罗扎尼单抗治疗重症肌无力的新疗法。

IF 2.3 4区 医学 Q3 PHARMACOLOGY & PHARMACY
Annals of Pharmacotherapy Pub Date : 2024-11-01 Epub Date: 2024-03-27 DOI:10.1177/10600280241239048
Emily M Hitt
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引用次数: 0

摘要

目的:本文旨在回顾罗扎尼单抗的临床方面,描述导致该药物获得批准的临床试验结果,并研究其对患者护理的影响,以帮助临床决策:使用Rystiggo™、罗扎尼珠单抗、罗扎尼珠单抗疗法和重症肌无力等术语在PubMed上进行了搜索。此外,还使用了最新的处方信息,以了解与该药物相关的信息并确定相关研究:I 期、II 期和 III 期随机对照试验均符合纳入条件。本文不包括会议摘要和关注罗扎尼珠单抗的使用或除全身性肌无力以外的任何适应症的文章:罗扎尼单抗获得美国食品药品管理局批准的依据是针对全身性重症肌无力患者的III期MycarinG研究。一项II期试验探讨了罗扎尼珠单抗在中度至重度重症肌无力患者中两个治疗期的剂量和频率的初步临床疗效和安全性:罗扎尼单抗是首个获准治疗两种抗体(抗乙酰胆碱受体或抗肌肉特异性酪氨酸激酶)均阳性的全身性肌无力患者的疗法:罗扎尼单抗的批准标志着全身性肌无力治疗的进步。提供个性化、有针对性和耐受性良好的治疗,对于重症肌无力未得到很好控制,并寻求一种起效迅速的药物来改善症状和整体生活质量的患者来说非常有价值。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Rozanolixizumab: A New Therapy in the Treatment of Myasthenia Gravis.

Objective: The aims of this article are to review the clinical aspects of rozanolixizumab, to describe clinical trial results that led to the drug's approval, and to examine the impact on patient care to aid clinical decision making.

Data sources: A PubMed search was conducted using the terms Rystiggo™, rozanolixizumab, rozanolixizumab therapy, and myasthenia gravis. The most recent prescribing information was also used for information relating to the drug and for identification of pertinent studies.

Study selection/data extraction: Phase I, II, and III randomized controlled trials were all eligible for inclusion. Meeting abstracts and articles focusing on the use of rozanolixizumab or any indication other than generalized myasthenia gravis were excluded from this article.

Data synthesis: Food and Drug Administration approval of rozanolixizumab is based on the phase III MycarinG study in patients with generalized myasthenia gravis. A phase II trial explored initial clinical efficacy and safety pertaining to the dose and frequency of rozanolixizumab across 2 treatment periods in patients with moderate to severe myasthenia gravis.

Relevance to patient care and clinical practice in comparison to existing agents: Rozanolixizumab is the first therapy approved to treat patients positive for both types of antibodies, anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase, in generalized myasthenia gravis.

Conclusion/relevance: The approval of rozanolixizumab represents an advancement in therapy for generalized myasthenia gravis. The provision of individualized, targeted, and well-tolerated treatment is valuable for the patients whose myasthenia gravis is not well controlled and who are seeking a medication with a rapid onset of action to improve their symptoms and overall quality of life.

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来源期刊
CiteScore
5.70
自引率
0.00%
发文量
166
审稿时长
3-8 weeks
期刊介绍: Annals of Pharmacotherapy (AOP) is a peer-reviewed journal that advances pharmacotherapy throughout the world by publishing high-quality research and review articles to achieve the most desired health outcomes.The articles provide cutting-edge information about the most efficient, safe and cost-effective pharmacotherapy for the treatment and prevention of various illnesses. This journal is a member of the Committee on Publication Ethics (COPE). Average time from submission to first decision: 14 days
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