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Introduction <p>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.</p> Methods <p>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.</p> Results <p>The patient population comprised 142 patients with RA (IFX-naive: <i>n</i> = 70; IFX-switched: <i>n</i> = 69; other [i.e., previously received IFX, but received another treatment before switching to CT-P13]: <i>n</i> = 3); 411 patients with AS (IFX-naive: <i>n</i> = 189; IFX-switched; n = 201; other: <i>n</i> = 21); and 96 patients with PsA (IFX-naive: <i>n</i> = 44; IFX-switched: <i>n</i> = 47; other: <i>n</i> = 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.</p> Conclusion <p>After 2 years of follow-up, the effectiveness of intravenous CT-P13 was maintained in &gt; 65% of IFX-switched patients and CT-P13 induced effective therapeutic maintenance in IFX-naive patients. CT-P13 had an acceptable safety profile.</p> Trial Registration <p>ClinicalTrials.gov identifier: NCT02925338.</p>

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Real-World Effectiveness and Safety of Infliximab Biosimilar CT-P13 for Rheumatic Diseases: A National Observational Cohort Study (ReFLECT)

  • 期刊论文

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  • 发表日期：

    2025年7月28日

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  • Hubert Marotte,
  • Alain Cantagrel,
  • Fabienne Coury,
  • Thierry Schaeverbeke,
  • Maryse Assing,
  • Meriem Kessouri,
  • Yves Brault,
  • Bruno Fautrel

摘要

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.