SUN-275 DOSE EQUIVALENCY AND EFFICACY OF BIOSIMILAR ERYTHROPOIETIN STIMULATING AGENTS: DATA FROM REAL CLINICAL PRACTICE

Abstract

Renal anemia is a common complication of end stage renal disease (ESRD) that require continuous replacement therapy with recombinant human erythropoietin stimulating agents (rESA) in most patients. Biosimilar erythropoietin stimulating agents (bESA) are available in Kazakhstan and that most of the dialysis centers switched their patients into the more cost effective bESA. However, important properties of bESA such as dose equivalency to rESA and the ability to maintain hemoglobin (HB) target levels were unknown. Thus, the current study aims to determine dose equivalency and HB target levels in a cohort of dialysis patients who were switched from rESA to bESA. Retrospective data of 74 patients from different dialysis centers were analyzed using different statistical methods. Inclusion: patients who received at least 6 months of rESA and switched to bESA and had at least 6 months follow up period. In addition, the results of a further 3 months period were analyzed to determine the long-term effect of bESA on dose equivalency and HB target level. Data of mean of ESA doses in IU/kg/week and mean HB levels in g/L, 6 months prior the reported switch were calculated and compared to the data from 6 months after the switch. The clinical data of 32 male and 42 female patients were collected. The mean age was 52.5 ± 13.5 years. There is no significant difference in mean levels of HB during pre-conversion from rESA to bESA (6 months prior) and post conversation period (9 months after) [Table 1], in fact the insignificant difference continued to decrease over the post-conversion period. Additionally, a subgroup analysis of patients who received epoetin beta (n=59) 6 months before the switch [Figure 1], showed similar level of HB (110.7±14 vs 113.2±10 g/L, p=0.053) 6 months after conversation to epoetin zeta at the equivalent dose regimen (69.5±29 vs 68.1±30 IU/kg/week, p=0.55). However, after the seven months of conversion, patients using lower doses of ESA (69.5±29 vs 63.3±30 IU/kg/week, p=0.0097), showed significantly higher levels of HB (110.7±14 vs 114.7±8 g/L, p=0.011) compared to pre-conversion period. The analyses of the retrospective data of dialysis patients, showed no inferiority of bESA compared to rESA on dose equivalency and maintaining HB target levels. Also, long-term use of lower doses of bESA managed to maintain HB within the target levels.