Safety and tolerability of conversion from stable Sandimmun maintenance treatment to Sandimmun Neoral in patients with rheumatoid arthritis.
Safety and tolerability of conversion from stable Sandimmun maintenance treatment to Sandimmun Neoral in patients with rheumatoid arthritis.
复制标题
类风湿关节炎患者从稳定的 Sandimmun 维持治疗转换为 Sandimmun Neoral 的安全性和耐受性。
作者：
R. Flipo;P. Emery;D. Scott;R. D. Situnayake;P. Prowse;D. James;M. Cawley;I. Whatmough;A. Schmidt
目标
评估将服用稳定剂量环孢菌素 A (CyA) 维持治疗 (Sandimmun, SIM) 的类风湿性关节炎 (RA) 患者转换为新的微乳胶囊制剂 Sandimmun Neoral (Neoral) 的安全性和耐受性，初始剂量为 2.5 mg/kg/天。
方法
在这项单臂、开放式多中心研究中，招募了 28 名患者进入为期 6 周的转换前期；其中，22 名患者完成了为期 12 周的 Neoral 治疗。
结果
在转换后的 12 周内，11 名患者经历了被认为与药物相关的不良事件；大多数的严重程度为轻度至中度，反映了 CyA 的已知安全性。转换后仅观察到功效变量的轻微差异。第 12 周时的平均 Neoral 剂量（2.84 mg/kg/天）低于 SIM 转换前的平均剂量（3.38 mg/kg/天）。研究表明，在接受稳定 SIM 维持治疗的 RA 患者中，转换为 2.5 mg/kg/天的初始 Neoral 剂量不会引起任何临床相关的安全性和耐受性问题，并且与 SIM 相比，治疗的疗效得以维持。
结论
这种转换策略构成了 1:1 剂量转换的临床可接受的替代方案。
OBJECTIVE
To assess the safety and tolerability of converting patients with rheumatoid arthritis (RA) taking a stable dose of cyclosporin A (CyA) maintenance treatment (Sandimmun, SIM) to a new microemulsion capsule formulation, Sandimmun Neoral (Neoral), at an initial dose of 2.5 mg/kg/day.
METHODS
In this single arm, open multicenter study, 28 patients were recruited to enter a 6 week pre-conversion period; of these, 22 patients completed 12 weeks' treatment with Neoral.
RESULTS
During the 12 week post-conversion period, 11 patients experienced adverse events considered to be drug related; most were mild to moderate in severity and reflected the known safety profile for CyA. Only slight 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, conversion 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 conversion strategy constitutes a clinically acceptable alternative to a 1:1 dose conversion.