Rm. Flipo et al., SAFETY AND TOLERABILITY OF CONVERSION FROM STABLE SANDIMMUN(R) MAINTENANCE TREATMENT TO SANDIMMUN NEORAL(R) IN PATIENTS WITH RHEUMATOID-ARTHRITIS, Journal of rheumatology, 25(7), 1998, pp. 1263-1269
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.