders to GLM induction were randomised 1:1:1 to GLM 50 mg, 100 mg, or placebo (PBO) maintenance for up to 1 year, administered every 4 weeks (q4w). Nonresponders to GLM or PBO induction received GLM 100 mg; responders to PBO induction received PBO (each administered q4w for up to 1 year). Participants experiencing loss of clinical response during maintenance were eligible for one treatment intensification (switch from PBO to GLM 100 mg, or GLM dose increase). Participants who completed PURSUIT-M were eligible to continue their treatment in the 3-year PURSUIT-LTE study. Colectomy (total or partial) was a prespecified outcome in PURSUIT-M; serious adverse event narratives and safety summaries were also examined for reports of colectomy (total or partial). For PURSUIT-LTE, serious adverse event narratives and safety summaries were examined for reports of colectomy (total or partial). The reasons for colectomy were not collected systematically in PURSUIT-M or -LTE. Descriptive information on colectomies was assessed and reported. Results A total of 60 (4.9%) colectomies were reported among the 1228 patients who enrolled in the 1-year PURSUIT-M study, including 672 participants who continued into the 3-year LTE study. The table shows the distribution of colectomies by study phase, induction responder status, initial treatment assignment, and treatment prior to colectomy. The colectomy rate during the 3-year extension was lower than that observed during the maintenance phase of the study [1.3% (9/672) compared to 4.2% (51/1228)]. Conclusion Consistent with previously reported data, this retrospective evaluation of colectomy data from the PURSUIT-M and -LTE studies in patients with moderate-to-severe active UC demonstrated a low occurrence of colectomy with long-term (up to 4 years) GLM treatment. The limited number of colectomies observed in the LTE study occurred predominantly in patients with more severe disease at baseline (induction non-responders) who had been receiving GLM 100 mg. References 1. Iborra M, et al. SciRep. 2020;10:17774 2. Sandborn WJ, et al. Gastroenterol. 2014;146:96–109 3. Reinisch W, et al. J Crohn’s Col. 2018;12:1053–1066 4. Sandborn WJ, et al. Gastroenterol. 2014;146:85–95 5. Rutgeerts P, et al. Aliment Pharmacol Ther. 2015;42:504–514