Persistence Among Patients with Crohn Disease Previously Treated with an Anti-tumor Necrosis Factor Inhibitor and Switching or Cycling to Another Biologic Agent.


Journal

Clinical therapeutics
ISSN: 1879-114X
Titre abrégé: Clin Ther
Pays: United States
ID NLM: 7706726

Informations de publication

Date de publication:
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

770-777

Informations 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.

Auteurs

Maryia Zhdanava (M)

Analysis Group, Inc., Montreal, Quebec, Canada. Electronic address: Masha.Zhdanava@analysisgroup.com.

Sumesh Kachroo (S)

Janssen Scientific Affairs LLC, Horsham, Pennsylvania.

Ameur M Manceur (AM)

Analysis Group, Inc., Montreal, Quebec, Canada.

Zhijie Ding (Z)

Janssen Scientific Affairs LLC, Horsham, Pennsylvania.

Christopher Holiday (C)

Analysis Group, Inc., Montreal, Quebec, Canada.

Ruizhi Zhao (R)

Janssen Scientific Affairs LLC, Horsham, Pennsylvania.

Bridget Godwin (B)

Janssen Scientific Affairs LLC, Horsham, Pennsylvania.

Dominic Pilon (D)

Analysis Group, Inc., Montreal, Quebec, Canada.

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Classifications MeSH