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从品牌到通用那他珠单抗醋酸酯的转换：15 个月 GATE 试验延长结果。

Switching from branded to generic glatiramer acetate: 15-month GATE trial extension results.

机构信息

Neurology Center Lodz, Lodz, Poland.

Image Analysis Center, Department of Radiology and Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands/Institutes of Neurology & Healthcare Engineering, UCL, London, UK.

出版信息

Mult Scler. 2017 Dec;23(14):1909-1917. doi: 10.1177/1352458516688956. Epub 2017 Jan 16.

DOI:10.1177/1352458516688956
PMID:28090798
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5700775/
Abstract

BACKGROUND

Open-label 15-month follow-up of the double-blind, placebo-controlled Glatiramer Acetate clinical Trial to assess Equivalence with Copaxone (GATE) trial.

OBJECTIVE

To evaluate efficacy, safety, and tolerability of prolonged generic glatiramer acetate (GTR) treatment and to evaluate efficacy, safety, and tolerability of switching from brand glatiramer acetate (GA) to GTR treatment.

METHODS

A total of 729 patients received GTR 20 mg/mL daily. Safety was assessed at months 12, 15, 18, 21, and 24 and Expanded Disability Status Scale and magnetic resonance imaging (MRI) scans at months 12, 18, and 24. The presence of glatiramer anti-drug antibodies (ADAs) was tested at baseline and months 1, 3, 6, 9, 12, 18, and 24.

RESULTS

The mean number of gadolinium-enhancing lesions in the GTR/GTR and GA/GTR groups was similar at months 12, 18, and 24. The change in other MRI parameters was also similar in the GTR/GTR and GA/GTR groups. The annualized relapse rate (ARR) did not differ between the GTR/GTR and GA/GTR groups, 0.21 and 0.24, respectively. The incidence, spectrum, and severity of reported adverse events did not differ between the GTR/GTR and GA/GTR groups. Glatiramer ADA titers were similar in the GTR/GTR and GA/GTR groups.

CONCLUSION

Efficacy and safety of GTR is maintained over 2 years. Additionally, switching from GA to GTR is safe and well tolerated.

摘要

背景

评估与 Copaxone（GATE）试验等效性的醋酸格拉替雷双盲、安慰剂对照临床试验的 15 个月开放性随访。

目的

评估延长使用通用型格拉替雷（GTR）的疗效、安全性和耐受性，并评估从品牌格拉替雷（GA）转换为 GTR 治疗的疗效、安全性和耐受性。

方法

共 729 例患者接受 GTR 20mg/ml 每日治疗。安全性评估在第 12、15、18、21 和 24 个月，扩展残疾状态量表和磁共振成像（MRI）扫描在第 12、18 和 24 个月进行。基线和第 1、3、6、9、12、18 和 24 个月时检测格拉替雷抗药物抗体（ADA）的存在。

结果

在第 12、18 和 24 个月，GTR/GTR 和 GA/GTR 组的钆增强病变数量的平均值相似。GTR/GTR 和 GA/GTR 组的其他 MRI 参数的变化也相似。GTR/GTR 和 GA/GTR 组的年复发率（ARR）分别为 0.21 和 0.24，无差异。GTR/GTR 和 GA/GTR 组报告的不良事件的发生率、类型和严重程度无差异。GTR/GTR 和 GA/GTR 组的格拉替雷 ADA 滴度相似。

结论

GTR 的疗效和安全性可维持 2 年以上。此外，从 GA 转换为 GTR 是安全且耐受良好的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31aa/5700775/552f9bccd547/10.1177_1352458516688956-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31aa/5700775/856cb61b5d5e/10.1177_1352458516688956-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31aa/5700775/71859f90bd89/10.1177_1352458516688956-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31aa/5700775/552f9bccd547/10.1177_1352458516688956-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31aa/5700775/856cb61b5d5e/10.1177_1352458516688956-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31aa/5700775/71859f90bd89/10.1177_1352458516688956-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31aa/5700775/552f9bccd547/10.1177_1352458516688956-fig3.jpg

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