DOP049 Efficacy and safety of golimumab induction for moderate-to-severe ulcerative colitis in the United Kingdom: results from the GO-COLITIS study
C. Probert*1, D. R. Gaya2, P. J. Hamlin3, P. Irving4, S. Sebastian5, G. Gillespie6, H. Tate6, C. Wheeler6
1University of Liverpool, Liverpool, United Kingdom, 2Glasgow Royal Infirmary, Glasgow, United Kingdom, 3Leeds Teaching Hospitals Trust, Leeds, United Kingdom, 4Guy’s and St. Thomas’ Hospitals, London, United Kingdom, 5Hull & East Yorkshire NHS Trust, Hull, United Kingdom, 6MSD UK, Hoddesdon, United Kingdom
Induction and maintenance of clinical response is a treatment goal for ulcerative colitis (UC). GO-COLITIS (NCT02092285; 2013-004583-56) is a phase 4, multicentre, open-label, single-arm trial in the United Kingdom aimed at evaluating the efficacy of golimumab (GLM) in induction and maintenance of clinical response in patients with moderate-to-severe UC. We report the results of an interim analysis of clinical response at the end of the GLM induction phase.
Anti-TNF naïve patients (≥ 18 y) with UC ≥ 3 months and with moderate-to-severe disease (partial Mayo score 4–9 or Mayo score 6–12) at baseline, Mayo rectal bleeding sub score ≥ 1, and Mayo endoscopy sub score ≥ 2 (if full Mayo was used) were included. Patients received SC GLM on day 0 (200 mg) and day 14 (100 mg) during the 6-week induction phase, followed by GLM 50 or 100 mg every 4 weeks during the 48-week maintenance phase with 12-week follow-up, in line with the Summary of Product Characteristics. During induction, clinical response and remission were summarised descriptively at the end of week 6. Clinical response was defined as decrease in partial Mayo score of ≥ 2 points and ≥3 0% from baseline, plus either a decrease in rectal bleeding sub score of ≥ 1 point or an absolute rectal bleeding score ≤ 1. Patients without scores were considered nonresponders. Clinical remission was defined as partial Mayo score ≤ 2 and no individual Mayo sub score > 1. All adverse events (AEs) were recorded.
Overall, 205 patients were enrolled (mean [range] age, 39.3 [18–79] years; male, n = 123 [60%]). The mean baseline (SD) partial Mayo score was 6.4 (1.4). All patients received 1 or 2 doses of induction GLM. Clinical responses occurred in 141/205 patients (response rate, 68.8%; 95% CI, 62.0%–75.1%). Clinical remission occurred in 79/205 patients (remission rate, 38.5%; 95% CI, 31.8%–45.6%). The mean (SD) change from baseline in partial Mayo score (n = 198) was –3.2 (2.4). AEs (any cause) occurred in 37 (18%) patients. Serious AEs occurred in 17 (8%) patients: UC flare/worsening (n = 11), accidental overdose (n = 2), anaphylaxis (n = 1), constipation (n = 1), rectal fissure (n = 1), and respiratory tract infection (n = 1). Eight patients (4%) discontinued due to serious AEs. There were no fatal AEs.
During the GLM induction phase of GO-COLITIS, 68.8% of patients had a partial Mayo response and were eligible to continue to the 48-week maintenance phase. AEs were consistent with previous observations; no new safety signals were identified.