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Enbrel biosimilar demonstrates comparable safety, efficacy in RA
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The etanercept biosimilar, LBEC0101, demonstrated equivalent clinical efficacy and comparable safety profile to etanercept, and was well tolerated among patients with rheumatoid arthritis who failed to respond to methotrexate, according to findings published in the Annals of the Rheumatic Diseases.
“This was the first large scale clinical study for the Enbrel biosimilar in Asian patients,” Yeong Wook Song, PhD, MS, of the Seoul National University Hospital, in the Republic of Korea, told Healio Rheumatology. “Through this study, we can prove that LBEC0101 is comparable in efficacy, safety and immunogenicity profile to Enbrel. In addition, LBEC0101’s incidence rates of injection site reaction and anti-drug antibody were much lower than those of Enbrel in this study, which are similar results with other approved [etanercept] biosimilars.”
To determine the efficacy and safety similarities between LBEC0101 and etanercept (Enbrel, Amgen) among patients with RA who were unresponsive to methotrexate, Song and colleagues conducted a phase 3, multicenter, double-blind, randomized, parallel-group study of 374 participants in Japan and Korea. The researchers randomly selected half of the participants to receive LBEC0101, while the other half received treatment with etanercept, all for 54 weeks.
The primary endpoint was disease activity score changes from baseline, measured in 28 joints and based on the erythrocyte sedimentation rate (DAS28-ESR), at week 24. The researchers also analyzed the patients’ American College of Rheumatology 20% (ACR20) response rate, adverse events, pharmacokinetics and development of antidrug antibodies.
According to Song and colleagues, least-squares mean changes in the DAS28-ESR from baseline to week 24 were 3.01 (95% CI, 3.198 to 2.820) in the LBEC0101 group, and 2.86 (95% CI, 3.051 to 2.667) in the etanercept cohort, with an estimated between-group difference of 0.15 (95%CI, 0.377 to 0.078). ACR20 response rates at week 24 were 93.3% for LBEC0101 and 86.7% for etanercept. Further, the incidence of adverse effects at week 54 was 92% for patients in the LBEC0101 group and 92.5% for those in the etanercept group. However, fewer patients treated with LBEC0101 developed antidrug antibodies — 1.6% — compared with those who received etanercept, 9.6%.
“Because the present study was the first clinical trial of LBEC0101 for RA conducted in Asia (Japan and Korea) only, the generalizability of the findings may be limited to the Asian population and a longer-term study is warranted,” Song and colleagues wrote.
“Based on these results, it will be the first and second biosimilar product approved in Japan and Korea, respectively,” Song told Healio Rheumatology. “Patients [will have] access to this cost-effective anti-TNF drug.” – by Jason Laday
Disclosure: The researchers report funding from LG Chem (formerly LG Life Sciences), Mochida Pharmaceutical and the Korea Health Industry Development Institute. Song reports grant support from LG Chem. Please see the full study for additional authors’ disclosures.
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