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一个多中心,随机,安慰剂对照的2b期研究
Kim A Papp1, Mark A Weinberg2, Alun Morris3
1Probity Medical Research, Waterloo, ON, Canada.
Lancet (London, England)
|April 25, 2021
概括
与安慰剂相比,sonelokimab在斑块性牛皮患者中显示出显著的临床益处,显示出快速和持久的改善,并具有可接受的安全性. 较高的sonelokimab剂量 (60mg和120mg) 在实现清晰或几乎清晰的皮肤方面特别有效.
科学领域:
- 免疫皮肤学
- 生物制剂和治疗蛋白质
- 临床试验研究
背景情况:
- 索内洛基马布是一种针对IL- 17A,IL- 17F和人血清白蛋白的新型三价纳米体.
- 纳米体是一种新型的治疗蛋白质,来源于驼类重链抗体.
- 斑块性牛皮是一种慢性炎症性皮肤疾病,通常需要全身治疗.
研究的目的:
- 评估sonelokimab在斑块型牛皮患者中的疗效,安全性和耐受性.
- 将四种剂量方案中的sonelokimab与安慰剂进行比较
- 用secokinumab作为一个积极的对照来进行比较.
主要方法:
- 一个多中心,随机,安慰剂控制的2b期试验,涉及313名中度至重度斑块牛皮的成年患者.
- 参与者被随机分为六个组:安慰剂,sonelokimab (30mg,60mg,120mg正常负荷,120mg增强负荷) 和secukinumab (300mg).
- 主要结局是患者在第12周达到0或1的研究人员总评分 (IGA) 的比例.
主要成果:
- 在第12周,所有sonelokimab组与安慰剂组相比,IGA得分显著改善 (0或1).
- 较高的sonelokimab剂量 (60mg和120mg) 的疗效率很高,达到84. 6%和88. 2%的IGA0/ 1.
- 大多数不良反应为轻度至中度;在52周内,sonelokimab的安全性与secukinumab相似,可控的Candida感染略有增加.
结论:
- 在治疗斑块性牛皮方面,sonelokimab比安慰剂具有显著的临床益处.
- 治疗显示出迅速开始的作用,持久的改善,以及可接受的安全性.
- 特别是在120毫克或更低的剂量中,sonelokimab代表了斑块性牛皮的有希望的治疗选择.
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