IF 2.7 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Aisling McGuigan
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引用次数: 0

摘要

CT-P47/tocilizumab-anoh (AVTOZMA®)是参考tocilizumab (IL-6R抑制剂)的生物仿制药。CT-P47已在美国和欧盟获批用于治疗类风湿性关节炎、巨细胞动脉炎、多关节幼年特发性关节炎、全身性幼年特发性关节炎、2019冠状病毒病和细胞因子释放综合征。CT-P47具有与托珠单抗相似的理化性质,在中重度类风湿性关节炎患者中具有明显的药代动力学可比性。在该患者群体中,CT-P47表现出与托珠单抗相当的临床疗效,并且通常耐受性良好。CT-P47的总体安全性和免疫原性与参考托珠单抗相似,从参考托珠单抗切换到CT-P47不影响安全性或有效性。参考tocilizumab在炎症性疾病治疗中的作用已得到证实,CT-P47为需要tocilizumab治疗的患者提供了有效的生物仿制药替代方案。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
CT-P47/Tocilizumab-anoh: A Tocilizumab Biosimilar.

CT-P47/tocilizumab-anoh (AVTOZMA®) is a biosimilar of reference tocilizumab, an IL-6R inhibitor. CT-P47 is approved for treating rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, Coronavirus disease 2019 and cytokine release syndrome in the USA and the EU. CT-P47 has similar physicochemical properties to those of reference tocilizumab, with demonstrated pharmacokinetic comparability in patients with moderate to severe rheumatoid arthritis. In this patient population, CT-P47 demonstrated clinical efficacy equivalent to reference tocilizumab and was generally well tolerated. The overall safety and immunogenicity profiles of CT-P47 were similar to those of reference tocilizumab, and switching from reference tocilizumab to CT-P47 did not affect safety or efficacy. The role of reference tocilizumab in the management of inflammatory diseases is well established and CT-P47 provides an effective biosimilar alternative for patients requiring tocilizumab therapy.

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来源期刊
CiteScore
5.90
自引率
3.10%
发文量
108
审稿时长
6-12 weeks
期刊介绍: Clinical Drug Investigation provides rapid publication of original research covering all phases of clinical drug development and therapeutic use of drugs. The Journal includes: -Clinical trials, outcomes research, clinical pharmacoeconomic studies and pharmacoepidemiology studies with a strong link to optimum prescribing practice for a drug or group of drugs. -Clinical pharmacodynamic and clinical pharmacokinetic studies with a strong link to clinical practice. -Pharmacodynamic and pharmacokinetic studies in healthy volunteers in which significant implications for clinical prescribing are discussed. -Studies focusing on the application of drug delivery technology in healthcare. -Short communications and case study reports that meet the above criteria will also be considered. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Clinical Drug Investigation may be accompanied by plain language summaries to assist readers who have some knowledge, but non in-depth expertise in, the area to understand important medical advances.
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