Pimecrolimus 1% cream for the treatment of discoid lupus erythematosus

• Published in: Rheumatology (Oxford, England) England), 2005-12, Vol.44 (12), p.1564-1568
• Main Authors: Tlacuilo-Parra, A., Guevara-Gutiérrez, E., Gutiérrez-Murillo, F., Soto-Ortiz, A., Barba-Gómez, F., Hernández-Torres, M., Salazar-Páramo, M.
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Antibacterial agents; Antibiotics. Antiinfectious agents. Antiparasitic agents; Biological and medical sciences; Child, Preschool; Clinical trial; Dermatologic Agents - adverse effects; Dermatologic Agents - therapeutic use; Discoid lupus; Diseases of the osteoarticular system; Facial Dermatoses - drug therapy; Facial Dermatoses - pathology; Female; Humans; Immunosuppressive Agents - adverse effects; Immunosuppressive Agents - therapeutic use; Lupus Erythematosus, Discoid - drug therapy; Lupus Erythematosus, Discoid - pathology; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Pimecrolimus; Quality of Life; Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis; Severity of Illness Index; Tacrolimus - adverse effects; Tacrolimus - analogs & derivatives; Tacrolimus - therapeutic use; Treatment; Treatment Outcome
• ISSN: 1462-0324; 1462-0332
• DOI: 10.1093/rheumatology/kei093

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.