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首页> 外文期刊>The Journal of dermatology >Efficacy and safety of ustekinumab in Japanese patients with moderate-to-severe plaque-type psoriasis: Long-term results from a phase 2/3 clinical trial
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Efficacy and safety of ustekinumab in Japanese patients with moderate-to-severe plaque-type psoriasis: Long-term results from a phase 2/3 clinical trial

机译：Ustekinumab在日本中度至重度斑块型牛皮癣患者中的疗效和安全性：2/3期临床试验的长期结果

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This phase 2/3, double-blind, placebo-controlled study was designed to assess the safety and efficacy of ustekinumab in Japanese patients with moderate-to-severe plaque-type psoriasis. Overall, 158 patients were randomized to receive ustekinumab 45 or 90 mg at weeks 0, 4, and every 12 weeks, or placebo with cross-over to ustekinumab at week 12. The primary end-point was the proportion of patients achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at week 12. Physician's Global Assessment (PGA), Dermatology Life Quality Index (DLQI), Nail Psoriasis Severity Index and joint pain Visual Analog Scale (VAS) were also measured. At week 12, 59.4% and 67.7% of ustekinumab 45 and 90 mg patients achieved PASI 75, respectively, compared with 6.5% in the placebo group (P < 0.0001 each). PASI 75 responses were maintained through week 64 in 65.0% and 78.6% of the ustekinumab-treated patients, respectively. Placebo cross-over patients had similar responses to ustekinumab-treated patients. Significant improvements in PGA, DLQI and VAS scores were observed at week 12 and generally maintained over time. Adverse events during the placebo-controlled period were similar among groups (45 mg, 65.6%; 90 mg, 59.7%; placebo, 65.6%). Serious adverse events were observed in 0%, 4.8% and 6.3% of patients, respectively. Through week 72, similar rates and types of adverse events and serious adverse events were reported in patients receiving 45 and 90 mg. Rates of injection site reactions and antibodies to ustekinumab were low. Ustekinumab was efficacious and generally well-tolerated in Japanese patients with moderate-to-severe plaque-type psoriasis through 72 weeks. These results are consistent with those reported in the global, phase 3 studies.
机译：这项2/3期，双盲，安慰剂对照研究旨在评估ustekinumab在日本中度至重度斑块型牛皮癣患者中的安全性和有效性。总体上，共有158位患者在第0、4周和每12周随机接受ustekinumab 45或90 mg，或者在第12周时接受安慰剂并与ustekinumab交叉使用。主要终点是达到75岁的患者比例在第12周时，牛皮癣面积和严重程度指数（PASI 75）的改善百分比。还测量了医师的整体评估（PGA），皮肤病生活质量指数（DLQI），指甲牛皮癣严重程度指数和关节疼痛视觉模拟量表（VAS）。在第12周时，ustekinumab 45和90 mg患者分别有59.4％和67.7％达到PASI 75，而安慰剂组为6.5％（每人P <0.0001）。到第64周，分别接受ustekinumab治疗的患者的PASI 75反应维持在65.0％和78.6％。安慰剂交叉治疗的患者对乌斯他单抗治疗的患者有相似的反应。在第12周观察到PGA，DLQI和VAS评分有显着改善，并且通常会随着时间的推移而保持。安慰剂对照期间的不良事件在各组中相似（45 mg，65.6％; 90 mg，59.7％;安慰剂，65.6％）。分别在0％，4.8％和6.3％的患者中观察到严重的不良事件。到第72周，据报道接受45和90 mg药物治疗的患者的不良事件和严重不良事件的发生率和类型相似。注射部位反应和抗ustekinumab抗体的发生率较低。 Ustekinumab对日本中度至重度斑块型银屑病患者有效且通常耐受72周。这些结果与全球第3期研究报告的结果一致。

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