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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

Ruzicka, T; Lynde, C W; Jemec, G B E; Diepgen, T; Berth-Jones, J; Coenraads, P J; Kaszuba, A; Bissonnette, R; Varjonen, E and Hollo, P, et al. (2008) In British Journal of Dermatology 158(4). p.808-817
Abstract
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... (More)
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. (Less)
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published
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keywords
randomized controlled trial, eczema, alitretinoin, 9-cis-retinoic acid
in
British Journal of Dermatology
volume
158
issue
4
pages
808 - 817
publisher
Wiley-Blackwell
external identifiers
  • wos:000254122100020
  • scopus:40949115877
ISSN
1365-2133
DOI
10.1111/j.1365-2133.2008.08487.x
language
English
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yes
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75c32935-ff2d-4c7e-bc44-405ba6a4a5ed (old id 1185117)
date added to LUP
2008-09-02 15:56:31
date last changed
2017-09-24 03:35:35
@article{75c32935-ff2d-4c7e-bc44-405ba6a4a5ed,
  abstract     = {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 &lt; 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.},
  author       = {Ruzicka, T and Lynde, C W and Jemec, G B E and Diepgen, T and Berth-Jones, J and Coenraads, P J and Kaszuba, A and Bissonnette, R and Varjonen, E and Hollo, P and Cambazard, F and Lahfa, M and Elsner, P and Nyberg, F and Svensson, Åke and Brown, T C and Harsch, M and Maares, J},
  issn         = {1365-2133},
  keyword      = {randomized controlled trial,eczema,alitretinoin,9-cis-retinoic acid},
  language     = {eng},
  number       = {4},
  pages        = {808--817},
  publisher    = {Wiley-Blackwell},
  series       = {British Journal of Dermatology},
  title        = {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},
  url          = {http://dx.doi.org/10.1111/j.1365-2133.2008.08487.x},
  volume       = {158},
  year         = {2008},
}