DOP025 Efficacy of vedolizumab on extraintestinal manifestation in patients with inflammatory bowel disease: a post-hoc analysis of the OBSERV-IBD cohort from the GETAID

Background: Up to 50% of patients with inflammatory bowel disease (IBD) experience at least one extraintestinal manifestation (EIM). Whether or not vedolizumab (VDZ) is effective on EIM needs to be assessed. Methods: Between June and December 2014, 173 patients with Crohn's disease (CD) and 121 with ulcerative colitis (UC) were followed up after VDZ introduction during 54 weeks. Efficacy of vedolizumab on EIM was estimated by using a 3-step scale: (1) complete remission meaning absence or almost absence of all clinical symptoms without increasing the steroid dose or introducing any other IBD-specific treatment (2) partial response meaning improvement of symptoms or reduction of the steroid dose without worsening of symptoms (3) no response, meaning no improvement or worsening of symptoms. Results: Among the 294 patients with IBD, 50 (17.2%) presented with EIM at baseline including 46 (15.6%) with arthropathies and 5 (1.7%) with skin manifestations. At week 14, complete remission was observed in 24 (52.2%) patients with arthropathies and in 4 (80%) patients with skin manifestation. At week 54, 21 (45.7%) and 3 (60%) were still in complete remission for athropathies and skin manifestations, respectively. During the follow-up period, 32 (15.8%) patients without any EIM at baseline, presented with arthropathies. The probabilities of developing arthropathies during VDZ therapy was 5.2%, 10% 13.9% and 17.5% at weeks 14, 22, 30 and 54, respectively. In multivariate analysis, predictors of arthropathies occurrence were prior ankylosing spondylitis (OR =3.70, IC95% [1.49–9.10], p=0.005) and Crohn's disease (OR =2.50, IC95% [1.04–5.88], p=0.04). During the follow-up period, 14 (4.8%) patients presented with paradoxical skin manifestation of whom 8 (57.1%) had previously experienced paradoxical skin manifestation associated with anti-TNF therapy. Among the 173 patients with Crohn's disease, 35 (20.2%) presented with active perianal disease at baseline including 30 (17.3%) with perianal fistula and 5 (2.9%) with perianal fissure. At week 14, complete remission of perianal Crohn's disease was observed in 15 (42.9%) of patients whereas partial remission was observed in 2 (5.7%) patients. At week 54, 12 (34.3%) patients were still in complete remission. Additionally, three patients presented with perianal disease during the follow-up period despite VDZ therapy. Conclusions: VDZ therapy was effective for achieving complete resolution of EIM in patients with IBD in approximately half of the cases. VDZ was also effective for perianal CD in one third of the patients. Paradoxical skin manifestation may occur upon VDZ therapy suggesting as a class effect not restricted to anti-TNF agents.