Vedolizumab is effective and safe in real-life treatment of inflammatory bowel diseases outpatients: A multicenter, observational study in primary inflammatory bowel disease centers.
Adult
Antibodies, Monoclonal, Humanized
/ adverse effects
C-Reactive Protein
/ metabolism
Colitis, Ulcerative
/ drug therapy
Crohn Disease
/ drug therapy
Feces
/ chemistry
Female
Humans
Italy
Kaplan-Meier Estimate
Leukocyte L1 Antigen Complex
/ metabolism
Male
Middle Aged
Remission Induction
Retrospective Studies
Wound Healing
/ drug effects
Crohn's disease
Remission
Safety
Ulcerative colitis
Vedolizumab
Journal
European journal of internal medicine
ISSN: 1879-0828
Titre abrégé: Eur J Intern Med
Pays: Netherlands
ID NLM: 9003220
Informations de publication
Date de publication:
Aug 2019
Aug 2019
Historique:
received:
19
03
2019
revised:
07
06
2019
accepted:
10
06
2019
pubmed:
19
6
2019
medline:
2
10
2020
entrez:
19
6
2019
Statut:
ppublish
Résumé
Italian data currently available in managing ulcerative colitis (UC) and Crohn's disease (CD) patients with vedolizumab (VDZ) are coming just from secondary and tertiary centers. The present study aimed to assess the real-life efficacy and safety of VDZ to achieve remission in inflammatory bowel diseases (IBD) outpatients in primary gastroenterology centers. Clinical activity was scored according to the Mayo score in UC and to the Harvey-Bradshaw Index (HBI) in CD. The primary endpoints were the achievement of clinical remission and safety. Secondary endpoints were clinical response to treatment, achievement of mucosal healing (MH), and steroid discontinuation. One hundred and thirty-six pts. were enrolled (91 UC and 45 CD pts). During an 18-month median follow-up, clinical remission was present in 63 (46.3%) pts.: in particular, it occurred in 48 (52.7%) patients in UC group and in 15 (33.3%) patients in CD group (p = 0.003). more in UC group. Fecal calprotectin ≥400 μg/g and presence of comorbidities were factors significantly related to the failure of remission in UC and CD, respectively. Ten (7.3%) cases of adverse events were recorded (2 required suspension of treatment). Clinical response was present in 105 (72.2%) pts.: 71 (78.0%) in UC and 34 (75.5%) in CD group. MH occurred in 47 (62.7%) UC and in 9 (50.0%) CD patients. Steroids discontinuation occurred in 92 (67.6%) pts.; 61 (67.0%) UC and 31 (68.9%) CD pts. VDZ is effective and safe in IBD outpatients, especially in UC patients.
Sections du résumé
BACKGROUND
BACKGROUND
Italian data currently available in managing ulcerative colitis (UC) and Crohn's disease (CD) patients with vedolizumab (VDZ) are coming just from secondary and tertiary centers. The present study aimed to assess the real-life efficacy and safety of VDZ to achieve remission in inflammatory bowel diseases (IBD) outpatients in primary gastroenterology centers.
METHODS
METHODS
Clinical activity was scored according to the Mayo score in UC and to the Harvey-Bradshaw Index (HBI) in CD. The primary endpoints were the achievement of clinical remission and safety. Secondary endpoints were clinical response to treatment, achievement of mucosal healing (MH), and steroid discontinuation.
RESULTS
RESULTS
One hundred and thirty-six pts. were enrolled (91 UC and 45 CD pts). During an 18-month median follow-up, clinical remission was present in 63 (46.3%) pts.: in particular, it occurred in 48 (52.7%) patients in UC group and in 15 (33.3%) patients in CD group (p = 0.003). more in UC group. Fecal calprotectin ≥400 μg/g and presence of comorbidities were factors significantly related to the failure of remission in UC and CD, respectively. Ten (7.3%) cases of adverse events were recorded (2 required suspension of treatment). Clinical response was present in 105 (72.2%) pts.: 71 (78.0%) in UC and 34 (75.5%) in CD group. MH occurred in 47 (62.7%) UC and in 9 (50.0%) CD patients. Steroids discontinuation occurred in 92 (67.6%) pts.; 61 (67.0%) UC and 31 (68.9%) CD pts.
CONCLUSION
CONCLUSIONS
VDZ is effective and safe in IBD outpatients, especially in UC patients.
Identifiants
pubmed: 31208827
pii: S0953-6205(19)30188-8
doi: 10.1016/j.ejim.2019.06.006
pii:
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Leukocyte L1 Antigen Complex
0
C-Reactive Protein
9007-41-4
vedolizumab
9RV78Q2002
Types de publication
Journal Article
Multicenter Study
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
85-91Informations de copyright
Copyright © 2019 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.