CONVERSION OF PSORIASIS PATIENTS FROM THE CONVENTIONAL FORMULATION OFCYCLOSPORINE-A TO A NEW MICROEMULSION FORMULATION - A RANDOMIZED, OPEN, MULTICENTER ASSESSMENT OF SAFETY AND TOLERABILITY

Objective: To assess the safety, tolerability and efficacy of a new cy closporin A (CyA) microemulsion formulation, Sandimmun Neoral(R) (Neor al), in patients with severe psoriasis that was stable on CyA administ ered as Sandimmun(R) (SIM). Methods: In this 24-week, open, randomized , prospective, multicentre trial, 28 patients continued on the same do sage of SIM, while 30 converted to Neoral at 2.5 mg/kg/day or a dosage equivalent to their pre-conversion SIM dosage. During the study, dosa ges could be adjusted to maintain efficacy, because of adverse events or after disease stabilization. The maximum permitted dosage for eithe r formulation was 5.0 mg/kg/day. Primary efficacy criteria were change in Psoriasis Area and Severity Index (PASI) from baseline and time to relapse. Results: The dosage was increased to maintain efficacy in 22 patients (Neoral 13; SIM 9) and 20 dose reductions for safety were re quired (Neoral 14, SIM 6). In both groups, PASI scores remained stable throughout and relapses were primarily a result of dosage reduction a fter disease stabilization. No significant difference was found betwee n groups in the proportion of patients remaining relapse-free. Adverse events were recorded in 20 patients receiving Neoral and 14 receiving SIM. Most drug-related events were of mild or moderate severity and r eflected the known CyA side-effect profile. Dose titration guidelines ensured that mean blood pressure and serum creatinine concentrations r emained Key Words stable in both groups. Conclusions: If the guideline s for CYA use are followed and the Neoral dosage does not exceed 5 mg/ kg/day, conversion of stable patients with severe psorisasis from SIM to Neoral should present no clinically relevant safety or tolerability problems and efficacy of treatment is maintained.