Low-dose cyclosporine A improves severe disabling psoriasis in Latin America. Latin American Multicenter Study.
BACKGROUND: Severe forms of psoriasis have been treated successfully with cyclosporine A (cyA) in Europe and North America. The aim of the present investigation was to record and evaluate this drug treatment in Latin American patients with severe psoriasis in a multicenter controlled dose-efficacy study. PATIENTS AND METHODS: One hundred and fifty-two patients from 10 Latin American countries had on entry to the study a Psoriasis Area Severity Index (PASI) of 18 or more. Initial treatment was with cyA, 2.5 mg per kg per day for 6 weeks. At week 6, 27 patients with a baseline PASI score reduction of < 33% had the dose increased to 4 mg/kg/day. At week 12, 48 patients, who had not improved their baseline PASI scores by 66% or more, had their dose increased to 4 or 5 mg/kg/day, respectively. At the end of the study, 74 patients (56%) received cyA 2.5 mg/kg/day, 41 patients (31%) received 4 mg/kg/day, and 16 patients (12%) received 5 mg/kg/day. RESULTS: Cyclosporine A treatment was considered successful in 84.7% of the patients, who reduced their initial PASI score by 66% or more at the end of treatment at week 18. Adverse effects were seen in 29 patients (19%). Hypertension occurred in 27% and an increase of serum creatinine level above 30% of the initial value in 40% of patients. Among other side effects were gastrointestinal complaints (5.1%), hirsutism (4.3%), muscle pain (2.2%), joint pain (2.2%), respiratory infections (2.2%), headache (1.4%), and hemorrhagic gingivitis (0.7%). Twenty-one patients (13.8%) were withdrawn from the study for various reasons: adverse events in five cases (3.3%), noncompliance in five cases (3.3%), lack of efficacy in three cases (2%) and nonrelated diseases in two cases (1.3%). There were also six patients of a group that finished earlier than planned. A follow-up at 8 weeks after treatment was performed in 106 patients; in this phase 60 patients (56.5%) continued with their previous successful PASI reduction. Relapses (i.e., PASI increasing by more than 50% over baseline) were seen in 22.6% of cases. CONCLUSIONS: Cyclosporine A is an effective and well-tolerated treatment for severe psoriasis. An initial dose of 2.5 mg/kg/day is recommended. Most of the patients have a good response to this dose.