Evaluation of anemia and the iron dynamics after administration of epoetin beta pegol(C.E.R.A.)

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Other Title
  • エポエチン ベータ ペゴル(C.E.R.A.)投与後の造血および鉄動態について
  • エポエチン ベータ ペゴル(C.E.R.A.)投与後の造血および鉄動態について : 投与3か月後までの検討
  • エポエチン ベータ ペゴル(C.E.R.A.)トウヨ ゴ ノ ゾウケツ オヨビ テツ ドウタイ ニ ツイテ : トウヨ 3カゲツ ゴ マデ ノ ケントウ
  • -three month-follow up after intravenous injection-
  • ―投与3か月後までの検討―

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Abstract

Objective: Epoetin beta pegol (C.E.R.A.) has a long half-life and exerts a more sustained effect on erythropoiesis as compared to epoetin beta. Therefore, the effects of C.E.R.A. on the correction of anemia and iron dynamics are potentially different from those of epoetin beta (EPOβ). We evaluated the state of anemia and the iron dynamics after treatment switch from EPOβ to C.E.R.A. in this clinical study. Subjects: A total of 8 patients undergoing stable maintenance hemodialysis were enrolled. Patients receiving under 4,500 IU/week of EPOβ were switched to C.E.R.A. 100 μg, and those receiving 4,500 IU/week or over of EPOβ were switched to C.E.R.A. 150 μg. Methods: The serum concentrations of erythropoietin (EPO), Fe, TSAT, ferritin and hepcidin-25, and the reticulocyte counts and hemoglobin (Hb) levels were measured on the 2nd, 4th, 7th, 14th, 21st and 28th day after the 1st intravenous injection, and on the 14th and 28th day after the 2nd and 3rd intravenous injections and the data were analyzed. Results: While the serum EPO concentrations were significantly higher until the 14th day (p<0.05), the serum Fe, TSAT and ferritin showed a tendency to become lower from the 7th day, and the serum hepcidin-25 became significantly lower from the 2nd day. The levels of each of the serum markers returned to the baseline after the 28th day. Similar changes of the iron dynamics were observed after the 2nd and 3rd injections. Conclusions: Following treatment switch from EPOβ to C.E.R.A., dramatic changes of both the parameters of iron dynamics and hematopoiesis were observed during the 4-week observation period after the treatment switch, and the Hb level was stably maintained for 12 weeks. Based on these findings, we do not recommend routine measurement of the serum markers related to the iron dynamics on the 7th and/or 14th day after switching of treatment from EPOβ to C.E.R.A.

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