一个多中心,大规模的观察性研究托西利祖马布在日本的巨细胞动脉炎患者
Masayoshi Harigai1, Takako Miyamae1, Hideyuki Hashimoto2
1Division of Rheumatology, Department of Internal Medicine, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.
Modern rheumatology
|July 31, 2023
概括
托西利祖马布 (TCZ) 在日本巨细胞动脉炎 (GCA) 患者中表现出良好的耐受性和有效性. 这种治疗选择在与葡萄糖皮质类药物一起用于GCA管理时可能是有益的.
科学领域:
- 类风湿病学 类风湿病学
- 免疫学 免疫学 免疫学
- 临床药理学 临床药理学
背景情况:
- 巨细胞动脉炎 (GCA) 是一种大血管血管炎,影响50岁以上的人.
- 托西利祖马布 (TCZ) 在临床试验中显示出对GCA的有效性.
- 在日本GCA患者中TCZ的现实数据有限.
研究的目的:
- 为了评估日本GCA患者中TCZ的现实世界耐受性.
- 评估TCZ在GCA的现实环境中的有效性.
- 确定与TCZ治疗的GCA患者复发相关的因素.
主要方法:
- 这是一项多中心,前性,第四阶段的观察性研究.
- 117名日本GCA患者 (前6个月没有TCZ) 接受了52周的每周皮下TCZ162毫克.
- 收集关于不良事件,复发率和同时使用药物的数据.
主要成果:
- 38.5%的患者报告了不良事件;中性质衰竭/白血病 (7.7%) 和严重感染 (6.0%) 是最常见的.
- 85.0%的患者没有复发,6.0%的患者在缓解后复发.
- 疲劳,头痛,部疼痛和没有大血管病变 (LVLs) 与复发有关.
结论:
- 在日本的GCA患者中,TCZ是有效的,并且耐受性很好.
- TCZ可能是GCA的有价值的治疗选择,特别是与葡萄糖皮质类药物结合使用.
- 进一步的研究可以探索复发和长期结果的预测因素.
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