依夫加替莫德全身性肌无力综述

IF 13 1区 医学 Q1 PHARMACOLOGY & PHARMACY Drugs Pub Date : 2024-11-07 DOI:10.1007/s40265-024-02101-9
Hannah A Blair
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引用次数: 0

摘要

依夫加替莫德(Vyvgart®;Vyvgart® Hytrulo)是一种新生儿片段可结晶受体(FcRn)拮抗剂,适用于治疗乙酰胆碱受体(AChR)抗体阳性(Ab+)的成人全身性重症肌无力(gMG)。依夫加替莫德被批准用于静脉注射(IV)和皮下注射(SC)。在一项关键的III期试验中,静脉注射依加替莫德可显著改善重症肌无力症状,减轻疾病负担,具有临床意义。静脉注射依加替莫德的疗效具有可重复性、持久性和长期维持性。静脉注射依加替莫德还能改善与健康相关的生活质量(HRQOL)。在另一项III期试验中,在降低总免疫球蛋白G水平方面,皮下注射依加替莫德PH20的效果不劣于静脉注射依加替莫德。依夫加替莫德PH20皮下注射液的临床改善效果与静脉注射依夫加替莫德一致,并且具有长期可重复性。依夫加替莫德的耐受性普遍良好;最常见的不良反应是头痛和感染(静脉注射依夫加替莫德)以及注射部位反应(皮下注射依夫加替莫德PH20)。尽管还需要进一步的长期数据,但依加替莫德静脉注射和皮下注射制剂为患有 AChR Ab+ gMG 的成人提供了有效、耐受性良好且灵活的治疗选择。
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Efgartigimod: A Review in Generalised Myasthenia Gravis.

Efgartigimod (Vyvgart®; Vyvgart® Hytrulo) is a neonatal fragment crystallizable receptor (FcRn) antagonist indicated for the treatment of generalised myasthenia gravis (gMG) in adults who are acetylcholine receptor (AChR) antibody positive (Ab+). Efgartigimod is approved for both intravenous (IV) and subcutaneous (SC) use. In a pivotal phase III trial, IV efgartigimod was associated with significant and clinically meaningful improvements in myasthenia gravis symptoms and reductions in disease burden. The beneficial effects of IV efgartigimod were reproducible, durable and maintained over the long term. IV efgartigimod also improved health-related quality of life (HRQOL). In another phase III trial, SC efgartigimod PH20 was noninferior to IV efgartigimod in reducing total immunoglobulin G levels. Clinical improvement with SC efgartigimod PH20 was consistent with that of IV efgartigimod and was reproducible over the long term. Efgartigimod was generally well tolerated; the most common adverse events were headache and infections (with IV efgartigimod) and injection-site reactions (with SC efgartigimod PH20). Although further long-term data are required, IV and SC formulations of efgartigimod provide effective, generally well-tolerated and flexible treatment options for adults with AChR Ab+ gMG.

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来源期刊
Drugs
Drugs 医学-毒理学
CiteScore
22.70
自引率
0.90%
发文量
134
审稿时长
3-8 weeks
期刊介绍: Drugs is a journal that aims to enhance pharmacotherapy by publishing review and original research articles on key aspects of clinical pharmacology and therapeutics. The journal includes: Leading/current opinion articles providing an overview of contentious or emerging issues. Definitive reviews of drugs and drug classes, and their place in disease management. Therapy in Practice articles including recommendations for specific clinical situations. High-quality, well designed, original clinical research. Adis Drug Evaluations reviewing the properties and place in therapy of both newer and established drugs. AdisInsight Reports summarising development at first global approval. Moreover, the journal offers additional digital features such as animated abstracts, video abstracts, instructional videos, and podcasts to increase visibility and educational value. Plain language summaries accompany articles to assist readers with some knowledge of the field in understanding important medical advances.
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