A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy

• Published in: Annals of the rheumatic diseases Vol. 76; no. 1; pp. 58 - 64
• Main Authors: Choe, Jung-Yoon, Prodanovic, Nenad, Niebrzydowski, Jaroslaw, Staykov, Ivan, Dokoupilova, Eva, Baranauskaite, Asta, Yatsyshyn, Roman, Mekic, Mevludin, Porawska, Wieskawa, Ciferska, Hana, Jedrychowicz-Rosiak, Krystyna, Zielinska, Agnieszka, Choi, Jasmine, Rho, Young Hee, Smolen, Josef S
• Format: Journal Article
• Language: English
• Published: England Elsevier Limited 01.01.2017; BMJ Publishing Group
• Series: Extended report
• Subjects: Adult; Aged; Antibodies - blood; Antirheumatic Agents - adverse effects; Antirheumatic Agents - pharmacokinetics; Antirheumatic Agents - therapeutic use; Arthritis, Rheumatoid - drug therapy; Biological products; Biosimilar Pharmaceuticals - adverse effects; Biosimilar Pharmaceuticals - pharmacokinetics; Biosimilar Pharmaceuticals - therapeutic use; Clinical and Epidemiological Research; Double-Blind Method; Drug dosages; Family medical history; Female; Humans; Infliximab - adverse effects; Infliximab - immunology; Infliximab - pharmacokinetics; Infliximab - therapeutic use; Male; Methotrexate - therapeutic use; Middle Aged; Rheumatoid arthritis; Severity of Illness Index; Therapeutic Equivalency; Treatment Outcome; Tuberculosis; Tumor necrosis factor-TNF; Anti-TNF; DMARDs (biologic); Disease Activity; Rheumatoid Arthritis

ObjectivesTo compare the efficacy, safety, immunogenicity and pharmacokinetics (PK) of SB2 to the infliximab reference product (INF) in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate therapy.MethodsThis is a phase III, randomised, double-blind, multinational, multice...