title: Biosimilar epoetin zeta in nephrology - a single-dialysis center experience.
abstract: OBJECTIVE
  An observational clinical study was performed to test the efficiency of the biosimilar product epoetin zeta to maintain stable hemoglobin levels in end-stage renal disease (ESRD) patients on intermittent high-flux hemodialysis.
  
  
  METHODS
  Before the start of the study, 17 out of 18 patients were on various erythropoiesis-stimulating agents (ESA). After a run-in period of 2 months, all patients switched to epoetin zeta and were followed for 6 months. The initial weekly doses as well as the frequency of application per week were kept constant. To convert patients on darbepoetin (n = 12) to epoetin zeta, a factor of 1 : 200 was used. During the follow-up, hemoglobin levels, iron status, dialysis efficiency, body weight, and adverse events were monitored at least once a month.
  
  
  RESULTS
  Comparing time 0 (before the start of epoetin zeta) with the end of the study (6 months of epoetin zeta), no significant changes were observed: Hemoglobin 11.72 ± 0.64 g/dl versus 11.62 ± 0.70 g/dl (p = 0.64); weekly dose of ESA: 79.4 ± 57.7 IU/kg/week at start versus 91.8 ± 65.4 IU/kg/week at the end (p = 0.55). It is noteworthy that the frequency of application could be reduced to once a week or less with epoetin zeta in 66% of the 18 patients. After 6 months of epoetin zeta, 10 patients received 1 dose/week, and 2 patients received only 1 dose every 2 weeks. There were no significant changes in mean blood pressure, body weight and hemodialysis efficiency comparing the end with the start of the observation. No side effects attributable to the ESA-therapy have been observed.
  
  
  CONCLUSIONS
  The biosimilar product epoetin zeta is safe in clinical practice and is effective and stable in the weekly dose as well as in the frequency of application. Biosimilars offer a welcome opportunity to reduce treatment costs of renal anemia.
authors.affiliation: Private Outpatient Clinic and Dialysis Centre, Langenhagen, Germany. Lonnemann@eickenhof-dialyse.de
authors.forename: G
authors.initials: G
authors.lastname: Lonnemann
authors.forename: E
authors.initials: E
authors.lastname: Wrenger
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D015415:Biomarkers / Q000097:blood; D004334:Drug Administration Schedule; D057915:Drug Substitution; D004920:Erythropoiesis / Q000187:drug effects*; D004921:Erythropoietin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005858:Germany; D006397:Hematinics / Q000008:administration & dosage* / Q000009:adverse effects; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007676:Kidney Failure, Chronic / Q000097:blood / Q000150:complications / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D006435:Renal Dialysis; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D006397:Hematinics; D006454:Hemoglobins; D011994:Recombinant Proteins; C530192:epoetin zeta; D004921:Erythropoietin