Rheumatology Advance Access originally published online on September 13, 2005
Rheumatology 2005 44(12):1564-1568; doi:10.1093/rheumatology/kei093
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Pimecrolimus 1% cream for the treatment of discoid lupus erythematosus
Medical Research Division, UMAE, Hospital de Pediatría, Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara, Jalisco and Universidad de Colima, 1 Dermatology Department, Instituto Dermatológico de Jalisco, Secretaría de Salud Jalisco, Zapopan, Jalisco and 2 Medical Research Division, UMAE, Hospital de Especialidades, Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social and CUCS, Universidad de Guadalajara, Guadalajara, Jalisco, México.
Correspondence to: A. Tlacuilo-Parra, Monte Olimpo 1413, Colonia Independencia, CP 44340, Guadalajara, Jalisco, México. E-mail: albtlacuilo{at}yahoo.com
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.
KEY WORDS: Pimecrolimus, Discoid lupus, Treatment, Quality of life, Clinical trial