Psoriasis-Center at the Department of Dermatology, Universitaetsklinikum Schleswig-Holstein, Kiel, Germany.
Comprehensive Center for Inflammation Medicine, University Hospital Schleswig-Holstein, Lübeck, Germany.
J Eur Acad Dermatol Venereol. 2018 Mar;32(3):420-427. doi: 10.1111/jdv.14605. Epub 2017 Nov 2.
EGALITY was a phase III confirmatory efficacy and safety study conducted in patients with plaque-type psoriasis as a part of totality of evidence gathered during the development of GP2015, an etanercept biosimilar.
To demonstrate equivalent efficacy and comparable safety and immunogenicity of GP2015 and the etanercept originator product (ETN, Enbrel ) and evaluate effects of repeated switching between GP2015 and ETN. Results for efficacy, safety and immunogenicity during treatment period (TP) 2 (TP2) are presented pooling the two continued treatment arms (pooled continued) versus the two treatment arms with repeated switches (pooled switched).
Patients (n = 531) were randomized 1:1 to self-administer GP2015 or ETN twice-weekly subcutaneously during TP1. Patients with a ≥50% improvement in Psoriasis Area and Severity Index (PASI 50) at week 12 were re-randomized for TP2 to continue the same treatment at once-weekly dosing or to undergo three consecutive treatment switches between GP2015 and ETN until week 30. Patients continued the last-assigned treatment during TP2, until week 52.
Mean (standard deviation [SD]) PASI scores at baseline were similar in patients who underwent multiple switches compared to those with continued treatments during TP2. During TP2, PASI 50, PASI 75 and PASI 90 response rates, percent change from baseline in PASI scores and all other efficacy parameters were similar between the pooled switched and pooled continued treatment groups at all time points. The incidence of treatment-emergent adverse events including injection site reactions was comparable between the pooled switched (36.7%) and pooled continued (34.9%) groups. None of the patients in either treatment group were positive for binding anti-drug antibodies in TP2.
Treatment efficacy, safety and immunogenicity were similar between the pooled continued and pooled switched treatments during TP2, indicating that there are no effects in the short term on clinical data of multiple switches between GP2015 and ETN.
EGALITY 是一项 III 期确证疗效和安全性研究，在斑块状银屑病患者中进行，作为 GP2015 开发过程中总证据的一部分，GP2015 是一种依那西普的生物类似药。
证明 GP2015 与依那西普原研药（ETN，Enbrel）具有等效疗效和相似安全性及免疫原性，并评估 GP2015 与 ETN 之间重复转换的影响。本文介绍了治疗期 2（TP2）时的疗效、安全性和免疫原性汇总结果，将两个持续治疗组（合并持续）与两个重复转换治疗组（合并转换）进行了汇总比较。
患者（n=531）按 1:1 随机接受 GP2015 或 ETN 皮下注射，每周 2 次，在 TP1 期间进行治疗。在第 12 周达到银屑病面积和严重程度指数（PASI）改善≥50%（PASI 50）的患者，在 TP2 中重新随机分配，接受每周 1 次剂量的相同治疗，或进行 GP2015 和 ETN 之间连续 3 次治疗转换，直至第 30 周。患者在 TP2 期间继续接受最后一次分配的治疗，直至第 52 周。
与接受持续治疗的患者相比，在 TP2 中接受多次转换的患者的平均（标准差 [SD]）基线 PASI 评分相似。在 TP2 期间，PASI 50、PASI 75 和 PASI 90 应答率、PASI 评分自基线的变化百分比以及所有其他疗效参数在合并转换和合并持续治疗组在所有时间点均相似。合并转换（36.7%）和合并持续（34.9%）组的治疗出现不良事件（包括注射部位反应）发生率相似。在 TP2 中，两组均无患者的抗药物结合抗体检测结果呈阳性。
在 TP2 期间，合并持续和合并转换治疗的疗效、安全性和免疫原性相似，表明在短期内 GP2015 与 ETN 之间多次转换对临床数据没有影响。
