The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis
The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis
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DOI：
10.1111/bjd.15152
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发表时间：
2017-04-01
影响因子：
10.3
通讯作者：
Afonso, M.
中科院分区：
文献类型：
--
作者：
Griffiths, C. E. M.;Thaci, D.;Afonso, M.
GP 2015是一种拟定的依那西普生物类似药。Objectives为了证明GP 2015和依那西普（ETN，Enbrel（R））在中重度慢性斑块型银屑病患者中的等效疗效，以及可比的安全性和免疫原性。方法共有531名符合条件的患者以1：1的比例随机接受GP 2015或ETN每周两次皮下注射。第12周时银屑病面积和严重程度指数（PASI 50）改善>= 50%的患者被重新随机分配，继续每周一次给药方案的相同治疗，或在GP 2015和ETN之间进行三次治疗转换，直至第30周。结果GP 2015和ETN（主要终点）在第12周时PASI 75（较基线PASI评分改善75%）应答率的差异为-2.3%。95%置信区间（-9.85至5.30）完全包含在预先规定的边界范围（-18至18）内。持续GP 2015（59.8%）和ETN（57.8%）之间直至第52周的治疗后出现的不良事件发生率相当;转换治疗显示了相当的安全性特征。抗药物抗体，所有非中和，仅限于5例ETN治疗期间1，和1例在转换ETN组，谁已与GP 2015治疗12周的时间finding.Conclusions EGALITY研究证明了等效的疗效和可比的安全性和免疫原性的GP 2015和ETN。本研究结果提供了生物相似性的最终临床确认，并有助于证明GP 2015是依那西普生物相似药的全部证据。
Background GP2015 is a proposed etanercept biosimilar. Objectives To demonstrate equivalent efficacy, and comparable safety and immunogenicity of GP2015 and the etanercept originator (ETN, Enbrel (R)) in patients with moderate-to-severe chronic plaque-type psoriasis.Methods In total, 531 eligible patients were randomized 1 : 1 to self-administer GP2015 or ETN twice weekly subcutaneously. Patients with >= 50% improvement in Psoriasis Area and Severity Index (PASI 50) at week 12 were rerandomized to continue the same treatment on a once-weekly dosing schedule or to undergo a sequence of three treatment switches between GP2015 and ETN until week 30. Thereafter, patients continued treatment with the product they had been assigned to last, up to week 52.Results The difference in PASI 75 (75% improvement from baseline PASI score) response rates at week 12 between GP2015 and ETN (primary end point) was -2.3%. The 95% confidence interval (-9.85 to 5.30) was well contained within the prespecified margin range of -18 to 18. The incidence of treatment-emergent adverse events up to week 52 was comparable between continued GP2015 (59.8%) and ETN (57.%); switching treatments revealed comparable safety profiles. Antidrug antibodies, all non-neutralizing, were limited to five patients on ETN during treatment period 1, and one patient in the switched ETN group, who had been treated with GP2015 for 12 weeks at the time of the finding.Conclusions The EGALITY study demonstrated equivalent efficacy and comparable safety and immunogenicity of GP2015 and ETN. The study results provide the final clinical confirmation of biosimilarity and contribute to the totality of the evidence proposing that GP2015 is an etanercept biosimilar.