Division of Dermatology, Social Insurance Central General Hospital, Tokyo, Japan.
J Dermatol. 2012 Mar;39(3):253-9. doi: 10.1111/j.1346-8138.2011.01459.x. Epub 2011 Dec 29.
European S3 Guidelines on the systemic treatment of psoriasis in 2009 propose 75% or more improvement in the Psoriasis Area and Severity Index from baseline (PASI 75) and a Dermatology Life Quality Index (DLQI) of 0 or 1 as treatment goals. However, the relationship of these two parameters is yet to be clarified. Herein, we analyzed the data pooled from two Japanese phase III clinical trials on psoriasis with infliximab to clarify the PASI response necessary to achieve a DLQI of 0 or 1. Of the 90 patients, the mean percent improvement in PASI at week 50 or 66 was 74.5%, and the PASI 75 and PASI 90 response rates were 66.7% and 46.7%, respectively; no difference in the improvement was noted among the body areas. Significant improvements in nail psoriasis were also observed. A negative correlation was shown between the improvement in PASI and DLQI. Patients who achieved a PASI 90 response had a significantly higher percentage of achieving a DLQI of 0 or 1 than the patients who achieved a PASI 75 but not a PASI 90 response. The median serum trough level of infliximab was maintained at 2 μg/mL or more in the PASI 90 responders, whereas it was less than 1 μg/mL at week 30 and on in the others. The present results demonstrate that a PASI 90 response is necessary to achieve a DLQI of 0 or 1. Infliximab is considered a useful drug in meeting the treatment goal of achieving a DLQI of 0 or 1 through the attainment of a PASI 90 response.
2009 年欧洲 S3 指南建议,银屑病的系统性治疗目标为从基线起 PASI(银屑病面积和严重程度指数)改善 75%或更多(PASI 75),同时达到皮肤病生活质量指数(DLQI)为 0 或 1。然而,这两个参数之间的关系尚不清楚。在此,我们分析了两项日本关于英夫利昔单抗治疗银屑病的 III 期临床试验的数据,以明确实现 DLQI 为 0 或 1 所需的 PASI 反应。90 例患者中,第 50 或 66 周时 PASI 的平均改善率为 74.5%,PASI 75 和 PASI 90 的应答率分别为 66.7%和 46.7%;各身体部位的改善程度无差异。指甲银屑病也有显著改善。PASI 的改善与 DLQI 呈负相关。达到 PASI 90 应答的患者达到 DLQI 为 0 或 1 的百分比明显高于仅达到 PASI 75 而未达到 PASI 90 的患者。PASI 90 应答者的英夫利昔单抗血清谷浓度中位数维持在 2μg/ml 或更高,而在第 30 周及以后的其他患者中,英夫利昔单抗血清谷浓度中位数低于 1μg/ml。这些结果表明,达到 PASI 90 应答是实现 DLQI 为 0 或 1 的必要条件。英夫利昔单抗被认为是一种有用的药物,通过达到 PASI 90 应答来实现 DLQI 为 0 或 1 的治疗目标。