Abstract
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.
Highlights
Hand eczema is the most common skin disorder affecting the hands, with an annual prevalence of 7–12% [1,2,3]
The objective of the study was to evaluate the effectiveness of oral alitretinoin, in accordance with chronic hand eczema (CHE) prescribing guidelines, on the quality of life (QoL) and work productivity of patients with severe CHE refractory to potent topical corticosteroids
Of the overall study population, 1.0% withdrew due to clinically-relevant changes in laboratory parameters, 5.9% withdrew due to adverse event (AE), 5.9% terminated early due to a lack of effectiveness, 9.7% withdrew consent and 27.1% discontinued for reasons unspecified or not given
Summary
Hand eczema is the most common skin disorder affecting the hands, with an annual prevalence of 7–12% [1,2,3]. Hand eczema is the most common occupational skin disease and is a pronounced problem in certain irritant- and allergen-exposed professions [4]. 5–7% of patients with chronic hand eczema (CHE) have disease rated as severe, characterised by extensive, long-lasting or recurrent severe skin changes such as rhagades, lichenification and infiltration, lasting more than three months or relapsing twice or more often per year [5,6,7]. Severe CHE is reported to reduce work productivity, increase the number of work days missed and markedly increase medical costs [11,12,13]. Total medical costs are reported to increase with disease severity, severe CHE may cause a significant economic burden [11]
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