生物类药物治疗类风湿性关节炎:药物动力学概述
Yeo-Jin Song1,2, Seoung Wan Nam3, Chang Hee Suh4
1Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea.
Expert opinion on drug metabolism & toxicology
|October 16, 2023
概括
对类风湿性关节炎 (RA) 的生物类似药物显示出与原始药物相比的有效性和安全性. 皮下注射的infliximab (CT-P13) 由于其药理动力学和患者报告的结果,为RA治疗提供了一个有吸引力的替代方案.
科学领域:
- 类风湿病学 类风湿病学
- 药理学 药理学是指药理学的学科.
- 免疫学 免疫学 免疫学
背景情况:
- 许多用于类风湿性关节炎 (RA) 的生物类药物已获得欧洲药物管理局 (EMA) 和美国FDA等监管机构的批准.
- 生物类似药的批准依赖于全面的数据,证明其与原始生物药物在物理化学性质,药理动力学 (PK),药理动力学 (PD),疗效和安全性方面具有可比性.
研究的目的:
- 审查批准的RA生物类似药的药理学数据.
- 评估免疫性对PK和临床反应的影响.
- 讨论监测生物药物的血清度的潜在好处以及皮下CT-P13在临床实践中的优势.
主要方法:
- 对已批准的生物类似药的第一阶段药理动力学研究进行系统的文献搜索.
- 评估免疫性对PK和临床结果的影响.
- 对 subcutaneous infliximab (CT-P13) 的临床数据和现实世界的证据的审查.
主要成果:
- 生物类似药物是根据证据的总和而被批准的,这些证据表明与原始药物可比性.
- 组合疾病修饰性抗风湿药物 (DMARD) 治疗可以减轻免疫性并保持疗效/PK概况.
- 皮下CT-P13 (infliximab生物类似剂) 是首个用于RA的SC配方,与IVinfliximab相比,它显示出有效性,有利的PK,患者的结果和安全性.
结论:
- 医生应该考虑组合DMARD疗法,以优化RA中生物类似药的使用.
- 虽然PK监测不是标准的,但皮下注射infliximab对于RA患者来说是一个有价值的治疗选择.
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