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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.
To view the Multimedia News Release, please click:
http://www.prnewswire.com/mnr/roche/38584/
'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.
- 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.
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

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
Galliard, Tel: +44(0)207-663-2265, Mobile: +44(0)7717-531-823

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