Darbepoetin alfa Administered Every Other Week Maintains Hemoglobin Levels over 52 Weeks in Patients with Chronic Kidney Disease Converting from Once-Weekly Recombinant Human Erythropoietin: Results from Simplify the Treatment of Anemia with Aranesp (STAAR)

Abstract

Background/Aim: Darbepoetin alfa, an effective treatment for anemia of chronic kidney disease (CKD), can be administered at extended intervals. Simplify the Treatment of Anemia with Aranesp^® (STAAR), a multicenter, 52-week study, was conducted to assess the efficacy of darbepoetin alfa administered subcutaneously every other week (Q2W) in maintaining hemoglobin (Hb) in CKD patients not receiving dialysis. Methods: This is a subgroup analysis of subjects converted from once-weekly (QW) recombinant human erythropoietin (rHuEPO; US Aranesp package insert) and who received up to 52 weeks of darbepoetin alfa therapy (evaluation period 20–32 weeks). Enrolled subjects had a creatinine clearance ≤70 ml/min or an estimated glomerular filtration rate ≤60 ml/min and transferrin saturation ≧20%. Darbepoetin alfa doses were titrated to maintain Hb levels ≤12 g/dl. The primary endpoint was mean Hb during evaluation. Results: There were 524 subjects enrolled in the study who were previously receiving rHuEPO QW. Mean Hb ± standard deviation was 11.2 ± 1.27 g/dl at baseline, and the least squares mean ± SE was 11.4 ± 0.04 during evaluation. The mean ± SD Q2W darbepoetin alfa dose was 49.7 ± 21.9 µg at baseline and 48.9 ± 35.5 µg at evaluation. Darbepoetin alfa was well tolerated. Conclusions: Study subjects with CKD receiving QW rHuEPO were effectively converted to Q2W darbepoetin alfa, which was well tolerated. Hb levels were maintained over 52 weeks without a significant change in darbepoetin alfa dose.

Every-Other-Week Darbepoetin Alfa in the Correction and Maintenance of Haemoglobin Levels in Elderly Patients with Chronic Kidney Disease

“…However, although numerous reports have described q2w dosing with darbepoetin alfa, [22,26,29,30] these analyses have not focused on an elderly cohort previously naive to ESA therapy. To our knowledge, the present report is the first analysis describing the response of an elderly population to de novo q2w administration of darbepoetin alfa.…”

“…Both patients who are naive to ESA therapy [22,26] and patients who were previously treated [29] have been shown to achieve and/or maintain target Hb levels with q2w darbepoetin alfa. Previous reports have also indicated that Hb levels in elderly subjects with CKD can be maintained with once-monthly darbepoetin alfa administration.…”

Poly(ethylene glycol)-Prodrug Conjugates: Concept, Design, and Applications

“…On the other hand, third-generation EPO (CERA) requires only monthly administration and thus helps in significantly improving the quality of life. However, it has been reported to have negligible effects on morbidity or mortality like other ESAs [70]. …”

Use of darbepoetin alfa in the treatment of anaemia of chronic kidney disease: clinical and pharmacoeconomic considerations

“…Darbepoetin alfa is indicated for less frequent administra- tion than the epoetins/epoetin biosimilars. Table 2a summa- rizes the evidence from clinical studies supporting the efficacy and safety of darbepoetin alfa administered once every 2 weeks (Q2W) and once every month (QM) in patients with CKD not on dialysis [21–28]. In Table 2b, studies supporting darbepoetin alfa once weekly (QW) and Q2W regimens in patients on dialysis are summarized [29–33].…”