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

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-contro...