血液透析中の腎性貧血患者に対するダルベポエチンアルファおよびバイオシミラーSK—1401 の第III相比較試験および継続長期投与試験

Background and Objectives　Several erythropoiesis stimulating agents, such as biopharmaceutical products, are used in the treatment of renal anemia. Biosimilars of these agents are being developed from a pharmacoeconomic perspective. This study aimed to confirm the equivalent efficacy and compare the safety of biosimilar SK-1401 with Darbepoetin Alfa in renal anemia patients on hemodialysis, and evaluate the longitudinal safety of SK-1401. Methods　In a randomized, single-blind, parallel comparative study, renal anemia patients on hemodialysis receiving Darbepoetin Alfa were recruited. The patients were randomized to Darbepoetin Alfa or SK-1401, intravenously administered once a week for 24 weeks. Next, all patients received SK-1401 for additional 28 weeks. The primary endpoint was the mean change in the hemoglobin（Hb）concentration. Secondary endpoints assessed included time course of Hb concentrations, target Hb concentration maintenance ratio, and endpoints regarding dosing schedule. Results　Mean change in Hb concentration was －0.23±0.82 g╱dL（mean±SD）in the SK-1401 group and － 0.29±1.00 g╱dL in the Darbepoetin Alfa group. The difference between the two treatments was 0.06 g╱dL（95％ CI：－0.22-0.34）. These results demonstrated an equivalent efficacy between the treatment groups. There were no differences regarding secondary endpoints between the two groups. Safety profiles of SK-1401 and Darbapoetin Alfa were similar, and no safety problems were reported during the 52 weeks. No antibodies to SK-1401 or Darbepoetin Alfa were detected. Conclusion　The results demonstrate equivalent efficacy and similar safety profile between SK-1401 and Darbepoetin Alfa and a well-tolerated profile of SK-1401 during the 52-week administration. （JapicCTI-173525）