Persistence Among Patients with Crohn Disease Previously Treated with an Anti-tumor Necrosis Factor Inhibitor and Switching or Cycling to Another Biologic Agent.
Adult
Humans
Female
Male
Crohn Disease
/ drug therapy
Tumor Necrosis Factor Inhibitors
/ therapeutic use
Infliximab
/ therapeutic use
Adalimumab
/ therapeutic use
Biological Factors
Certolizumab Pegol
/ therapeutic use
Ustekinumab
Retrospective Studies
Tumor Necrosis Factor-alpha
Necrosis
/ chemically induced
Anti-TNF
Biologic
Crohn disease
Persistence
Real-world evidence
Ustekinumab
Journal
Clinical therapeutics
ISSN: 1879-114X
Titre abrégé: Clin Ther
Pays: United States
ID NLM: 7706726
Informations de publication
Date de publication:
08 2023
08 2023
Historique:
received:
15
03
2023
revised:
15
06
2023
accepted:
15
06
2023
medline:
4
9
2023
pubmed:
14
7
2023
entrez:
13
7
2023
Statut:
ppublish
Résumé
Nonresponse to an anti-tumor necrosis factor (TNF) agent in patients with Crohn disease (CD) is often managed by either a switch to a different class of biologic (ie, ustekinumab, vedolizumab) or by cycling to another anti-TNF agent (ie, adalimumab, infliximab, certolizumab pegol). Persistence after a switch to a different biologic class or after cycling within the anti-TNF class was assessed in patients with nonresponse to an anti-TNF agent. Adults with CD who discontinued from an anti-TNF agent and either switched to a different class of biologic (ie, anti-interleukin/integrin; the switching cohort) or cycled within the anti-TNF class (the cycling cohort) between September 23, 2016, and August 1, 2019, were selected from a commercial database. The index date was defined as the date of the first claim of the subsequent-line biologic (index biologic) after an anti-TNF. The switching and cycling cohorts were balanced with regard to baseline characteristics, using inverse probability of treatment weights-average treatment effect (IPTW-ATE). Persistence with the index biologic was defined as consistent use with no gaps of >120 days (ustekinumab, vedolizumab, infliximab) or of >60 days (adalimumab, certolizumab pegol) in biologic supply. Composite end points were persistence while being corticosteroid-free (defined as no use of corticosteroids with ≥14 days of supply after day 90 post-index) and persistence while on monotherapy (no immunomodulators/nonindex biologics). Weighted Kaplan-Meier and Cox models were used to assess outcomes at 12 months post-index. There were 444 patients in the weighted switching cohort (mean age, 40.4 years; 56.3% female) and 441 in the weighted cycling cohort (mean age, 39.5 years; 58.4% female). At 12 months post-index, the rate of persistence with the index biologic was 75.7% in the switching cohort compared to 67.5% in the cycling cohort (log-rank P = 0.023); the rate of persistence while on monotherapy was 58.2% compared to 44.2%, respectively (log-rank P < 0.001). The rate of persistence was 44% greater in the switching compared to that in the cycling cohort (hazard ratio [HR] = 1.44; 95% CI, 1.11-1.88; P = 0.007); the rate of persistence while on monotherapy was 56% greater in the switching cohort (HR = 1.56; 95% CI, 1.28-1.90; P < 0.001). The between-cohort difference in persistence while being corticosteroid-free was not statistically significant (HR = 1.08; 95% CI, 0.89-1.32; P = 0.426). Patients with CD who switched to a different biologic class were more persistent than were patients who cycled to another anti-TNF agent. These findings may be useful for physicians when considering the treatment of patients who have experienced nonresponse or loss of response to the first-line anti-TNF agent.
Identifiants
pubmed: 37442653
pii: S0149-2918(23)00218-7
doi: 10.1016/j.clinthera.2023.06.013
pii:
doi:
Substances chimiques
Tumor Necrosis Factor Inhibitors
0
Infliximab
B72HH48FLU
Adalimumab
FYS6T7F842
Biological Factors
0
Certolizumab Pegol
UMD07X179E
Ustekinumab
FU77B4U5Z0
Tumor Necrosis Factor-alpha
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
770-777Informations de copyright
Copyright © 2023 Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest S.K., Z.D., R.Z., and B.G. are employees of Janssen Scientific Affairs, LLC and stockholders of Johnson & Johnson. M.Z., A.M.M., C.H., and D.P. are employees of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC, which funded the development and conduct of this study and manuscript.