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

• Published in: Clinical drug investigation Vol. 45; no. 8; pp. 551 - 563
• Main Authors: Burmester, Gerd, Trefler, Jakub, Racewicz, Artur, Jaworski, Janusz, Zielińska, Agnieszka, Krogulec, Marek, Jeka, Sławomir, Wojciechowski, Rafał, Kolossa, Katarzyna, Dudek, Anna, Krajewska-Włodarczyk, Magdalena, Hrycaj, Paweł, Klimiuk, Piotr Adrian, Kim, SungHyun, Suh, JeeHye, Yang, GoEun, Kim, YunAh, Jung, YooBin, Park, GaHee, Smolen, Josef S.
• Format: Journal Article
• Language: English
• Published: New Zealand Springer Nature B.V 01.08.2025; Springer International Publishing
• Subjects: Adolescent; Adult; Aged; Antibodies; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - adverse effects; Antibodies, Monoclonal, Humanized - pharmacokinetics; Antibodies, Monoclonal, Humanized - therapeutic use; Antirheumatic Agents - administration & dosage; Antirheumatic Agents - adverse effects; Antirheumatic Agents - pharmacokinetics; Antirheumatic Agents - therapeutic use; Arthritis, Rheumatoid - drug therapy; Biological products; Biosimilar Pharmaceuticals - administration & dosage; Biosimilar Pharmaceuticals - adverse effects; Biosimilar Pharmaceuticals - pharmacokinetics; Biosimilar Pharmaceuticals - therapeutic use; Boolean; Disease; Double-Blind Method; Drug dosages; FDA approval; Female; Humans; Male; Middle Aged; Original; Pharmacokinetics; Remission (Medicine); Rheumatoid arthritis; Treatment Outcome; Young Adult; Poland; United States > US
• ISSN: 1173-2563; 1179-1918; 1179-1918
• DOI: 10.1007/s40261-025-01453-8

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. 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. 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. 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. NCT05489224, 24 July 2022.