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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.
Clinical trial registration: 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/kgBW) were smaller than in patients staying on their epoetin beta therapy (89.0–98.0 IU/kgBW). 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.
Transparency
Declaration of funding
This clinical study and resulting paper were sponsored by BioGeneriX AG, a member of the ratiopharm Group.
Declaration of financial/other relationships
P.B., A.B., R.E., B.G. and E.K. have disclosed that they are employees of the ratiopharm Group (including BioGeneriX AG and Merckle GmbH). P.K. has disclosed that he was the coordinating investigator of this clinical study and receives research grants from Hoffmann-La Roche Ltd and Novartis International AG. A.E. has disclosed that he was the coordinating investigator of similar clinical trials with epoetin theta and that he has no financial interests to declare.
Acknowledgements
The authors thank the participating investigators: Bulgaria: Kraev Z. (Sofia), Parvanova I. (Karlovo), Blagov B. (Plovdiv) and Delibatov I. (Sofia). Croatia: Belavic Z. (Karlovac), Heinrich B. (Koprivnica), Jakic M. (Osijek), Krpan D. (Zagreb) and Racki S. (Rijeka). Israel: Bernheim J. (Kfar Saba), Rapoport J. (Rechovot), Schwartz (Tel-Aviv), Weissgarten J. (Zerifin), Yanay N.B. (Hadera) and Yagil Y. (Ashkelon). Poland: Daniewska D. (Warszawa), Grochowski J. (Makow Mazowiecki), Hruby Z. (Wroclaw), Klatko W. (Chiechanow), Kopecka L. (Gdansk), Malecki R. (Warszawa), Manitius J. (Bydgoszcz), Nowicki M. (Lodz), Stryjewski D. (Pabianice) and Ksiazek A. (Lublin). Turkey: Ataman R. (Capa-Istanbul), Ates K. (Cebeci-Ankara), Cavdar C. (Inciralti-Ismir), Erkoc R. (Van), Karayaylali (Balcali-Adana), Ursalan C. (Sahinbey-Gaziantep) and Cirit M. (Buca-Izmir).
Notes
* Eporatio is a registered trade name of ratiopharm GmbH, Ulm, Germany.
† Biopoin is a registered trade name of CT Arzneimittel, Berlin, Germany.
* NeoRecormon, a registered trade name of Roche Registration Ltd, Welwyn Garden City, UK.