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Background and Objective <p>This phase III study conducted in 22 centres in Poland assessed the efficacy equivalence of candidate tocilizumab biosimilar, CT-P47, and European Union-approved reference tocilizumab (r-TCZ) in rheumatoid arthritis. We report 1-year data, including switching from r-TCZ to CT-P47.</p> Methods <p>This active-controlled, double-blind, multicentre trial randomised (1:1) adults (aged 18–75 years) with moderate-to-severe rheumatoid arthritis diagnosed for ≥&#xa0;24 weeks and treated with methotrextate for ≥&#xa0;12&#xa0;weeks before the first study drug administration, to receive CT-P47 or r-TCZ every 4 weeks (8&#xa0;mg/kg, intravenous) up to week&#xa0;20. At week 24, those on CT-P47 continued maintenance treatment; those on r-TCZ were re-randomised (1:1) to continue r-TCZ (r-TCZ maintenance) or to switch to CT-P47 (CT-P47 switched) until week 48 (Treatment Period 2). After week 48, patients were followed up until week 52 (end of study). Efficacy, pharmacokinetics, safety and immunogenicity were evaluated.</p> Results <p>In Treatment Period 2, 225 patients continued CT-P47 maintenance, 109 continued r‑TCZ maintenance and 110 switched to CT-P47. During Treatment Period 2, efficacy findings were comparable between groups. At week 52, the mean change from baseline in Disease Activity Score in 28 joints-erythrocyte sedimentation rate was −&#xa0;4.279, −&#xa0;4.231 and −&#xa0;4.376 in the CT-P47 maintenance, r-TCZ maintenance and CT-P47 switched groups, respectively. Joint damage progression over 1 year was minimal in all groups. Drug serum concentrations were relatively consistent throughout Treatment Period 2. The safety profile and antidrug antibody-positive conversion rate (&lt;&#xa0;5% in each group) were similar between groups.</p> Conclusions <p>Week 52 results show maintained efficacy after switching from r-TCZ to CT-P47, and comparable efficacy, pharmacokinetics, safety and immunogenicity of CT-P47 versus r-TCZ over 1 year of treatment.</p> Clinical Trial Registration <p>NCT05489224, 24 July 2022.</p>

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Efficacy and Safety of Biosimilar CT-P47 Versus Reference Tocilizumab: 1-Year Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study in Patients with Rheumatoid Arthritis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年7月12日

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  • Gerd Burmester,
  • Jakub Trefler,
  • Artur Racewicz,
  • Janusz Jaworski,
  • Agnieszka Zielińska,
  • Marek Krogulec,
  • Sławomir Jeka,
  • Rafał Wojciechowski,
  • Katarzyna Kolossa,
  • Anna Dudek,
  • Magdalena Krajewska-Włodarczyk,
  • Paweł Hrycaj,
  • Piotr Adrian Klimiuk,
  • SungHyun Kim,
  • JeeHye Suh,
  • GoEun Yang,
  • YunAh Kim,
  • YooBin Jung,
  • GaHee Park,
  • Josef S. Smolen

摘要

Background and Objective

This phase III study conducted in 22 centres in Poland assessed the efficacy equivalence of candidate tocilizumab biosimilar, CT-P47, and European Union-approved reference tocilizumab (r-TCZ) in rheumatoid arthritis. We report 1-year data, including switching from r-TCZ to CT-P47.

Methods

This active-controlled, double-blind, multicentre trial randomised (1:1) adults (aged 18–75 years) with moderate-to-severe rheumatoid arthritis diagnosed for ≥ 24 weeks and treated with methotrextate for ≥ 12 weeks before the first study drug administration, to receive CT-P47 or r-TCZ every 4 weeks (8 mg/kg, intravenous) up to week 20. At week 24, those on CT-P47 continued maintenance treatment; those on r-TCZ were re-randomised (1:1) to continue r-TCZ (r-TCZ maintenance) or to switch to CT-P47 (CT-P47 switched) until week 48 (Treatment Period 2). After week 48, patients were followed up until week 52 (end of study). Efficacy, pharmacokinetics, safety and immunogenicity were evaluated.

Results

In Treatment Period 2, 225 patients continued CT-P47 maintenance, 109 continued r‑TCZ maintenance and 110 switched to CT-P47. During Treatment Period 2, efficacy findings were comparable between groups. At week 52, the mean change from baseline in Disease Activity Score in 28 joints-erythrocyte sedimentation rate was − 4.279, − 4.231 and − 4.376 in the CT-P47 maintenance, r-TCZ maintenance and CT-P47 switched groups, respectively. Joint damage progression over 1 year was minimal in all groups. Drug serum concentrations were relatively consistent throughout Treatment Period 2. The safety profile and antidrug antibody-positive conversion rate (< 5% in each group) were similar between groups.

Conclusions

Week 52 results show maintained efficacy after switching from r-TCZ to CT-P47, and comparable efficacy, pharmacokinetics, safety and immunogenicity of CT-P47 versus r-TCZ over 1 year of treatment.

Clinical Trial Registration

NCT05489224, 24 July 2022.