P422 Sustained corticosteroid-free remission with vedolizumab in moderate-to-severe ulcerative colitis: A post hoc analysis of GEMINI 1

Abstract

Background: Corticosteroid (CS)-free remission is an important treatment goal for patients with ulcerative colitis (UC). This post hoc analysis of GEMINI 1 data evaluated the efficacy of vedolizumab (VDZ) to maintain sustained CS-free remission through Week 52 in patients with moderate-to-severe UC. Method(s): GEMINI 1 (NCT00783718) included a 6-week induction followed by a 46-week maintenance phase in patients with moderate-to-severe UC. Patients included in this analysis had stable doses of CS (prednisone or equivalent; < 0.0001) and pCAI (baseline: mean[SD] = 9.4[3.4], EOT: mean [SD] = 2.7[4.3]; p < 0.0001). The response rate was 71% in CD and 59% in UC, while remission rate was 52% in CD and 57% in UC. In the combined CD and UC patient population SIBDQ was significantly improved (baseline: mean[SD] = 4.0[1.0]; EOT: mean[SD] = 5.6 [1.0]; p < 0.0001). on achievement of clinical response. There were three treatment groups: VDZ (VDZ during induction and maintenance); VDZ/placebo (PLA) (VDZ during induction switched to PLA during maintenance); and PLA (PLA during induction and maintenance). The primary endpoint was sustained CS-free clinical remission, defined as CS-free status and clinical remission (partial Mayo score 1) for >=32 weeks through Week 52. Data were analysed in the overall population and in subgroups based on TNF antagonist treatment history. A multivariate analysis to identify the covariates associated with the primary endpoint was performed. Result(s): The analysis population (n = 454) comprised 313, 67 and 74 patients in the VDZ, VDZ/PLA and PLA groups, respectively. Baseline demographics and concomitant CS use were similar across treatment groups. In the overall population, a greater proportion (95% confidence interval [CI]) of patients achieved sustained CS-free clinical remission in VDZ (10.2% [6.9, 13.6]) and VDZ/PLA (7.5% [2.5, 16.6]) vs. PLA (1.4% [0.0, 7.3]) (Table 1). In the TNF-antagonist-naive subgroup, proportions were 16.2% [10.4, 22.1], 10.0% [2.8, 23.7] and 0% [0.0, 8.6], respectively. In the TNF-antagonist-failure subgroup, proportions were 5.4% [1.5, 9.3], 0% [0.0, 16.1] and 3.4% [0.1, 17.8], respectively (Table 1). Covariates associated with the odds of achieving sustained CS-free remission (odds ratio [95% CI]) were treatment (PLA vs. VDZ: 0.1 [0.0, 0.8]), TNF antagonist exposure (no vs. yes: 3.9 [1.8, 8.5]) and disease duration (>2 years vs.