DOP007 Efficacy of vedolizumab induction therapy on clinical and endoscopic activity in patients with anti-tumour necrosis factor alpha-resistant inflammatory bowel disease. (16th January 2018)

• Record Type: Journal Article
• Authors: Bor, R; Klaudia, F; Miheller, P; Palatka, K; Szamosi, T; Vincze, Á; Rutka, M; Szántó, K; Bálint, A; Szepes, Z; Nagy, F; Milassin, Á; Fábián, A; Csontos, Á; Golovics, P; Lakner, L; Müllner, K; Papp, M; Salamon, Á; Sarang, K; Vitális, Z; Schafer, E; Sarlós, P; Molnár, T
• Is Part Of: Journal of Crohn's and colitis. Volume 12:Number 1(2018:Jan.)Supplement 1
• Page Start: S034
• Page End: S035
• Publication Date: 2018-01-16
• Subjects: Inflammatory bowel diseases -- Periodicals; 616.344005
• DOI: 10.1093/ecco-jcc/jjx180.044
• Languages: English
• ISSNs: 1873-9946

Abstract

Abstract: Background: Vedolizumab (VDZ) is the first gut-specific monoclonal antibody alternative to anti-tumour necrosis factor alpha (anti-TNF-alpha) therapy in patients with moderate-to-severe inflammatory bowel disease (IBD). It has been registered since 2016 in Hungary. All newly initiated VDZ therapy was individualised, it should be approved by the steering committee of five Hungarian IBD specialists. Aims of our non-interventional retrospective study to assess the efficacy of induction VDZ therapy on clinical and endoscopic activity in moderate or severe active IBD with previous anti-TNF failure or intolerance in real-life setting. Methods: Anti-TNF-alpha therapy intolerant IBD patients who received induction VDZ therapy were enrolled between July 2016 and July 2017 in Hungary. The therapeutic response was assessed based on the changes of clinical (Crohn's Disease Activity Index [CDAI], Mayo score) and endoscopic (Simple Endoscopic Score for Crohn Disease [SES-CD], endoscopic Mayo score) scores. Clinical response was defined as >3 points decrease in the total Mayo score or >100 decrease in CDAI score from baseline. Remission was defined as Mayo score ≤2, with no individual subscores >1, or as CDAI score ≤150. Mucosal healing was defined as Mayo endoscopic subscore ≤1 or as SES CD score ≤4. Results: 40 Crohn's disease (CD) and 52 ulcerative colitis (UC) patients received VDZ induction therapy after anti-TNF failure or intolerance. The mean age was 39.3 years (range 18–79; median 39) and the average disease duration was 11.4 years (range 1–36; median 10). At the baseline the mean CDAI and SES-CD were 306 (range 190–430; median: 316) and 19.2 (range 6–37; median 18) in the CD group and mean Mayo and eMayo score were 9.7 (range 5–12; median 10) and 2.75 (range 2–3; median 3) in the UC group. Extra intestinal manifestations were occurred in 26 patients (28.3%), and in 7 cases (7.6%) the IDB was associated with primary sclerosing cholangitis. 26 (65.0%) CD and 44 (84.6%) UC patients showed clinical response on the induction VDZ therapy. The number of patients with clinical remission was 21 (52.5%) in the CD and 24 (46.2%) in the UC subgroup. Rate of steroid-free remission was 42.5% ( n = 17) in CD and 26.9% ( n = 14) in UC. Steroids could be stopped in 54.7% of the patients receiving systemic corticosteroids at inclusion. Mucosal healing at week 14 was achieved in 8 (20.0%) and CD and 28 (53.8%) UC patients. Conclusions: Our results suggest that induction VDZ therapy is effective and it is a safe therapeutic option in anti-TNF-alpha failure or intolerant IBD patients with moderate or severe disease activity. Mucosal healing was achievable in every second UC and in every fifth CD patients by the end of the induction treatment in this difficult-to-treat population.