活跃牛皮关节炎患者的比梅奇祖马布: 48 周的随机,双盲,安慰剂对照,剂量范围的2b 期试验结果
Christopher T Ritchlin1, Arthur Kavanaugh2, Joseph F Merola3
1University of Rochester Medical Center, Rochester, NY, USA.
Lancet (London, England)
|February 10, 2020
概括
与安慰剂相比,Bimekizumab是IL- 17A和IL- 17F的双抑制剂,显著改善了牛皮关节炎患者的ACR50反应. 治疗表明可接受的安全性,支持进一步的调查.
科学领域:
- 关节病学
- 免疫学
- 药理学
背景情况:
- 牛皮关节炎是一种慢性炎症.
- 对17A (IL17A) 和IL17F的双重中和为PsA提供了一种新的治疗策略.
- 比梅基祖马布是一种单克隆抗体,针对IL17A和IL17F.
研究的目的:
- 评估活跃牛皮关节炎患者的比梅奇祖马布的疗效和安全性.
- 确定用于治疗牛皮关节炎的最佳剂量.
主要方法:
- 进行了一项随机,双盲,安慰剂控制,剂量范围的2b期研究 (BE ACTIVE).
- 在206名患有活跃牛皮关节炎的成年患者中,给予安慰剂或多种剂量 (16 mg,160 mg,160 mg加重剂量,320 mg) 每4周一次进行皮下注射,持续12周.
- 主要终点是美国风湿病学学院 (ACR50) 响应标准在第12周达到至少50%的改善的患者比例.
主要成果:
- 与安慰剂相比,在第12周使用比梅奇祖马布 (16 mg,160 mg和160 mg加重剂量) 时观察到显著更高的ACR50反应率 (p< 0. 05).
- 在接受比梅奇祖马布治疗的患者中,有41%的人报告了与治疗相关的不良反应,而在接受安慰剂治疗的患者中,有57%的人报告了这些不良反应,其中大多数是轻度至中度的.
- 没有报告死亡或炎症性肠病病例;在8名接受比梅奇祖马布治疗的患者中发生了严重的不良反应.
结论:
- 在牛皮关节炎患者中,16毫克和160毫克的Bimekizumab剂量显著改善了ACR50反应.
- 在治疗牛皮关节炎的第三阶段试验中,Bimekizumab表现出可接受的安全性概况.
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