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The phase III correction studies investigated the effects of MIRCERA® in erythropoiesis-stimulating agent (ESA)-naïve patients not on dialysis (ARCTOS) or on dialysis (AMICUS).^1,2

 

The primary objective of these two studies was to evaluate the efficacy and safety of MIRCERA dosed twice weekly, administered subcutaneously (SC) or intravenously (IV), in patients not on dialysis (ARCTOS) and on dialysis (AMICUS). The haemoglobin (Hb) response was defined as an increase in Hb ≥1 g/dL from baseline and an Hb level ≥11 g/dL without red blood cell transfusion throughout the core study period (28 weeks in ARCTOS and 24 weeks in AMICUS).^1,2

 

ARCTOS study
Following a 1–2 week run-in period, 324 chronic kidney disease patients not on dialysis were randomised (1:1) to receive SC MIRCERA once every two weeks or SC darbepoetin alfa once weekly. Administration of SC MIRCERA was associated with a high response rate (97.5% of patients achieved target Hb levels).¹ The response rate with MIRCERA was comparable to that achieved with SC darbepoetin alfa (96.3% of patients achieved target Hb levels). The MIRCERA median dose at time of response was 0.60 µg/kg/2 weeks.

 

MIRCERA also demonstrated a smooth and steady rise in Hb levels; significantly fewer patients treated with MIRCERA vs darbepoetin alfa developed Hb levels exceeding 13 g/dL in the first 8 weeks of treatment (12.4% vs 33.5%, respectively, p<0.001) (see graph)¹ This significant difference was maintained throughout the 28 week core study period: 80.6% of patients receiving darbepoetin alfa experienced Hb values >13 g/dL vs 67.7% of patients receiving MIRCERA (p<0.0082).¹

 

AMICUS study
After a 1–2 week run-in period, 181 patients on dialysis were randomised (3:1) to receive IV MIRCERA once every two weeks or IV epoetin three times per week. Similar response rates to the ARCTOS study (SC MIRCERA) were observed with a smooth and steady rise in Hb levels. A total of 93.3% of patients treated with IV MIRCERA every two weeks achieved target Hb levels vs 91.3% of patients on IV epoetin three times per week.² The MIRCERA median dose at time of response was 0.60 µg/kg/2 weeks.

 

Fewer patients receiving MIRCERA had at least 1 Hb level >13 g/dL during the first 8 weeks of treatment compared with patients receiving epoetin three times per week (8.2% vs 17.4%, p=0.095).2 In the overall study period (24 weeks) ~60% of patients in both treatment groups experienced Hb levels >13 g/dL.

 

References:

 

1. Macdougall IC, Walker R, Provenzano R, et al. C.E.R.A. corrects anaemia in patients with chronic kidney disease not on dialysis: Results of a randomized clinical trial. Clin J Am Soc Nephrol. 2007 In press.
2. Klinger M, Aria M, Vargemezis V, et al. Intravnous pegzerepoetin alfa, a continuous receptor activator (C.E.R.A.), administered twice monthly corrects haemoglobin levels in patients with chronic kidney disease on dialysis: results of AMICUS, a randomized prospective study vs epoetin given once to three times weekly. Am J Kidney Dis. 2007 Submitted.