Objective To evaluate the similarities between LBEC0101 (etanercept biosimilar) and the etanercept reference product (ETN-RP) in terms of efficacy and safety, including immunogenicity, in patients with active rheumatoid arthritis despite methotrexate treatment. Methods This phase III, multicentre, randomised, double-blind, parallel-group, 54-week study was conducted in Japan and Korea. The primary efficacy endpoint was the change from baseline in the disease activity score in 28 joints based on erythrocyte sedimentation rate (DAS28-ESR) at week 24. American College of Rheumatology 20% (ACR20) response rate, adverse events (AEs), pharmacokinetics and development of antidrug antibodies (ADAs) were also evaluated. Results In total, 374 patients were randomised to LBEC0101 (n=187) or ETN-RP (n=187). The least squares mean changes from baseline in DAS28-ESR at week 24 in the per-protocol set 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 ETN-RP group. The estimated between-group difference was −0.15 and its 95% CI was −0.377 to 0.078, which was within the prespecified equivalence margin of −0.6 to 0.6. ACR20 response rates at week 24 were similar between the groups (LBEC0101 93.3% vs ETN-RP 86.7%). The incidence of AEs up to week 54 was comparable between the groups (LBEC0101 92.0% vs ETN-RP 92.5%), although fewer patients in the LBEC0101 group (1.6%) than the ETN-RP group (9.6%) developed ADAs. 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. Trial registration number NCT02357069.

中文翻译：

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III 期、多中心、双盲、随机、平行组研究，以评估 LBEC0101 和依那西普参考产品在对甲氨蝶呤反应不足的活动性类风湿性关节炎患者的疗效和安全性方面的相似性

目的 评估 LBEC0101（依那西普生物仿制药）与依那西普对照品（ETN-RP）在接受甲氨蝶呤治疗的活动性类风湿性关节炎患者的有效性和安全性（包括免疫原性）方面的相似性。方法 这项 III 期、多中心、随机、双盲、平行组、为期 54 周的研究在日本和韩国进行。主要疗效终点是第 24 周基于红细胞沉降率 (DAS28-ESR) 的 28 个关节疾病活动评分与基线相比的变化。 美国风湿病学会 20% (ACR20) 反应率、不良事件 (AE)、药代动力学还评估了抗药抗体 (ADA) 的开发。结果 总共有 374 名患者被随机分配至 LBEC0101（n=187）或 ETN-RP（n=187）。LBEC0101 组第 24 周 DAS28-ESR 从基线的最小二乘平均变化为 -3.01（95% CI -3.198 至 -2.820）和 -2.86（95% CI -3.051 至 -2.667）在 ETN-RP 组中。估计的组间差异为 -0.15，其 95% CI 为 -0.377 至 0.078，在 -0.6 至 0.6 的预设等价范围内。第 24 周的 ACR20 反应率在各组之间相似（LBEC0101 93.3% 与 ETN-RP 86.7%）。直至第 54 周的 AE 发生率在各组之间具有可比性（LBEC0101 92.0% 与 ETN-RP 92.5%），尽管 LBEC0101 组（1.6%）中的患者发生 ADA 的人数少于 ETN-RP 组（9.6%）。结论 LBEC0101的临床疗效与ETN-RP相当。LBEC0101 耐受性良好，安全性与 ETN-RP 相当。试验注册号 NCT02357069。