Japanese guidance for use of biologics for psoriasis (the 2013 version)
Japanese guidance for use of biologics for psoriasis (the 2013 version)
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DOI：
10.1111/1346-8138.12239
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发表时间：
2013-09-01
影响因子：
3.1
通讯作者：
Nakagawa, Hidemi
中科院分区：
文献类型：
--
作者：
Ohtsuki, Mamitaro;Terui, Tadashi;Nakagawa, Hidemi
阿达木单抗和英夫利西单抗（人抗肿瘤坏死因子（TNF）-α单克隆抗体）于2010年1月开始用于银屑病的临床治疗。2011年1月，乌司奴单抗（一种人抗白细胞介素-12/23p40（IL-12/23 p40）单克隆抗体）被新批准为第三种适应症为银屑病的生物制剂。虽然所有这些生物制剂都有望对银屑病表现出优异的治疗效果，并有助于改善患者的生活质量，但这些药物需要采取谨慎的安全措施，以防止药物不良反应，如严重感染。新指南是通过修订2011年日本生物制品使用指南/安全手册编写的英文版（日文），旨在提供关于生物制品使用的最新循证建议和安全措施，并描述了三种生物制品的最佳使用，使用生物制品的设施的医疗要求，详细介绍了防止结核病和B型肝炎病毒感染复发的安全性措施，以及与生物制剂的联合治疗。
The clinical use of adalimumab and infliximab, human anti-tumor necrosis factor (TNF)-alpha monoclonal antibodies, for psoriasis began in January 2010. In January 2011, ustekinumab, a human anti-interleukin-12/23p40 (IL-12/23p40) monoclonal antibody, was newly approved as the third biologic with an indication for psoriasis. While all of these biologics are expected to exhibit excellent therapeutic effect for psoriasis and to contribute to the improvement of quality of life in patients, these drugs require careful safety measures to prevent adverse drug reactions, such as serious infections. The new guidance, an English version prepared by revising the Japanese Guidance/Safety Manual for Use of Biologics for Psoriasis 2011 (in Japanese), is intended to provide up-to-date, evidence-based recommendations and safety measures on the use of biologics, and describes the optimal use of the three biologics, medical requirements for facilities for using biologics, details of safety measures against reactivation of tuberculosis and hepatitis B virus infection, and recommendable combination therapies with biologics.