Real-world Effectiveness and Safety of Vedolizumab for the Treatment of Inflammatory Bowel Disease: The Scottish Vedolizumab Cohort.

Adult Antibodies, Monoclonal, Humanized / adverse effects C-Reactive Protein / analysis Colitis, Ulcerative / drug therapy Crohn Disease / drug therapy Feces / chemistry Female Gastrointestinal Agents / adverse effects Humans Inflammatory Bowel Diseases / drug therapy Intestinal Mucosa / pathology Kaplan-Meier Estimate Leukocyte L1 Antigen Complex / analysis Male Middle Aged Retrospective Studies Scotland Treatment Outcome

Crohn’s disease Vedolizumab mucosal healing real-world ulcerative colitis

Journal

Journal of Crohn's & colitis

ISSN: 1876-4479

Titre abrégé: J Crohns Colitis

Pays: England

ID NLM: 101318676

Informations de publication

Date de publication:
19 Sep 2019

Historique:

pubmed: 16 2 2019

medline: 13 2 2020

entrez: 16 2 2019

Statut: ppublish

Résumé

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

Sections du résumé

BACKGROUND & AIMS OBJECTIVE

METHODS 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 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 CONCLUSIONS

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

Identifiants

DOI: 10.1093/ecco-jcc/jjz042 PMID: 30768123

pubmed: 30768123

pii: 5320521

doi: 10.1093/ecco-jcc/jjz042

doi:

Substances chimiques

Antibodies, Monoclonal, Humanized 0

Gastrointestinal Agents 0

Leukocyte L1 Antigen Complex 0

C-Reactive Protein 9007-41-4

vedolizumab 9RV78Q2002

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

Pagination

1111-1120