Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose:SB2 is approved by the European Medicines Agency as a biosimilar of the reference infliximab (INF). The 30-week and 54-week results of Phase III study have been reported1,2. The objective of this transition period of Phase III study is 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 is a randomized, double-blind phase III transition study. Patients with moderate to severe RA were randomized 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-randomized 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 among patients with negative ADA up to Week 54. The efficacy was sustained and comparable between the treatment groups.
Conclusion: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. Reference: 1. Choe JY et al. Ann Rheum Dis. 2015-207764 [Epub ahead of print] 2. Choe JY et al. Arthritis Rheumatol. 2015; 67 (suppl 10), 2056
To cite this abstract in AMA style:Smolen JS, Choe JY, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, Baranauskaite A, Yatsyshyn R, Mekic M, Porawska W, Ciferska H, Jedrychowicz-Rosiak K, Zielinska A, Choi J, Rho YH. Comparable Safety and Immunogenicity and Sustained Efficacy after Transition to SB2 (An Infliximab Biosimilar) Vs Ongoing Reference Infliximab (Remicade®) in Patients with Rheumatoid Arthritis: Results of Phase III Transition Study [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/comparable-safety-and-immunogenicity-and-sustained-efficacy-after-transition-to-sb2-an-infliximab-biosimilar-vs-ongoing-reference-infliximab-remicade-in-patients-with-rheumatoid-arthrit/. Accessed October 28, 2020.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/comparable-safety-and-immunogenicity-and-sustained-efficacy-after-transition-to-sb2-an-infliximab-biosimilar-vs-ongoing-reference-infliximab-remicade-in-patients-with-rheumatoid-arthrit/