A real-world, long-term experience on effectiveness and safety of vedolizumab in adult patients with inflammatory bowel disease: The Cross Pennine study

Lenti MV1, Levison S2, Eliadou E2, Willert R2, Kemp K2, Carter A2, Stansfield C3, Assadsangabi A3, Singh S4, Crooks B4, Tattersall S4, Fairhurst F4, Kenneth C5, Subramanian S6, Probert C6, Storey D6, Gregg B6, Smith P7, Liu E7, Limdi JK8, Johnston A9, Hamlin PJ9, Selinger CP10. Dig Liver Dis. 2018 Jul 18. pii: S1590-8658(18)30818-1. doi: 10.1016/j.dld.2018.07.007. [Epub ahead of print]

Author information

1 Department of Gastroenterology, Leeds Teaching Hospitals, Leeds, UK; First Department of Internal Medicine, San Matteo Hospital Foundation, University of Pavia, Pavia, Italy.

2 Department of Gastroenterology, Manchester Royal Infirmary, Central Manchester University Hospitals, Manchester, United Kingdom.

3 Department of Gastroenterology, Salford Royal Hospitals, Salford, United Kingdom.

4 Department of Gastroenterology, Bolton NHS Trust, Bolton, United Kingdom.

5 Department of Gastroenterology, Bradford Teaching Hospital, Bradford, United Kingdom.

6 Gastroenterology & Liver Services, The Royal Liverpool and Broadgreen University Hospitals, Liverpool, United Kingdom.

7 Department of Gastroenterology, Wrightington, Wigan and Leigh NHS Trust, Wigan, United Kingdom.

8 Department of Gastroenterology, The Pennine Acute Hospitals NHS Trust, Manchester, United Kingdom.

9 Department of Gastroenterology, Leeds Teaching Hospitals, Leeds, UK.

10 Department of Gastroenterology, Leeds Teaching Hospitals, Leeds, UK. Electronic address: Christian.selinger@web.de.


BACKGROUND: Real-life data on vedolizumab effectiveness in inflammatory bowel disease (IBD) are still emerging. Data on the comparative safety of the gut selective profile are of particular interest.

AIMS: To assess clinical outcome and safety in IBD patients treated with vedolizumab.

METHODS: We retrospectively collected data of patients treated with vedolizumab at eight UK hospitals (August 2014-January 2018). Clinical response and remission at 14 and 52 weeks evaluated through Physician Global Assessment (PGA) and adverse events were recorded. Possible predictors of clinical response were examined.

RESULTS: Two hundred and three IBD patients (mean treatment 16 ± 8 months) were included. Of these, 135 patients (mean age 40.6 ± 16.0 years; F:M 1.9:1) had CD and 68 (mean age 44.5 ± 18.1 years; F:M 1:1.2) had UC. According to PGA, 106/135 (78.5%) CD and 62/68 (91.2%) UC patients (p = 0.02) had a clinical response/remission at 14 weeks, whereas 76/119 (63.9%) CD and 52/63 (82.5%) UC patients (p < 0.01) showed a sustained response or remission at 52 weeks, with a high adherence rate (97%). No predictors of clinical response were found. The cumulative incidence of infectious diseases was 11.9 per 100 person-years.

CONCLUSION: Vedolizumab is an effective therapy for inducing and maintaining remission of IBD, with better results for UC, and with a good safety profile.

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