Gottlieb Alice B, Gordon Kenneth B, Lebwohl Mark G, Caro Ivor, Walicke Patricia A, Li Nicole, Leonardi Craig L
Clinical Research Center, UMDNJ-Robert Wood Johnson Medical School, New Brunswick, NJ 08901-0019, USA.
J Drugs Dermatol. 2004 Nov-Dec;3(6):614-24.
Agents that safely provide long-term control of psoriasis are needed. To determine the safety and efficacy of extended efalizumab therapy, 339 patients with moderate to severe chronic plaque psoriasis received 2 mg/kg subcutaneous (SC) efalizumab weekly for 12 weeks. At Week 12, 290 patients who achieved > or =50% Psoriasis Area and Severity Index (PASI-50) improvement or a static Physician's Global Assessment grading of "mild," "minimal," or "clear" entered maintenance treatment with weekly SC efalizumab. At Week 12, 82%, 41%, and 13% of 339 patients achieved a PASI-50, PASI-75, and PASI-90 response, respectively. At 15 months, 65%, 50%, and 25% of patients achieved a PASI-50, PASI-75, and PASI-90 response, respectively (intent-to-treat, n = 339). The incidence of adverse events did not increase over time, and no new common adverse events were reported. The majority of patients experienced sustained efficacy with no increase in toxicity. This study is planned to continue; patients will receive up to 36 months of continuous efalizumab.
需要能安全实现对银屑病长期控制的药物。为确定延长依法利珠单抗治疗的安全性和疗效，339例中度至重度慢性斑块状银屑病患者每周皮下注射（SC）依法利珠单抗2mg/kg，共12周。在第12周时，290例达到银屑病面积和严重程度指数（PASI-50）改善≥50%或静态医师整体评估分级为“轻度”“极轻度”或“清除”的患者进入维持治疗阶段，每周皮下注射依法利珠单抗。在第12周时，339例患者中分别有82%、41%和13%达到PASI-50、PASI-75和PASI-90反应。在15个月时，分别有65%、50%和25%的患者达到PASI-50、PASI-75和PASI-90反应（意向性治疗分析，n = 339）。不良事件的发生率未随时间增加，且未报告新的常见不良事件。大多数患者疗效持续，毒性未增加。本研究计划继续进行；患者将接受长达36个月的持续依法利珠单抗治疗。
