单克隆抗体研究进展

IF 3.2 Q2 Pharmacology, Toxicology and Pharmaceutics
Surjit Singh, Nitish K Kumar, Pradeep Dwiwedi, Jaykaran Charan, Rimplejeet Kaur, Preeti Sidhu, Vinay K Chugh
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引用次数: 220

摘要

背景:在过去的三十年中,单克隆抗体(mab)已经从科学工具转变为强大的人类治疗药物。Muromonab cd3a小鼠单抗是FDA批准的首个用于预防肾移植排斥反应的治疗性单抗。自1986年获批以来,进一步的申请和批准数量一直在下降,直到20世纪90年代末,第一个嵌合单抗利妥昔单抗于1997年被批准用于治疗低级别B细胞淋巴瘤。随着嵌合抗体、人源化抗体和全人源化单克隆抗体得到许可当局的批准,市场上用于治疗各种疾病的单克隆抗体的批准率和可用性急剧增加。截至2017年3月,FDA已经批准了大约60种治疗性单克隆抗体,目前正在临床试验的各个阶段进行评估。目的:单克隆抗体被批准用于治疗心血管、呼吸、血液、肾脏、免疫和肿瘤等各个系统的疾病。单克隆抗体被批准用于治疗罕见疾病或适应症,如阵发性夜间血红蛋白尿,以及数百名患者正在接受治疗的癌症和多发性硬化症,甚至乳腺癌、哮喘和类风湿关节炎等疾病也有数百万人正在接受治疗。本文简要介绍了FDA批准的单抗产品的类型、分子靶点、作用机制和治疗适应症。结论:随着全人单克隆抗体的出现,其治疗各种心血管、癌症、呼吸系统、血液病、自身免疫性疾病和感染的有效性和安全性得到了提高。生物仿制药的引入将提高单克隆抗体在各种疾病治疗中的可负担性和利用率。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Monoclonal Antibodies: A Review.

Background: Over the last three decades, monoclonal antibodies (MAbs) have made a striking transformation from scientific tools to powerful human therapeutics. Muromonab CD3 a murine MAb was the first FDA approved therapeutic MAb for the prevention of kidney transplant rejection. Since its approval in 1986, there has been a decline in further application and approvals until the late 1990s when the first chimeric Mab, Rituximab was approved for the treatment of lowgrade B cell lymphoma in 1997. With the approval by licensing authorities of chimeric, followed by humanized and then fully human monoclonal antibodies, the rate of approval and monoclonal antibodies available in the market for the treatment of various diseases has increased dramatically. As of March 2017, FDA has approved approximately 60 therapeutic MAbs which are currently under evaluation in various phases of clinical trials.

Objective: MAbs are approved for the treatment of diseases belonging to various systems like cardiovascular, respiratory, hematology, kidney, immunology and oncology. MAbs are approved for the treatment of orphan diseases or indications such as paroxysmal nocturnal hemoglobinuria as well as cancers and multiple sclerosis where hundreds of patients are treated and even diseases such as breast cancer, asthma and rheumatoid arthritis where millions are being treated. This review focuses briefly on types, molecular targets, mechanism of actions and therapeutic indications of FDA approved MAb products that are currently available in the market.

Conclusion: With the advent of fully human MAbs, the efficacy and safety have improved in the treatment of various cardiovascular, cancer, respiratory, hematology, autoimmune diseases and infections. The introduction of biosimilars will increase the affordability and utilization of MAbs in the treatment of various diseases.

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来源期刊
Current clinical pharmacology
Current clinical pharmacology PHARMACOLOGY & PHARMACY-
CiteScore
3.60
自引率
0.00%
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0
期刊介绍: Current Clinical Pharmacology publishes frontier reviews on all the latest advances in clinical pharmacology. The journal"s aim is to publish the highest quality review articles in the field. Topics covered include: pharmacokinetics; therapeutic trials; adverse drug reactions; drug interactions; drug metabolism; pharmacoepidemiology; and drug development. The journal is essential reading for all researchers in clinical pharmacology.
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