PRAGUE — Steroid-resistant hand eczema responds almost half the time to treatment with oral alitretinoin, data from randomized clinical trials have shown.
Furthermore, 80% of patients who relapsed after alitretinoin treatment was stopped regained disease control when treated again with the agent, Dr. Uwe Hillen of University Clinic in Essen, Germany, reported at the International Congress of Dermatology.
“Alitretinoin produced improvement in all of the individual signs and symptoms of chronic hand eczema,” said Dr. Hillen. “Patients who relapse after initial treatment can be effectively retreated with alitretinoin, suggesting it is a suitable, intermittent treatment option for the long-term management of this chronic, relapsing disease.”
Hand eczema often evolves into a chronic condition, even with strict avoidance of environmental triggers. Standard therapy is topical corticosteroids, and patients have few alternatives if the combination of emollients and topical steroids doesn't work.
Dr. Hillen summarized data from three phase III clinical trials, the largest involving 1,032 patients enrolled at 111 sites in Europe and Canada. Patients in that trial were randomized to oral alitretinoin 10 mg or 30 mg once daily or placebo for 12 or 24 weeks. All patients were advised to avoid known triggers and irritants. The primary end point was the proportion of patients who had a Physician Global Assessment rating of “clear” or “almost clear” at the end of treatment.
Almost half (48%) of patients treated with 30 mg of alitretinoin had complete responses, as did 28% of patients treated with 10 mg, while just 17% of placebo-treated patients had complete or almost complete responses, Dr. Hillen reported.
The second study, a safety study, involved 249 patients from 37 centers in Europe and Canada. All had chronic hand eczema unresponsive to topical steroids, and received open-label alitretinoin 30 mg daily for as long as 24 weeks. Again, almost half (47%) of patients in the alitretinoin group had complete responses, Dr. Hillen said. When response criteria were expanded to include “mild disease,” the response rate increased to 64%.
The third trial included two groups of patients from the first study: 117 patients who initially responded to alitretinoin but relapsed within 24 weeks, and 243 patients who previously had not responded to initial treatment.
Patients in the relapse group were randomized to receive their initial dose of alitretinoin or placebo. Patients in the second group received open-label alitretinoin 30 mg. Among patients who had relapsed, 80% who were randomized a second time to alitretinoin 30 mg had clear or almost clear hands at the end of the study, compared with 8% of patients receiving placebo. Patients retreated with alitretinoin 10 mg had a response rate of 48%, compared with 10% in patients on placebo.
Topical alitretinoin gel 0.1% is approved for the treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma, but oral alitretinoin is not available.
Dr. Hillen reported no disclosures.