AB0456 Efficacy and safety of switching from etanercept reference product to lbec0101 (ETANERCEPT BIOSIMILAR) compared with continuing lbec0101 in patients with rheumatoid arthritis
Authors: Y.W. Song, H. Matsuno, M.-C. Park, M. Tomomitsu, S. Shin, J. Lee
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> LBEC0101 is a newly developed biosimilar of etanercept (ETN). As rheumatoid arthritis (RA) treatment is a long-standing process in the clinical practice, the long-term safety and efficacy of anti-TNF inhibitors have been studied and reported.<sup>1</sup> Clinical studies have been conducted to evaluate the efficacy and safety of biosimilar after switching from their originator drug.<sup>2</sup> <h3>Objectives</h3> To evaluate the long-term efficacy, safety, and immunogenicity of switching from the ETN reference product (RP) to LBEC0101 or continuing LBEC0101 in patients with RA. <h3>Methods</h3> This multicenter, single-arm, open-label extension study enrolled patients with RA who had completed the 52 week treatment period of the randomised, double-blind, parallel-group, Phase III study for LBEC0101 (NCT02357069). Patients who were deemed requiring continuous treatment for RA upon the investigator’s discretion and agreed to participate in this study were allowed for participation. All patients received LBEC0101 50 mg/ml once a week for 48 weeks with the stable dose of methotrexate regardless of the randomization group in the Phase III study. Efficacy, safety and immunogenicity were assessed up to Week 100. Data were analysed for patients who continued to receive LBEC0101 for 100 weeks (maintenance group) and for those who had received ETN-RP for 52 weeks and then switched to LBEC0101 for 48 weeks (switch group). <h3>Results</h3> A total of 148 patients were enrolled in this study; 70 patients continued to receive LBEC0101 and 78 patients switched to receive LBEC0101 from ETN-RP. DAS28-ESR score in the full analysis set were maintained in both groups from week 52 through week 100 (from 3.068 to 3.103 in maintenance group vs. from 3.161 to 3.079 in switch group). Response rates at week 100 for maintenance and switch groups, respectively, were 79.7% vs. 83.3% for ACR20, 65.2% vs. 66.7% for ACR50% and 44.9% vs. 42.3% for ACR70. The incidences of adverse events were comparable between the groups (70.0% for maintenance group and 70.5% for switch group, respectively). The proportion of patients who newly developed antidrug antibodies was similar between the groups (1.4% for maintenance group and 1.3% for switch group, respectively). <h3>Conclusions</h3> The efficacy and safety of LBEC0101 were comparable in both maintenance and switch groups. The efficacy of LBEC0101 was well sustained over 100 weeks. <h3>References</h3> [1] Weinblatt ME, Bathon JM, Kremer JM, et al. Safety and efficacy of etanercept beyond 10 years of therapy in North American patients with early and longstanding rheumatoid arthritis. Arthritis Care Res (Hoboken)2011;63:373–82. [2] Emery P, Vencovský J, Sylwestrzak A, et al. Long-term efficacy and safety in patients with rheumatoid arthritis continuing on SB4 or switching from reference etanercept to SB4. Ann Rheum Dis2017 [Epub ahead of print]. <h3>Acknowledgements</h3> HanJoo Baek, HoonSuk Cha, JungYoon Choe, ChanBum Choi, InAh Choi, SeungJae Hong, JinWuk Hur, GeunTae Kim, HyunAh Kim, Jinseok Kim, Jisoo Lee, SangHeon Lee, SangIl Lee, SeungGeun Lee, ShinSeok Lee, YunJong Lee, JunKi Min, KyungSu Park, SungHwan Park, Won Park, YongBeom Park, DongHyuk Sheen, SeungCheol Shim, KichulShin, ChangHee Suh, HyungIn Yang, Bin Yoo and WanHee Yoo. <h3>Disclosure of Interest</h3> Y. W. Song: None declared, H. Matsuno Consultant for: Mochida Pharmaceutical Co., Ltd., AYUMI Pharmaceutical Corporation, Nichi-Iko Pharmaceutical Co., Ltd., Meiji Seika Pharma Co., Ltd., M.-C. Park: None declared, M. Tomomitsu Employee of: Mochida Pharmaceutical Co., Ltd., S. Shin Employee of: LG Chem, Ltd., J. Lee Employee of: LG Chem, Ltd.