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Aliment Pharmacol Ther. 2016 Dec;44(11-12):1199-1212. doi: 10.1111/apt.13813. Epub 2016 Oct 7.

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

Author information

1
Jena, Germany.
2
Erlangen, Germany.
3
Frankfurt/Main, Germany.
4
Erfurt, Germany.
5
Dresden, Germany.
6
Berlin, Germany.
7
Leipzig, Germany.
8
Magdeburg, Germany.

Abstract

BACKGROUND:

Vedolizumab, a monoclonal antibody targeting the α4β7-integrin, is effective in inducing and maintaining clinical remission in Crohn's disease and ulcerative colitis according to randomised clinical trials.

AIM:

To determine the long-term effectiveness of vedolizumab in a real-world clinical setting.

METHODS:

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.

RESULTS:

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.

CONCLUSION:

Among patients who started vedolizumab for active inflammatory bowel disease, clinical remission rates are 21-25% after 54 weeks.

PMID:
27714831
DOI:
10.1111/apt.13813
[Indexed for MEDLINE]
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