ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2441

A Phase III, Multicenter, Double-Blind, Randomized, Parallel-Group Study to Evaluate the Similarities between LBEC0101 and Etanercept Reference Product in Terms of Efficacy and Safety in Patients with Active Rheumatoid Arthritis Inadequately Responding to Methotrexate

Hiroaki Matsuno1,2, Masato Tomomitsu3, Atsushi Hagino3, Seonghye Shin4, Jiyoon Lee4 and Yeong Wook Song5,6, 1Matsuno Clinic for Rheumatic Diseases, Toyama, Japan, 2Institute of Medical Science, Tokyo Medical University, Tokyo, Japan, 3Mochida Pharmaceutical Co.,Ltd., Tokyo, Japan, 4Clinical Development, LG Chem, Ltd., Seoul, Korea, Republic of (South), 5Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, and College of Medicine, Seoul National University, Seoul, Korea, Republic of (South), 6Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, and College of Medicine, Medical Research Center, Seoul National University, Seoul, Korea, Republic of (South)

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: ,

Session Information

Date: Tuesday, November 7, 2017

Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster III: Efficacy and Safety of Originator Biologics and Biosimilars

Session Type: ACR Poster Session C

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

Background/Purpose: LBEC0101 has been developed as a biosimilar to the etanercept reference product (ETN-RP). This study was to evaluate the similarities between LBEC0101 and ETN-RP as adjunctive therapy to methotrexate (MTX), in patients with active rheumatoid arthritis despite MTX treatment. In this abstract, not only the equivalence of the primary endpoint at Week 24 but also the results up to 52 weeks of the study comparing the long term efficacy, safety and immunogenicity between LBEC0101 and ETN-RP are reported.

Methods: This phase III, multicenter, randomized, double-blind, parallel-group, reference product-controlled study was conducted in Japan and Korea. Patients with active RA for ≥6 months who had an inadequate response to MTX were randomly assigned to receive weekly dose of 50 mg LBEC0101 or ETN-RP administered subcutaneously for 52 weeks. The primary efficacy endpoint was the mean change from baseline in the disease activity score in 28 joints based on erythrocyte sedimentation rate (DAS28-ESR) at Week 24. Efficacy, safety and immunogenicity outcomes were assessed up to Week 52.

Results: In total, 374 patients were randomized to LBEC0101 (N=187) or ETN-RP (N=187). The least square mean changes from baseline in DAS28-ESR score at Week 24 in the per-protocol set (PPS) were −3.009 in the LBEC0101 group and −2.859 in the ETN-RP group. The estimated treatment difference in change from baseline to Week 24 in DAS28-ESR between the two groups was −0.150 and the 95% confidence interval (CI) of the difference was −0.3768 to 0.0775, which was completely within the pre-specified equivalence margin of −0.6 to 0.6, indicating that equivalence in efficacy between LBEC0101 and ETN-RP was proved. As a secondary endpoint, ACR20 response rate was similar between the groups (93.3% for LBEC0101 and 86.7% for ETN-RP) at Weeks 24.
The incidence of AEs up to Week 54 was comparable, except for injection site reaction which was reported in the ETN-RP group (438 events in 64 subjects [34.2%]) and in the LBEC0101 group (77 events in 19 subjects [10.2%]), respectively.
Three (1.6%) and 18 (9.6%) patients in the LBEC0101 and ETN-RP groups, developed anti-drug antibody (ADA) up to 52 weeks, respectively.

Conclusion: The clinical efficacy of LBEC0101 was equivalent to that of ETN-RP. LBEC0101 was well tolerated and had a comparable safety profile to ETN-RP.

Disclosure: H. Matsuno, Mochida Pharmaceutical Co., Ltd., AYUMI Pharmaceutical Corporation, Nichi-Iko Pharmaceutical Co., Ltd., Meiji Seika Pharma Co., Ltd., 5; M. Tomomitsu, Mochida Pharmaceutical Co.,Ltd., 3; A. Hagino, Mochida Pharmaceutical Co.,Ltd., 3; S. Shin, LG Chem, Ltd., 3; J. Lee, LG Chem, Ltd., 3; Y. W. Song, LG Chem, 2.

To cite this abstract in AMA style:

Matsuno H, Tomomitsu M, Hagino A, Shin S, Lee J, Song YW. A Phase III, Multicenter, Double-Blind, Randomized, Parallel-Group Study to Evaluate the Similarities between LBEC0101 and Etanercept Reference Product in Terms of Efficacy and Safety in Patients with Active Rheumatoid Arthritis Inadequately Responding to Methotrexate [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/a-phase-iii-multicenter-double-blind-randomized-parallel-group-study-to-evaluate-the-similarities-between-lbec0101-and-etanercept-reference-product-in-terms-of-efficacy-and-safety-in-patients-with/. Accessed .

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