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Br J Dermatol:ixekizumab与guselkumab治疗中重度斑块状银屑病的疗效和安全性

2021-12-17 MedSci原创 MedSci原创

近日,发表于Br J Dermatol的一项随机试验对比了ixekizumab与guselkumab治疗后的皮肤和指甲清除率以及患者报告的结果。

在IXORA-R头对头试验中,接受白细胞介素(IL)-17A抑制剂ixekizumab与IL-23p19抑制剂guselkumab治疗的中重度斑块状银屑病患者在第12周实现了银屑病面积和严重程度指数(PASI 100)的100%改善。近日,发表于Br J Dermatol的一项随机试验对比了ixekizumab与guselkumab治疗后的皮肤和指甲清除率以及患者报告的结果。

IXORA-R招募了患有中重度斑块状银屑病的成人,定义为静态医生全球评估≥3,PASI≥12,受累体表面积≥10%。采用Cochran-Mantel-Haenszel检验进行统计学比较,按集合地点进行分层。使用Kaplan-Meier分析进行首次发生时间的比较,并使用按治疗组分层的校正后的对数rank检验产生P值。临床和患者报告反应的累积天数通过ancheova进行比较。

 

结果显示,在随机分配的1027名患者中,90%完成了试验(520名ixekizumab中的465名和507名guselkumab中的459名)。早在第2周至第16周,更多使用ixekizumab的患者达到PASI 100(P < 0.01)。在第24周,ixekizumab不逊于guselkumab(50% vs. 52%,差异-2-3%),在PASI 100方面没有统计学意义的差异(P = 0.41)。更多接受ixekizumab的患者在第24周实现指甲完全透明(52% vs. 31%,P = 0.007)。与guselkumab患者相比,ixekizumab患者首次达到PASI 50/75/90和PASI 100的中位时间分别缩短了2周和7.5周(P < 0.001)。使用ixekizumab的患者也有更大的累积效益,有更多天处于PASI 90和100,皮肤科生活质量指数为0或1,并且无瘙痒(P < 0.05)。每组的严重不良事件发生频率为3%,没有新的安全性事件。

综上所述,该研究结果表明,Ixekizumab在完全清除皮肤皮损方面不逊于guselkumab,在第24周清除指甲方面更有优势。Ixekizumab对中重度斑块状银屑病患者的皮肤清除速度更快,累积效益也比guselkumab大。总的来说,安全性研究结果与ixekizumab的已知安全状况一致。

 

原始出处:

 

A Blauvelt, C Leonardi, et al., A head-to-head comparison of ixekizumab vs. guselkumab in patients with moderate-to-severe plaque psoriasis: 24-week efficacy and safety results from a randomized, double-blinded trial. Br J Dermatol. 2021 Jun;184(6):1047-1058. doi: 10.1111/bjd.19509.

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    2022-09-26 snf701207
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