Roche Pharmaceuticals

First Head-to-Head Study Shows Superiority of Once-Monthly Mircera in the Treatment of Renal Anaemia

    Basel, Switzerland (ots/PRNewswire) -

    - Mircera Maintained Haemoglobin Levels in Significantly More Patients With CKD on Dialysis

    Data from the first head-to-head study in patients with chronic kidney disease (CKD) on dialysis who need treatment for renal anaemia have demonstrated that Mircera(R) (methoxy polyethylene glycol-epoetin beta) helps more of these patients achieve stable haemoglobin levels with simple once-monthly dosing.[1] This is the key finding from the PATRONUS study presented today at the World Congress of Nephrology (WCN) where a significantly greater proportion of this patient group maintained stable haemoglobin levels with once-monthly Mircera compared to a similar regimen with darbepoetin alfa*. Effective management of renal anaemia is important in these patients as keeping haemoglobin within current narrow target ranges can be a challenge and CKD patients are at a higher risk of death or hospitalization when their haemoglobin fluctuates outside recommended ranges.

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    'This first head-to-head study shows that Mircera effectively maintains stable haemoglobin with a once-monthly treatment schedule, which could help simplify anaemia management, freeing up valuable time for physicians to manage the many other conditions dialysis patients suffer,' said Dr Fernando Carrera, PATRONUS investigator and nephrologist at Eurodial, Portugal. He added, `this time could be used by staff to focus on other aspects of patient care, offering clear advantages for patients and healthcare providers.'

    Frequent administration, management of dose changes and close monitoring of haemoglobin concentrations can complicate the treatment of anaemia.[2] A recent publication showed that dialysis centres may be able to cut nearly in half the amount of time healthcare professionals spend on anaemia management if dialysis centres switched to a once-monthly anaemia treatment from more frequently administered agents.[3]

    Worldwide around 1.5 million patients with CKD are on dialysis. Up to 95% of these patients have anaemia, which is an abnormally low level of the oxygen-carrying protein haemoglobin found in red blood cells, and are likely to require treatment with an erythropoiesis stimulating agent, or ESA.[4],[5],[6] Patients on dialysis with anaemia are at a higher risk of death or hospitalization.[7] Clinical and real-life studies have demonstrated that all types of adult CKD patients, including those on dialysis, can be switched to once-monthly Mircera and reliably maintain stable haemoglobin levels irrespective of their previous treatment and frequency of dosing.[8],[9],[10]

    * Dosing once a month is not indicated for darbepeotin alfa in dialysis, except in Switzerland.

    About the study:

    PATRONUS (comPArator sTudy of CERA and darbepOetin alfa in patieNts Undergoing dialysiS) is a phase III randomized, controlled, open-label, multi-centre study, conducted over 56 weeks involving 490 patients with CKD who were on dialysis.

@@start.t1@@      - The primary study endpoint was the haemoglobin (Hb) response rate
         (defined as the proportion of patients who maintained an average Hb
         greater than or equal to 10.5 g/dL and who had a maximum Hb decrease
         from baseline of 1 g/dL during the evaluation period) for both Mircera
         and darbepoetin alfa treatment groups.
      - Following a 4-week screening period, patients who were stable on
         once-weekly intravenous (IV) darbepoetin alfa received either IV
         Mircera once-monthly or IV darbepoetin alfa once-every-two-weeks for
         26-weeks. After this initial period, patients entered a second 26-week
         period and either continued on IV once-monthly Mircera or received IV
         darbepoetin alfa administered once a month.
      - During both treatment periods, patients' Hb was to be maintained within
         the range of 11 to 13 g/dL, with a maximum Hb decrease from baseline of
         1 g/dL.
      Key results:
      - During the evaluation period, in the Mircera treatment group 157
         patients (64.1%) achieved an average Hb greater than or equal to 10.5
         g/dL, with a Hb decrease not exceeding 1.0 g/dL, compared to 99
         Patients (40.4%) in the darbepoetin alfa treatment group (P-value
         <0.0001).
      - During the second 26-week period, when both treatment groups were
         receiving once-monthly doses, the median darbepoetin alfa dose
         increased by 34.7% (150 to 225 micro g/month) while the median
         Mircera dose changed  very little over the same period (200 to 196
         micro g/month).
      - The safety profile was similar between Mircera and darbepoetin alfa
         treatment groups and characteristic of the CKD population under study.@@end@@

    About Mircera

    Mircera, the first continuous erythropoietin receptor activator indicated for the treatment of symptomatic anaemia in chronic kidney disease, is now approved in over 70 countries and launched in over 50, including the major EU markets, Germany, the UK, Spain, Italy and France. It has a different receptor interaction and longer half-life than other ESAs which allows for sustained and reliable anaemia management.[11],[12] 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 dosing. All CKD patients - whether on dialysis or not on dialysis, irrespective of the ESA they are on - can be directly switched to a once-monthly maintenance schedule. This ability to switch patients directly has the potential to simplify anaemia management.

    About Roche

    Information about the Roche Group is available on the Internet at http://www.roche.com

    Editor's Notes

    For more information about the study: http://www.roche-trials.com/patient/trials/trial110682.html

    All trademarks used or mentioned in this release are protected by law.

    References

    ---------------------------------

    [1] Carrera F, for the PATRONUS investigators, C.E.R.A. vs darbepoetin alfa as maintenance therapy for anemia in patients with chronic kidney disease (CKD): the PATRONUS study. Abstract Number: 953981. WCN meeting May 22-26 2009, Milan, Italy

    [2] Levin NW, Fishbane S, Valdé Cañedo F, et al. Intravenous methoxy polyethylene glycol-epoetin beta for haemoglobin control in patients with chronic kidney disease who are on dialysis: a randomised non-inferiority trial (MAXIMA). Lancet 2007;370:1415-1421

    [3] Saueressig U, Kwan J, De Cock E, Sapède C. Healthcare Resource Utilization for Anemia Management: Current Practice With Erythropoiesis-Stimulating Agents and the Impact of Converting to Once-Monthly C.E.R.A. Blood Purif 2008;26:537-546

    [4] International Federation of Kidney Foundations. http://www.ifkf.net/resources.php

    [5] Astor BC, Muntner P, Levin A, et al. Association of kidney function with anaemia: the third national health and nutrition examination survey (1988-1992). Arch Intern Med 2002;162:1401-1408

    [6] McClellan W, Aronoff SL, Bolton WK, et al. The prevalence of anemia in patients with chronic kidney disease. Curr Med Res Opin 2004;20:1501-1510

    [7] Gilbertson DT, Ebben J, Foley RN, Weinhandi ED, Bradbury BC, Collins AJ. Hemoglobin level variability: associations with mortality. Clin J Am Soc Nephrol 2008;3:133-138

    [8] Macdougall I, Walker R, Provenzano R, et al. C.E.R.A. corrects anemia in patients with chronic kidney disease not on dialysis: results of a randomized clinical trial (ARCOTS). CJASN 2008;3(2):337-347

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

    [10] Fliser D, on behalf of Miracel study group. Once Monthly C.E.R.A. provides stable Hb levels in CKD patients on dialysis following direct switch from short acting ESAs. Abstract SA-PO2669. ASN Annual meeting November 6-9 2008, Philadelphia, PA

    [11] MIRCERA(R) Summary of Product Characteristics. F. Hoffmann-La Roche Ltd, 2007

    [12] 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

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.ch

Contact:
For further information please contact: Julia Pipe at Roche, Tel:
+41(0)61-687-4376, Mobile: +41(0)79-263-9715; Diane Lorton at
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