Effectiveness and safety of recombinant human erythropoietin beta in maintaining common haemoglobin targets in routine clinical practice in Europe: the GAIN study

ABSTRACT

Objective: The Gain effectiveness in Anaemia treatment wIth NeoRecormon^* (epoetin beta) study (GAIN) evaluated the effectiveness and safety of recombinant human erythropoietin beta in correcting and/or maintaining common haemoglobin (Hb) targets in routine clinical practice in Europe.

* NeoRecormon is a registered trade name of F. Hoffmann-La Roche, Basel, Switzerland

Research design and methods: European 18-month observational, prospective clinical practice study across 217 centres from 13 countries. During a 3-month retrospective period, patients received any erythropoiesis stimulating agent (ESA). For the subsequent 18-month study phase, patients receiving intravenous (IV) epoetin beta or any other ESA were recommended to be switched to subcutaneous (SC) epoetin beta. Presence of anti-erythropoietin antibodies (AEAB) and related outcomes was investigated before and during the study.

Clinical trial registration: ClinicalTrials.gov number: NCT00551603.

Main outcome measures: Correction and maintenance of Hb levels within recommended target range and mean dose requirement to correct and maintain target Hb levels.

Results: A total of 4264 patients on haemodialysis received an ESA for treatment of renal anaemia. During the study period, the number of patients who maintained Hb levels in the recommended target range of 10–12 g/dL increased from 57% to 62%. Administration of SC epoetin beta resulted in a 24% lower mean dose requirement to maintain target Hb levels compared to IV administration (p < 0.001). Considerable differences were observed between countries in the study. No patients developed pure red cell aplasia associated with AEAB during observation.

Conclusion: This observational study suggests that haemodialysis patients who are receiving any ESA via SC or IV administration for treatment of their renal anaemia can be safely and effectively switched to SC epoetin beta to achieve or maintain the currently recommended Hb targets. SC required a lower dose than IV administration to maintain similar efficacy, thereby potentially lowering the drug costs.

Trial registration: ClinicalTrials.gov identifier: NCT00551603.

Key words: :

• Anaemia
• Chronic kidney disease
• Epoetin beta
• GAIN
• Haemoglobin

Acknowledgements

Declarations of interest: This study was sponsored by F. Hoffmann-La Roche Ltd who was responsible for the collection and processing of all study data and the statistical analyses.

The manuscript was drafted by the authors, with editorial support from Charles Robinson, PHOCUS Services GmbH, Switzerland. The editorial support was sponsored by F. Hoffmann-La Roche Ltd.

Armin Scherhag is an employee of F. Hoffmann-La Roche Ltd and holds an external professorship of clinical medicine at the University of Heidelberg, Germany. None of the other authors hold any shares or is a consultant for F. Hoffmann-La Roche Ltd. Authors have received honoraria for lectures or panels from F. Hoffmann-La Roche Ltd. Institutions of the authors have also received research grants from F. Hoffmann-La Roche Ltd, as well as from many other companies and research bodies.

Data from this study has previously been presented resented in abstract form: American Society of Nephrology (ASN), Philadelphia, 8–13 November 2005; ASN, San Diego, 14–19 November 2006; ASN, San Francisco, 31 October to 5 November 2007; European Renal Association/European Dialysis and Transplant Association (ERA/EDTA), Glasgow, 15–18 July 2006; ERA/EDTA, Barcelona, 21–24 June 2007; World Congress of Nephrology (WCN), Rio de Janeiro, 22–25 April 2007.

The authors gratefully acknowledge the invaluable contribution made by all investigators and clinical monitors of the GAIN study for their valuable contribution. Without their continuous commitment to collection of high quality data this study would not have been possible.

Notes

* NeoRecormon is a registered trade name of F. Hoffmann-La Roche, Basel, Switzerland

* NeoRecormon is a registered trade name of F. Hoffmann-La Roche, Basel, Switzerland