Factors influencing the outcome of vedolizumab treatment: Real-life data with objective outcome measurements.
Adult
Antibodies, Monoclonal, Humanized
/ therapeutic use
Biomarkers
/ analysis
Cohort Studies
Colitis, Ulcerative
/ drug therapy
Crohn Disease
/ drug therapy
Female
Gastrointestinal Agents
/ therapeutic use
Humans
Inflammatory Bowel Diseases
/ drug therapy
Leukocyte L1 Antigen Complex
/ analysis
Male
Odds Ratio
Outcome Assessment, Health Care
Remission Induction
Steroids
/ therapeutic use
Tumor Necrosis Factor Inhibitors
/ therapeutic use
Crohn's disease
adverse events
anti-TNF experienced
anti-TNF naive
inflammatory bowel disease
real-life data
remission
safety
ulcerative colitis
vedolizumab
Journal
United European gastroenterology journal
ISSN: 2050-6414
Titre abrégé: United European Gastroenterol J
Pays: England
ID NLM: 101606807
Informations de publication
Date de publication:
04 2021
04 2021
Historique:
received:
14
05
2020
accepted:
17
09
2020
pubmed:
19
11
2020
medline:
8
1
2022
entrez:
18
11
2020
Statut:
ppublish
Résumé
Vedolizumab (VDZ), a humanised monoclonal antibody against a4ß7-integrin, has shown efficacy in inflammatory bowel disease (IBD). It is of importance to assess the mid-to long-term efficacy of VDZ using real-life data. Our study aimed to determine the efficacy of VDZ in patients with IBD with and without prior exposure to anti-tumour necrosis factor (TNF) treatments in a real-life setting. Furthermore, we investigated confounding factors influencing the remission to VDZ. Patients participating in the Swiss IBD Cohort Study were included in this study. Remission was defined as calprotectin less than 200 mg/kg stool and/or mucosal healing determined by endoscopy. End points were determined between Months 4 and 8 (T1) and between Months 12 and 16 (T2) after VDZ induction. Remission was reported in 50.5% (110/218) of patients in T1 (48.7% Crohn's disease [CD] and 52.5% ulcerative colitis [UC]) and 46.8% (102/218) in T2 (47% CD and 46.5% UC). In UC patients, a significantly higher remission rate was achieved in T2 among anti-TNF-naive patients (57.7%) compared to anti-TNF-experienced patients (34.7%; p = 0.02; odds ratio = 0.39, 95% confidence interval: 0.17-0.87). In patients with CD, no difference could be seen in either evaluation interval. Multivariable analysis showed that disease duration significantly influenced remission rates among UC patients. A late response to VDZ therapy with an achievement of remission in T2 was seen in a fifth of all patients (CD: 21.7%, UC: 20.8%). VDZ treatment was stopped in a third of all patients (31.8%) due to nonresponse, adverse events or aggravation of extra-intestinal manifestations. In a real-life national cohort setting, VDZ induced remission in more than half of IBD patients. Previous treatment with anti-TNF agents was associated with a significant lower efficacy of VDZ in UC but not in CD patients.
Sections du résumé
BACKGROUND
Vedolizumab (VDZ), a humanised monoclonal antibody against a4ß7-integrin, has shown efficacy in inflammatory bowel disease (IBD). It is of importance to assess the mid-to long-term efficacy of VDZ using real-life data.
OBJECTIVE
Our study aimed to determine the efficacy of VDZ in patients with IBD with and without prior exposure to anti-tumour necrosis factor (TNF) treatments in a real-life setting. Furthermore, we investigated confounding factors influencing the remission to VDZ.
METHODS
Patients participating in the Swiss IBD Cohort Study were included in this study. Remission was defined as calprotectin less than 200 mg/kg stool and/or mucosal healing determined by endoscopy. End points were determined between Months 4 and 8 (T1) and between Months 12 and 16 (T2) after VDZ induction.
RESULTS
Remission was reported in 50.5% (110/218) of patients in T1 (48.7% Crohn's disease [CD] and 52.5% ulcerative colitis [UC]) and 46.8% (102/218) in T2 (47% CD and 46.5% UC). In UC patients, a significantly higher remission rate was achieved in T2 among anti-TNF-naive patients (57.7%) compared to anti-TNF-experienced patients (34.7%; p = 0.02; odds ratio = 0.39, 95% confidence interval: 0.17-0.87). In patients with CD, no difference could be seen in either evaluation interval. Multivariable analysis showed that disease duration significantly influenced remission rates among UC patients. A late response to VDZ therapy with an achievement of remission in T2 was seen in a fifth of all patients (CD: 21.7%, UC: 20.8%). VDZ treatment was stopped in a third of all patients (31.8%) due to nonresponse, adverse events or aggravation of extra-intestinal manifestations.
CONCLUSION
In a real-life national cohort setting, VDZ induced remission in more than half of IBD patients. Previous treatment with anti-TNF agents was associated with a significant lower efficacy of VDZ in UC but not in CD patients.
Identifiants
pubmed: 33203339
doi: 10.1177/2050640620965106
pmc: PMC8259282
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Biomarkers
0
Gastrointestinal Agents
0
Leukocyte L1 Antigen Complex
0
Steroids
0
Tumor Necrosis Factor Inhibitors
0
vedolizumab
9RV78Q2002
Types de publication
Journal Article
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
398-406Informations de copyright
© 2020 The Authors. United European Gastroenterology Journal published by Wiley Periodicals LLC. on behalf of United European Gastroenterology.
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