Pivotal MIRCERA Study Published In The Lancet - First To Convert Dialysis Patients From Frequent Dosing Directly To Once Every Four Weeks

Main Category: Urology / Nephrology
Article Date: 19 Oct 2007 - 2:00 PDT

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Data published in The Lancet show that dialysis patients can be effectively converted from their current, frequently dosed treatment for renal anaemia, to a new, innovative therapy called MIRCERA (methoxy polyethylene glycol-epoetin beta), which only needs to be administered once a month.1 The new data follow the UK launch of MIRCERA last month, the first once monthly maintenance treatment of anaemia in adults with chronic kidney disease (CKD).2

The results of the MAXIMA (Maintenance of HAemoglobin EXcels in IV AdMinistration of C.E.R.A.) study demonstrate that once patients are converted to MIRCERA from the more frequently dosed erythropoiesis-stimulating agents (ESAs) epoetin alfa or beta, their haemoglobin (Hb) levels are maintained within the target range as effectively.1

Dr Iain Macdougall, Consultant Nephrologist, King's College Hospital and MIRCERA clinical investigator said, "These data are very encouraging and will give healthcare professionals confidence to convert their patients from current therapies to monthly dosing without sacrificing haemoglobin stability."

The MAXIMA study is the first randomised, comparative study to investigate the direct conversion of patients on dialysis from epoetin given up to three times a week, to new IV MIRCERA injected only once every four weeks.1 This ability to convert patients directly may also help to simplify the overall management of renal anaemia for healthcare professionals.

The study authors note that traditional ESAs having short half-lives, necessitate frequent administration to maintain stable Hb levels.1 Frequent administration, dose changes and close monitoring of Hb concentrations complicate management of anaemia.

In addition, MIRCERA offers the benefit of reducing the number of injections a patient receives, allowing healthcare professionals more time to interact with patients and optimise care.

MIRCERA is supported by the largest ever clinical trial programme for an ESA in CKD-related anaemia and has a similar efficacy and safety profile to shorter-acting ESAs. 3-7 The Summary of Product Characteristics for MIRCERA is available at http://www.rocheuk.com.

About the MAXIMA study1:

- The results of the study are published in The Lancet. Electronic copies can be accessed at http://www.thelancet.com/journals/lancet.

- The MAXIMA study randomised 673 adult patients with stable chronic renal anaemia on dialysis therapy and IV maintenance epoetin at 91 centres in eight countries. Most patients were from North America (USA - 68%; Canada - 11%) and Europe (21%).

- The study compared two administration intervals of IV MIRCERA (once every two weeks or once every four weeks) with continued IV epoetin treatment (once to three-times a week) in patients with chronic renal anaemia. After a run-in period, patients were randomly assigned to either the MIRCERA arms or to continue epoetin alfa or beta at their current dose and administration interval. Patients randomised to MIRCERA received a starting dose based on the previous weekly dose of epoetin.

- The MAXIMA results showed:

-- Minute changes in Hb levels throughout the duration of the study (mean changes from the baseline to the evaluation periods were -0.71, -0.25, and -0.75 g/L in the MIRCERA once every two weeks; MIRCERA once every four weeks and epoetin groups, respectively), illustrating that the primary efficacy parameter (mean change in Hb level between baseline and evaluation periods) was met.

-- For the secondary analysis, the proportion of patients maintaining a mean Hb within ±10 g/L of baseline was 68%, 68%, and 67% in the MIRCERA once every two weeks and MIRCERA once every four weeks and epoetin groups, respectively.

-- A similar incidence of adverse events across all treatment arms with the most frequent adverse events mild to moderate and had a distribution typical for this patient population.

- In contrast to previous studies in which dialysis patients were converted from IV epoetin using sequential increases in dosing intervals, most patients in MAXIMA were converted directly from a predominantly three-times-a-week regimen of epoetin (87% of patients) directly to IV MIRCERA administered once every four weeks.

- The study authors note that these results are generalisable to the maintenance haemodialysis population and this may represent an opportunity for simplified anaemia management compared with traditional ESAs.

