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

TY - JOUR

T1 - Real-world effectiveness and safety of Vedolizumab for the treatment of Inflammatory Bowel Disease

T2 - The Scottish Vedolizumab Cohort

AU - Plevris, N.

AU - Chuah, C. S.

AU - Allen, R. M.

AU - Arnott, I. D.

AU - Brennan, P. N.

AU - Chaudhary, S.

AU - Churchhouse, A. M. D.

AU - Din, S.

AU - Donoghue, E.

AU - Gaya, Daniel R.

AU - Groome, M.

AU - Jafferbhoy, H. M.

AU - Jenkinson, P. W.

AU - Lam, W. L.

AU - Lyons, M.

AU - Macdonald, J. C.

AU - MacMaster, M.

AU - Mowat, C.

AU - Naismith, G. D.

AU - Potts, L. F.

AU - Saffouri, E.

AU - Seenan, J. P.

AU - Sengupta, A.

AU - Shasi, P.

AU - Sutherland, D. I.

AU - Todd, J. A.

AU - Veryan, J.

AU - Watson, A. J. M.

AU - Watts, David

AU - Jones, G. R.

AU - Lees, C. W.

PY - 2019/9

Y1 - 2019/9

N2 - 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.

AB - 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.

KW - Vedolizumab

KW - real-world

KW - Crohn’s disease

KW - Ulcerative colitis

KW - mucosal healing

UR - https://www.scopus.com/pages/publications/85072380935

U2 - 10.1093/ecco-jcc/jjz042

DO - 10.1093/ecco-jcc/jjz042

M3 - Article

C2 - 30768123

SN - 1873-9946

VL - 13

SP - 1111

EP - 1120

JO - Journal of Crohn's and Colitis

JF - Journal of Crohn's and Colitis

IS - 9

ER -