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Role of biologics and biosimilars in inflammatory bowel disease: current trends and future perspectives

机译:生物制品和生物仿制药在炎症性肠病中的作用:当前趋势和未来观点

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摘要

Inflammatory bowel disease (IBD) is an idiopathic chronic inflammatory disease of the gastrointestinal system. The spectrum is of predominantly two types, namely, ulcerative colitis and Crohn’s disease. The incidence of IBD has been increasing steadily since 1990, and so the number of agents used in their treatment. Biologics that are derived partly or completely from living biological sources such as animals and humans have become widely available, which provide therapeutic benefits to the IBD patients. Currently, monoclonal antibodies against tumor necrosis factor-alpha (infliximab, adalimumab, certolizumab, and golimumab), integrins (vedolizumab and natalizumab), and interleukin (IL)-12 and IL-23 antagonists (ustekinumab) are approved for use in IBD. Biosimilars of infliximab and adalimumab are also available for the treatment of IBD. This review summarizes the clinical pharmacology, studies leading to their approval, overall indications and their use in IBD, usage in pregnancy and lactation, and the adverse effects of these agents. This review also summarizes the recent advances and future perspectives specific to biologics and biosimilars in IBD.
机译:炎性肠病(IBD)是胃肠系统的特发性慢性炎性疾病。频谱主要是两种类型,即溃疡性结肠炎和克罗恩氏病。自1990年以来,IBD的发病率一直在稳定增长,因此治疗中使用的药物数量也有所增加。已经部分或全部源自诸如动物和人类等生物活体来源的生物制品,这为IBD患者提供了治疗益处。目前,已批准将针对肿瘤坏死因子-α(英夫利昔单抗,阿达木单抗,西妥珠单抗和戈利木单抗),整联蛋白(维多珠单抗和那他珠单抗)以及白介素(IL)-12和IL-23拮抗剂(ustekinumab)的单克隆抗体用于IBD。英夫利昔单抗和阿达木单抗的生物仿制药也可用于治疗IBD。这篇综述总结了临床药理学,导致其批准的研究,总体适应症及其在IBD中的用途,在妊娠和哺乳期的用途以及这些药物的不良作用。这篇综述还总结了IBD中生物制品和生物仿制药特有的最新进展和未来观点。

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