FRI0162 Comparable Safety and Immunogenicity and Sustained Efficacy after Transition To SB2 (An Infliximab Biosimilar) vs Ongoing Infliximab Reference Product in Patients with Rheumatoid Arthritis: Results of Phase III Transition Study

Background SB2 is developed as a biosimilar of the infliximab reference product (INF). The 30-week and 54-week results of Phase III study have been reported1,2. Objectives To evaluate the safety, immunogenicity, and efficacy in patients with RA who transitioned from INF to SB2 vs maintained INF and who continued to receive SB2 after Week 54 up to Week 78. Methods This study is a randomised, double-blind phase III transition study. Patients with moderate to severe RA were randomised in a 1:1 ratio to receive either SB2 or INF at Weeks 0, 2, 6, and then every 8 weeks thereafter until week 46. At Week 54, patients previously receiving INF were re-randomised in a 1:1 ratio to either receive SB2 (INF/SB2) or continue INF (INF/INF) up to week 70; patients receiving SB2 continued to receive SB2 (SB2/SB2) up to Week 70. Safety, immunogenicity and efficacy were assessed up to week 78. Results At Week 54, 94 patients from INF were transitioned to SB2 (INF/SB2), 101 patients from INF continued to receive INF (INF/INF), and 201 patients from SB2 continued to receive SB2 (SB2/SB2). The safety profile during the transition period was comparable between INF/SB2, INF/INF, and SB2/SB2. The incidence of adverse events during the transition period was 36.2% in INF/SB2, 35.6% in INF/INF, and 40.3% in SB2/SB2. The incidence of infusion related reaction during the transition period was 3.2%, 2.0%, and 3.5%, respectively. Among the patients with overall negative anti-drug antibodies (ADA) results up to Week 54, ADAs were newly developed in 14.6% (6/41) in INF/SB2, 14.9% (7/47) in INF/INF, and 14.1% (11/78) in SB2/SB2. The efficacy was sustained and comparable between the treatment groups.Table 1. Safety Profile During the Transition Period (From Week 54 to Week 78) Number of patients with INF/SB2 INF/INF SB2/SB2 (N=94) (N=101) (N=201) n (%) n (%) n (%) At least 1 treatment-emergent adverse event 34 (36.2) 36 (35.6) 81 (40.3) At least 1 serious adverse event 6 (6.4) 3 (3.0) 7 (3.5) Serious infections 2 (2.1) 1 (1.0) 1 (0.5) Active tuberculosis 0 (0.0) 0 (0.0) 0 (0.0) Infusion-related reaction 3 (3.2) 2 (2.0) 7 (3.5) Malignancy 0 (0.0) 0 (0.0) 0 (0.0) Death 0 (0.0) 0 (0.0) 0 (0.0) Overall ADA positive 43 (45.7) 51 (50.5) 104 (53.6)a Newly ADA positiveb 6 7 11 aPercentage is based on 194 patients with available ADA results. bNewly developed ADA in patients with negative overall ADA up to Week 54. Conclusions The safety, immunogenicity, and efficacy profiles remained comparable between the INF/SB2, INF/INF, and SB2/SB2 up to Week 78, revealing that there were no treatment emergent issues or clinically relevant immunogenicity after switching from INF to SB2. References Choe JY et al. Ann Rheum Dis. 2015–207764 [Epub ahead of print] Choe JY et al. Arthritis Rheumatol. 2015; 67 (suppl 10), 2056 Disclosure of Interest J. S. Smolen Consultant for: Abbvie, Amgen, Astra-Zeneca, Astro, Celgene, Glazo, Janssen, Lilly, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung Bioepis, Sanofi, UCB, J.-Y. Choe Grant/research support from: Samsung Bioepis, Consultant for: Samsung Bioepis, N. Prodanovic Grant/research support from: Samsung Bioepis, J. Niebrzydowski Grant/research support from: Samsung Bioepis, I. Staykov Grant/research support from: Samsung Bioepis, E. Dokoupilova Grant/research support from: Samsung Bioepis, A. Baranauskaite Grant/research support from: AbbVie, Samsung Bioepis, R. Yatsyshyn Grant/research support from: Samsung Bioepis, M. Mekic Grant/research support from: Samsung Bioepis, W. Porawska Grant/research support from: Samsung Bioepis, H. Ciferska Grant/research support from: Samsung Bioepis, K. Jedrychowicz-Rosiak Grant/research support from: Samsung Bioepis, A. Zielinska Grant/research support from: Samsung Bioepis, J. Choi Employee of: Samsung Bioepis, Y. H. Rho Employee of: Samsung Bioepis