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Real-World Effectiveness and Safety of Infliximab Biosimilar CT-P13 for Rheumatic Diseases: A National Observational
Hubert Marotte1,2, Alain Cantagrel3, Fabienne Coury4
1Département de Rhumatologie, Université Jean Monnet, CHU de Saint-Etienne, INSERM, Mines Saint-Etienne, SAINBIOSE 1059, Saint-Etienne, France. hubert.marotte@chu-st-etienne.fr.
Introduction:
ReFLECT was a French multicenter, observational cohort study evaluating the effectiveness and safety of CT-P13, an infliximab (IFX) biosimilar, in a real-world setting. Here, we describe the results for patients with rheumatic disease.
Methods:
Eligible patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), or psoriatic arthritis (PsA) were recruited and received intravenous CT-P13 induction and/or maintenance therapy. Patients were either naive to IFX (IFX-naive) or had been previously treated with IFX originator or another IFX biosimilar (IFX-switched). CT-P13 persistence (primary objective) was measured as a time-dependent variable during a 2-year follow-up period. Safety was also assessed.
Results:
The patient population comprised 142 patients with RA (IFX-naive: n = 70; IFX-switched: n = 69; other [i.e., previously received IFX, but received another treatment before switching to CT-P13]: n = 3); 411 patients with AS (IFX-naive: n = 189; IFX-switched; n = 201; other: n = 21); and 96 patients with PsA (IFX-naive: n = 44; IFX-switched: n = 47; other: n = 5). After 2 years of follow-up, CT-P13 persistence rates were 49.6% (95% confidence interval [CI] 40.4-60.8%), 62.7% (95% CI 56.6-69.5%), and 73.0% (95% CI 62.7-85.1%) in patients with RA, AS, and PsA, respectively. CT-P13 persistence was greater for IFX-switched than IFX-naive groups in patients with RA (65.4% [95% CI 52.8-81.0%] vs. 33.3% [22.7-49.1%]) and AS (66.5% [95% CI 58.3-76.0%] vs. 56.6% [47.6-67.4%]) and was similar between IFX-switched and IFX-naive groups in patients with PsA (75.9% [95% CI 62.2-92.8%] vs. 72.0% [57.5-90.1%]). The main reason for CT-P13 discontinuation was loss of response (RA/AS/PsA) in both IFX-naive (38.6%/23.3%/22.7%) and IFX-switched 18.8%/18.4%/12.8%) groups. Among patients (RA, AS, and PsA), 52.1%, 57.9%, and 56.3%, respectively, reported ≥ 1 adverse event (AE), and 14.1%, 11.4%, and 10.4%, respectively, reported serious AEs.
Conclusion:
After 2 years of follow-up, the effectiveness of intravenous CT-P13 was maintained in > 65% of IFX-switched patients and CT-P13 induced effective therapeutic maintenance in IFX-naive patients. CT-P13 had an acceptable safety profile.
Trial Registration:
ClinicalTrials.gov identifier: NCT02925338.
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