P740 Efficacy and safety of vedolizumab in inflammatory bowel disease: Real-life experience

• Published in: Journal of Crohn's and colitis 2018-01, Vol.12 (supplement_1), p.S486-S486
• Main Authors: González Muñoza, C, Mesonero, F, Bargalló, A, Clos, A, Aràjol, C, Gordillo, J, López- San Román, A, Guardiola, J, Navarro-Llavat, M, Bertoletti, F, Fernández, C, Domènech, E, Garcia-Planella, E
• Format: Article
• Language: English
• ISSN: 1873-9946; 1876-4479
• DOI: 10.1093/ecco-jcc/jjx180.867

Abstract Background Vedolizumab (VDZ) is a monoclonal antibody that blocks integrin α4β7 preventing the migration of lymphocytes to the intestinal wall, recently approved for Crohn’s disease (CD) and ulcerative colitis (UC), so that scarce data are available in clinical practice. Methods All patients with CD and UC treated with VDZ in five Spanish hospitals were retrospectively identified. Clinical and biochemical data at baseline and during VDZ treatment were recorded. Results In total, 107 patients were included (58 CD, 49 UC). Among UC patients, 67% had extensive UC. In CD, disease location was 33% ileal, 21% colic, and 46% ileo-colic. 40% of CD patients had an inflammatory pattern. Median disease duration was 123 months (IQR 6–420) and the median follow-up with VDZ was 7 months (IQR 1–26). The most frequent indication for VDZ in CD was secondary loss of response to anti-TNF (36%) and, in UC, primary failure to anti-TNF (37%). At the onset of VDZ, 80% of patients with UC and 62% with CD received steroids; 22% and 21%, respectively, received co-treatment with thiopurines, and 12% and 3%, respectively, co-treatment with calcineurinics. 10% of patients (4 CD, 7 CU) were dose-escalated (after a median of 20 weeks [IQR 10–52]). The rate of steroid-free clinical remission at 6 months was 52%. In addition, among those patients with elevated CRP or faecal calprotectin at the time VDZ was started, 40% achieved at some point the normalisation of CRP and 14% of calprotectin. Treatment was discontinued in 34% of patients (73% due to lack of improvement [66% CD and 34% UC], 19% due to side effects). The cumulative probability of treatment survival was 72% and 84% at 6 months, and 47% and 69% at 12 months, in CD and UC, respectively (p = 0.013). 22% of patients developed at least one side effect, leading to treatment discontinuation in five patients. Conclusions In clinical practice VDZ has a different profile of use in CD and CU. Co-treatment with immunosuppressants seems less frequent than with anti-TNF, but it is most frequently initiated with concomitant systemic corticosteroids. The results in real-life seem to confirm a lower efficacy in CD than in UC.