title: Dosing regimen and tolerability of methoxy polyethylene glycol-epoetin beta in Chinese dialysis patients.
abstract: OBJECTIVE
  To investigate methoxy polyethylene glycol-epoetin beta dosing regimen in treatment naïve subjects and dose conversion in darbepoetin alpha treated subjects, in Chinese dialysis patients.
  
  
  METHODS
  Adult Chinese patients on peritoneal dialysis (PD) or haemodialysis (HD), with no prior treatment with erythropoiesis-stimulating agents and haemoglobin below 8 g/dL (Group I) or receiving darbepoetin alpha and had stable haemoglobin at 10-12 g/dL (Group II) were included in this prospective open-label study. In Group I methoxy polyethylene glycol-epoetin beta was started at 0.6 μg/kg subcutaneously fortnightly till haemoglobin reached 10 g/dL, after which it was given monthly. A dose conversion table was devised for Group II. Follow-up was 36 weeks.
  
  
  RESULTS
  Forty-five patients were included. Haemoglobin in Group I (n=23, PD/HD:19/4) increased from 7.5 ± 0.9 g/dL at baseline to 10.7 ± 1.0 g/dL after 16 weeks, while it remained stable at 10.4 ± 1.0 g/dL after conversion in Group II (n=22, PD/HD:15/7). Actual dose required after stabilization was 1.7 μg/kg per month in Group I and 2.3 μg/kg per month in Group II. Median number of dose adjustment was three in Group I and one in Group II, while haemoglobin overshoot to 13 g/dL or above occurred in 4.4% and 9.1%, respectively. No significant side-effect was observed.
  
  
  CONCLUSIONS
  Our dosing regimen for methoxy polyethylene glycol-epoetin beta, for treatment naïve subjects or for conversion from darbepoetin alpha, is safe and effective. The dose required to achieve a haemoglobin concentration of 10-11 g/dL in Chinese dialysis patients is approximately 2 μg/kg monthly.
authors.affiliation: Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong SAR, China.
authors.forename: Bo Ying
authors.initials: BY
authors.lastname: Choy
authors.forename: Man Fai
authors.initials: MF
authors.lastname: Lam
authors.forename: Terence
authors.initials: T
authors.lastname: Yip
authors.forename: Hon Lok
authors.initials: HL
authors.lastname: Tang
authors.forename: Ping Nam
authors.initials: PN
authors.lastname: Wong
authors.forename: Chik Cheung Vincent
authors.initials: CC
authors.lastname: Chow
authors.forename: Desmond Yh
authors.initials: DY
authors.lastname: Yap
authors.forename: Tak Mao
authors.initials: TM
authors.lastname: Chan
mesh_terms: D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D044466:Asian People; D015415:Biomarkers / Q000097:blood; D000068256:Darbepoetin alfa; D004334:Drug Administration Schedule; D057915:Drug Substitution; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use*; D005260:Female; D006397:Hematinics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006454:Hemoglobins / Q000378:metabolism; D006723:Hong Kong; D006801:Humans; D007674:Kidney Diseases / Q000097:blood / Q000175:diagnosis / Q000208:ethnology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010530:Peritoneal Dialysis / Q000009:adverse effects; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D006435:Renal Dialysis / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D006397:Hematinics; D006454:Hemoglobins; C508420:continuous erythropoietin receptor activator; D004921:Erythropoietin; D000068256:Darbepoetin alfa; D011092:Polyethylene Glycols
keywords: anaemia; darbepoetin alpha; dialysis; erythropoiesis-stimulating agent; methoxy polyethylene glycol-epoetin beta