BACKGROUND:Patients with severe chronic hand eczema (CHE) often respond to therapy with oral alitretinoin (9-cis retinoic acid). However, the efficacy of alitretinoin after disease relapse has not been demonstrated. OBJECTIVES: To assess the efficacy and safety of a second course of oral alitretinoin in patients with severe CHE who relapsed after achieving 'clear' or 'almost clear' hands following a previous course of alitretinoin. METHODS: The double-blind study included 117 patients with CHE who had responded to therapy in an earlier clinical trial and subsequently relapsed. Patients were randomized to receive their previous treatment or placebo. Treatment was alitretinoin 30 mg or 10 mg or placebo given once daily for 12-24 weeks. Response was defined as an overall Physician's Global Assessment rating of 'clear' or 'almost clear' hands at the end of therapy. RESULTS:Response rates were 80% in patients retreated with 30 mg alitretinoin compared with 8% for placebo (P < 0.001). In patients retreated with 10 mg alitretinoin response rates were 48%, compared with 10% in the placebo group. Alitretinoin was well tolerated. Adverse reactions comprised typical retinoid class effects, and no late-arising side-effects were observed during this second course of treatment. CONCLUSIONS: The majority of patients with CHE who previously achieved 'clear' or 'almost clear' hands following treatment with alitretinoin 30 mg per day also responded to a second course of treatment. Retreatment was well tolerated. Intermittent treatment with alitretinoin is suitable for the long-term management of CHE.
RCT Entities:
BACKGROUND:Patients with severe chronic hand eczema (CHE) often respond to therapy with oral alitretinoin (9-cis retinoic acid). However, the efficacy of alitretinoin after disease relapse has not been demonstrated. OBJECTIVES: To assess the efficacy and safety of a second course of oral alitretinoin in patients with severe CHE who relapsed after achieving 'clear' or 'almost clear' hands following a previous course of alitretinoin. METHODS: The double-blind study included 117 patients with CHE who had responded to therapy in an earlier clinical trial and subsequently relapsed. Patients were randomized to receive their previous treatment or placebo. Treatment was alitretinoin 30 mg or 10 mg or placebo given once daily for 12-24 weeks. Response was defined as an overall Physician's Global Assessment rating of 'clear' or 'almost clear' hands at the end of therapy. RESULTS: Response rates were 80% in patients retreated with 30 mg alitretinoin compared with 8% for placebo (P < 0.001). In patients retreated with 10 mg alitretinoin response rates were 48%, compared with 10% in the placebo group. Alitretinoin was well tolerated. Adverse reactions comprised typical retinoid class effects, and no late-arising side-effects were observed during this second course of treatment. CONCLUSIONS: The majority of patients with CHE who previously achieved 'clear' or 'almost clear' hands following treatment with alitretinoin 30 mg per day also responded to a second course of treatment. Retreatment was well tolerated. Intermittent treatment with alitretinoin is suitable for the long-term management of CHE.
Authors: D C Soler; X Bai; L Ortega; T Pethukova; S T Nedorost; D L Popkin; K D Cooper; T S McCormick Journal: Med Hypotheses Date: 2015-02-11 Impact factor: 1.538
Authors: Diana Rita Szabó; Kornélia Baghy; Peter M Szabó; Adrienn Zsippai; István Marczell; Zoltán Nagy; Vivien Varga; Katalin Éder; Sára Tóth; Edit I Buzás; András Falus; Ilona Kovalszky; Attila Patócs; Károly Rácz; Peter Igaz Journal: Cell Mol Life Sci Date: 2013-06-27 Impact factor: 9.261
Authors: Wietske Andrea Christoffers; Pieter-Jan Coenraads; Åke Svensson; Thomas L Diepgen; Janine L Dickinson-Blok; Jun Xia; Hywel C Williams Journal: Cochrane Database Syst Rev Date: 2019-04-26
Authors: G D Schmith; R Singh; R Gomeni; O Graff; A G Hamedani; J S Troughton; S M Learned Journal: CPT Pharmacometrics Syst Pharmacol Date: 2015-04-17