Observational studyAdvances in therapy2025
Real-World Effectiveness and Safety of Infliximab Biosimilar CT-P13 for Rheumatic Diseases: A National Observational Cohort Study (ReFLECT).
Observational study in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02925338 (OBSERVATOIRE NATIONAL D'UTILISATION D'INFLECTRA™ EN VIE RÉELLE.), which is not on this map. Not yet cited in PubMed.
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Observatoire national d'utilisation d'inflectra™ en vie réelle.
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionReFLECT 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.
methodsEligible 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.
resultsThe 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.
conclusionAfter 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 registrationClinicalTrials.gov identifier: NCT02925338.
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