Pimecrolimus 1% cream for the treatment of discoid lupus erythematosus.

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.

• Authors: A Tlacuilo-Parra, E Guevara-Gutiérrez, F Gutiérrez-Murillo, A Soto-Ortiz, F Barba-Gómez, M Hernández-Torres, M Salazar-Páramo
• Journal: Rheumatology (Oxford, England) (Rheumatology (Oxford)) Vol. 44 Issue 12 Pg. 1564-8 (Dec 2005) ISSN: 1462-0324 [Print] England
• PMID: 16159951 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Dermatologic Agents
• Immunosuppressive Agents
• pimecrolimus
• Tacrolimus

Topics

• Adolescent
• Adult
• Child, Preschool
• Dermatologic Agents (adverse effects, therapeutic use)
• Facial Dermatoses (drug therapy, pathology)
• Female
• Humans
• Immunosuppressive Agents (adverse effects, therapeutic use)
• Lupus Erythematosus, Discoid (drug therapy, pathology)
• Male
• Middle Aged
• Quality of Life
• Severity of Illness Index
• Tacrolimus (adverse effects, analogs & derivatives, therapeutic use)
• Treatment Outcome