Effectiveness of alitretinoin in severe chronic hand eczema: PASSION, a real-world observational study

被引:18
作者
Thaci, Diamant [1 ]
Augustin, Matthias [2 ]
Westermayer, Bernd [3 ]
Kamps, Anja [4 ,5 ]
Hennig, Michael [3 ]
机构
[1] Univ Hosp Schleswig Holstein, Comprehens Ctr Inflammat Med, Campus Lubeck, Kiel, Germany
[2] Univ Med Ctr Hamburg, Inst Hlth Serv Res Dermatol & Nursing, Hamburg, Germany
[3] GlaxoSmithKline Germany, Biostat & Epidemiol, Munich, Germany
[4] Stiefel, Med Dept, Munich, Germany
[5] Hexal, Med Affairs Dept, Holzkirchen, Germany
关键词
Alitretinoin; chronic hand eczema; patient benefits; quality of life; work productivity; QUALITY-OF-LIFE; ROUTINE CARE; DOUBLE-BLIND; EFFICACY; PREVALENCE; ILLNESS; SAFETY; COST; MULTICENTER; POPULATION;
D O I
10.1080/09546634.2016.1227422
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
Purpose: 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. Methods: 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. Results: 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. Conclusions: Alitretinoin produced marked improvement in the QoL and work productivity of patients with severe CHE.
引用
收藏
页码:577 / 583
页数:7
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