07.06.2007 – 07:33
Innovative New Anaemia Drug MIRCERA Demonstrates Ability to Maintain Tight Haemoglobin Levels at Once Monthly Dosing in Dialysis Patients With Chronic Kidney Disease
Basel, Switzerland (ots/PRNewswire)
- First Publication of Phase III Data in the Clinical Journal of the American Society of Nephrology
Results from a multi-centre renal anaemia study show that switching patients directly from frequent doses of epoetin therapies (epoetin alfa or beta administered one to three times weekly) to extended dosing intervals of MIRCERA (up to once a month) is effective for maintaining tight, sustained, and predictable control of haemoglobin levels within a target range in dialysis patients with chronic kidney disease (CKD).
The results of the first large-scale study to demonstrate direct conversion of dialysis patients to monthly subcutaneous MIRCERA, will be published in the July edition of the Clinical Journal of the American Society of Nephrology (CJASN).(1) This is the first time a study has shown direct conversion to a monthly administration; a previous attempt with another erythropoiesis stimulating agent (ESA) showed that it requires a stepwise approach to extended dosing depending on the patient's response each time the dosing interval is extended.
"In an environment where government bodies and guidelines are increasingly requiring physicians to maintain patients in a narrow haemoglobin target range, it's encouraging to see that MIRCERA, the first continuous erythropoietin receptor activator, can provide stable haemoglobin levels with the added benefit of once-monthly dosing," said Prof. Wladyslaw Sulowicz, Collegium Medicum, Jagiellonian University, Krakow, Poland, the lead investigator of the study.
The PROTOS (Patients Receiving C.E.R.A. Once a month for the maintenance Of Stable haemoglobin) study included 572 dialysis patients from the EU, US, Asia Pacific and South America. PROTOS was a three-arm, controlled, open-label, randomized, Phase III study designed to compare the efficacy and tolerability of two dosing intervals (one and twice a month) of subcutaneous MIRCERA with that of patients continuing their subcutaneous epoetin therapy one to three times a week for the maintenance treatment of anaemia.
The study results showed:
- Minute changes in patients' haemoglobin (Hb) levels from baseline to evaluation (-0.131g/dL for MIRCERA once monthly, 0.032g/dL for MIRCERA twice monthly and -0.109g/dL for epoetin) showing that patients can be converted directly to therapy given up to once a month without compromising stability.
- The proportion of patients maintaining stable Hb within the range 10-13.5 g/dL during the evaluation period was similarly high in all groups (88.1% for MIRCERA once monthly, 91.5% for MIRCERA twice monthly and 88.1% for epoetin).
- The proportions of patients with mean Hb within plus or minus 1.0 g/dL of baseline values during the evaluation period were 66.1%, 75.6%, and 72.2% respectively in the MIRCERA once monthly, MIRCERA twice monthly and epoetin groups.
- MIRCERA is well tolerated with a safety profile that is characteristic of the patient population under study. The most commonly reported adverse events (AEs) were hypertension, procedural hypotension (induced by dialysis), nasopharyngitis, headache, and diarrhoea. Most events were mild or moderate in intensity and distributed evenly across the three treatment groups.
The authors noted that mean Hb levels during the evaluation period for patients receiving MIRCERA were within current guideline ranges and the difference in Hb level between baseline and evaluation was within plus or minus0.15 g/dL in both MIRCERA groups. "Hence, the results of this study show that switching directly from one to three times weekly administration of epoetin alfa or beta to C.E.R.A. at extended dosing intervals is effective for maintaining tight, sustained, and predictable control of Hb levels within target range in this patient population. Moreover, mean Hb values remained stable during the evaluation and long- term safety periods, demonstrating maintenance of Hb control over time."
"We proposed in the publication that the ability of MIRCERA to maintain tight haemoglobin levels with once-monthly administration should improve anaemia management in CKD by alleviating the increasing workload of healthcare professionals," said Prof. Sulowicz, adding "Once-monthly administration will also save up to 144 injections per patient per year compared with three-times weekly dosing."
MIRCERA, is a continuous erythropoietin receptor activator that shows a different activity at the receptor level characterized by a slower association to and faster dissociation from the receptor, a reduced specific activity in vitro with an increased activity in vivo, as well as an increased half-life, in contrast to erythropoietin. MIRCERA is the only drug to have compared itself in its registration program to three ESAs: epoetin alfa, beta and darbepoetin alfa. In May, MIRCERA received an approvable letter from the US FDA and a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) recommending a marketing authorisation be granted in the EU.
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. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolism and central nervous system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 worldwide and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet at www.roche.com.
Note to Editor on Study:
After a 4-week baseline period, when patients continued to receive epoetin, those eligible were randomized (1:1:1) to receive subcutaneous MIRCERA once monthly, subcutaneous MIRCERA twice monthly or to continue receiving subcutaneous epoetin at their current dose and administration interval. Patients were randomly assigned to study treatment via a central randomization centre with stratification by geographical region.
Starting doses of MIRCERA were based on the epoetin dose received during the week preceding randomization. The study consisted of a dose titration period during the first 28 weeks after the initial dose of study drug (week 1-28), followed by an 8-week efficacy evaluation period (week 29-36), and a 16-week long-term safety follow up (week 37-52). In the titration and evaluation periods, the dose of MIRCERA was adjusted to maintain patients' Hb within a range of plus or minus1.0 g/dL of their baseline Hb and between 10 and 13.5 g/dL. During the long-term safety observation period, the dose of MIRCERA was adjusted to maintain Hb levels within a range of 11 to 13 g/dL.
(1)This publication is now available through the on-line E-Press version at www.cjasn.asnjournals.org
Additional information about renal anaemia is available on the Internet at www.AnaemiaWorld.com.
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