Revicki Dennis A, Willian Mary K, Menter Alan, Saurat Jean-Hilaire, Harnam Neesha, Kaul Martin
Center for Health Outcomes Research, United Biosource Corporation, Bethesda, MD 20814, USA.
Dermatology. 2008;216(3):260-70. doi: 10.1159/000113150. Epub 2008 Jan 11.
Health-related quality of life (HRQOL) outcomes are associated with clinical response to treatment in psoriasis. However, the association between HRQOL outcomes and more substantial degrees of Psoriasis Area and Severity Index (PASI) response and physician and patient global ratings remains ill defined.
This study examined the relationship between achieving a 75% or > or =90% improvement in PASI and HRQOL outcome measures.
Secondary analyses were completed using data for 1,469 patients with moderate to severe plaque psoriasis from two adalimumab clinical trials. HRQOL was measured via the Dermatology Life Quality Index (DLQI) and the Short Form 36 (SF 36) Health Survey. Clinical response was assessed by the PASI, physician's global assessment and patient's global assessment status scores. Clinical response was categorized into 6 groups based on PASI response: <25% (n = 332); 25 to <50% (n = 137); 50 to <75% (n = 170); 75 to <90% (n = 288); 90 to <100% (n = 255), and 100% (n = 192). Analysis of covariance models compared baseline measures and 16-week changes in HRQOL scores.
Statistically significant differences were observed between PASI response groups in DLQI total scores and in SF 36 summary and scale scores (p < 0.0001). The PASI 100 and PASI 90 to <100 groups demonstrated a >10-point decrease in DLQI total scores. Moreover, these changes were statistically significantly greater than those observed for the PASI 75 to <90 group (p < 0.001) and the other PASI response groups (p < 0.001). For the SF 36, the greatest changes were observed in the PASI 75 to <90, PASI 90 to <100 and PASI 100 groups, which all had improvements of >4 points in the Mental Component and Physical Component Summary (MCS and PCS) scores. Statistically significantly greater differences in DLQI total and SF 36 summary and scale scores were also observed between patient's global assessment categories (p < 0.0001) and between physician's global assessment categories (p < 0.0001).
Improvement in PASI response of >75% corresponded to improvements in HRQOL outcome measures for patients with moderate to severe psoriasis. PASI 90 or 100 responders had greater improvements in DLQI total score than PASI 75 responders.
与健康相关的生活质量（HRQOL）结果与银屑病治疗的临床反应相关。然而，HRQOL结果与更显著程度的银屑病面积和严重程度指数（PASI）反应以及医生和患者整体评分之间的关联仍不明确。
本研究探讨PASI改善75%或≥90%与HRQOL结果指标之间的关系。
使用来自两项阿达木单抗临床试验的1469例中度至重度斑块状银屑病患者的数据进行二次分析。通过皮肤病生活质量指数（DLQI）和简明健康调查问卷36项版（SF-36）测量HRQOL。通过PASI、医生整体评估和患者整体评估状态评分评估临床反应。根据PASI反应将临床反应分为6组：<25%（n = 332）；25%至<50%（n = 137）；50%至<75%（n = 170）；75%至<90%（n = 288）；90%至<100%（n = 255），以及100%（n = 192）。协方差分析模型比较了HRQOL评分的基线测量值和16周变化。
在DLQI总分以及SF-36总结和量表评分方面，PASI反应组之间观察到统计学上的显著差异（p < 0.0001）。PASI 100以及PASI 90至<1百组的DLQI总分下降超过10分。此外，这些变化在统计学上显著大于PASI 75至<90组（p < 0.001）和其他PASI反应组（p < 0.001）观察到的变化。对于SF-36，在PASI 75至<90、PASI 90至<100和PASI 100组中观察到最大变化，这些组的心理成分和身体成分总结（MCS和PCS）评分均提高超过4分。在患者整体评估类别之间（p < 0.0001）以及医生整体评估类别之间（p < 0.0001），DLQI总分以及SF-36总结和量表评分也观察到统计学上的显著更大差异。
PASI反应改善>75%对应于中度至重度银屑病患者HRQOL结果指标的改善。PASI 90或100的反应者在DLQI总分上的改善大于PASI 75的反应者。
