Department of Dermatology, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
J Dermatol Sci. 2011 Sep;63(3):154-63. doi: 10.1016/j.jdermsci.2011.05.005. Epub 2011 May 20.
Ustekinumab has been evaluated in Caucasian patients with psoriasis, but no studies have been conducted in Asian patients.
To assess the efficacy and safety of ustekinumab in Taiwanese and Korean patients with moderate-to-severe psoriasis.
In this 36-week, multicenter, double-blind, placebo-controlled study, 121 patients with moderate-to-severe psoriasis were randomized (1:1) to receive subcutaneous injections of ustekinumab 45mg at weeks 0, 4, 16 or placebo at weeks 0, 4 and ustekinumab 45mg at weeks 12, 16. Efficacy endpoints at week 12 included the proportion of patients achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI 75; primary endpoint), proportion of patients with Physician's Global Assessment (PGA) of cleared or minimal, and change from baseline in Dermatology Life Quality Index (DLQI).
At week 12, the proportion of patients achieving PASI 75 was 67.2% and 5.0% in the ustekinumab 45mg and placebo groups, respectively (p<0.001). PGA of cleared or minimal was achieved by 70.5% (ustekinumab) and 8.3% (placebo; p<0.001), and median DLQI changes were -11.0 and 0.0, respectively (p<0.001). Efficacy was maintained through week 28 in ustekinumab-treated patients. Adverse event (AE) profiles at week 12 were similar between the ustekinumab and placebo groups: 65.6% and 70.0%, respectively, had at least one reported AE. Through week 36, no disproportionate increase in AEs was observed, with the exception of abnormal hepatic function, which was related to concomitant isoniazid treatment for latent tuberculosis. Injection-site reactions were rare and mild. No deaths, malignancies, or cardiovascular events were reported.
Treatment with subcutaneous ustekinumab 45mg offers a favorable benefit/risk profile for Taiwanese and Korean patients with moderate-to-severe psoriasis. The efficacy and safety profile is consistent with the global phase III studies of ustekinumab in psoriasis.
乌司奴单抗已在白种人银屑病患者中进行了评估，但尚未在亚洲患者中进行研究。
评估乌司奴单抗在台湾和韩国中重度银屑病患者中的疗效和安全性。
在这项为期 36 周、多中心、双盲、安慰剂对照研究中，121 例中重度银屑病患者按 1:1 随机分为接受皮下注射乌司奴单抗 45mg 组（第 0、4、16 周）和安慰剂组（第 0、4 周），随后在第 12、16 周时接受乌司奴单抗 45mg 治疗。第 12 周的主要疗效终点包括：从基线改善至少 75%的患者比例（PASI75；主要终点）、医师总体评估（PGA）为清除或最小的患者比例，以及皮肤病生活质量指数（DLQI）的变化。
第 12 周时，乌司奴单抗 45mg 组和安慰剂组分别有 67.2%和 5.0%的患者达到 PASI75（p<0.001）。PGA 为清除或最小的患者比例分别为 70.5%（乌司奴单抗）和 8.3%（安慰剂；p<0.001），DLQI 中位数变化分别为-11.0 和 0.0，均有统计学意义（p<0.001）。乌司奴单抗治疗组的疗效在第 28 周时仍得以维持。第 12 周时，乌司奴单抗组和安慰剂组的不良事件（AE）发生率相似，分别为 65.6%和 70.0%，均有至少 1 例报告 AE。至第 36 周时，AE 未出现不成比例的增加，除外与同时使用异烟肼治疗潜伏性结核病相关的肝功能异常。注射部位反应少见且轻微。未报告死亡、恶性肿瘤或心血管事件。
乌司奴单抗皮下注射 45mg 为台湾和韩国中重度银屑病患者提供了有利的获益/风险比。疗效和安全性与乌司奴单抗在全球银屑病 III 期研究中的结果一致。
