C Lynde1, F Cambazard, T Ruzicka, M Sebastian, T C Brown, J Maares.
Abstract
BACKGROUND: In a previous large trial (Benefit of Alitretinoin in Chronic Hand Eczema; BACH), 47.7% of patients with severe chronic hand eczema (CHE) who received alitretinoin 30 mg achieved 'clear' or 'almost clear' hands during the initial 24-week treatment course.
OBJECTIVES: The current open-label trial was designed to study extended treatment with a further 12- to 24-week course of oral alitretinoin 30 mg in patients who did not fully respond to initial treatment in the BACH study.
METHODS: At the end of the BACH study, patients whose eczema was rated 'mild', 'moderate' or 'severe' according to the Physician's Global Assessment (PGA) were eligible for a 24-week, open-label, multicentre study. Patients (n=243) received 30 mg of alitretinoin once daily, irrespective of previous treatment in BACH; either alitretinoin 30 mg, alitretinoin 10 mg or placebo.
RESULTS: By the end of the follow-on study, the PGA response rate to the subsequent course of alitretinoin 30 mg was 50% and 39% in patients treated previously in BACH with 10 or 30 mg per day, respectively, and 51% in patients who previously received placebo in BACH. Alitretinoin was well tolerated, and no significant late-arising toxicities were seen.
CONCLUSIONS: For a considerable number of patients with CHE who did not fully respond after an initial 24-week treatment period, a switch from either placebo to the active compound at 30 mg or from the lower to the higher dose, or treatment prolongation at the higher dose could be beneficial. Alitretinoin remains well tolerated for overall treatment durations of up to 48 weeks. © The Author(s). CED
RCT Entities:
BACKGROUND: In a previous large trial (Benefit of Alitretinoin in Chronic Hand Eczema; BACH), 47.7% of patients with severe chronic hand eczema (CHE) who received alitretinoin 30 mg achieved 'clear' or 'almost clear' hands during the initial 24-week treatment course.
OBJECTIVES: The current open-label trial was designed to study extended treatment with a further 12- to 24-week course of oral alitretinoin 30 mg in patients who did not fully respond to initial treatment in the BACH study.
METHODS: At the end of the BACH study, patients whose eczema was rated 'mild', 'moderate' or 'severe' according to the Physician's Global Assessment (PGA) were eligible for a 24-week, open-label, multicentre study. Patients (n=243) received 30 mg of alitretinoin once daily, irrespective of previous treatment in BACH; either alitretinoin 30 mg, alitretinoin 10 mg or placebo.
RESULTS: By the end of the follow-on study, the PGA response rate to the subsequent course of alitretinoin 30 mg was 50% and 39% in patients treated previously in BACH with 10 or 30 mg per day, respectively, and 51% in patients who previously received placebo in BACH. Alitretinoin was well tolerated, and no significant late-arising toxicities were seen.
CONCLUSIONS: For a considerable number of patients with CHE who did not fully respond after an initial 24-week treatment period, a switch from either placebo to the active compound at 30 mg or from the lower to the higher dose, or treatment prolongation at the higher dose could be beneficial. Alitretinoin remains well tolerated for overall treatment durations of up to 48 weeks. © The Author(s). CED
© 2012 British Association of Dermatologists.
Entities:
Mesh：
Substances：
Year: 2012
PMID： 22731739 DOI： 10.1111/j.1365-2230.2012.04396.x
Source DB: PubMed Journal: Clin Exp Dermatol ISSN： 0307-6938 Impact factor: 3.470