THU0140 Efficacy and Safety Analysis by Overall anti-Drug Antibody Results Up To Week 30 in Patients with Rheumatoid Arthritis Treated with Sb2 (An Infliximab Biosimilar) or Infliximab Reference Product in Phase III Study
Authors: J.-Y. Choe, J.S. Smolen, E. Keystone, M.C. Genovese, J. Choi, Y.H. Rho
Journal: Annals of the Rheumatic Diseases (2016)

<h3>Background</h3> SB2 is developed as a biosimilar of the infliximab reference product (INF). The clinical results of this Phase III study have been reported<sup>1,2</sup>. <h3>Objectives</h3> To compare efficacy results (ACR responses, ACR-N, DAS28, and proportion of patients with remission/low disease activity based on DAS28, SDAI or CDAI) and safety results including infusion related reaction by anti-drug antibody (ADA) status up to Week 30 in patients with rheumatoid arthritis (RA) treated with SB2 or INF. <h3>Methods</h3> This study is a randomised, double-blind phase III study. A total of 583 patients with RA were treated with 3 mg/kg of SB2 or INF with background methotrexate (MTX). Efficacy, safety and immunogenicity were measured. <h3>Results</h3> Patients who developed ADA up to Week 30 were 55.1% in SB2 and 49.7% in INF. In both ADA positive and ADA negative subgroups, the ACR responses and other efficacy endpoints were comparable between SB2 and INF up to Week 30. There was a trend towards decreased efficacy in ADA positive subgroups compared with ADA negative subgroups for all efficacy parameters evaluated in both treatment arms. Safety profiles were also comparable between SB2 and INF in both ADA positive and negative subgroups. Within each treatment group, safety profiles were comparable between ADA positive and negative subgroups. Two patients (1.6%) treated with SB2 and 4 patients (2.7%) treated with INF in the ADA negative subgroups, and 8 patients (5.1%) treated with SB2 and 9 patients (6.2%) treated with INF in the ADA positive subgroups reported an infusion related reaction. <h3>Conclusions</h3> Regardless of the overall 30-week ADA status, efficacy results were comparable between SB2 and INF. Efficacy tends to be lower in ADA positive subgroups compared with ADA negative subgroups of patients treated with either SB2 or INF. Safety profiles including infusion related reactions were also comparable between SB2 and INF regardless of ADA status, but a higher proportion of patients reported infusion related reactions in ADA positive subgroups compared to ADA negative subgroups in both treatment groups. <h3>References</h3> Choe JY et al. Ann Rheum Dis. 2015–207764 [Epub ahead of print] Choe JY et al. Arthritis Rheumatol. 2015; 67 (suppl 10), 2056 <h3>Disclosure of Interest</h3> J.-Y. Choe Grant/research support from: Samsung Bioepis, Consultant for: Samsung Bioepis, J. S. Smolen Consultant for: Abbvie, Amgen, Astra-Zeneca, Astro, Celgene, Glazo, Janssen, Lilly, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung Bioepis, Sanofi, UCB, E. Keystone Grant/research support from: Pfizer, Roche, Janssen, Amgen, Consultant for: Pfizer, Roche, Janssen, Amgen, BMS, Merck, Celltrion, Samsung Bioepis, M. C. Genovese Consultant for: Samsung Bioepis, J. Choi Employee of: Samsung Bioepis, Y. H. Rho Employee of: Samsung Bioepis