Effectiveness of Alitretinoin in Severe Chronic Hand Eczema: PASSION, a Real-World Observational Study
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Effectiveness of Alitretinoin in Severe Chronic Hand Eczema: PASSION, a Real-World Observational Study. / Thaçi, Diamant; Augustin, Matthias; Westermayer, Bernd; Kamps, Anja; Hennig, Michael.
in: J DERMATOL TREAT, Jahrgang 27, Nr. 6, 11.2016, S. 577-583.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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T1 - Effectiveness of Alitretinoin in Severe Chronic Hand Eczema: PASSION, a Real-World Observational Study
AU - Thaçi, Diamant
AU - Augustin, Matthias
AU - Westermayer, Bernd
AU - Kamps, Anja
AU - Hennig, Michael
PY - 2016/11
Y1 - 2016/11
N2 - 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.
AB - 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.
U2 - 10.1080/09546634.2016.1227422
DO - 10.1080/09546634.2016.1227422
M3 - SCORING: Journal article
C2 - 27618281
VL - 27
SP - 577
EP - 583
JO - J DERMATOL TREAT
JF - J DERMATOL TREAT
SN - 0954-6634
IS - 6
ER -
