P381 Predictors of vedolizumab response to induction: Real-life experience

Abstract

Introduction: Vedolizumab is a humanized immunoglobulin G1 monoclonal antibody (mAb) directed towards the integrin alpha4beta 7. Clinical trials have demostrated the efficacy and safety of vedolizumab (VDZ) in the induction and maintenance of Crohn's disease (CD) and ulcerative colitis (UC). We describe real-world treatment outcomes with VDZ in five tertiary Spanish hospitals. Aims and Methods: EC treated with VDZ until october 2017 in five Spanish hospitals. - Clinical response and remission were defined by Partial Mayo Score (UC) or Harvey Bradshaw Index (HBI) and were assessed after induction, at 6 and 12 months. We evaluated treatment persistence as well. - We studied predictive factors of clinical benefit (response or remission) after induction in UC and CD patients. - We evaluated if clinical benefit was different in UC and CD patients after exposure to one or more antiTNF agents. Result(s): One hundred and three patients were included (52 female (50.5%), UC 40(38.8%), CD63(61.2%), median age 42.9+/-15.01 y, median disease duration 11.5+/-8.15 years). Median HBI was 7+/-3 and PMS was 6+/-2 at baseline. Majority of patients were refractory to antiTNF treatment: 22 patients (21.6%) had failed to 1 antiTNF and 71 (69.6%) to 2 or more antiTNF agents. Almost 60% of patients were using steroids during induction and 25 (24.5%) received concomitant immunomodulators. Median duration of VDZ treatment was 8.5+/-6.3 months. Clinical response after loading VDZ was achieved by 79 patients (77.5%). Clinical response and remission at 6 and 12 months were: 42.5%(25/59),33.9%(20/59),41.4%(12/29) and 41.4%(12/29), respectively. In October 2017, 72 patients (70,6%) were persistent on VDZ therapy. Clinical benefit (response or remission) was not associated to the number of antiTNF agents used previously or disease type (UC or CD). No factor (age, sex, disease duration, concomitant immunomodulators or steroids, smoking habit, disease type or severity of illness,) was associated to induction response in UC patients. Disease duration (67%<5 years vs 85.3% > 5 years, p=0.04) and baseline HBI (<7:96.3% vs >7:67.6%, p=0.05) were associated to induction response in CD patients. Thirty-five patients (34.3%) needed dose scalation. Conclusion(s): VDZ is effective in IBD patients with long-term persistence of treatment in almost 70% of them. Severity of illness actvity and shorter time duration disease were associated to worse induction response in CD patients.