Retacrit(R) Data Confirm Equivalent Efficacy To Epoetin Alfa In Renal Anaemia

Main Category: Urology / Nephrology
Also Included In: Blood / Hematology;  Clinical Trials / Drug Trials
Article Date: 08 Sep 2008 - 4:00 PDT

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Hospira (NYSE: HSP), the world leader in generic injectable pharmaceuticals, today presented new data showing Retacrit® (epoetin zeta) corrects low haemoglobin (Hb) levels as effectively and rapidly as epoetin alfa (Erypo®) in patients with chronic kidney disease (CKD).1 Other data also presented at the joint European Dialysis and Transplant Nurses Association/European Renal Care Association (EDTNA/ERCA) conference show Retacrit has equivalent efficacy to epoetin alfa in reducing the need for blood transfusions2 and is effective in maintaining target Hb levels in adult patients.3

Principal investigator of all three analyses, Professor Paul Scigalla of International Clinical Research Consulting (ICRC), commented, "These new data give further evidence that Retacrit provides a viable alternative to epoetin alfa in the treatment of anaemia associated with chronic kidney disease, offering equivalent clinical benefits and greater cost-effectiveness".

Analyses were presented from two randomised, double-blind Phase III trials involving 609 patients (305 receiving Retacrit) in the correction phase study4 and 313 patients (300 receiving Retacrit) in the crossover maintenance phase study.5

In the analysis of time to Hb response (based on data from the correction phase study), treatment efficacy was similar in Retacrit and epoetin alfa treatment arms (84% of patients achieved a Hb response on Retacrit versus 86% on epoetin alfa). The average time to Hb response was also equivalent in both study arms (12.5 weeks for patients on Retacrit, and 12.1 weeks for those on epoetin alfa).1

Additionally, the analysis of transfusion requirements showed a similar transfusion requirement in the two treatment groups in both the correction and maintenance phase studies. In the correction phase study, 96.3% of patients in the Retacrit-treated group and 95.1% of patients in the epoetin alfa-treated group did not require any blood transfusions during treatment. In the maintenance phase study, three patients in the group receiving Retacrit and two in the group receiving epoetin alfa required blood transfusions.2

Finally, the effectiveness of Retacrit in maintaining Hb levels in patients with renal anaemia was analysed by age: 81 patients aged over 65 years were compared with 232 patients aged up to and including 65 years. In both the younger age group (≤65) and older age group (>65), Retacrit was effective in maintaining target Hb levels. The mean Hb levels in the younger group were 11.4 g/dL for Retacrit-treated patients and 11.6 g/dL for epoetin alfa-treated patients. In the over-65 age group, mean Hb levels were 11.3 g/dL for patients receiving Retacrit and 11.5 g/dL for patients receiving epoetin alfa. Further, no significant differences were seen between the mean dose of each drug administered in both age groups.3

"Hospira is pleased to present these new Retacrit data, which confirm a commitment to develop, manufacture and market biosimilars in order to meet future demand for cost-effective alternatives to proprietary biopharmaceuticals" said Islah Ahmed, Medical Director, Global Medical Affairs, Hospira.

About the analyses

Time to haemoglobin response analysis: 609 patients (18��"75 years old) with CKD maintained on haemodialysis and with anaemia (Hb <9.0 g/dL despite optimal iron supplementation) in the correction phase study were randomly allocated to receive either Retacrit or epoetin alfa intravenously, 1-3 times weekly for 24 weeks. The time to Hb response was analysed in relation to the secondary efficacy endpoint - proportion of patients with Hb response.

Haemoglobin response: This was defined as the week at which a Hb level of at least 11.0 g/dL was reached for two consecutive weeks, without the need for a blood transfusion within the preceding three months.

Transfusion requirement analysis: Data from the correction phase study and the maintenance phase study were analysed to assess transfusion requirements. The maintenance phase study involved 313 patients, 18-75 years old with CKD maintained on haemodialysis with stable Hb levels of 10.5-12.5g/dL achieved with constant epoetin alfa dosing. Patients were randomised to receive either Retacrit or epoetin alfa for 12 weeks, then switched to the alternative treatment for a further 12 weeks.

Efficacy of epoetin zeta in renal anaemia analysis; comparing patients aged >65 years and ≤65 years: Data from the maintenance phase study was analysed to assess efficacy in maintaining Hb levels according to age: the 81 patients aged over 65 being compared with the 232 patients aged up to and including 65 years.

About Retacrit

Retacrit is a biosimilar erythropoietin approved in Europe6 for the treatment of anaemia associated with chronic kidney disease (administered intravenously) and chemotherapy (administered subcutaneously). Approval was granted on the basis of strong safety and efficacy data, as well as compliance with extensive quality, clinical and non-clinical guidelines. Retacrit has been launched in several European countries including Germany, Austria, the UK, Ireland, Greece, Sweden, Norway and Portugal, and is manufactured and packaged in Germany using advanced technology and following Good Manufacturing Practice (GMP) standards.

About Hospira

Hospira is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness™. As the world leader in specialty generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management solutions. Through its products, Hospira helps improve the safety, cost and productivity of patient care. The company is headquartered in Lake Forest, Illinois, United States, and has more than 14,000 employees. The head office for Hospira in Europe, Middle East and Africa is in Leamington Spa, UK. Learn more about Hospira at http://www.hospira.com

References

1. Scigalla P, Koytchev R. Time to haemoglobin response with epoetin zeta compared with epoetin alfa in patients with renal anaemia. Presented at European Dialysis and Transplant Nurses Association/European Renal Care Association conference (EDTNA/ERCA), Prague, Czech Republic 6-9 September 2008. Abstract P07.

2. Scigalla P, Koytchev R. Reduction of transfusion requirements with epoetin zeta in patients with renal anaemia. Presented at European Dialysis and Transplant Nurses Association/European Renal Care Association conference (EDTNA/ERCA), Prague, Czech Republic 6-9 September 2008. Abstract P05.

3. Scigalla P, Koytchev R. Efficacy of epoetin zeta in renal anaemia: comparing patients aged >65 years and ≤ 65 years. Presented at European Dialysis and Transplant Nurses Association/European Renal Care Association conference (EDTNA/ERCA), Prague, Czech Republic 6-9 September 2008. Abstract P06.

4. Krivoshiev S, Todorov VV, Manitius J, Czekalski S, Scigalla P and Koytchev R on behalf of the Epoetin Zeta Study Group. Comparison of the therapeutic effects of epoetin zeta and epoetin alfa in the correction of renal anaemia. Curr Med Res Opin 2008; 24(5): 1407-1415.

5. Wizemann V, Rutkowski B, Baldamus C et al. Comparison of the therapeutic effects of epoetin zeta to epoetin alfa in the maintenance phase of renal anaemia treatment [published erratum in Curr Med Res Opin 2008; 24(4): 1155]. Curr Med Res Opin 2008; 24(3): 625-637.

6. European Medicines Agency (EMEA) European Public Assessment Report: Retacrit®. Available at http://www.emea.europa.eu. Accessed September 2008.

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