Pimecrolimus 1% cream for the treatment of discoid lupus erythematosus

Objectives. To determine the safety and efficacy of pimecrolimus cream on lesions of discoid lupus erythematosus. Methods. In an open-label phase II trial, patients with discoid lupus were treated with pimecrolimus 1% cream twice daily for 8 weeks. We assessed skin involvement with a clinical severity score, quality of life, patient improvement and toxicity. The changes were documented by skin biopsy at baseline and at the end of treatment. Results. Ten patients with a mean age of 34 ± 17 yr and disease duration of 3 yr (range 1-8) were studied; 90% were female and 40% had received prior topical or systemic therapy without response. In all patients, improvement of skin damage was observed after therapy. A significant decrease of 52% was observed in the mean ± S.D. clinical severity score, from 6.1 ± 1.4 before treatment to 2.9 ± 1.5 after treatment (P = 0.005). Quality of life score (0 = no effect, 100 = maximum effect on quality of life) showed a mean improvement of 46%, from 42.8 ± 23.1 before to 23 ± 16.5 after treatment (P = 0.008). According to the patients' assessment of the response to treatment, 50% qualified as marked improvement, 40% moderate and 10% slight improvement. The treatment was well tolerated; adverse reactions consisted of minimal erythema and pruritus, which resolved without any further action. Conclusions. Our data suggest that pimecrolimus cream for discoid lupus erythematosus seems to be a safe and clinically effective option. However, this was an open and uncontrolled study, and double-blind, placebo-controlled studies are needed. © The Author 2005. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved