Journal
FRONTLINE GASTROENTEROLOGY
Volume 8, Issue 3, Pages 196-202Publisher
BMJ PUBLISHING GROUP
DOI: 10.1136/flgastro-2016-100720
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Funding
- Abbvie
- Warner Chilcott
- Ferring
- Falk Pharma
- Takeda
- MSD
- Johnson and Johnson
- Shire
- Vifor Pharma
- Pharmacosmos
- Topivert
- Genentech
- Hospira
- Samsung Bioepis
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Objective To gain an understanding of the efficacy of vedolizumab in a 'real-world' setting. Design Retrospective cohort study using prospectively maintained clinical records. Setting Two UK tertiary inflammatory bowel disease (IBD) centres. Patients Patients with IBD commenced on vedolizumab at Guy's & St Thomas' and King's College Hospitals during November 2014-November 2015. Intervention Vedolizumab, a monoclonal antibody to alpha-4 beta-7 integrins that selectively inhibit leucocyte migration into the gut. Main outcome measures Clinical disease activity was assessed at baseline, weeks 14 and 30 using Harvey-Bradshaw Index (HBI) for Crohn's disease (CD) and Simple Clinical Colitis Activity Index (SCCAI) for ulcerative colitis (UC). Response was defined as HBI or SCCAI reduction >= 3. Remission was defined as HBI <5 or SCCAI <3. Continuous data are summarised as medians, followed by range. Results Fifty patients were included: 27 CD, 20 UC and 3 IBD-U(included in the UC group for analysis). At baseline visit, the median HBI was 8 (1-16) and SCCAI was 6 (0-15). At week 14, these values had fallen to 5 (0-15) (p=0.117) and 4 (0-10) (p=0.005), respectively. Additionally, week 30 data were available for 19 patients (9 CD, 10 UC). The clinical disease activity scores at that point were HBI 2 (0-7) (p=0.039) and SCCAI 2 (0-10) (p=0.023). At baseline, 37 (74%) of the 50 patients had clinically active disease. Of the patients with active disease, 22 (59%) responded and 14 (38%) achieved remission at week 14. Conclusions Our early experience with vedolizumab demonstrates a clear benefit in terms of disease control as well as a steroid-sparing effect in a cohort, which included patients with complex and previously refractory disease.
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