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Blood, 15 November 2005, Vol. 106, No. 10, pp. 3343-3347.
Prepublished online as a Blood First Edition Paper on August 11, 2005; DOI 10.1182/blood-2005-02-0508.
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CLINICAL TRIALS AND OBSERVATIONS
Long-term outcome of individuals with pure red cell aplasia and antierythropoietin antibodies in patients treated with recombinant epoetin: a follow-up report from the Research on Adverse Drug Events and Reports (RADAR) Project
Charles L. Bennett,
Denis Cournoyer,
Kenneth R. Carson,
Jerome Rossert,
Stefano Luminari,
Andrew M. Evens,
Francesco Locatelli,
Steven M. Belknap,
June M. McKoy,
E. Alison Lyons,
Benjamin Kim,
Rishi Sharma,
Stacey Costello,
Edwin B. Toffelmire,
George A. Wells,
Hans A. Messner,
Paul R. Yarnold,
Steven M. Trifilio,
Dennis W. Raisch,
Timothy M. Kuzel,
Allen Nissenson,
Lay-Cheng Lim,
Martin S. Tallman, and
Nicole Casadevall
From the MidWest Center for Health Services Research and Policy Studies, VA Chicago Healthcare System, Chicago, IL; Divisions of Hematology/Oncology, Geriatrics, and General Internal Medicine, Department of Medicine and the Department of Emergency Medicine and the Institute for Healthcare Studies, Northwestern University, Feinberg School of Medicine, Chicago, IL; Department of Pharmacy, Northwestern Memorial Hospital, Chicago, IL; Cancer Control Program of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL; VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, University of New Mexico, Albuquerque, NM; Department of Nephrology, Tenon Hospital and Pierre and Marie Curie University, Paris, France; Departments of Medicine and Oncology, McGill University Health Centre, Montreal, QC, Canada; Departments of Medicine, Pharmacology, and Toxicology, Queen's University, Kingston, ON, Canada; Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, ON, Canada; University Health Network, Princess Margaret Hospital, Toronto, ON, Canada; Dipartimento di Oncologia ed Ematologia, Università di Modena e Reggio Emilia, Modena, Italy; Department of Medicine, Division of Nephrology, David Geffen School of Medicine, University of California, Los Angeles, CA; Department of Hematology, Singapore General Hospital, Singapore; Department of Nephrology and Dialysis, "A. Manzoni" Hospital, Lecco, Italy; and Department of Hematology, Hôtel-Dieu, Paris, France.
Since its introduction in 1988, recombinant human erythropoietin (epoetin) has been standard treatment for patients with anemia due to chronic kidney disease. From 1998 to 2004, nearly 200 epoetin-treated persons with chronic kidney disease developed antibodies to epoetin, resulting in pure red cell aplasia (PRCA). The majority of these patients received Eprex, an epoetin alfa product marketed exclusively outside the United States. Herein, we report on the long-term outcome of these individuals. For 170 chronic kidney disease patients who developed epoetin-associated PRCA and had 3 months or more follow-up information available, case reports from the Food and Drug Administration and epoetin manufacturers were reviewed for information on clinical characteristics of the patients, immunosuppressive treatments, epoetin responsiveness, and hematologic recovery. Overall, 64% of the PRCA patients received immunosuppressive therapy, including 19 who also underwent a renal transplantation. Thirty-seven percent experienced a hematologic recovery, with higher hematologic recovery rates among PRCA patients who received immunosuppressive therapy (57% vs 2%, P < .001). Among 34 patients who received epoetin after the onset of PRCA, 56% regained epoetin responsiveness. The highest rates of epoetin responsiveness were observed among persons whose antierythropoietin antibodies were undetectable when epoetin was administered (89%). Among chronic kidney disease patients with epoetin-associated PRCA, epoetin discontinuation and immunosuppressive therapy or renal transplantation is necessary for hematologic recovery. Reinitiation of epoetin therapy among individuals could be considered if antierythropoietin antibodies are undetectable.
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