Thaçi Diamant, Augustin Matthias, Westermayer Bernd, Kamps Anja, Hennig Michael
a Comprehensive Centre for Inflammation Medicine, University Hospital Schleswig Holstein , Campus Lübeck , Germany.
b Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg , Hamburg , Germany.
J Dermatolog Treat. 2016 Nov;27(6):577-583. doi: 10.1080/09546634.2016.1227422. Epub 2016 Oct 3.
Severe chronic hand eczema (CHE) has a debilitating effect on quality of life (QoL). PASSION evaluated the effectiveness of oral alitretinoin on QoL and work productivity in patients with severe CHE following prescribing guidelines.
A non-interventional, open-label, observational, multicentre study conducted in Germany in fulfilment of German guidelines. Patients (n = 631) were treated with once-daily alitretinoin for ≤24 weeks under standard daily practise conditions. Effectiveness was assessed by Physician Global Assessment (PGA), QoL Assessment (EQ-5D) and work impairment. Tolerability and safety were assessed by adverse event (AE) monitoring.
In total, 279 (44.2%) patients dropped out before Week 24. Of the 631 patients enrolled, 29.8% achieved a PGA rating of clear/almost clear at Week 24. Mean (standard deviation) EQ-5D utility and EQ-5D visual analogue scale scores at baseline were 0.76 (0.25) and 53.6 (23.55), respectively, and increased to 0.94 (0.12) and 80.8 (19.23) at Week 24, indicating improved QoL. At baseline, 49.4%/29.1% of patients reported strong/very strong workplace impairment, respectively, and decreased to 8.5%/1.4%, respectively, at Week 24. AEs were reported in 116 (18.4%) patients. No new safety signals were observed.
Alitretinoin produced marked improvement in the QoL and work productivity of patients with severe CHE.
重度慢性手部湿疹（CHE）对生活质量（QoL）有严重影响。PASSION研究按照处方指南评估了口服阿维A对重度CHE患者生活质量和工作效率的有效性。
在德国进行的一项非干预性、开放标签、观察性多中心研究，符合德国指南要求。患者（n = 631）在标准日常实践条件下接受每日一次阿维A治疗≤24周。通过医生整体评估（PGA）、生活质量评估（EQ-5D）和工作障碍评估有效性。通过不良事件（AE）监测评估耐受性和安全性。
共有279名（44.2%）患者在第24周前退出。在纳入的631名患者中，29.8%在第24周时达到PGA评分为清除/几乎清除。基线时EQ-5D效用和EQ-5D视觉模拟量表评分的平均值（标准差）分别为0.76（0.25）和53.6（23.55），在第24周时分别增至0.94（0.12）和80.8（19.23），表明生活质量有所改善。基线时，分别有49.4%/29.1%的患者报告工作场所严重/非常严重受损，在第24周时分别降至8.5%/1.4%。116名（18.4%）患者报告了不良事件。未观察到新的安全信号。
阿维A使重度CHE患者的生活质量和工作效率有显著改善。
