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

• Published in: Clinical therapeutics Vol. 45; no. 8; pp. 770 - 777
• Main Authors: Zhdanava, Maryia, Kachroo, Sumesh, Manceur, Ameur M., Ding, Zhijie, Holiday, Christopher, Zhao, Ruizhi, Godwin, Bridget, Pilon, Dominic
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.08.2023; Elsevier Limited
• Subjects: Anti-TNF; Arthritis; Biologic; Biological products; Corticoids; Corticosteroids; Crohn disease; Crohn's disease; Crohns disease; Cycles; Females; Health insurance; Health services; Immunomodulation; Immunomodulators; Inflammatory bowel disease; Infliximab; Monoclonal antibodies; Patients; Persistence; Pharmacy; Real-world evidence; Statistical analysis; Steroids; Tumor necrosis factor-TNF; Tumor necrosis factor-α; Ustekinumab; United States > US; Persistence; Anti-TNF; Ustekinumab; Crohn disease; Biologic; Real-world evidence
• ISSN: 0149-2918; 1879-114X
• DOI: 10.1016/j.clinthera.2023.06.013

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.