A phase III study of BCD-055 compared with innovator infliximab in patients with active rheumatoid arthritis: 54-week results from the LIRA study

• Published in: Rheumatology international 2019-09, Vol.39 (9), p.1537-1546
• Main Authors: Lila, Alexander M., Mazurov, Vadim I., Denisov, Lev N., Nesmeyanova, Olga B., Ilivanova, Elena P., Eremeeva, Anna V., Usacheva, Julia Valentinovna, Dokukina, Ekaterina A., Chernyaeva, Ekaterina V., Ivanov, Roman A.
• Format: Article
• Language: English
• Subjects: Adult; Antirheumatic Agents - adverse effects; Antirheumatic Agents - immunology; Antirheumatic Agents - therapeutic use; Arthritis, Rheumatoid - diagnosis; Arthritis, Rheumatoid - drug therapy; Arthritis, Rheumatoid - immunology; Biosimilar Pharmaceuticals - adverse effects; Biosimilar Pharmaceuticals - therapeutic use; Clinical Trials; Disease Progression; Female; Humans; Immunotherapy; India; Infliximab - adverse effects; Infliximab - immunology; Infliximab - therapeutic use; Male; Medicine; Medicine & Public Health; Middle Aged; Monoclonal antibodies; NCT; NCT02762838; Remission Induction; Republic of Belarus; Rheumatoid arthritis; Rheumatology; Russia; Therapeutic Equivalency; Time Factors; TNF inhibitors; Treatment Outcome
• ISSN: 0172-8172; 1437-160X
• DOI: 10.1007/s00296-019-04359-9

BCD-055 is a biosimilar of innovator infliximab (IFX). Here we present the 54-week results from phase 3 clinical study in patients with rheumatoid arthritis (RA). The aim of this study was to demonstrate the equivalent efficacy and safety of BCD-055 and IFX in patients with active rheumatoid arthritis. 426 adults with active RA were enrolled. Patients were randomized into 2 study arms in 2:1 ratio to receive BCD-055 or IFX innovator in dose of 3 mg/kg at week 0, 2, 6 and then every 8 weeks up to week 54. Primary efficacy endpoint was the rate of American College of Rheumatology (ACR) 20 response at week 14. The equivalence margin was set as 15%. Immunogenicity and safety were also assessed. Rate of ACR20 at week 14 in PP (Per-Protocol) population was 71.2% in BCD-055 group and 67.9% in IFX group. Difference in ACR20 rates between groups was 3.2% with 95% CI [− 7.0%; 13.5%] ( р  = 0.587). Throughout 54-week study period, both groups were characterized by similar rates of ACR20/50/70 response at all timepoints without significant differences ( p  > 0.05). The rates of adverse events (AE) were similar in groups (74.64% in BCD-055 arm vs 66.67% in IFX arm, p  = 0.111). Antibodies to infliximab were detected in 28.46% patients for BCD-055 arm and 26.56% for IFX arm ( p  = 0.786). BCD-055 and IFX were comparable in efficacy (including radiographic progression), safety and immunogenicity throughout the 54-week study. Trial registration ClinicalTrials.gov ID, number NCT02762838.