对复发多发性硬化症药物开发。

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阿里R,尼古拉斯·RS Muraro PA

对复发多发性硬化症药物开发。

药。2013年5月,73 (7):625 - 50。doi: 10.1007 / s40265 - 013 - 0030 - 6。

PubMed ID
23609782 (在PubMed
]
文摘

药物开发的多发性硬化症(MS)、和其他神经系统疾病一样,面临着众多的挑战,许多药物失败在不同的发展阶段。疾病修饰治疗(儿童)首次引入女士只是适度有效,但由于缺乏竞争,他们在临床实践中已经被广泛接受。虽然安全性和有效性的两个主要指标继续药物将判断,新代理也在市场上面临的挑战更比较自然——他们比目前市场上的药品更有效?他们是安全的或更好的容忍吗?他们提供任何实际优于目前的治疗吗?Fingolimod代表一个里程碑批准后作为2010年女士的口服药物,提供病人更方便管理路线。然而,与心血管并发症导致在其最初的处方更加谨慎的方法,现在要求心脏监测第一6 h以及后续监测血压和黄斑水肿。Natalizumab,在许可的药物,代表了当前基准功效。的风险渐进多焦点的脑白质病在治疗natalizumab现在更多的可量化的。其他单克隆抗体在不同的发展阶段。 Marketing authorisation for alemtuzumab has been filed, and whilst trial data suggest that its efficacy outperforms both licensed drugs and others in development, there is a significant risk of secondary autoimmunity. Its once-yearly administration, however, seems particularly advantageous. Rituximab is unlikely to be developed further as its license will expire, but ocrelizumab, another monoclonal antibody directly targeting B cells, is currently in phase 2 development and looks promising. Daclizumab is also moderately efficacious but may struggle to establish itself given its monthly subcutaneous dosing. There are new oral drugs in development, and it is likely that BG-12 will be licensed this year. This has been licensed for psoriasis so there are good safety data in humans that may also hold true in MS; however, its three times daily dosage will probably impact on patient compliance. Laquinimod has lower efficacy than BG-12 but appears safe and could find a place as a first-line agent. Teriflunomide has just been licensed by the US FDA and may challenge the current injectable first-line therapies as it has a similar efficacy but the advantage of being taken orally. However, risk of teratogenicity may caution against its use in some women of child-bearing potential. This review will examine drugs that have been recently approved as well as those that are in late phase 2 or 3 development as treatment for relapsing MS, highlighting their mechanism of action as well as the clinical trial and safety data before discussing their potential for success in an increasingly florid and complex DMT armamentarium.

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