薬理と治療

Abstract

Background and Objectives　Several erythropoiesis stimulating agents, including biopharmaceutical products, are used in the treatment of renal anemia. Biosimilars of these agents are being developed from a pharmacoeconomic perspective. This study was conducted to evaluate safety and efficacy of a biosimilar of Darbepoetin Alfa, SK-1401, in renal anemia patients associated with non-dialysis chronic kidney disease. Methods　Renal anemia patients associated with non-dialysis chronic kidney disease were recruited in a long-term open study. Patients treated with any erythropoiesis stimulating agent were recruited and SK-1401 was administered subcutaneously every 2 or 4 weeks for 52 weeks. Safety was evaluated by analyzing the adverse events and adverse reactions reported, laboratory tests, electrocardiogram, and anti-SK-1401 antibody. The efficacy endpoints were the time course of hemoglobin（Hb）concentration, target Hb concentration maintenance ratio, and time course of dose. Results　Incidences of adverse events and adverse reaction were 86.6％（58╱67）and 4.5％（3╱67）, respectively. Twenty-five serious adverse events in 15 patients were reported, of which one case of stroke was assessed as an adverse reaction. No antibodies to SK-1401 were detected. Mean Hb concentration assessed every 4 weeks was maintained between 10.0 g╱dL and 12.0 g╱dL. Target Hb maintenance ratio at the 52-week timepoint, was 60.4％. The mean dose of SK-1401 increased throughout the trial period. Conclusion　The results of this study revealed the well-tolerated profile of SK-1401 and its clinical availability during the 52-week administration in renal anemia patients associated with non-dialysis chronic kidney disease.（ JapicCTI-173526）