Efficacy and safety of oral alitretinoin (9-cis retinoic acid) in patients with severe chronic hand eczema refractory to topical corticosteroids:: results of a randomized, double-blind, placebo-controlled, multicentre trial

被引：255

作者：

Ruzicka, T. ^{[1
]}

Lynde, C. W. ^{[2
]}

Jemec, G. B. E. ^{[3
]}

Diepgen, T. ^{[4
]}

Berth-Jones, J. ^{[5
]}

Coenraads, P. J. ^{[6
]}

Kaszuba, A. ^{[7
]}

Bissonnette, R. ^{[8
]}

Varjonen, E. ^{[9
]}

Hollo, P. ^{[10
]}

Cambazard, F. ^{[11
]}

Lahfa, M. ^{[12
]}

Elsner, P. ^{[13
]}

Nyberg, F. ^{[14
]}

Svensson, A. ^{[15
]}

Brown, T. C. ^{[16
]}

Harsch, M. ^{[16
]}

Maares, J. ^{[16
]}

机构：

[1] Univ Munich, Dept Dermatol, D-80337 Munich, Germany

[2] Lynderm Res, Markham, ON, Canada

[3] Univ Copenhagen, Dept Dermatol, Rosklide Hosp, Roskilde, Denmark

[4] Univ Heidelberg, Ruprecht Karls Clin, Heidelberg, Germany

[5] George Elliot Hosp, Dept Dermatol Outpatient Clin, Nuneaton, England

[6] Univ Groningen, Univ Med Ctr, Groningen, Netherlands

[7] Med Univ Lodz, Dermatol Clin, Lodz, Poland

[8] Innovaderm Res Inc, Montreal, PQ, Canada

[9] Helsinki Univ Hosp, Skin & Allergy Hosp, Helsinki, Finland

[10] Diagnost Unit Hungary Ltd, Budapest, Hungary

[11] Hop Nord, Dermatol Clin, St Priest en Jarez, France

[12] Hop St Louis, Dermatol Clin, Paris, France

[13] Univ Jena, Dept Dermatol & Allergy, Jena, Germany

[14] Danderyd Hosp, Karolinska Inst, Dept Clin Sci, Div Dermatol, Stockholm, Sweden

[15] Malmo Univ, Dept Dermatol, Malmo, Sweden

[16] Basilea Pharmaceut Ltd, Basel, Switzerland

来源：

BRITISH JOURNAL OF DERMATOLOGY | 2008年 / 158卷 / 04期

关键词：

alitretinoin; 9-cis-retinoic acid; eczema; randomized controlled trial;

D O I：

10.1111/j.1365-2133.2008.08487.x

中图分类号：

R75 [皮肤病学与性病学];

学科分类号：

100206 [皮肤病与性病学];

摘要：

Background Patients with severe chronic hand eczema (CHE) refractory to topical corticosteroids currently have limited treatment options suited for chronic use, and few controlled clinical studies have investigated new therapies in this setting. Objectives To assess the efficacy and safety of oral alitretinoin (9-cis retinoic acid) taken at 10 mg or 30 mg once daily for up to 24 weeks, compared with placebo control, in the treatment of severe CHE refractory to topical corticosteroids. Methods A randomized, double-blind, placebo-controlled, prospective, multicentre trial was conducted in 111 dermatology outpatient clinics in Europe and Canada. A total of 1032 patients with severe refractory CHE were randomized in a 1 : 2 : 2 ratio to placebo, or 10 mg or 30 mg of oral alitretinoin once daily for up to 24 weeks. Safety was assessed for all patients during a follow-up period of 4 weeks, and responders were observed for relapse for 24 weeks after the end of therapy. The primary efficacy parameter was Physician Global Assessment of overall CHE severity, with response defined as clear or almost clear hands. Results Responses, defined as clear or almost clear hands, were achieved in up to 48% of patients treated with alitretinoin, compared with 17% for placebo (P < 0.001), with up to 75% median reduction in disease signs and symptoms. Treatment was well tolerated, with dose-dependent adverse effects comprising headache, mucocutaneous events, hyperlipidaemia, and decreased free thyroxine and thyroid-stimulating hormone. The median time to relapse, defined as recurrence of 75% of initial signs and symptoms, was 5.5-6.2 months in the absence of anti-eczema medication. Conclusions Alitretinoin given at well-tolerated doses induced clearing of CHE in a substantial proportion of patients with severe disease refractory to standard therapy.

引用

页码：808 / 817

页数：10

共 21 条

[1]

Successful treatment of chronic hand eczema with oral 9-cis-retinoic acid [J].