在患有活性类风湿性关节炎的患者中,AZD9567与普雷迪尼索隆相比:IIa期,随机,双盲,疗效和安全性研究
Jacob M van Laar1, Alejhandra Lei2, Mary Safy-Khan1
1Division of Internal Medicine and Dermatology, Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.
Clinical and translational science
|October 24, 2023
概括
选择性葡萄糖皮质体受体调节剂AZD9567在类风湿性关节炎患者中表现出与普雷迪尼索隆相当的疗效. 与普雷迪尼索隆不同,AZD9567没有破坏电解质平衡,为炎症性疾病提供了潜在的更安全的替代方案.
科学领域:
- 药理学 药理学是指药理学的学科.
- 类风湿病学 类风湿病学
- 药物开发 药物开发
背景情况:
- 口服皮质类固醇如普雷迪尼索隆受到副作用的限制,包括由于非目标矿物质皮质类固醇受体活性导致的电解质失衡.
- AZD9567是一种新型的,选择性的,非类固醇葡萄糖皮质体受体调节剂,旨在减轻这些副作用.
研究的目的:
- 在患有活性类风湿性关节炎的患者中,评估AZD9567与普得尼索隆相比的疗效,安全性和耐受性.
- 在体外评估AZD9567的抗炎作用机制.
主要方法:
- 一个随机的,双盲的,平行组的,多中心的IIa期研究.
- 21名患有活性类风湿性关节炎的患者随机分配,接受AZD9567 40mg或普雷迪尼索隆20mg每天一次,持续14天.
- 主要终点:第15天DAS28-CRP与基线的变化. 二级终点包括ACR反应标准和血清电解质.
主要成果:
- AZD9567的疗效与普得尼索隆相似,在DAS28-CRP变化中没有临床意义上的差异 (LS平均差异:0.47).
- 二次疗效终点也显示了两种治疗方法之间的可比结果.
- 重要的是,AZD9567没有影响血清:比率,与普得尼索隆不同,具有类似的整体安全性.
结论:
- 在类风湿性关节炎患者中,AZD9567的疗效与普得尼索隆相当.
- 通过避免皮质类固醇诱导的电解质失衡,AZD9567提供了潜在的优势.
- 需要进行更大,更长时间的研究来确认AZD9567是治疗炎症疾病的普雷尼索隆的可行替代品.
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