Long-term efficacy, safety and immunogenicity in patients with rheumatoid arthritis continuing on an etanercept biosimilar (LBEC0101) or switching from reference etanercept to LBEC0101: an open-label extension of a phase III multicentre, randomised, double-blind, parallel-group study

Min Chan Park ,Yun Jong Lee,In Ah Choi,Won Park,Kichul Shin,Hyun Ah Kim,Kyung Su Park ,Chang Hee Suh ,Seung-Il Shin ,Shin Seok Lee ,Hiroaki Matsuno,Jinseok Kim,Sang Il Lee ,Sang Hoon Lee ,Bin Yoo,Seung Jae Hong ,Geun Tae Kim ,Ji-Yoon Lee ,Sung Hwan Park ,Jin Hur ,Sang‐Heon Lee ,Yong Bum Park ,Dong‐Hoon Sheen ,Chan Bum Choi ,Jung Yoon Choe ,Masato Tomomitsu,Seung Cheol Shim,Hoon Suk ,Haesik Yang ,Han Joo Baek,Wan Hee Yoo ,Yeong Wook Song

doi:10.1186/s13075-019-1910-2

Abstract

BackgroundTo evaluate the long-term efficacy, safety and immunogenicity of continuing LBEC0101; the etanercept (ETN) biosimilar; or switching from the ETN reference product (RP) to LBEC0101 in patients with rheumatoid arthritis (RA).MethodsThis multicentre, single-arm, open-label extension study enrolled patients who had completed a 52-week randomised, double-blind, parallel phase III trial of LBEC0101 vs ETN-RP. Patients treated with ETN-RP during the randomised controlled trial switched to LBEC0101; those treated with LBEC0101 continued to receive LBEC0101 in this study. LBEC0101 (50 mg) was administered subcutaneously once per week for 48 weeks with a stable dose of methotrexate. Efficacy, safety and immunogenicity of LBEC0101 were assessed up to week 100.ResultsA total of 148 patients entered this extension study (70 in the maintenance group and 78 in the switch group). The 28-joint disease activity scores (DAS28)-erythrocyte sedimentation rate (ESR) were maintained in both groups from week 52 to week 100 (from 3.068 to 3.103 in the maintenance group vs. from 3.161 to 3.079 in the switch group). ACR response rates at week 100 for the maintenance vs. switch groups were 79.7% vs. 83.3% for ACR20, 65.2% vs. 66.7% for ACR50 and 44.9% vs. 42.3% for ACR70. The incidence of adverse events and the proportion of patients with newly developed antidrug antibodies were similar in the maintenance and switch groups (70.0% and 70.5%, 1.4% and 1.3%, respectively).ConclusionsAdministration of LBEC0101 showed sustained efficacy and acceptable safety in patients with RA after continued therapy or after switching from ETN-RP to LBEC0101.Trial registrationClinicalTrials.gov, NCT02715908. Registered 22 March 2016.

Highlights

To evaluate the long-term efficacy, safety and immunogenicity of continuing LBEC0101; the etanercept (ETN) biosimilar; or switching from the ETN reference product (RP) to LBEC0101 in patients with rheumatoid arthritis (RA)
The incidence of adverse events and the proportion of patients with newly developed antidrug antibodies were similar in the maintenance and switch groups (70.0% and 70.5%, 1.4% and 1.3%, respectively)
One patient failed to complete the post-week 52 28-joint disease activity (DAS28)-erythrocyte sedimentation rate (ESR) assessments, leaving 69 patients in the maintenance group and 78 in the switch group included in the full analysis set (FAS)

Summary

Introduction

To evaluate the long-term efficacy, safety and immunogenicity of continuing LBEC0101; the etanercept (ETN) biosimilar; or switching from the ETN reference product (RP) to LBEC0101 in patients with rheumatoid arthritis (RA). The use of biologic disease-modifying anti-rheumatic drugs (bDMARDs) has contributed markedly to the improvement in the treatment of rheumatoid arthritis (RA) [1]. Biosimilars, which are similar but not identical to their innovator bDMARDs, have a cost advantage over innovator products for individuals and healthcare systems, and this may help improve access to therapy [5, 6]. ETN was the first approved bDMARD for the treatment of RA [10, 11], and its biosimilar, LBEC0101, was recently approved in Korea (Eucept®) and Japan (Etanercept BS “MA”) in 2018 for the treatment of the same indications as ETN, including RA [12, 13]

Methods

Results

Discussion

Conclusion