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Rheumatology Advance Access published online on September 13, 2005
Rheumatology, doi:10.1093/rheumatology/kei093
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© The Author 2005. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org
Received May 3, 2005
Accepted August 1, 2005

Original Articles

Pimecrolimus 1% cream for the treatment of discoid lupus erythematosus

A. Tlacuilo-Parra 1*, E. Guevara-Gutiérrez 2, F. Gutiérrez-Murillo 2, A. Soto-Ortiz 2, F. Barba-Gómez 2, M. Hernández-Torres 2, and M. Salazar-Páramo 3

1 Medical Research Division, UMAE, Hospital de Pediatría, Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara, Jalisco and Universidad de Colima, México
2 Dermatology Department, Instituto Dermatológico de Jalisco, Secretaría de Salud Jalisco, Zapopan, Jalisco, México
3 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

* To whom correspondence should be addressed.
A. Tlacuilo-Parra, E-mail: albtlacuilo{at}yahoo.com


  Abstract

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.

Keywords: Pimecrolimus; Discoid lupus; Treatment; Quality of life; Clinical trial.
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