Patients with moderate or severe hand dermatitis responsive to drug therapy

December 20, 2004

CHICAGO - Use of the oral medication alitretinoin was effective in treating moderate or severe hand dermatitis in nearly half of patients previously unresponsive to standard treatment, according to an article in the December issue of The Archives of Dermatology, one of the JAMA/Archives journals.

Hand dermatitis affects six to 11 percent of the population in northern Europe, according to background information in the article. The disease can include redness, scaling, blistering, swelling, itching, and fissures of the skin on the hands. Chronic hand dermatitis (CHaD) has been known to cause psychological distress and temporary or permanent working disability. Although mild cases of CHaD usually respond to topical treatment, more severe cases can be incapacitating in patients who are unresponsive to standard therapy.

Thomas Ruzicka, M.D., of Heinrich-Heine University Hospital Dusseldorf, Germany, and colleagues tested the safety and effectiveness of oral alitretinoin in the treatment of CHaD in patients previously unresponsive to treatment. Three-hundred nineteen patients with moderate or severe CHaD were divided into four treatment groups: to take 10 mg/day, 20 mg/day, or 40 mg/day of alitretinoin, or placebo orally once a day for twelve weeks. Participants were classified as responsive if their dermatitis was clear (no visible dermatitis) or almost clear (minimal redness and/or scaling).

Twenty-nine to 39 percent of patients receiving 10 mg/day of alitretinoin were responsive, 34 to 41 percent in the 20 mg/day group were responsive, and 43 to 53 percent of those in the 40 mg/day group were responsive to treatment, compared to 12 to 27 percent of patients in the placebo group who were responsive. Headache was the most frequent adverse effect leading to withdrawal from the study in participants who received alitretinoin.

"In this study, oral alitretinoin induced clinically significant responses in a high percentage of patients with moderate or severe CHaD refractory [unresponsive] to standard topical therapy. Response in this study was defined as the complete disappearance of disease signs and symptoms and was reported for 53 percent of patients treated with the highest alitretinoin dose of 40 mg/d." (Arch Dermatol. 2004; 140:1453 - 1459. Available post-embargo at www.archdermatol.com)
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Editor's Note: This study was supported and funded by Basilea Pharmaceutica Ltd., Basel, Switzerland.

Financial Disclosure: Drs. Ruzicka, and Larsen, Galewicz, Horvath, Coenraads, Thestrup-Pedersen, Ortonne, and Zouboulis (co-authors) received grants from Basilea Pharmaceutica for the performance of this study. Drs. Ruzicka, and Coenraads, Thestrup-Pedersen, and Ortonne (co-authors) have received consultancy fees from Basilea Pharmaceutica. Drs. Harsch, Brown, and Zultak (co-authors) are employees of Basilea Pharmaceutica.

For more information, contact JAMA/Archives Media Relations at 312-464-JAMA (5262) or e-mail mediarelations@jama-archives.org.

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