Effectiveness of alitretinoin in severe chronic hand eczema: PASSION, a real-world observational study.
OBJECTIVE
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.
a Comprehensive Centre for Inflammation Medicine, University Hospital Schleswig Holstein , Campus Lübeck , Germany.
Diamant
D
Thaçi
b Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg , Hamburg , Germany.
Matthias
M
Augustin
c Biostatistics & Epidemiology, GlaxoSmithKline Germany , Munich , Germany.
Bernd
B
Westermayer
d Medical Department, Stiefel , a GlaxoSmithKline Company , Munich , Germany.
Anja
A
Kamps
c Biostatistics & Epidemiology, GlaxoSmithKline Germany , Munich , Germany.
Michael
M
Hennig
D000077556:Alitretinoin; D000970:Antineoplastic Agents / Q000627:therapeutic use; D002908:Chronic Disease; D003879:Dermatologic Agents / Q000627:therapeutic use*; D004485:Eczema / Q000188:drug therapy*; D005260:Female; D006229:Hand Dermatoses / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D014212:Tretinoin / Q000627:therapeutic use*
D000970:Antineoplastic Agents; D003879:Dermatologic Agents; D000077556:Alitretinoin; D014212:Tretinoin
Alitretinoin; chronic hand eczema; patient benefits; quality of life; work productivity