Real-world effectiveness and safety of CT-P13, an infliximab biosimilar, for inflammatory bowel diseases: A prospective national observational cohort study (ReFLECT study)
- PMID: 39448029
- DOI: 10.1016/j.clinre.2024.102483
Real-world effectiveness and safety of CT-P13, an infliximab biosimilar, for inflammatory bowel diseases: A prospective national observational cohort study (ReFLECT study)
Abstract
Background: ReFLECT was a French, prospective, multicenter, observational cohort study evaluating the effectiveness and safety of the infliximab (IFX) biosimilar CT-P13 in a real-world setting. Here, we describe the results for adults with inflammatory bowel disease (IBD).
Methods: Eligible patients with IBD were recruited and received intravenous CT-P13 induction and/or maintenance therapy; patients were either naive to IFX (IFX-naive) or previously treated with IFX originator or another IFX biosimilar (IFX-switched). The primary objective was CT-P13 persistence, which was measured as a time-dependent variable during a two-year follow-up period with four prespecified visits. Safety was assessed.
Results: The adult IBD population comprised 530 patients with Crohn's disease (CD), including 327 categorized as IFX-naive, 188 as IFX-switched, 11 as other (i.e., previously received IFX but received another treatment before switching to CT-P13), and 4 with missing data; and 221 patients with ulcerative colitis (UC), including 152 categorized as IFX-naive, 59 as IFX-switched, 8 as other, and 2 with missing data. After two years of follow-up, the rates of CT-P13 persistence were 71.7 % (95 % CI: 66.7, 77.0) and 63.7 % (55.3, 73.3) in patients with CD and UC, respectively. CT-P13 persistence was greater for IFX-switched patients than for IFX-naive patients (CD: 83.7 % [95 % CI: 78.0, 89.9] vs 65.7 % [58.6, 73.7]; UC: 91.2 % [81.7, 100.0] vs 53.4 % [43.0, 66.2]). The main reason for CT-P13 discontinuation was loss of response (CD/UC) in both IFX-naive (14.7 %/21.7 %) and IFX-switched (7.4 %/5.1 %) groups. Among patients (CD and UC, respectively), 51.3 % and 45.2 % reported ≥1 adverse event (AE), and 13.2 % and 12.7 % reported serious AEs, respectively.
Conclusion: After two years of follow-up, the effectiveness of intravenous CT-P13 was maintained in >80 % of IFX-switched patients. CT-P13 induced effective therapeutic maintenance in IFX-naive patients. CT-P13 had an acceptable safety profile.
Trial registration: ClinicalTrials.gov identifier: NCT02925338.
Keywords: Biosimilar; CT-P13; Crohn's disease; Real world; Ulcerative colitis.
Copyright © 2024. Published by Elsevier Masson SAS.
Conflict of interest statement
Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: D. Laharie: Counseling, boards, transports, or fees: AbbVie, Amgen, Biogen, Celltrion, Eli Lilly, Ferring Pharmaceuticals, Galápagos NV, Janssen Pharmaceuticals, MSD, Pfizer, Prometheus Laboratories, Roche, Takeda Pharmaceuticals. Y. Bouhnik: Research grants: AbbVie, Amgen, Fresnius Kabi, Janssen Pharmaceuticals, Takeda Pharmaceuticals, Viatris Inc. Consulting fees: AbbVie, Boehringer Ingelheim, Celltrion, Eli Lilly, Ferring Pharmaceuticals, Fresnius Kabi, Galápagos NV, Gilead Sciences Inc, Hospira, Iterative Health, Janssen Pharmaceuticals, Mayoly Spindler, Merck & Co., Inc, MSD, Norgine, Pfizer, Roche, Sandoz, Sanofi, Takeda Pharmaceuticals. Payment/honoraria: AbbVie, Celltrion, Eli Lilly, Fresnius Kabi, Galápagos NV, Gilead Sciences Inc, Janssen Pharmaceuticals, MSD, Pfizer, Takeda Pharmaceuticals. L. Vuitton: Lecture and/or consulting fees: AbbVie, Amgen, Celltrion, Dr Falk Pharma GmbH, Eli Lilly, Galápagos NV, Janssen Pharmaceuticals, Pfizer, Takeda Pharmaceuticals, Viatris Inc. A. Biron: Research grants: AbbVie, Amgen, Biogen, Celltrion, Ferring Pharmaceuticals, Takeda Pharmaceuticals, Tillotts Pharma. Consulting fees: Biogen, Ferring Pharmaceuticals. Lecture fees: AbbVie, Amgen, Takeda Pharmaceuticals, Tillotts Pharma. Travel accommodation fees: Amgen, Celltrion. A. Amiot: Consulting fees: AbbVie, Adacyte Therapeutics, Fresenius Kabi, Gilead Sciences Inc, Janssen Pharmaceuticals, Pfizer, Takeda Pharmaceuticals, Tillotts Pharma. Lecture fees: AbbVie, Adacyte Therapeutics, Biogen, Eli Lilly, Ferring Pharmaceuticals, Fresenius Kabi, MSD, Pfizer, Takeda Pharmaceuticals, Tillotts Pharma. Travel accommodation fees: AbbVie, Adacyte Therapeutics, Biogen, Janssen Pharmaceuticals.
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