Department of Dermatology, Blackrock Clinic, Dublin, Ireland.
Department of Dermatology, Baylor University Medical Center, Dallas, TX, U.S.A.
Br J Dermatol. 2018 Oct;179(4):844-852. doi: 10.1111/bjd.16736. Epub 2018 Jul 22.
Genital psoriasis (GenPs) is a common, debilitating and difficult-to-treat manifestation of plaque psoriasis. However, few controlled, interventional studies of GenPs exist.
To 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.
At week 12, ixekizumab was superior to placebo for sPGA-G 0/1 (73% vs. 8%, P < 0·001), overall sPGA 0/1 (73% vs. 3%, P < 0·001), GenPs-SFQ item 2 score of 0 or 1 (78% vs. 21%, P < 0·001) and genital itch (60% vs. 8%, P < 0·001). 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.
生殖器银屑病（GenPs）是斑块型银屑病的一种常见、使人虚弱且难以治疗的表现。然而，目前仅有少数针对 GenPs 的对照、干预性研究。
评估依奇珠单抗治疗中重度 GenPs（受累体表面积≥1%）患者的疗效。
本研究纳入中重度 GenPs 患者（基线时生殖器静态医师总体评估[sPGA-G]评分≥3 分，受累体表面积≥1%），按 1:1 随机分组，分别接受安慰剂（n=74）或依奇珠单抗（n=75）治疗。主要终点为生殖器 sPGA-G 评分达到 0 或 1 分的患者比例（主要终点）、总体 sPGA、GenPs 性频率问卷（GenPs-SFQ）第 2 项、GenPs 瘙痒数字评定量表（GenPs-itch NRS）自基线改善≥3 分的患者比例。
治疗 12 周时，依奇珠单抗组 sPGA-G 评分 0/1 患者比例（73% vs. 8%，P＜0.001）、总体 sPGA 评分 0/1 患者比例（73% vs. 3%，P＜0.001）、GenPs-SFQ 第 2 项评分 0/1 患者比例（78% vs. 21%，P＜0.001）、生殖器瘙痒患者比例（60% vs. 8%，P＜0.001）均显著高于安慰剂组。安慰剂组无念珠菌病报告，无死亡病例，1 例（1%）患者发生严重不良事件。
依奇珠单抗治疗受累体表面积≥1%的中重度 GenPs 患者的疗效优于安慰剂，安全性与既往中重度斑块型银屑病研究一致。
