Long-term maintenance of hemoglobin levels in hemodialysis patients treated with bi-weekly epoetin beta pegol switched from darbepoetin alfa: a single-center, 12-month observational study in Japan.

Recent evidence on maintenance administration of epoetin beta pegol, a continuous erythropoiesis receptor activator (CERA), in dialysis patients shows the clinical benefit of bi-weekly administration (Q2W) in improving hematopoiesis and iron use efficiency. We undertook a single-center observational study of 33 Japanese maintenance dialysis patients, whose anemia had been kept stable through weekly administration (Q1W) of darbepoetin (DA), to evaluate the effectiveness of CERA Q2W switched from DA in maintaining hemoglobin (Hb) levels over a 12-month period. The target Hb level was 10.0-12.0 g/dL. Throughout the 12-month period, the mean Hb was stably maintained at 10.5-10.8 g/dL, 69.7-87.9% of the patients achieving the target Hb level. The mean CERA dose was within the range of 62.9-78.8 µg/2 weeks. The average CERA dose adjustment frequency after switching was low at 0.42-0.67 times/3 months. In both subgroups stratified by the DA dose prior to the switch, Hb levels were kept stable during CERA administration; however, in the low-dose group (10-20 µg/week of DA), the CERA and iron doses decreased over time, whereas in the high-dose group (30-60 µg/week of DA) they remained unchanged. CERA Q2W achieved long-term successful anemia management in Japanese maintenance dialysis patients after switching from DA Q1W. CERA dose was adjusted based on an overall consideration of past changes in Hb levels, erythropoiesis-stimulating agent and iron doses. Subgroup analysis showed the CERA dose in the low-dose group decreased continuously, due possibly to a long-term improvement in iron use efficiency.