Adis, Auckland, New Zealand.
Am J Clin Dermatol. 2012 Apr 1;13(2):135-7. doi: 10.2165/11208650-000000000-00000.
Ustekinumab (Stelara™) is a human monoclonal antibody that binds to the p40 subunit common to both interleukin (IL)-12 and IL-23. It is indicated in the US for use in adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. In the EU, it is indicated for those who failed to respond to, have a contraindication to, or are intolerant of other systemic therapies or phototherapy. In well designed, randomized clinical trials, regimens of subcutaneous ustekinumab 45 or 90 mg provided a rapid and durable improvement in Psoriasis Area and Severity Index scores for patients with moderate to severe plaque psoriasis. Treatment with ustekinumab 45 or 90 mg also improved health-related quality-of-life scores from baseline. More limited data indicate that ustekinumab also improves the symptoms of arthritis in patients with plaque psoriasis and psoriatic arthritis. Subcutaneous ustekinumab was generally well tolerated in clinical trials; most adverse events were mild in intensity and did not require dosage adjustment. A pooled analysis of clinical trial data indicated no specific patterns of infection for recipients of ustekinumab and that infection rates remained stable following cumulative exposure to the agent. Thus, subcutaneous ustekinumab provides an effective and well tolerated alternative for the symptomatic treatment of patients with moderate to severe plaque psoriasis.
乌司奴单抗（喜达诺）是一种人源化单克隆抗体，可与白细胞介素（IL）-12 和 IL-23 的 p40 亚单位结合。在美国，它被批准用于治疗适合光疗或全身治疗的中重度斑块状银屑病的成年患者。在欧盟，它被批准用于对其他全身治疗或光疗无反应、有禁忌或不耐受的患者。在精心设计的随机临床试验中，中重度斑块状银屑病患者接受乌司奴单抗 45 或 90mg 皮下注射治疗，可迅速且持久地改善银屑病面积和严重程度指数评分。乌司奴单抗 45 或 90mg 治疗还可改善健康相关生活质量评分。更有限的数据表明，乌司奴单抗也可改善斑块状银屑病和银屑病关节炎患者的关节炎症状。在临床试验中，乌司奴单抗通常具有良好的耐受性；大多数不良反应为轻度，无需调整剂量。一项临床试验数据的汇总分析表明，接受乌司奴单抗治疗的患者没有特定的感染模式，并且在累积暴露于该药物后感染率保持稳定。因此，乌司奴单抗提供了一种有效且耐受良好的替代方案，可用于中重度斑块状银屑病患者的症状治疗。
