早期的类风湿性关节炎治疗托西利祖马布,甲状腺或其组合 (U-Act-Early):多中心,随机,双盲,双模拟,战略试验
Johannes W J Bijlsma1, Paco M J Welsing1, Thasia G Woodworth2
1Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, Netherlands.
Lancet (London, England)
|June 12, 2016
概括
在新诊断的类风湿性关节炎患者中,早期使用托西利祖马布 (含或不含甲醇) 显著改善持续缓解率. 这种策略提供了更高的疗效和与甲基单一治疗相比较的安全性.
科学领域:
- 关节病学
- 免疫学
- 临床试验
背景情况:
- 风湿性关节炎 (RA) 治疗的目标是早期,快速和持续的缓解.
- 目前的指导方针通常启动甲基酸 (一种常规的合成修饰疾病的抗风湿药物) 单一治疗.
- 这项研究将以托西巴为基础的策略与新诊断的 RA 的单一疗法进行比较.
研究的目的:
- 为了比较开始使用托西利祖马布 (一种阻断interleukin- 6受体的单克隆抗体) 的疗效和安全性,与甲基和甲基单独治疗相比.
- 评估在风湿性关节炎中实现早期,快速和持续缓解的策略.
主要方法:
- 一项为期2年,多中心,随机,双盲,双模拟的策略研究,涉及317名未接受DMARD治疗的RA患者 (在1年内诊断,年龄≥18,DAS28≥2. 6).
- 患者被分配为 (1:1:1) 托西利祖马布加上甲醇,托西利祖马布加上安慰剂-甲醇,或甲醇加上安慰剂-托西利祖马布.
- 通过治疗意向分析评估的主要终点是持续缓解 (DAS28<2. 6与≤4个胀的关节).
主要成果:
- 在初始治疗方案中,持续缓解的比率显著高: 86% (托西利祖马布 + 甲铁酸) 和 84% (托西利祖马布) 与 44% (甲铁酸) (p< 0. 0001).
- 基于托西利祖马布的策略的总体持续缓解率也高于甲状腺素 (77%).
- 鼻炎是最常见的不良事件;严重的不良事件和死亡率在各组之间没有显著差异.
结论:
- 在新诊断的 RA 患者中,开始使用托西利祖马布 (含或不含甲醇) 更有效地实现持续缓解.
- 这些基于托西利祖马布的策略表现出与单独治疗甲基的安全性.
- 这些发现支持使用托西利祖马布进行早期干预,以改善RA治疗结果.
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