After approval by the Local Ethical Committee, 60 psoriatic patients,
who participated in a previous pharmacokinetic study on cyclosporin A
(CsA), gave their informed consent to continue to be studied during th
e maintenance treatment and at withdrawal. Peak concentration (C-max),
area under the concentration-time curve (AUC), bioavailability, elimi
nation half-life, distribution volume, and body clearance were determi
ned at monthly check-ups, along with blood pressure, psoriasis area, s
everity index (PASI), and creatinine serum levels. No modifications ov
er time of treatment were observed on kinetic parameters. At the dose
of 5 mg/kg in two daily administrations, a complete remission of the d
isease was observed after 1 month's treatment. At withdrawal, a worsen
ing of PASI appeared when CsA daily dose reached 2 mg/kg b.w., the mea
n trough levels or AUC values being, respectively, 100 and 2,200 ng/ml
. hr. There was a trend for patients with hypertension and nephrotoxi
city at the end of the maintenance treatment to have higher trough, C-
max, and AUC values. Furthermore, blood pressure and serum creatinine
tended to correlate better with AUC and C-max, than with trough levels
.