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Impact on quality of life of alitretinoin in severe chronic hand eczema: FUGETTA real‐world study
Author(s) -
Augustin Matthias,
Thaçi Diamant,
Kamps Anja
Publication year - 2016
Publication title -
jddg: journal der deutschen dermatologischen gesellschaft
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.463
H-Index - 60
eISSN - 1610-0387
pISSN - 1610-0379
DOI - 10.1111/ddg.12870
Subject(s) - medicine , dermatology life quality index , quality of life (healthcare) , observational study , refractory (planetary science) , adverse effect , medical prescription , hand eczema , incidence (geometry) , multicenter study , dermatology , psoriasis , randomized controlled trial , allergy , contact dermatitis , physics , nursing , astrobiology , optics , immunology , pharmacology
Summary 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.