在患有多发性硬化症的患者中,格拉托帕和科帕的有效性和安全性的比较
Ning Lyu1, Jieni Li2, George J Hutton3
1Department of Pharmaceutical Health Outcomes and Policy, University of Houston College of Pharmacy, TX, USA.
Multiple sclerosis and related disorders
|September 20, 2025
概括
格拉托帕 (格拉蒂拉默酸盐) 在减少多发性硬化症 (MS) 复发和严重感染的安全性方面表现出相似的有效性,与Copaxone在现实世界的研究中相比.
科学领域:
- 神经学 神经学
- 药理学 药理学是指药理学的学科.
- 现实世界的证据.
背景情况:
- 格拉托帕 (Glatopa) 是一种通用格拉蒂拉默酸盐,是美国首个被批准用于多发性硬化症 (MS) 的通用疾病修饰疗法.
- 它的批准是基于结构和功能等同于Copaxone.
- 关于Glatopa与Copaxone的有效性和安全性的比较数据有限.
研究的目的:
- 为了比较使用Glatopa和Copaxone的患者之间MS复发和严重感染的风险.
- 为了评估通用Glatiramer酸盐与其品牌对应物的实际有效性和安全性.
主要方法:
- 一项回顾性队列研究利用了2017-2019年Merative MarketScan®商业索赔数据.
- 包括18-64岁的多发性硬化症患者,在经过6个月的洗期后,开始使用格拉托帕或科帕.
- 与第一个MS复发和严重感染的时间相比,使用Cox比例危险 (CPH) 模型对治疗权重的逆概率 (IPTW).
主要成果:
- 该研究包括3193名多发性硬化症患者:668名 (20.9%) 开始使用Glatopa和2525名 (79.1%) 开始使用Copaxone.
- 在两种类型分析中,研究小组之间的复发率 (11.9%对12.5%) 或严重感染率 (0.3%对0.4%) 没有显著差异.
- 根据IPTW调整的CPH模型显示,在Glatopa和Copaxone用户之间,MS复发 (aHR 0.93) 或严重感染 (aHR 0.74) 的风险没有显著差异.
结论:
- 现实数据表明,Glatopa在MS复发方面与Copaxone的有效性相比.
- 此外,Glatopa和Copaxone的安全性,特别是严重感染的安全性,也被发现是可比的.
- 这项研究支持使用Glatopa作为治疗上相当于Copaxone的替代方案来治疗MS.
相关概念视频
Bioequivalence of Drugs: Drugs with Multiple Indications
151
The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each...
151
Antiepileptic Drugs: Glutamate Antagonists
902
Glutamate is a fundamental neurotransmitter in the central nervous system, playing a vital role in neuronal communication and various cognitive processes. Glutamate stands as the principal excitatory neurotransmitter in the brain. Its presence is crucial for the communication between neurons, underpinning essential processes such as synaptic transmission, neuronal excitability, and plasticity. These functions are vital for higher-order cognitive processes, including learning and memory. The...
902
Peripherally and Centrally Acting Muscle Relaxants: A Comparison
4.5K
Skeletal muscle relaxants can target the central nervous system [CNS] to reduce muscle tension or act directly at the neuromuscular junction to induce temporary paralysis. These two classes of muscle relaxants are called centrally acting muscle relaxants and peripherally acting muscle relaxants. They differ in their action, mechanism, administration route, and clinical uses.
Centrally acting muscle relaxants can be further divided into spasmolytic and antispasmodic drugs. Spasmolytic...
Centrally acting muscle relaxants can be further divided into spasmolytic and antispasmodic drugs. Spasmolytic...
4.5K
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence
179
Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
179
Open Angle Glaucoma: Treatment
963
In open-angle glaucoma, the iridocorneal angle remains open, but the trabecular meshwork becomes stiff, slowing down the outflow of aqueous humor. This causes a buildup of aqueous humor in the anterior chamber, leading to a sudden increase in intraocular pressure. The treatment for open-angle glaucoma focuses on reducing the elevated intraocular pressure by either decreasing the secretion of aqueous humor or increasing its outflow.
Drugs such as carbonic anhydrase inhibitors, α2- and...
Drugs such as carbonic anhydrase inhibitors, α2- and...
963
Antiepileptic Drugs: Potassium Channel Activators
635
Ezocgabine or retigabine, an antiepileptic drug of remarkable efficacy, has revolutionized the management of seizures. It is a potassium channel activator, explicitly targeting the family of Q subtype potassium channels. It enhances the transmembrane potassium currents, regulating neuronal excitability. This action stabilizes the resting membrane potential, a pivotal factor in mitigating the hyperexcitability that characterizes epilepsy.
Ezogabine has gained approval as an adjunctive treatment...
Ezogabine has gained approval as an adjunctive treatment...
635


