RESUMO
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 α-4 ß-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.