Pimecrolimus 1% cream for the treatment of discoid lupus erythematosus.
OBJECTIVE
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.
Tlacuilo-Parra
A
A
Medical Research Division, UMAE, Hospital de Pediatría, Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara, Jalisco, México. albtlacuilo@yahoo.com
Guevara-Gutiérrez
E
E
Gutiérrez-Murillo
F
F
Soto-Ortiz
A
A
Barba-Gómez
F
F
Hernández-Torres
M
M
Salazar-Páramo
M
M
D000293:Adolescent; D000328:Adult; D002675:Child, Preschool; D003879:Dermatologic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005148:Facial Dermatoses / Q000188:drug therapy / Q000473:pathology; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use; D008179:Lupus Erythematosus, Discoid / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
D003879:Dermatologic Agents; D007166:Immunosuppressive Agents; C117268:pimecrolimus; D016559:Tacrolimus