MIRCERA:

- is a long-acting ESA designed to mimic the action of erythropoietin, a hormone produced by the kidneys to stimulate red blood cell production, in order to compensate for a shortage of the natural hormone in patients with renal anaemia.

- has a safety device to reduce the risk to patients and staff of needle-related injury or infection.

- has the largest clinical programme ever carried out for a drug treating anaemia associated with CKD comprising 10 global studies involving more than 2,700 patients from 29 countries.3-7

- is the only drug to have compared itself in its registration programme to three ESAs: epoetin alfa, beta and darbepoetin alfa. Two Phase III studies investigated correction of anaemia and four investigated maintenance of haemoglobin (Hb) level.1,3-7

Time-saving benefits:

- A study in 6 UK dialysis centres estimated that the average time for an ESA injection to be administered is approximately 3 minutes per patient.8

- Modelling data showed a potential saving of 44 days of healthcare professional time per year in a busy dialysis unit, if the unit changed to MIRCERA once-monthly from the previous ESA. The assumptions in the model were a reduction in the number of ESA injections from 83 to 12 per patient, per year, a 100% adoption of MIRCERA and an average number of 120 patients for a centre.8

About CKD and renal anaemia:

- Chronic kidney disease (CKD) leads to permanent loss of kidney function and results from damage to the kidney tissue.

- At least 1.5 million people in the UK have chronic kidney disease (CKD).9

- Anaemia is a common complication of CKD. There are approximately 100,000 people in the UK with CKD and anaemia.10

- Renal anaemia can also lead to serious heart problems. Approximately two thirds of patients die within five years, particularly due to cardiovascular complications, so it is essential that anaemia is well managed.11

Roche in anaemia:

- Roche has been committed to improving the lives of patients with anaemia for over 15 years through the provision of treatment and the support of innovative programmes, such as the Roche Foundation for Anaemia Research (RoFAR). By founding RoFAR, Roche aims to encourage new research that will take knowledge and understanding of anaemia and the use of anti-anaemia agents into new areas of medicine, such as neurology and cardiology.

- Roche's contribution to the management of anaemia in both renal disease and cancer has been pioneered through the availability of NeoRecormon® (epoetin beta), which has been prescribed widely since it was first authorised for use in 1991.

About Roche in the UK:

- Roche aims to improve people's health and quality of life with innovative products and services for the early detection, prevention, diagnosis and treatment of disease. Part of one of the world's leading healthcare groups, Roche in the UK employs nearly 2,000 people in pharmaceuticals and diagnostics.

- Globally Roche is the leader in diagnostics, and a major supplier of medicines for the treatment of cancer, transplantation, virology, bone and rheumatology, obesity and renal anaemia.

- Find out more at http://www.rocheuk.com.

References:

1. Levin N et al. Intravenous methoxy polyethylene glycol-epoetin beta for haemoglobin control in patients with chronic kidney disease who are on dialysis: a randomized non-inferiority trial (MAXIMA). The Lancet vol 370: 1415-1421. 2. MIRCERA Summary of Product Characteristics (SPC)

3. Sulowicz W et al. Poster presented at 43rd European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Glasgow, Scotland, 2006

4. Canaud B et al. Poster presented at 43rd European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Glasgow, Scotland, 2006

5. Klinger M et al. Poster presented at 39th annual meeting of the American Society of Nephrology ,San Diego, USA, 2006

6. Macdougall I et al. Poster presented at 39th annual meeting of the American Society of Nephrology, San Diego, USA, 2006

7. Spinowitz B et al. Abstract presented at 39th annual meeting of the American Society of Nephrology, San Diego, USA, 2006

8. Saueressig U. Poster presented at European Renal Association European Dialysis and Transplantation (ERA-EDTA), Barcelona, Spain, 2007

9. Department of Health. The National Service Framework for Renal Services. Second Progress Report, 2007

10. National Collaborating Centre for Chronic Conditions at the Royal College of Physicians. Anaemia management in chronic kidney disease: national clinical guidelines for management in adults and children. March 2006-7

11. Kalantar-Zadeh K et al. The 58th annual conference and scientific sessions. Hypertension 2005; 45(part 2):811-817

http://www.rocheuk.com

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