Effectiveness and safety of vedolizumab induction with or without budesonide in patients with moderately to severely active Crohn's disease in Europe: a retrospective observational study.
Budesonide
Crohn’s disease
Moderately to severely active crohn’s disease
Vedolizumab
Journal
BMC gastroenterology
ISSN: 1471-230X
Titre abrégé: BMC Gastroenterol
Pays: England
ID NLM: 100968547
Informations de publication
Date de publication:
29 Nov 2023
29 Nov 2023
Historique:
received:
26
04
2023
accepted:
06
11
2023
medline:
1
12
2023
pubmed:
30
11
2023
entrez:
29
11
2023
Statut:
epublish
Résumé
Vedolizumab (VDZ), a gut-selective anti-lymphocyte trafficking integrin antibody, is effective in treating patients with moderately to severely active Crohn's disease (CD). In this study, we examined the real-world effectiveness and safety of induction therapy using VDZ alone or in combination with budesonide (VDZ + BUD) among patients with CD in Belgium, Israel, and Switzerland. This retrospective chart review analysis included adult patients with moderately to severely active CD who started induction treatment with VDZ or VDZ + BUD (January 2015 through January 2019). The primary objective of this study was to assess the effectiveness in terms of clinical remission of VDZ alone or VDZ + BUD using patient-reported outcomes (PRO) of abdominal pain (AP) and/or loose stool frequency (LSF) (PRO-2) at weeks 0, 2, 6, 10, and 14. Regression models were used to assess differences and associations between the treatment groups. Overall, 123 patients were included (VDZ, n = 73; VDZ + BUD, n = 50). Clinical remission rates at week 14 were 71.4% (50/70) and 68.0% (34/50) with VDZ and VDZ + BUD, respectively. Mean percentage change in AP and LSF from baseline to week 14 was comparable between the groups. Median (95% confidence interval [CI]) time to clinical remission was 91 [70.0-98.0] and 95 [70.0-98.0] days, respectively. One patient in each group discontinued VDZ and 68.0% of patients in the VDZ + BUD group discontinued BUD before week 14. The rates of overall adverse events were similar between the groups (VDZ, 23.3%; VDZ + BUD, 26.0%). In this retrospective study, VDZ alone and VDZ + BUD showed similar high remission rates in patients with moderately to severely active CD. Prospective randomized studies are needed to conclude on the role of combining VDZ with BUD. Not applicable.
Sections du résumé
BACKGROUND
BACKGROUND
Vedolizumab (VDZ), a gut-selective anti-lymphocyte trafficking integrin antibody, is effective in treating patients with moderately to severely active Crohn's disease (CD). In this study, we examined the real-world effectiveness and safety of induction therapy using VDZ alone or in combination with budesonide (VDZ + BUD) among patients with CD in Belgium, Israel, and Switzerland.
METHODS
METHODS
This retrospective chart review analysis included adult patients with moderately to severely active CD who started induction treatment with VDZ or VDZ + BUD (January 2015 through January 2019). The primary objective of this study was to assess the effectiveness in terms of clinical remission of VDZ alone or VDZ + BUD using patient-reported outcomes (PRO) of abdominal pain (AP) and/or loose stool frequency (LSF) (PRO-2) at weeks 0, 2, 6, 10, and 14. Regression models were used to assess differences and associations between the treatment groups.
RESULTS
RESULTS
Overall, 123 patients were included (VDZ, n = 73; VDZ + BUD, n = 50). Clinical remission rates at week 14 were 71.4% (50/70) and 68.0% (34/50) with VDZ and VDZ + BUD, respectively. Mean percentage change in AP and LSF from baseline to week 14 was comparable between the groups. Median (95% confidence interval [CI]) time to clinical remission was 91 [70.0-98.0] and 95 [70.0-98.0] days, respectively. One patient in each group discontinued VDZ and 68.0% of patients in the VDZ + BUD group discontinued BUD before week 14. The rates of overall adverse events were similar between the groups (VDZ, 23.3%; VDZ + BUD, 26.0%).
CONCLUSIONS
CONCLUSIONS
In this retrospective study, VDZ alone and VDZ + BUD showed similar high remission rates in patients with moderately to severely active CD. Prospective randomized studies are needed to conclude on the role of combining VDZ with BUD.
TRIAL REGISTRATION
BACKGROUND
Not applicable.
Identifiants
pubmed: 38030966
doi: 10.1186/s12876-023-03032-7
pii: 10.1186/s12876-023-03032-7
pmc: PMC10688148
doi:
Substances chimiques
Budesonide
51333-22-3
vedolizumab
9RV78Q2002
Gastrointestinal Agents
0
Antibodies, Monoclonal, Humanized
0
Types de publication
Observational Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
417Informations de copyright
© 2023. The Author(s).
Références
Gut. 2017 May;66(5):839-851
pubmed: 26893500
N Engl J Med. 2013 Aug 22;369(8):699-710
pubmed: 23964932
Gastroenterology. 2020 Feb;158(3):562-572.e12
pubmed: 31470005
J Crohns Colitis. 2020 Jan 1;14(1):4-22
pubmed: 31711158
Ther Adv Chronic Dis. 2010 Jul;1(4):177-86
pubmed: 23251737
Lancet. 2017 Apr 29;389(10080):1741-1755
pubmed: 27914655
Cureus. 2020 May 29;12(5):e8351
pubmed: 32617224
Clin Gastroenterol Hepatol. 2019 Jan;17(1):130-138.e7
pubmed: 29857145
Am J Gastroenterol. 2015 Sep;110(9):1324-38
pubmed: 26303131
Expert Opin Drug Metab Toxicol. 2017 Jul;13(7):793-801
pubmed: 28612627
Dig Dis. 2012;30(4):368-75
pubmed: 22796798
Inflamm Bowel Dis. 2019 Jul 17;25(8):1375-1382
pubmed: 30615117
N Engl J Med. 2013 Aug 22;369(8):711-21
pubmed: 23964933
J Gastroenterol Hepatol. 2018 Mar 30;:
pubmed: 29603368
J Pharmacol Exp Ther. 2009 Sep;330(3):864-75
pubmed: 19509315
Ann Intern Med. 2007 Jun 19;146(12):829-38
pubmed: 17470824
N Engl J Med. 1994 Sep 29;331(13):842-5
pubmed: 8078530
Gastroenterology. 2021 Apr;160(5):1570-1583
pubmed: 33359090