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.
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 August 23, 2019.
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