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Aliment Pharmacol Ther. 2016 May;43(10):1090-102. doi: 10.1111/apt.13594. Epub 2016 Apr 1.

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

Author information

1
Department of Gastroenterology and Hepatology, Charité Medical School, Humboldt-University of Berlin, Berlin, Germany.
2
Gastroenterology Practice, Minden, Germany.
3
Biostatistics Consulting, Münster, Germany.
4
Department of Internal Medicine IV (Gastroenterology, Hepatology and Infectious Diseases), University Hospital Jena, Jena, Germany.
5
Department Internal Medicine I, University Hospital Schleswig-Holstein Campus, Kiel University of Schleswig-Holstein, Kiel, Germany.

Abstract

BACKGROUND:

Vedolizumab (VDZ) is a humanised monoclonal IgG1 antibody targeting α4 β7 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-TNFα naïve. 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-TNFα (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.

PMID:
27038247
DOI:
10.1111/apt.13594
[Indexed for MEDLINE]
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