Real-world effectiveness and safety of Vedolizumab for the treatment of Inflammatory Bowel Disease: The Scottish Vedolizumab Cohort

N. Plevris (Lead / Corresponding author), C. S. Chuah, R. M. Allen, I. D. Arnott, P. N. Brennan, S. Chaudhary, A. M. D. Churchhouse, S. Din, E. Donoghue, Daniel R. Gaya, M. Groome, H. M. Jafferbhoy, P. W. Jenkinson, W. L. Lam, M. Lyons, J. C. Macdonald, M. MacMaster, Craig Mowat, G. D. Naismith, L. F. PottsE. Saffouri, J. P. Seenan, A. Sengupta, P. Shasi, D. I. Sutherland, J. A. Todd, J. Veryan, A. J. M. Watson, David Watts, G. R. Jones, C. W. Lees

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Abstract

Background & Aims: Vedolizumab is an anti-a4b7 monoclonal antibody that is licensed for the treatment of moderate to severe Crohn's disease and ulcerative colitis. The aims of this study were to establish the real-world effectiveness and safety of vedolizumab for the treatment of inflammatory bowel disease.

Methods: This was a retrospective study involving seven NHS health boards in Scotland between June 2015 and November 2017. Inclusion criteria included: a diagnosis of ulcerative colitis or Crohn's disease with objective evidence of active inflammation at baseline (Harvey-Bradshaw Index[HBI] ≥5/Partial Mayo ≥2 plus C-reactive protein [CRP] >5 mg/L or faecal calprotectin ≥250 µg/g or inflammation on endoscopy/magnetic resonance imaging [MRI]); completion of induction; and at least one clinical follow-up by 12 months. Kaplan-Meier survival analysis was used to establish 12-month cumulative rates of clinical remission, mucosal healing, and deep remission [clinical remission plus mucosal healing]. Rates of serious adverse events were described quantitatively.

Results: Our cohort consisted of 180 patients with ulcerative colitis and 260 with Crohn's disease. Combined median follow-up was 52 weeks (interquartile range [IQR] 26-52 weeks). In ulcerative colitis, 12-month cumulative rates of clinical remission, mucosal healing, and deep remission were 57.4%, 47.3%, and 38.5%, respectively. In Crohn's disease, 12-month cumulative rates of clinical remission, mucosal healing, and deep remission were 58.4%, 38.9%, and 28.3% respectively. The serious adverse event rate was 15.6 per 100 patient-years of follow-up.

Conclusions: Vedolizumab is a safe and effective treatment for achieving both clinical remission and mucosal healing in ulcerative colitis and Crohn's disease.

Original languageEnglish
Pages (from-to)1111-1120
Number of pages10
JournalJournal of Crohn's and Colitis
Volume13
Issue number9
Early online date14 Feb 2019
DOIs
Publication statusPublished - Sep 2019

Keywords

  • Vedolizumab
  • real-world
  • Crohn’s disease
  • Ulcerative colitis
  • mucosal healing

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    Plevris, N., Chuah, C. S., Allen, R. M., Arnott, I. D., Brennan, P. N., Chaudhary, S., Churchhouse, A. M. D., Din, S., Donoghue, E., Gaya, D. R., Groome, M., Jafferbhoy, H. M., Jenkinson, P. W., Lam, W. L., Lyons, M., Macdonald, J. C., MacMaster, M., Mowat, C., Naismith, G. D., ... Lees, C. W. (2019). Real-world effectiveness and safety of Vedolizumab for the treatment of Inflammatory Bowel Disease: The Scottish Vedolizumab Cohort. Journal of Crohn's and Colitis, 13(9), 1111-1120. https://doi.org/10.1093/ecco-jcc/jjz042