治疗活跃牛皮关节炎的secukinumab与adalimumab (EXCEED):一个双盲,并行组,随机,主动对照的3b期试验
Iain B McInnes1, Frank Behrens2, Philip J Mease3
1Institute of Infection, Immunity and Inflammation, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.
Lancet (London, England)
|May 11, 2020
概括
在治疗牛皮关节炎方面,secukinumab 没有表现优于 adalimumab,但患者保留时间更好. 这项对比试验为治疗牛皮关节炎提供了有价值的数据.
科学领域:
- 关节病学
- 免疫学
- 临床试验
背景情况:
- 牛皮关节炎需要有效的治疗方案.
- 对比试验对于比较生物疗法至关重要.
- 在活动性牛皮关节炎中,EXCEED研究比较了secokinumab和adalimumab.
研究的目的:
- 为了评估sequinumab与adalimumab的疗效和安全性.
- 评估两种药物作为一线生物单一疗法.
- 为了确定美国风湿病学会 (ACR) 的初级终点,52周后的反应.
主要方法:
- 这是一项双盲随机对照试验,涉及853名患者.
- 患者可以通过皮下注射Secukinumab或Adalimumab.
- 主要结局是患者在第52周达到ACR20反应的比例.
主要成果:
- 在52周的ACR20反应中,secukinumab (67%) 没有比adalimumab (62%) 具有统计学意义的优势 (p=0. 0719).
- 治疗的持续时间在sequinumab组 (86%) 与adalimumab组 (76%) 相比较高.
- 安全性与先前的研究一致,严重感染没有显著差异.
结论:
- 在牛皮关节炎中,secukinumab没有达到与adalimumab优势的主要终点.
- 这表明Secukinumab可能有长期益处.
- 这项试验的比较数据有助于治疗牛皮关节炎的临床决策.
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