Real-world evaluation of the transition between originator and follow-on glatiramer acetate in people with multiple sclerosis: the “GA transition” study

IF 3 3区医学 Q2 CLINICAL NEUROLOGY

Multiple sclerosis and related disorders Pub Date : 2026-05-01 Epub Date: 2026-02-21 DOI:10.1016/j.msard.2026.107088

Irene Schiavetti , Pietro Annovazzi , Cinzia Cordioli , Mattia Pozzato , Sarah Rasia , Elisabetta Signoriello , Giacomo Lus , Livia Pasquali , Beatrice Giovannini , Alice Laroni , Alessio Carbone , Paola Cavalla , Sara La Gioia , Valentina Torri Clerici , Chiara Zecca , Francesca Caleri , Alessia Di Sapio , Maria Pia Sormani

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引用次数: 0

Abstract

Introduction and objective

The introduction of follow-on formulations of glatiramer acetate (GA) has raised questions regarding their equivalence to the originator in real-world practice. This study aimed to evaluate the clinical effectiveness and safety of switching from originator GA to its follow-on product, Copemyl® (CO), in people with multiple sclerosis (MS).

Methods

A multicenter, retrospective observational study was conducted, including patients with MS treated for at least two years with GA followed by at least two years with CO. The primary outcome was the annualized relapse rate (ARR), whereas secondary outcomes included disability progression assessed by the Expanded Disability Status Scale (EDSS), MRI activity, and adverse events (AEs).

Results

A total of 138 patients were included. The ARR was very low and comparable across treatments (GA: 0.028; CO: 0.019), with a mean paired difference of –0.009 (95 % CI –0.028 to 0.010; p = 0.38), falling within the predefined equivalence margin. Disability progression over six months occurred in 6.0 % of GA and 7.3 % of CO periods (HR 1.53; 95 % CI 0.74–3.16; p = 0.26). No significant difference was found in MRI activity (52.2 % vs 60.1 %, p = 0.14). Safety profiles were comparable, with mostly mild to moderate AEs; four serious AEs occurred under CO, two of them possibly treatment-related.

Conclusions

Switching from originator GA to CO did not influence clinical outcomes or safety. These findings support the therapeutic equivalence of the two formulations in real-world clinical practice, by supporting previous evidence from randomized trials.

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多发性硬化症患者初始药物与后续药物醋酸格拉替默转换的真实评估：“GA转换”研究

前言和目的：醋酸格拉替默（GA）的后续配方的介绍引起了关于它们在实际应用中与原药等效性的问题。本研究旨在评估多发性硬化症（MS）患者从初始产品GA切换到后续产品Copemyl®（CO）的临床有效性和安全性。方法：进行了一项多中心、回顾性观察性研究，包括接受GA治疗至少两年的MS患者，随后接受CO治疗至少两年。主要结果是年化复发率（ARR），而次要结果包括通过扩展残疾状态量表（EDSS）评估的残疾进展、MRI活性和不良事件（ae）。结果：共纳入138例患者。不同处理的ARR非常低且具有可比性（GA: 0.028; CO: 0.019），平均配对差异为-0.009 (95% CI -0.028至0.010;p = 0.38)，落在预定义的等效范围内。6个月的残疾进展发生在6.0%的GA期和7.3%的CO期（HR 1.53; 95% CI 0.74-3.16; p = 0.26）。MRI活动无显著差异（52.2% vs 60.1%, p = 0.14）。安全性具有可比性，大多数为轻度至中度ae；4例严重不良反应在CO治疗期间发生，其中2例可能与治疗有关。结论：从初始GA切换到CO不影响临床结果或安全性。这些发现通过支持先前随机试验的证据，支持了两种配方在实际临床实践中的治疗等效性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Multiple sclerosis and related disorders CLINICAL NEUROLOGY-

CiteScore

5.80

自引率

20.00%

发文量

814

审稿时长

66 days

期刊介绍： Multiple Sclerosis is an area of ever expanding research and escalating publications. Multiple Sclerosis and Related Disorders is a wide ranging international journal supported by key researchers from all neuroscience domains that focus on MS and associated disease of the central nervous system. The primary aim of this new journal is the rapid publication of high quality original research in the field. Important secondary aims will be timely updates and editorials on important scientific and clinical care advances, controversies in the field, and invited opinion articles from current thought leaders on topical issues. One section of the journal will focus on teaching, written to enhance the practice of community and academic neurologists involved in the care of MS patients. Summaries of key articles written for a lay audience will be provided as an on-line resource. A team of four chief editors is supported by leading section editors who will commission and appraise original and review articles concerning: clinical neurology, neuroimaging, neuropathology, neuroepidemiology, therapeutics, genetics / transcriptomics, experimental models, neuroimmunology, biomarkers, neuropsychology, neurorehabilitation, measurement scales, teaching, neuroethics and lay communication.