SAFETY AND TOLERABILITY OF CONVERSION FROM STABLE SANDIMMUN(R) MAINTENANCE TREATMENT TO SANDIMMUN NEORAL(R) IN PATIENTS WITH RHEUMATOID-ARTHRITIS

Objective, To assess the safety and tolerability of converting patient s with rheumatoid arthritis (RA) taking a stable dose of cyclosporin A (CyA) maintenance treatment (Sandimmun(R), SIM) to a new microemulsio n capsule formulation, Sandimmun Neoral(R) (Neoral), at an initial dos e of 2.5 mg/kg/day. Methods. In this single arm, open multicenter stud y, 28 patients were recruited to enter a 6 week preconversion period; of these, 22 patients completed 12 weeks' treatment with Neoral. Resul ts. During the 12 week post-conversion period, 11 patients experienced adverse events considered to be drug related; most were mild to moder ate in severity and reflected the known safety profile for CBA. Only s light differences in efficacy variables were observed after conversion . The mean Neoral dose at Week 12 (2.84 mg/kg/day) was lower than the mean SIM pre-conversion dose (3.38 mg/kg/day). The study showed that, in patients with RA undergoing stable SIM maintenance treatment, conve rsion to an initial Neoral dose of 2.5 mg/kg/day did not give rise to any clinically relevant safety and tolerability concerns, and efficacy of the treatment was maintained compared with SIM. Conclusion, This c onversion strategy constitutes a clinically acceptable alternative to a 1:1 dose conversion.