Der Einfluss von Alitretinoin auf die Lebensqualität bei Patienten mit schwerem chronischen Handekzem. FUGETTE - Beobachtungsstudie unter Praxisbedingungen
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Der Einfluss von Alitretinoin auf die Lebensqualität bei Patienten mit schwerem chronischen Handekzem. FUGETTE - Beobachtungsstudie unter Praxisbedingungen. / Augustin, Matthias; Thaçi, Diamant; Kamps, Anja.
in: J DTSCH DERMATOL GES, Jahrgang 14, Nr. 12, 12.2016, S. 1261-1270.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Der Einfluss von Alitretinoin auf die Lebensqualität bei Patienten mit schwerem chronischen Handekzem. FUGETTE - Beobachtungsstudie unter Praxisbedingungen
AU - Augustin, Matthias
AU - Thaçi, Diamant
AU - Kamps, Anja
N1 - © 2016 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd.
PY - 2016/12
Y1 - 2016/12
N2 - BACKGROUND AND OBJECTIVES: Alitretinoin is the only approved treatment for severe chronic hand eczema (CHE) refractory to potent topical corticosteroids. This study (FUGETTA) evaluated the effectiveness and impact on quality of life (QoL) of oral alitretinoin in patients with severe refractory CHE in accordance with prescription guidelines.PATIENTS AND METHODS: Open-label, multicenter, noninterventional, observational study conducted in Germany. Patients were treated at their physician's discretion with once-daily alitretinoin 10 mg or 30 mg for a maximum of 24 weeks. Effectiveness was assessed by Physician Global Assessment (PGA) and Dermatology Life Quality Index (DLQI). Adverse events (AEs) were assessed.RESULTS: The study population included 658 patients (30 mg n = 581; 10 mg n = 77). At baseline, most patients had CHE characterized as severe by PGA (83 %). At last visit, 48 % of patients had a PGA response of clear/almost clear (30 mg: 49 %; 10 mg: 43 %). Mean improvement in DLQI scores at week 24 was 58 % (30 mg: mean [SD] change from baseline -10.4 [8.04]) and 70 % (10 mg: mean [SD] change from baseline -10.8 [7.29]). The overall incidence of AEs was low and similar in both groups.CONCLUSIONS: Alitretinoin produced rapid, marked improvement in QoL of patients with severe CHE.
AB - BACKGROUND AND OBJECTIVES: Alitretinoin is the only approved treatment for severe chronic hand eczema (CHE) refractory to potent topical corticosteroids. This study (FUGETTA) evaluated the effectiveness and impact on quality of life (QoL) of oral alitretinoin in patients with severe refractory CHE in accordance with prescription guidelines.PATIENTS AND METHODS: Open-label, multicenter, noninterventional, observational study conducted in Germany. Patients were treated at their physician's discretion with once-daily alitretinoin 10 mg or 30 mg for a maximum of 24 weeks. Effectiveness was assessed by Physician Global Assessment (PGA) and Dermatology Life Quality Index (DLQI). Adverse events (AEs) were assessed.RESULTS: The study population included 658 patients (30 mg n = 581; 10 mg n = 77). At baseline, most patients had CHE characterized as severe by PGA (83 %). At last visit, 48 % of patients had a PGA response of clear/almost clear (30 mg: 49 %; 10 mg: 43 %). Mean improvement in DLQI scores at week 24 was 58 % (30 mg: mean [SD] change from baseline -10.4 [8.04]) and 70 % (10 mg: mean [SD] change from baseline -10.8 [7.29]). The overall incidence of AEs was low and similar in both groups.CONCLUSIONS: Alitretinoin produced rapid, marked improvement in QoL of patients with severe CHE.
U2 - 10.1111/ddg.12870
DO - 10.1111/ddg.12870
M3 - SCORING: Zeitschriftenaufsatz
C2 - 27992140
VL - 14
SP - 1261
EP - 1270
JO - J DTSCH DERMATOL GES
JF - J DTSCH DERMATOL GES
SN - 1610-0379
IS - 12
ER -
