Vedolizumab provides clinical benefit over 1 year in patients with active inflammatory bowel disease - a prospective multicenter observational study

Stallmach A, Langbein C, Atreya R, Bruns T, Dignass A, Ende K, Hampe J, Hartmann F, Neurath M, Maul J, Preiss JC, Schmelz R, Siegmund B, Schulze H, Teich N, Von Arnim U, Baumgart DC, Schmidt C (2016)

Publication Type: Journal article

Publication year: 2016

Journal

Alimentary Pharmacology & Therapeutics Wiley-Blackwell

Book Volume: 44

Pages Range: 1199-1212

Journal Issue: 11-12

DOI: 10.1111/apt.13813

Abstract

Vedolizumab, a monoclonal antibody targeting the ?4?7-integrin, is effective in inducing and maintaining clinical remission in Crohn's disease and ulcerative colitis according to randomised clinical trials.To determine the long-term effectiveness of vedolizumab in a real-world clinical setting.This observational registry assessed the clinical outcome in patients treated with vedolizumab for clinically active Crohn's disease (n = 67) or ulcerative colitis (n = 60). Primary endpoint was clinical remission (HBI <= 4/pMayo <= 1) at week 54. Secondary endpoints included clinical response rates (HBI/pMayo score drop >=3) and steroid-free clinical remission at weeks 30 and 54.Vedolizumab was stopped in 69/127 (56%) patients after a median time of 18 weeks (range 2-49) predominantly owing to lack or loss of response. Using nonresponder imputation analysis, clinical remission and steroid-free remission rates were 21% and 15% in Crohn's disease and 25% and 22% in ulcerative colitis, respectively. Lack of clinical remission was associated with prior treatment with anti-TNF or with steroids for more than 3 months in the last 6 months in ulcerative colitis. At week 14, the absence of remission in Crohn's disease or nonresponse in ulcerative colitis indicated a low likelihood of clinical remission at week 54 [2/31 (7%) in Crohn's disease, 4/41 (10%) in ulcerative colitis]. Accordingly, declining C-reactive protein in inflammatory bowel disease and/or lower faecal calprotectin in ulcerative colitis at week 14 predicted remission at week 54.Among patients who started vedolizumab for active inflammatory bowel disease, clinical remission rates are 21-25% after 54 weeks.

Authors with CRIS profile

Raja Atreya Professur für Translationale Immunforschung bei chronisch entzündlichen Darmerkrankungen (Heisenberg-Professur) Markus Neurath Lehrstuhl für Innere Medizin I

Involved external institutions

Universitätsklinikum Jena DE Germany (DE) Technische Universität Dresden DE Germany (DE) Humboldt-Universität zu Berlin DE Germany (DE) Otto-von-Guericke-Universität Magdeburg DE Germany (DE) Agaplesion Markus Krankenhaus DE Germany (DE) Charité - Universitätsmedizin Berlin DE Germany (DE) HELIOS Kliniken DE Germany (DE)

How to cite

APA:

Stallmach, A., Langbein, C., Atreya, R., Bruns, T., Dignass, A., Ende, K.,... Schmidt, C. (2016). Vedolizumab provides clinical benefit over 1 year in patients with active inflammatory bowel disease - a prospective multicenter observational study. Alimentary Pharmacology & Therapeutics, 44(11-12), 1199-1212. https://doi.org/10.1111/apt.13813

MLA:

Stallmach, A., et al. "Vedolizumab provides clinical benefit over 1 year in patients with active inflammatory bowel disease - a prospective multicenter observational study." Alimentary Pharmacology & Therapeutics 44.11-12 (2016): 1199-1212.

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