ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2596

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

Josef S. Smolen1, Jung-Yoon Choe2, Nenad Prodanovic3, Jaroslaw Niebrzydowski4, Ivan Staykov5, Eva Dokoupilova6, Asta Baranauskaite7, Roman Yatsyshyn8, Mevludin Mekic9, Wieslawa Porawska10, Hana Ciferska11, Krystyna Jedrychowicz-Rosiak12, Agnieszka Zielinska13, Jasmine Choi14 and Young Hee Rho14, 1Medical University of Vienna, Vienna, Austria, 2Division of Rheumatology, Daegu Catholic University Medical Center, Daegu, South Korea, 3Clinical Center Banja Luka, Banja Luka, Bosnia, 4Medica Pro Familia, Gdynia, Poland, 5MHAT "Dr. Ivan Seliminski", AD, Sliven, Bulgaria, 6MEDICAL PLUS s.r.o, Uherske Hradiste, Czech Republic, 7Lithuanian University of Health Sciences, Kaunas, Lithuania, 8SHEI Ivano-Frankivsk NMU, Ivano-Frankivsk, Ukraine, 9University Clinic Centre Sarajevo, Sarajevo, Bosnia, 10Poznanski Osrodek Medyczny NOVAMED, Poznan, Poland, 11Revmatologicky ustav, Praha 2, Czech Republic, 12MCBK S.C., Grodzisk Mazowiecki, Poland, 13Medica Pro Familia Sp. z o.o. Spolka Komandytowo-Akcyjna, Warszawa, Poland, 14Samsung Bioepis Co., Ltd., Incheon, South Korea

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: ,

Session Information

Date: Tuesday, November 15, 2016

Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster III

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

Disclosure: J. S. Smolen, AbbVie, Jassen, MSD, Pfizer, Roche, UCB, 2,AbbVie, Amgen, AstraZeneca, Astro-Pharma, Celgene, GSK, Jassen, Lilly, Medimmune, MSD, Norvartis-Sandoz, Novo Nordisk, Pfizer, Roche, Samsung Bioepis, Sanofi, UCB, 5; J. Y. Choe, Samsung Bioepis, 2,Samsung Bioepis, 5; N. Prodanovic, Samsung Bioepis, 2; J. Niebrzydowski, Samsung Bioepis, 2; I. Staykov, Samsung Bioepis, 2; E. Dokoupilova, Samsung Bioepis, 2; A. Baranauskaite, AbbVie, Samsung Bioepis, 2; R. Yatsyshyn, Samsung Bioepis, 2; M. Mekic, Samsung Bioepis, 2; W. Porawska, Samsung Bioepis, 2; H. Ciferska, Samsung Bioepis, 2; K. Jedrychowicz-Rosiak, Samsung Bioepis, 2; A. Zielinska, Samsung Bioepis, 2; J. Choi, Samsung Bioepis, 3; Y. H. Rho, Samsung Bioepis, 3.

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 .

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