Efficacy and safety of ixekizumab in a randomized, double-blinded, placebo-controlled phase IIIb study of patients with moderate-to-severe genital psoriasis
Efficacy and safety of ixekizumab in a randomized, double-blinded, placebo-controlled phase IIIb study of patients with moderate-to-severe genital psoriasis
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DOI：
10.1111/bjd.16736
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发表时间：
2018-10-01
影响因子：
10.3
通讯作者：
Bleakman, A. Potts
中科院分区：
文献类型：
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作者：
Ryan, C.;Menter, A.;Bleakman, A. Potts
背景：生殖器牛皮癣（GenPs）是一种常见的、使人衰弱的、难以治疗的斑块型牛皮癣。然而，对GenPs的控制性、介入性研究很少。目的方法比较ixekizumab与安慰剂在1%体表面积（BSA）累及的中重度GenPs患者中的疗效。中度至重度GenPs患者，定义为基线静态医师生殖器整体评估（sPGA-G）评分为3分，BSA为1%，随机分配1:1接受安慰剂（n = 74）或推荐剂量的ixekizumab （n = 75）。主要结局包括在sPGA- g（主要终点）、总体sPGA、GenPs性频率问卷（GenPs- sfq）第2项得分达到0或1分的患者百分比，以及GenPs瘙痒数值评定量表较基线改善3分的患者百分比。结果结论在第12周，ixekizumab在sPGA- g 0/1 （73% vs. 8%, P < 0001）、总sPGA 0/1 （73% vs. 3%, P < 0001）、GenPs-SFQ项目2评分为0或1 （78% vs. 21%, P < 0001）和生殖器瘙痒（60% vs. 8%, P < 0001）方面优于安慰剂。未报告念珠菌病，未发生死亡，接受安慰剂的患者报告了1（1%）严重不良事件。Ixekizumab治疗BSA为1%的中重度GenPs优于安慰剂。ixekizumab在中度至重度斑块性银屑病中的安全性与先前的研究一致。
BackgroundGenital psoriasis (GenPs) is a common, debilitating and difficult-to-treat manifestation of plaque psoriasis. However, few controlled, interventional studies of GenPs exist.ObjectivesMethodsTo determine the efficacy of ixekizumab vs. placebo in patients with moderate-to-severe GenPs with 1% involved body surface area (BSA).Patients with moderate-to-severe GenPs, defined as a baseline static Physician's Global Assessment of Genitalia (sPGA-G) score of 3, with BSA 1% were randomized 1 : 1 to receive placebo (n = 74) or the recommended dosing of ixekizumab (n = 75). Major outcomes included the percentage of patients achieving 0 or 1 scores on the sPGA-G (primary end point), overall sPGA, GenPs Sexual Frequency Questionnaire (GenPs-SFQ) item 2, and 3-point improvement from baseline on the GenPs itch numerical rating scale.ResultsConclusionsAt week 12, ixekizumab was superior to placebo for sPGA-G 0/1 (73% vs. 8%, P < 0001), overall sPGA 0/1 (73% vs. 3%, P < 0001), GenPs-SFQ item 2 score of 0 or 1 (78% vs. 21%, P < 0001) and genital itch (60% vs. 8%, P < 0001). No candidiasis was reported, no deaths occurred and one (1%) serious adverse event was reported in a patient receiving placebo.Ixekizumab was superior to placebo for the treatment of moderate-to-severe GenPs with BSA 1%. The safety profile of ixekizumab was consistent with previous studies in moderate-to-severe plaque psoriasis.