Roche Pharmaceuticals

MIRCERA Keeps Haemoglobin Levels Stable With Significantly Fewer Dose Changes Than With Other ESAs

Basel, Switzerland (ots/PRNewswire) - - Dose Adjustments Considered to be one of the Main Causes of Haemoglobin Instability in Chronic Kidney Disease Patients A new analysis has shown that once-monthly Mircera(R) maintains stable haemoglobin (Hb) levels in patients with chronic kidney disease (CKD) with significantly fewer dose changes than more frequently administered erythropoiesis-stimulating agents (ESAs).

The pooled analysis showed that patients receiving Mircera once a month in the four maintenance studies needed 25% fewer dose changes during the initial titration period, 44% fewer during the evaluation phase and 36% fewer during the follow-up period(1), compared to the commonly used agents, epoetin and darbepoetin alfa.

Dose changes (increasing or decreasing the amount of drug required to maintain a stable Hb level) have been identified as one of the major causes of Hb fluctuations and is clear evidence that anaemia is not being effectively managed(2). It is important to keep Hb levels stable since fluctuating outside of the target ranges exposes patients to a greater risk of death or hospitalization(3),(4),(5),(6)(7). Indeed, fluctuations have been reported to be experienced in up to 80% of CKD patients on shorter-acting ESAs,(8).

Professor Angel de Francisco, a leading nephrologist at Hospital Marques de Valdecilla, Santander, Spain who presented the findings said, "The data confirm that a simple and practical treatment like Mircera given once a month maintains stable haemoglobin levels with fewer dose changes than other drugs. This difference is important as we aim now in anaemia management to keep haemoglobin in quite a tight range and a drug that has few dose changes will minimize this risk of moving out of these boundaries."

The data, presented at the 45th European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Congress in Stockholm, confirm that once-monthly Mircera offers not only an effective treatment option but also one that can help to simplify anaemia management(1).

Editor's Notes

About the analysis

- Pooled data from four pivotal Phase III maintenance studies (MAXIMA, PROTOS, RUBRA and STRIATA) in patients with CKD on dialysis who received treatment with Mircera (once-monthly and twice a month) or a comparator ESA (epoetin or darbepoetin alfa, at their prescribed dose and administration intervals) were evaluated for frequency of dose changes.

- 410 patients were treated with Mircera once-monthly and 740 with a comparator ESA for up to 52 weeks. The dose of Mircera and ESA comparator agents was adjusted to maintain patients' haemoglobin within plus or minus1 g/dL of baseline and between plus or minus10.0-13.5 g/dL.

- The mean number of dose changes for Mircera once-monthly vs. comparator ESA:

- Titration period (28 wk): Mircera 2.9 - comparator ESA 3.9

- Evaluation period (8 wk): Mircera 0.5 - comparator ESA 0.9

- Follow-up period (16 wk): Mircera 1.6 - comparator ESA 2.5

About Mircera

Mircera is the first continuous erythropoietin receptor activator indicated for the treatment of symptomatic anaemia in chronic kidney disease. It has a different receptor interaction and longer half-life than other ESAs which allows for sustained and predictable anaemia management(9),(10),(11). It is now approved in 46 countries including the European Union, the USA, Norway and Switzerland. Mircera's method of administration is simple: it is the only ESA approved in the EU to correct anaemia with an immediate once-every-two-week treatment schedule in all CKD patient types (those on or not on dialysis) with either an IV or SC dose. CKD patients on dialysis or not, on any ESA, can then be directly switched to a once-monthly maintenance schedule. This ability to switch patients directly has the potential to simplify anaemia management(12).

Simplifying anaemia management means physicians and nurses may be able to focus their time and resources on managing the underlying conditions that affect their patients such as high blood pressure, high cholesterol, and diabetes. Modelling data presented at ERA-EDTA last year showed that it may be possible to cut nearly in half the annual time spent on anaemia management in a dialysis centre by using a once-monthly anaemia agent(13).

For patients, less frequent dosing can mean a reduction in the burden of avoidable office visits and as few as 12 injections a year. This may be especially important for patients who are not on dialysis and therefore have no need for frequent clinic visits.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Additional information about the Roche Group is available on the Internet at http://www.roche.com.

Additional information about renal anaemia is available on the Internet at http://www.AnaemiaWorld.com

References

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(1) Johannes Mann, Angel De Francisco, George Nassar and Uli Beyer, Fewer dose changes with once-monthly C.E.R.A. than with other erythropoiesis-stimulating agents (ESAs) in patients with chronic kidney disease (CKD): a pooled analysis of four studies. Abstract SP 369 45th ERA/EDTA Stockholm 2008

(2) Fishbane S. and Berns J. S. Haemoglobin cycling in hemodialysis patients treated with recombinant human erythropoietin. Kidney International. 2005; 68/3:1337

(3) Gilbertson D. T. et al. Hemoglobin Level Variability: Associations with Mortality. Clin J Am Soc Nephrol 3: 133-138, 2008

(4) Ebben JP, Gilbertson DT, Foley RN, Collins AJ. Hemoglobin level variability: associations with comorbidity, intercurrent events, and hospitalizations. Clin J Am Soc Nephrol. 2006;1:1205-1210.

(5) Gilbertson DT, Ebben JP, Bradbury B, Dunning SC, Collins AJ. The effect of hemoglobin (Hb) variability and trends on mortality. J Am Soc Nephrol. 2006;17:582A (abstract SA-PO032).

(6) Feldman HI, Israni RK, Yang W, Fishbane F, Joffe M. Hemoglobin variability (HgbVar) and mortality among hemodialysis patients. J Am Soc Nephrol. 2006;17:583A (abstract SA-PO034).

(7) Feldman HI, Joffe, M, Yang W, Israni R, Fishbane S. Causal analysis of hemoglobin variability and mortality among hemodialysis patients. J Am Soc Nephrol. 2006;17:583A (abstract SA-PO035).

(8) Fishbane S. and Berns J. S. Haemoglobin cycling in hemodialysis patients treated with recombinant human erythropoietin. Kidney International. 2005; 68/3:1337

(9) MIRCERA® Summary of Product Characteristics. F. Hoffmann-La Roche Ltd, 2007

(10) Sulowicz W, Locatelli F, Ryckelynck J-P, et al. Once-monthly subcutaneous C.E.R.A. maintains stable hemoglobin control in patients with chronic kidney disease on dialysis and converted directly from epoetin one to three times weekly. Clin J Am Soc Nephrol. 2007;2:637-646

(11) Jarsch M, Brandt M, Haselbeck A. Consumption of C.E.R.A. and epoetin beta in a cellular assay: UT-7 consumption model. Presented at American Society of Hematology (ASH) 48th Meeting, December 9-12, 2006, Orlando, FL

(12) Levin NW. et al. The effect of intravenous C.E.R.A. given every 4 weeks in maintaining stable control of haemoglobin in chronic kidney disease patients on dialysis. Lancet. 2007;370:1415-1421

(13) Ulrich Saueressig, et al. Staff time and costs for anaemia management with erythropoietic stimulating agents in patients on haemodialysis. Abstract SaP341 44th ERA-EDTA Barcelona 2007

For further information please contact: Sheila Kolesaire at Roche Diane Lorton at Galliard Tel: +973-235-4347 Tel: +44(0)207-663-2265 Mobile: +973-687-0188 Mobile: +44(0)7717-531-823

Contact:

For further information please contact: Sheila Kolesaire at Roche,
Tel: +973-235-4347, Mobile: +973-687-0188; Diane Lorton at Galliard,
Tel: +44(0)207-663-2265, Mobile: +44(0)7717-531-823

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