Vedolizumab induction therapy for inflammatory bowel disease in clinical practice - a nationwide consecutive German cohort study

Baumgart, D. C., Bokemeyer, B., Drabik, A., Stallmach, A., Schreiber, Stefan and Vedolizumab Germany, Consortium (2016) Vedolizumab induction therapy for inflammatory bowel disease in clinical practice - a nationwide consecutive German cohort study Alimentary Pharmacology & Therapeutics, 43 (10). pp. 1090-1102. DOI 10.1111/apt.13594.

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Supplementary data:

Abstract

Background Vedolizumab (VDZ) is a humanised monoclonal IgG1 antibody targeting alpha(4)beta(7) integrin. Aim To investigate the real-world efficacy of vedolizumab for the treatment of Crohn's disease (CD) and ulcerative colitis (UC). Methods A consecutive cohort of 212 adult IBD patients with active disease (HBI > 7/ partial Mayo > 4) newly receiving VDZ was prospectively recruited from 7 academic and 17 community centres. The primary endpoint was clinical remission (CRM) (CD HBI <= 4, UC pMayo < 1) in week 14. Secondary endpoints included steroid-free remission (SFCRM), clinical response (CRS) (HBI/pMayo score drop = 3), vedolizumab impact on CRP, calprotectin and haemoglobin. Results Data of 97 CD (71.1% female, HBI 11) and 115 UC (42.6% female, pMayo 6) patients were analysed. Only 5.2% CD and 24.3% UC were anti-TNF alpha naive. Most had extensive mucosal involvement (Montreal L3 69.1%/E3 53.9%). At week 14, 23.7% vs. 23.5% of CD vs. UC patients achieved CRM, 19.6% vs. 19.1% SFCRM and 60.8% vs. 57.4% CRS, respectively (all based on NRI). Week 14 CRM in CD was significantly associated with no history of extraintestinal manifestations (P = 0.019), no prior adalimumab use (P = 0.011), no hospitalisation in the past 12 months (P = 0.015) and low HBI score (P = 0.02) and in UC with active or previous smoking (P = 0.044/0.028) and no anti-TNFa (P = 0.023) use. Low HBI (P = 0.019) and no hospitalisation in the past 12 months (P = 0.01) predict CD CRM. The three most common AE were joint pain, acne and nasopharyngitis. Conclusion Vedolizumab is effective in routine use.

Document Type: Article
Additional Information: Times Cited: 4 Baumgart, D. C. Bokemeyer, B. Drabik, A. Stallmach, A. Schreiber, S.
Research affiliation: OceanRep > The Future Ocean - Cluster of Excellence
Kiel University
Refereed: Yes
DOI etc.: 10.1111/apt.13594
ISSN: 0269-2813
Projects: Future Ocean
Date Deposited: 19 Mar 2017 07:50
Last Modified: 19 Dec 2017 12:42
URI: http://eprints.uni-kiel.de/id/eprint/36007

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