P702 Head-to-head comparison of biological drugs in the treatment of ulcerative colitis: Suggestions from a real-life, inception cohort, single-centre study on consecutive post-marketing treatments

Abstract

Background: Anti-TNF-alpha drugs, including infliximab (IFX), adalimumab (ADA), golimumab (GOL), and the anti-integrin vedolizumab (VDZ) have been sequentially approved in Italy for the treatment of ulcerative colitis (UC). Despite their efficacy was shown in phase III trial, no head-to-head comparisons have been performed in the real life. Method(s): All consecutive UC patients treated at our centre with IFX, ADA, GOL, and VDZ after their sequential approval in Italy were included. Patients were followed-up for 1 year or until relapse. All drugs were compared with each other in terms of steroid-free remission (SFR) at 6, 14, and 54 weeks. Any demographic, clinical, biochemical, and endoscopic predictors of SFR at week 54 were also analysed for each drug. Result(s): A total of 100 patients with moderate-severe UC were enrolled and treated with IFX (n = 25), ADA (n = 25), GOL (n = 24) and VDZ (n = 26). Baseline characteristics of patients were similar among all groups, except for a higher rate of patients refractory to anti-TNF-alpha in the group of the latest approved drug (VDZ). SFR rates at 6, 14 and 54 weeks were 40%, 28%, 32% for IFX, 24%, 32%, 36% for ADA, 33%, 50%, 12% for GOL, and 46%, 50%, 26% for VDZ, respectively (all p not significant). Significant positive predictors of SFR at week 54 were clinical remission at week 14 for ADA (67% vs. 19%; p = 0.0466 ) and IFX (75% vs. 12%; p = 0.0016) and concomitant corticosteroids at baseline for VDZ (46% vs. 8%; p = 0.0271). Conclusion(s): Each form of anti-TNF-alpha drugs and vedolizumab are equally effective in the induction and maintenance of steroid-free remission after 1 year in UC. Safety and costs should be also evaluated in larger cohorts.