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  1. 首页
  2. 在获得临床缓解的日本类风湿性关节炎患者中,从原始的infliximab转换为生物类似的infliximab (ifx- Sirius研究i):一个干预性,多中心的,开放的,单臂的临床试验,包括临床,超声波和生物标志物评估
  1. 首页
  2. 在获得临床缓解的日本类风湿性关节炎患者中,从原始的infliximab转换为生物类似的infliximab (ifx- Sirius研究i):一个干预性,多中心的,开放的,单臂的临床试验,包括临床,超声波和生物标志物评估

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在获得临床缓解的日本类风湿性关节炎患者中,从原始的infliximab转换为生物类似的infliximab (IFX- SIRIUS研究I):一个干预性,多中心的,开放的,单臂的临床试验,包括临床,超声波和生物标志物评估

Toshimasa Shimizu1,2, Shin-Ya Kawashiri1,3, Tomohiro Koga1

  • 1Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Naga-saki University Graduate School of Biomedical Sciences, Nagasaki, Japan.

Drug discoveries & therapeutics
|August 24, 2025

在PubMed 上查看摘要

概括
此摘要是机器生成的。

将类风湿性关节炎患者从原始药物infliximab转换为生物类似药CT- P13, 维持了临床缓解和疾病活性. 肌肉骨超声波和生物标志物证实了这种转换在生物DMARD治疗中的安全性和有效性.

关键词:
CT-P13 在生物标志物生物类药物肌肉骨超声波检查类风湿性关节炎

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科学领域:

  • 关节病学
  • 免疫学
  • 药理学

背景情况:

  • 风湿性关节炎 (RA) 是一种全身性炎症性自身免疫性疾病.
  • 伊弗利西马布 (IFX) 是一种针对TNF-α的生物修饰性抗风湿药物 (DMARD),有效但昂贵.
  • 生物相似版本,如CT-P13,提供了具有成本效益的替代品,需要对有效性和安全性进行评估.

研究的目的:

  • 在RA患者中从原始药物infliximab (IFX) 转换为其生物类似物CT- P13的疗效和安全性.
  • 通过临床指数和肌肉骨超声波 (MSUS) 评估疾病活动.
  • 监测血清中细胞因子和化学因子水平作为潜在的生物标志物.

主要方法:

  • 一个前性的,开放的,单臂的干预试验,随访时间为24周.
  • 在治疗原始IFX的临床缓解期的18名RA患者被转换为CT- P13的不变剂量.
  • 评估包括临床疾病活性评分 (DAS28- ESR,DAS28- CRP,HAQ- DI),MSUS (灰度和功率多普勒),以及血清细胞因子/ 化学因子水平.

主要成果:

  • 在18名患者中只有2名 (11.1%) 在24周内出现了临床复发.
  • 没有观察到MSUS得分,临床疾病活动指数或范德海德修改的Sharp总得分的显著变化.
  • 血清中细胞因子和化学因子水平保持稳定,只有三次不严重的不良事件发生而没有停止研究.
  • 结论:

    • 在临床缓解期的RA患者中,从原始药物Infliximab转换为生物类似药CT- P13是安全有效的.
    • 根据临床,成像和生物标志物的数据,转换并没有导致复发率的增加或疾病活动的恶化.
    • 在治疗类风湿性关节炎方面,CT-P13是原始IFX的可行,成本高效的替代品.