Upfront Combination Therapy, Compared With Monotherapy, for Patients Not Previously Treated With a Biologic Agent Associates With Reduced Risk of Inflammatory Bowel Disease-related Complications in a Population-based Cohort Study.
Adalimumab
/ therapeutic use
Adult
Azathioprine
/ therapeutic use
Cohort Studies
Colitis, Ulcerative
/ drug therapy
Crohn Disease
/ drug therapy
Digestive System Surgical Procedures
/ statistics & numerical data
Drug Substitution
Drug Therapy, Combination
Female
Glucocorticoids
/ therapeutic use
Hospitalization
/ statistics & numerical data
Humans
Immunologic Factors
/ therapeutic use
Inflammatory Bowel Diseases
/ drug therapy
Infliximab
/ therapeutic use
Male
Manitoba
Methotrexate
/ therapeutic use
Prednisone
/ therapeutic use
Proportional Hazards Models
Retrospective Studies
Tumor Necrosis Factor Inhibitors
/ therapeutic use
Combined
Management
Thiopurines
Treatment Comparison
Journal
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
ISSN: 1542-7714
Titre abrégé: Clin Gastroenterol Hepatol
Pays: United States
ID NLM: 101160775
Informations de publication
Date de publication:
08 2019
08 2019
Historique:
received:
12
07
2018
revised:
29
10
2018
accepted:
02
11
2018
pubmed:
19
11
2018
medline:
29
10
2020
entrez:
19
11
2018
Statut:
ppublish
Résumé
Although guidelines recommend inclusion of immune modulators in anti-tumor necrosis factor (TNF) initiation therapy for Crohn's disease (CD) or ulcerative colitis (UC), there are limited data on the incremental effectiveness of this treatment strategy from the real world. We collected data from the Manitoba Inflammatory Bowel Disease (IBD) Epidemiology database on persons with CD (n=852) or UC (n=303), from 2001 through 2016, who began treatment with a TNF antagonist. New and/or continuing users of immunomodulators at the time anti-TNF therapy began were considered recipients of combination therapy. The main outcome was treatment ineffectiveness (IBD-related hospitalization, intestinal resection, corticosteroid use, or change of anti-TNF agent) during TNF antagonist-based therapy or within 90 days after the anti-TNF agent was discontinued. We used Cox proportional hazards models to assess the association between concomitant use of immunomodulators and treatment ineffectiveness. In patients with CD, combination therapy was associated with a significant decrease in likelihood of treatment ineffectiveness (adjusted hazard ratio [aHR] for ineffectiveness, 0.62; 95% CI, 0.49-0.79). However, this association was not significant in patients with UC (aHR, 0.82; 95% CI, 0.56-1.20). In patients with CD, combination therapy was also associated with increased time to first IBD-related hospitalization (aHR 0.53; 95% CI, 0.36-0.80) and switching anti-TNF agents (aHR, 0.63; 95% CI, 0.41-0.97), but not associated with IBD-related surgery (aHR, 0.76; 95% CI, 0.51-1.12) or new or recurrent use of corticosteroids (aHR, 0.75; 95% CI, 0.55-1.04). In an analysis of a database of real-world patients with IBD, we associated initiation therapy with a combination immune modulators and anti-TNF agents with a decreased likelihood of treatment ineffectiveness for patients with CD but not UC.
Sections du résumé
BACKGROUND & AIMS
Although guidelines recommend inclusion of immune modulators in anti-tumor necrosis factor (TNF) initiation therapy for Crohn's disease (CD) or ulcerative colitis (UC), there are limited data on the incremental effectiveness of this treatment strategy from the real world.
METHODS
We collected data from the Manitoba Inflammatory Bowel Disease (IBD) Epidemiology database on persons with CD (n=852) or UC (n=303), from 2001 through 2016, who began treatment with a TNF antagonist. New and/or continuing users of immunomodulators at the time anti-TNF therapy began were considered recipients of combination therapy. The main outcome was treatment ineffectiveness (IBD-related hospitalization, intestinal resection, corticosteroid use, or change of anti-TNF agent) during TNF antagonist-based therapy or within 90 days after the anti-TNF agent was discontinued. We used Cox proportional hazards models to assess the association between concomitant use of immunomodulators and treatment ineffectiveness.
RESULTS
In patients with CD, combination therapy was associated with a significant decrease in likelihood of treatment ineffectiveness (adjusted hazard ratio [aHR] for ineffectiveness, 0.62; 95% CI, 0.49-0.79). However, this association was not significant in patients with UC (aHR, 0.82; 95% CI, 0.56-1.20). In patients with CD, combination therapy was also associated with increased time to first IBD-related hospitalization (aHR 0.53; 95% CI, 0.36-0.80) and switching anti-TNF agents (aHR, 0.63; 95% CI, 0.41-0.97), but not associated with IBD-related surgery (aHR, 0.76; 95% CI, 0.51-1.12) or new or recurrent use of corticosteroids (aHR, 0.75; 95% CI, 0.55-1.04).
CONCLUSION
In an analysis of a database of real-world patients with IBD, we associated initiation therapy with a combination immune modulators and anti-TNF agents with a decreased likelihood of treatment ineffectiveness for patients with CD but not UC.
Identifiants
pubmed: 30448599
pii: S1542-3565(18)31246-1
doi: 10.1016/j.cgh.2018.11.003
pii:
doi:
Substances chimiques
Glucocorticoids
0
Immunologic Factors
0
Tumor Necrosis Factor Inhibitors
0
Infliximab
B72HH48FLU
Adalimumab
FYS6T7F842
Azathioprine
MRK240IY2L
Prednisone
VB0R961HZT
Methotrexate
YL5FZ2Y5U1
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1788-1798.e2Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2019 AGA Institute. Published by Elsevier Inc. All rights reserved.