Alitretinoin as a Potential Advance in the Management of Severe Chronic Hand Eczema

Abstract

Question: Is oral alitretinoin, at a dose of 10 or 30 mg once daily, an effective and safe treatment for severe chronic hand eczema (CHE) refractory to topical corticosteroids? Design: Randomized controlled trial. Setting: Multicenter trial performed in 111 dermatology outpatient clinics in Europe and Canada. Patients: A total of 1032 patients with severe chronic hand eczema of at least 6 months’ duration and refractory to standard therapy were randomized; 759 completed the trial period. Study groups had similar baseline characteristics. Interventions: Participants were randomized in a 1:2:2 ratio to receive placebo, 10-mg alitretinoin doses, or 30-mg alitretinoin doses daily for 24 weeks (or only 12 weeks if their hand eczema responded to treatment by this time). Main Outcome Measures: The primary end point was treatment response, defined as a physician global assessment (PGA) of “clear” or “almost clear” at the end of therapy. Secondary end points included time to relapse during a further 24 weeks of follow-up after treatment discontinuation and a patient global assessment (PaGA) of “clear” or “almost clear” at the end of therapy. Results: Treatment response occurred in 48%, 28%, and 17% of patients in the 30-mg alitretinoin, 10-mg alitretinoin, andplacebogroups, respectively (P .001when tested for heterogeneity with the Pearson 2 test). The difference between both alitretinoin doses and placebo were statistically significant (P .001 for 30-mg and P=.004 for 10-mg doses compared with placebo). These response rates correspond to a number needed to treat (NNT) of about 4 (95% confidence interval [CI], 2.63-4.25) for 30-mg alitretinoin and 10 (95% CI, 5.76-23.42) for 10-mg alitretinoin compared with placebo. Median time to relapse was 5.5, 6.2, and 5.4 months for the 30-mg, 10-mg, and placebo groups, respectively. The PaGA response was 40%, 24%, and 15% in the 3 groups, respectively. Headache was the most common adverse event and occurred in 20%, 11%, and 6% in the 3 groups, respectively.