Microemulsion formulation of cyclosporin (Sandimmun Neoral (R)) vs Sandimmun (R): Comparative safety, tolerability and efficacy in severe active rheumatoid arthritis

Objective. To compare the safety, tolerability and efficacy of the new oral microemulsion formulation of cyclosporin A (CyA, Sandimmun Neoral(R)) and the original CyA formulation (Sandimmun(R)), in patients with severe active rheumatoid arthritis (RA), over a 12-month period. Methods. In this double-blind. multicentre study. patients were randomized to treatment with Neoral or Sandimmun. starting with 2.5 mg/kg/day, with do se adjustments after 4 weeks. Primary efficacy criteria included patients' assessment of disease activity. Pharmacokinetic and safety assessments were performed at regular intervals. Results. Compared with Sandimmun, Neoral showed a consistent trend towards greater clinical efficacy from week 12 onwards, including a significant dif ference in patients' assessment of disease activity at the study end-points . A significantly lower increase in dose from baseline was observed with Ne oral at week 24. Pharmacokinetic assessments at week 24 showed increased ab sorption and decreased variability with Neoral. No differences in safety we re found between treatment groups. Conclusion. These observations indicate that Neoral is as safe and at least as effective as Sandimmun and have important implications for patient mana gement given the increasing role for CyA in the treatment of severe, active RA.