Treatment with lenalidomide, a thalidomide analogue, was safe and effective in patients with refractory cutaneous lupus erythematosus, according to study results.
In a single-center, open-label trial, researchers in Spain studied 15 patients (median age, 40 years; 100% women) with refractory cutaneous lupus erythematosus between 2009 and 2010. Most of the patients had previously been treated with thalidomide and did not respond and/or developed severe side effects. Patients initially received oral lenalidomide at 5 mg/day for 4 weeks, with the dosage increased to 10 mg/day if no clinical improvement was observed. In cases of partial response, lenalidomide was sustained at 5 mg/day or decreased progressively monthly if patients achieved complete response. Follow-up was a mean of 15 months. A Cutaneous Lupus Erythematosus Disease Area and Severity index (CLASI) activity score of 0 was used to define the proportion of patients achieving complete response, the primary efficacy endpoint. Side effect developments, evaluation of cutaneous and systemic flares and impact on immunological parameters were secondary endpoints.
Fourteen patients completed treatment and saw clinical improvement after 2 weeks (CLASI activity score decreased from 11±5.9 to 4.13±3.66; P=.0009). Twelve patients (86%) achieved complete response. However, 75% of those patients had clinical relapse, which usually occurred 2 to 8 weeks after withdrawal from lenalidomide. Researchers did not observe a significant influence on systemic disease, immunological parameters or CLASI damage score. Two patients (13%) developed side effects, which were minor and included insomnia, grade 2 neutropenia and gastrointestinal symptoms, and resolved after medication withdrawal. No other haematological or biochemical toxicities were observed; nor were there thrombotic events or ovarian toxicity.
“As with thalidomide, cutaneous relapse was frequent,” the researchers reported.
“The present study confirms the efficacy and safety of lenalidomide for refractory cutaneous lupus disease. The benefit of lenalidomide is in reducing disfigurement without thalidomide’s toxicity profile.”