Experiences of using vedolizumab in the treatment of inflammatory bowel disease in the East Midlands UK – a retrospective observational study

White, Jonathan R.; Din, Said; Ingram, Richard J M.; Foley, Stephen; Alam, Mohammad Aftab; Robinson, Richard; Francis, Rodric; Tucker, Emily; Jalal, Mustafa; Elphick, David; Atallah, Edmond; Norman, Anthony; Amin, Muhammad; Sajjad, Aamir; Heggs, Nicola; Meadowcroft, Simon; Moran, Gordon W.

Abstract

Purpose
Clinical trials have demonstrated efficacy of vedolizumab in ulcerative colitis (UC) and Crohn’s disease (CD). Further real-world data is needed to inform clinical practice. The primary outcome was to assess corticosteroid-free and clinical remission after vedolizumab initiation. Secondary outcomes included effect on disease activity scores, biochemical markers, concomitant drug use, endoscopic remission, surgical intervention, hospital admissions and adverse events.

Materials and methods
A multi-centre retrospective observational study was conducted with patients initiated on vedolizumab across seven UK hospitals 1/11/14-30/11/16. Clinical disease activity was assessed using the partial Mayo Scores (pMS) and Harvey Bradshaw Index (HBI). Clinical remission was defined as HBI [less than] 4 or pMS [less than]2 with a combined stool frequency and rectal bleeding sub score of [less than] 1. Clinical response was defined as ≥2-point decrease from baseline in pMS and ≥3-point decrease from baseline in HBI.

Results
One hundred ninety-two patients were included in the final analysis. 45% of UC and 10% of CD patients were anti-TNF naive. Over the observation period corticosteroid-free remission rates for UC and CD were 46% and 45%, while clinical remission rates were 52% and 44%, respectively. Time to corticosteroid free remission for UC and CD was 17.6 [IQR: 8.7–29.6] and 14.1 [QR: 6.0–21.7] weeks, respectively. Time to clinical response for UC was 9.4 [IQR: 5.7–15.4] and CD was 9.5 [IQR: 6.1–18.2] weeks. There was a substantial decrease in the concomitant use of immunomodulators and a similar decrease in concomitant corticosteroid use over the study period.

Conclusions
Results in this predominately anti-TNF experienced population mirror other published real-world data, demonstrating good clinical effectiveness and a comparable safety profile.

Citation

White, J. R., Din, S., Ingram, R. J. M., Foley, S., Alam, M. A., Robinson, R., …Moran, G. W. (2020). Experiences of using vedolizumab in the treatment of inflammatory bowel disease in the East Midlands UK – a retrospective observational study. Scandinavian Journal of Gastroenterology, 55(8), 907-916. https://doi.org/10.1080/00365521.2020.1790647

• Journal Article Type: Article
• Acceptance Date: Jun 28, 2020
• Online Publication Date: Jul 11, 2020
• Publication Date: Jul 11, 2020
• Deposit Date: Jul 6, 2020
• Publicly Available Date: Jul 12, 2021
• Journal: Scandinavian Journal of Gastroenterology
• Print ISSN: 0036-5521
• Electronic ISSN: 1502-7708
• Publisher: Taylor & Francis Open
• Peer Reviewed: Peer Reviewed
• Volume: 55
• Issue: 8
• Pages: 907-916
• DOI: https://doi.org/10.1080/00365521.2020.1790647
• Keywords: Gastroenterology
• Public URL: https://nottingham-repository.worktribe.com/output/4752678
• Publisher URL: https://www.tandfonline.com/doi/full/10.1080/00365521.2020.1790647