Papp Kim A, Henninger Eric
Probity Medical Research, 135 Union Street East, Waterloo, Ontario, Canada.
BMC Dermatol. 2006 Sep 19;6:8. doi: 10.1186/1471-5945-6-8.
Safe Psoriasis Control (SPC) is an important comprehensive measure that is validated for the assessment of benefit:risk of psoriasis treatments, combining efficacy, quality of life, and safety measures. The objective of this analysis was to assess the benefit:risk of efalizumab, a novel biologic agent indicated for the treatment of moderate-to-severe plaque psoriasis, by applying the SPC to data from randomized, placebo-controlled clinical studies of efalizumab.
SPC was applied to week 12 data from four placebo-controlled, Phase III studies: three retrospective and one prospective, the latter including a cohort of "high-need" patients for whom existing therapies were inadequate or unsuitable.
In the retrospective analysis, 39.4% of patients achieved SPC after 12 weeks of treatment with efalizumab, compared with 10.4% for placebo. In the prospective analysis, 34.3% of patients achieved SPC after 12 weeks of treatment with efalizumab, compared with 7.3% on placebo. Among high-need patients, 33.0% achieved SPC, compared with 3.4% on placebo.
Efalizumab has a favorable benefit:risk profile using the comprehensive outcome measure SPC.
安全银屑病控制（SPC）是一项重要的综合措施，已被验证用于评估银屑病治疗的获益风险，它综合了疗效、生活质量和安全指标。本分析的目的是通过将SPC应用于依法利珠单抗随机、安慰剂对照临床研究的数据，评估依法利珠单抗（一种用于治疗中度至重度斑块状银屑病的新型生物制剂）的获益风险。
将SPC应用于四项安慰剂对照的III期研究第12周的数据：三项回顾性研究和一项前瞻性研究，后者纳入了一组现有治疗方法不足或不合适的“高需求”患者。
在回顾性分析中，依法利珠单抗治疗12周后39.4%的患者实现了SPC，而安慰剂组为10.4%。在前瞻性分析中，依法利珠单抗治疗12周后34.3%的患者实现了SPC，而安慰剂组为7.3%。在高需求患者中，33.0%的患者实现了SPC，而安慰剂组为3.4%。
使用综合结局指标SPC，依法利珠单抗具有良好的获益风险特征。
