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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. This Article Full Text (PDF) All Versions of this Article: 2005-02-0508v1 106/10/3343    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Bennett, C. L Articles by Casadevall, N. Search for Related Content PubMed PubMed Citation Articles by Bennett, C. L Articles by Casadevall, N. Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted February 7, 2005 Accepted June 28, 2005 Long-term outcome of individuals with pure red cell aplasia and anti-erythropoietin 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. Allison Lyons, Benjamin Kim, Rishi Sharma, Stacy Costello, Edwin B Toffelmire, George A Wells, Hans A Messner, Paul R Yarnold, Steven M Trifilio, Dennis W Raisch, Timothy M Kuzel, Allen Nissenson, Ley-Cheng Lim, Martin S Tallman, and Nicole Casadevall Division of Hematology/Oncology, MidWest Center for Health Services Research and Policy Studies, VA Chicago Healthcare System, Chicago, IL, USA; Feinberg School of Medicine, Institute for Healthcare Studies, Northwestern University, Chicago, IL, USA; Program of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL, USA Departments of Medicine and Oncology, McGill University Health Centre, Montreal, Canada Division of Hematology/Oncology, MidWest Center for Health Services Research and Policy Studies, VA Chicago Healthcare System, Chicago, IL, USA; Feinberg School of Medicine, Institute for Healthcare Studies, Northwestern University, Chicago, IL, USA Department of Nephrology, Tenon Hospital and Pierre and Marie Curie University, Paris, France Dipartimento di Oncologia ed Ematologia, Universita di Modena e Reggio Emilia, Modena, Italy Program of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL, USA Department of Nephrology and Dialysis, A. Manzoni Hospital, Lecco, Italy Division of Geriatrics, MidWest Center for Health Services Research and Policy Studies, VA Chicago Healthcare System, Chicago, IL, USA Feinberg School of Medicine, Institute for Healthcare Studies, Northwestern University, Chicago, IL, USA Department of Medicine, MidWest Center for Health Services Research and Policy Studies, VA Chicago Healthcare System, Chicago, IL, USA Departments of Medicine, Pharmacology, and Toxicology, Queen's University, Kingston, Canada Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada University Health Network, Princess Margaret Hospital, Toronto, Canada Department of Emergency Medicine, MidWest Center for Health Services Research and Policy Studies, VA Chicago Healthcare System, Chicago, IL, USA Department of Pharmacy, Northwestern Memorial Hospital, Chicago, IL, USA VA Cooperative Studies Program Clinical Research Pharmaceutical Coordinating Center, University of New Mexico, Albuquerque, NM, USA Department of Medicine, Division of Nephrology, David Geffen School of Medicine, University of California, Los Angelos, CA, USA Department of Hematology, Singapore General Hospital, Singapore Department of Hematology, Hotel-Dieu, Paris, France * Corresponding author; email: cbenne{at}northwestern.edu. Background: 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. Methods: For 170 chronic kidney disease patients who developed epoetin-associated PRCA and had three 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. Results: Overall, 64% of the PRCA patients received immunosuppressive therapy, including 19 who also underwent a renal transplant. Thirty-seven percent experienced a hematologic recovery, with higher hematologic recovery rates among PRCA patients who received immunosuppressive therapy (57% vs. 2%, p<0.0001). 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 anti-erythropoietin antibodies were undetectable when epoetin was administered (89%). Conclusions: Among chronic kidney disease patients with epoetin-associated PRCA, epoetin discontinuation and immunosuppressive therapy or renal transplantation is necessary for hematologic recovery. Re-initiation of epoetin therapy among individuals could be considered if anti-erythropoietin antibodies are undetectable. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: F. Locatelli, A. Covic, K.-U. Eckardt, A. Wiecek, R. Vanholder, and on behalf of the ERA-EDTA ERBP Advisory Board Anaemia management in patients with chronic kidney disease: a position statement by the Anaemia Working Group of European Renal Best Practice (ERBP) Nephrol. Dial. Transplant., February 1, 2009; 24(2): 348 - 354. [Full Text] [PDF] S. Summers, S. Holdsworth, and E. Sharples The (re)challenging question of erythropoiesis-stimulating agents inducing pure red cell aplasia Nephrol. Dial. Transplant., October 1, 2008; 23(10): 3053 - 3055. [Full Text] [PDF] E. Bouman-Thio, K. Franson, B. Miller, J. Getsy, A. Cohen, S. A. Bai, J. Yohrling, B. Frederick, S. Marciniak, Q. Jiao, et al. A Phase I, Single and Fractionated, Ascending-Dose Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of an Erythropoietin Mimetic Antibody Fusion Protein (CNTO 528) in Healthy Male Subjects J. Clin. 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