• 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>International journal of clinical rheumatology. >Single- versus dual-infusion of B-cell-depleting antibody ocrelizumab in rheumatoid arthritis: results from the Phase III FEATURE trial
【24h】

Single- versus dual-infusion of B-cell-depleting antibody ocrelizumab in rheumatoid arthritis: results from the Phase III FEATURE trial

机译：类风湿关节炎中单次或两次输注消耗B细胞的抗体ocrelizumab的治疗：III期FEATURE试验的结果

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Aim: To test the hypothesis that a therapeutic dose of ocreiizumab (200 mg x 2), can be administered as a single-infusion (400 mg x 1) to achieve clinical efficacy and safety in patients with active rheumatoid arthritis. Patients & methods: Three hundred and fourteen patients were randomized to double-blind placebo, ocrelizumab single-infusion or dual-infusion. The primary end point is American College of Rheumatology (ACR)20 response at week 24 for single-infusion ocrelizumab versus placebo. Results: At 24 weeks, ACR20 responses for patients treated with single-infusion ocrelizumab were not statistically significantly superior to placebo (37.6% [95% Cl: 28.8-46.4%] vs 28.1% [95% Cl: 17.1-39.1%]; p = 0.2253). ACR20 for dual-infusion ocrelizumab was 52.7% (95% Cl: 44.1-61.2%). Initial depletion of peripheral B cells appeared comparable after single and dual-infusions. However, subsequent B-cell repletion occurred earlier after single-infusion. Adverse events were comparable across groups. Conclusion: Ocrelizumab 200 mg x2 was efficacious, consistent with two other pivotal Phase III trials. The same drug amount administered as single-infusion was not significantly more efficacious than placebo and revealed differences in pharmacokinetic and pharmacodynamic profiles.
机译：目的：为了检验这样的假设：治疗剂量的奥雷珠单抗（200 mg x 2）可以单次输注（400 mg x 1）给药，以在活动性类风湿关节炎患者中实现临床疗效和安全性。患者与方法：314例患者被随机分为双盲安慰剂，ocrelizumab单次输注或两次输注。主要终点是美国风湿病学会（ACR）20在第24周就单次输注ocrelizumab与安慰剂的反应。结果：在第24周，单次输注奥克珠单抗治疗的患者的ACR20反应在统计学上没有明显优于安慰剂（37.6％[95％Cl：28.8-46.4％] vs 28.1％[95％Cl：17.1-39.1％]; p = 0.2253）。二次输注奥珠单抗的ACR20为52.7％（95％Cl：44.1-61.2％）。一次和两次输注后，外周血B细胞的初始耗竭似乎相当。但是，单次输注后较早发生了随后的B细胞补充。不良事件在各组之间具有可比性。结论：Ocrelizumab 200 mg x2有效，与其他两项关键的III期试验一致。与单次输注相同的药物剂量没有比安慰剂有效得多，并且揭示了药代动力学和药效学特征的差异。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号