HDCN Abstract:  ASN Annual Meeting -- San Diego  

Froissart MC, Eckardt KU, Tucker B, et al.

Efficacy and Safety of Hematide in Patients with Anti-Erythropoietin (EPO) Antibody-Mediated Pure Red Cell Aplasia (Ab+PRCA).

ASN Annual Meeting -- San Diego
J Am Soc Nephrol (Nov) 20:365A 2009

Background: HematideTM, a synthetic peptidic ESA linked to polyethylene glycol, is being evaluated to treat anemia in patients (pts) who developed Ab+PRCA while receiving an epoetin or darbepoetin.

Objective: Primary endpoint is to achieve hemoglobin (Hb) concentrations >11g/dL in the absence of transfusions.

Methods: In this ongoing, open-label study, 14 pts with Ab+PRCA received SC Hematide every 4 wk. Hb, reticulocytes, serum chemistry, iron status, anti-EPO Abs, anti-Hematide Abs, transfusion requirements, and adverse events (AEs) were monitored.

Results: As of April 2009, 9 pts on dialysis and 5 pts not on dialysis have received Hematide for 336 mo (median 28 mo), totaling 26 pt-yrs of exposure. Twelve pts required transfusions within 3 mo of study entry. Median pretreatment Hb increased from 9.0g/dL to 11.4g/dL. Only 1 pt required regular transfusions after 6 mo. Median reticulocytes increased in all pts 2 wks after each Hematide injection, from 10x109/L to 79x109/L. Median ferritin levels fell from 1713g/L to 780g/L and anti-EPO Abs decreased from a median titer of 2.1 U EPO/mL (range 0.1851) to 0.4 U EPO/mL (range BLQ185). AEs occurred in 13 pts; most were mild or moderate and unrelated to Hematide. Nine pts had a serious AE; 2 (severe anemia and lack of response) were considered related to Hematide and occurred in a pt who developed anti- Hematide Abs with loss of clinical response. The pt resumed transfusions; anti-Hematide Ab titers remain unchanged 3 mo following the last dose. One pt died because of a recurrent vascular event (unrelated to Hematide) and 2 were withdrawn following renal transplantation.

Conclusion: Hematide increased Hb to target levels and eliminated the need for regular RBC transfusions in 13 of 14 pts with anti-EPO Ab+PRCA.

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