title: Epoetin theta: efficacy and safety of IV administration in anaemic haemodialysis patients in the maintenance phase in comparison to epoetin beta.
abstract: OBJECTIVE
  To compare the efficacy and safety of epoetin theta and epoetin beta in anaemic patients with chronic kidney disease, undergoing haemodialysis and previously on stable maintenance therapy with epoetin beta.
  
  
  METHODS
  In this multicentre, randomised, controlled, double-blind study 270 haemodialysis patients were treated intravenously (i.v.) for 24 weeks with either epoetin theta (n = 180) or epoetin beta (n = 90). The primary efficacy endpoint was the change in haemoglobin (Hb) from baseline to end of treatment (efficacy evaluation period, EEP, weeks 15-26). Hb levels, weekly doses of epoetin theta or epoetin beta required to maintain Hb levels, dose changes, safety, tolerability and immunogenicity were evaluated.
  
  
  BACKGROUND
  EudraCT No. 2005-000143-28.
  
  
  RESULTS
  Mean Hb values were similar in both treatment groups at baseline and during the 24-weeks treatment period. The estimated treatment difference between epoetin theta and epoetin beta from baseline to EEP was -0.01 g/dL (95% confidence interval: -0.24, 0.21), p = 0.9021, indicating that the difference between both groups was not statistically significant. The weekly doses of epoetin theta or epoetin beta required to maintain Hb levels were nearly the same. The changes from baseline to EEP in patients who switched to treatment with epoetin theta (95.5-99.7 IU/kg(BW)) were smaller than in patients staying on their epoetin beta therapy (89.0-98.0 IU/kg(BW)). The profile and the frequency of adverse drug reactions (ADRs) were similar in both treatment groups (21.7% epoetin theta; 22.2% epoetin beta). The most common ADRs were hypertension, headache and arteriovenous fistula thrombosis. None of the patients developed anti-erythropoietin antibodies.
  
  
  CONCLUSIONS
  Epoetin theta (i.v.) has a similar efficacy compared to epoetin beta (i.v.) in haemodialysis patients based on Hb changes from baseline to end of treatment (non-inferiority). The safety profile was similar in both groups. Patients could be switched from maintenance treatment with epoetin beta to epoetin theta without relevant dose changes.
authors.affiliation: BioGeneriX AG, Mannheim, Germany. beate.gertz@biogenerix.com
authors.forename: B
authors.initials: B
authors.lastname: Gertz
authors.forename: E
authors.initials: E
authors.lastname: Kohler
authors.forename: P
authors.initials: P
authors.lastname: Kes
authors.forename: A
authors.initials: A
authors.lastname: Essaian
authors.forename: P
authors.initials: P
authors.lastname: Bias
authors.forename: A
authors.initials: A
authors.lastname: Buchner
authors.forename: R
authors.initials: R
authors.lastname: Elsässer
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000150:complications / Q000188:drug therapy*; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D004921:Erythropoietin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006397:Hematinics / Q000008:administration & dosage / Q000009:adverse effects; D015312:Hemodialysis Solutions / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011994:Recombinant Proteins; D006435:Renal Dialysis / Q000379:methods*; D051436:Renal Insufficiency, Chronic / Q000150:complications / Q000628:therapy*; D016896:Treatment Outcome
chemical_list: D006397:Hematinics; D015312:Hemodialysis Solutions; D010919:Placebos; D011994:Recombinant Proteins; C103998:epoetin beta; C555712:epoetin theta; D004921:Erythropoietin