P714 Vedolizumab, an adequate option in medically refractory and thiopurine-intolerant inflammatory bowel disease patients

• Published in: Journal of Crohn's and colitis Vol. 12; no. supplement_1; pp. S472 - S473
• Main Authors: Iborra, M, Maroto, N, Navarro-Cortes, P, Beltran, B, Boscá-Watts, M, Ferrer, I, Garcia-Morales, N, Sáez-González, E, Hinojosa, J, Minguez, M, Nos, P
• Format: Journal Article
• Language: English
• Published: UK Oxford University Press 16.01.2018
• DOI: 10.1093/ecco-jcc/jjx180.841
• ISSN: 1873-9946

Abstract Background The effect of Vedolizumab (VDZ), a gut-selective monoclonal anti-α4β7-integrin antibody approved for treatment of Crohn’s disease (CD) and ulcerative colitis (UC) has been demonstrated in clinical trials. The aim of this study was to describe a VDZ-treated patient population and assess long-term effectiveness and safety in clinical practice. Methods Observational and multicentre study in IBD patients treated with VDZ for at least a year. Effectiveness was evaluated with clinical scores and levels of faecal calprotectin (FC) and C-reactive protein (CRP) at 6 and 12 months. We also investigated the hospitalisations, surgeries, and adverse events. Results A total of 73 patients (43 UC and 30 CD) were analysed. Table 1 illustrates the baseline characteristics of the patients. BASELINE CHARACTERISTICS 47% of the patients had a prior adverse event with azathioprine. VDZ was stopped in 17 patients (23%), 10 UC and 7 CD, due to lack or loss of response prior to the first year. Twenty-seven (63%) UC and 16 (53%) CD patients required dose escalation. At 6 months, 70% and 42% UC patients and 80% and 43% CD patients, respectively, achieved clinical response and remission. At 1 year, 58% and 35% UC and 47% and 43% CD patients maintained clinical response and remission, respectively. A reduction of CRP was accomplished in CD and UC. However, declining of FC was achieved during the follow-up in UC but not in CD (2256, 978, 729 vs. 1078, 703, 802 µg/g, basal, 6 and 12 months, respectively). The 8 CD patients who had been previously treated with ustekinumab avoided surgery at 1 year. Eight (19%) UC patients underwent colectomy and 4 (13%) CD patients needed surgery. Two patients had post-operative complications (paralytic ileus in UC and abdominal wall abscess in CD). Ten (23%) UC patients and 8 (27%) CD required hospitalisation. Six patients (8%) had adverse events during follow-up, mainly arthralgia, non-opportunistic infections and one infusion-related reaction. The concomitant use of corticosteroids or immunomodulators did not increase effectiveness. The absence of remission in UC and non-response in CD were associated with the number of prior treatments with anti-TNF. Conclusions One year of VDZ induces clinical response and remission in IBD patients who were refractory not only to anti-TNF but also to ustekinumab. VDZ is probably a good alternative in medically refractory and thiopurine intolerant IBD patients due to its reduced immunogenicity, with few adverse events, post-operative complications and hospitalisations. FC may not be a liable predictor of VDZ response in CD.