ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 603

Additional Efficacy Results of SB4 (Etanercept Biosimilar) up to Week 100: Comparison Between Continuing SB4 and Switching from Reference Etanercept (Enbrel®) to SB4

Paul Emery1, Jiří Vencovský2, Anna Sylwestrzak3, Piotr Leszczyñski4, Wieslawa Porawska5, Barbara Stasiuk6, Joanna Hilt7, Zdenka Mosterova8, Soo Yeon Cheong9 and Jeehoon Ghil9, 1University of Leeds, Midlothian, United Kingdom, 2Institute of Rheumatology, Department of Rheumatology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic, 3NZOZ Medica Pro Familia Sp. z o.o., Warsaw, Poland, 4Rheumatology and Rehabilitation, Poznan University of Medical Sciences, Poznan, Poland, 5Poznanski Osrodek Medyczny NOVAMED, Poznan, Poland, 6Medicome Sp. z o.o., Oswiecim, Poland, 7Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp., Bialystok, Poland, 8Revmacentrum MUDr.Mostera sro, Brno, Czech Republic, 9Samsung Bioepis Co., Ltd., Incheon, South Korea

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords:

Session Information

Date: Sunday, November 13, 2016

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

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: SB4 is approved by the European Medicines Agency as a biosimilar of the reference etanercept (ETN). Long term safety and efficacy of SB4 up to Week 100 have been reported previously.1 Additional long term efficacy results will be reported.

Methods: In the phase III 52-week randomized, double-blind period of the study, patients with moderate to severe rheumatoid arthritis (RA) were treated with either 50 mg/week SB4 or ETN with background methotrexate (MTX). Patients in Czech Republic and Poland were enrolled into the following 48-week open-label, extension period of the study and received SB4. Efficacy in terms of ACR responses, disease activity score based on 28 joints (DAS28), simplified disease activity index (SDAI), clinical disease activity index (CDAI), and health assessment questionnaire-disability index (HAQ-DI) up to week 100 were compared. Radiographic progression was measured through modified Total Share Score.

Results: 245 patients from the randomized, double-blind study period enrolled into the extension study: 126 patients continued to receive SB4 (SB4/SB4) and 119 patients switched from ETN to SB4 (ETN/SB4). The ACR responses were comparable between SB4/SB4 and ETN/SB4 and they were also sustained in the extension period. The mean DAS28, SDAI, and CDAI were comparable between SB4/SB4 and ETN/SB4 during the extension period (Figure). At Week 100, similar proportion of patients achieved low disease activity based on DAS28, SDAI, or CDAI (49.2% vs. 54.8%; 33.3% vs. 38.3%; 30.9% vs. 40.0% in SB4/SB4 and ETN/SB4, respectively) and remission based on DAS28, SDAI, or CDAI (30.3% vs. 34.8%; 30.9% vs. 33.9%; 32.5% vs. 28.7% in SB4/SB4 and ETN/SB4, respectively). Patient-reported outcome measured by HAQ-DI was also comparable between SB4/SB4 and ETN/SB4 up to week 100. Radiographic progression was comparable and negligible between SB4/SB4 and ETN/SB4.

Conclusion: Long-term efficacy including DAS28, SDAI, CDAI, and HAQ-DI was comparable between SB4/SB4 and ETN/SB4 during the extension period. Efficacy was sustained after switching from ETN to SB4.

Reference

1. Emery P. et al. Ann Rheum Dis 2016;75(Suppl2): 236

 

 

 

Disclosure: P. Emery, Pfizer,MSD,Abbvie,BMS,UCB,Roche,Novartis,Samsung Bioepis, Sandoz, Eli Lillyand Company, 5; J. Vencovský, Biogen, Samsung Bioepis, 5; A. Sylwestrzak, Samsung Bioepis, 2; P. Leszczyñski, Samsung Bioepis, Roche, MSD, Janssen, UCB, Novartis, GSK, BMS,, 2,Roche, MSD, UCB, Pfizer, Abbvie, 5; W. Porawska, Samsung Bioepis, 2; B. Stasiuk, Samsung Bioepis, 2; J. Hilt, Samsung Bioepis, 2; Z. Mosterova, Samsung Bioepis, 2; S. Y. Cheong, Samsung Bioepis, 3; J. Ghil, Samsung Bioepis, 3.

To cite this abstract in AMA style:

Emery P, Vencovský J, Sylwestrzak A, Leszczyñski P, Porawska W, Stasiuk B, Hilt J, Mosterova Z, Cheong SY, Ghil J. Additional Efficacy Results of SB4 (Etanercept Biosimilar) up to Week 100: Comparison Between Continuing SB4 and Switching from Reference Etanercept (Enbrel®) to SB4 [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/additional-efficacy-results-of-sb4-etanercept-biosimilar-up-to-week-100-comparison-between-continuing-sb4-and-switching-from-reference-etanercept-enbrel-to-sb4/. Accessed .

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