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

Blood

Volumn 106, Issue 10, 2005, Pages 3343-3347

  Bennett, Charles L ^a,b   Cournoyer, Denis ^d   Carson, Kenneth R ^d   Rossert, Jerome ^d   Luminari, Stefano ^d   Evens, Andrew M ^d   Locatelli, Francesco ^b   Belknap, Steven M ^d   McKoy, June M ^d   Lyons, E Alison ^d   Kim, Benjamin ^d   Sharma, Rishi ^d   Costello, Stacey ^d   Toffelmire, Edwin B ^d   Wells, George A ^d   Messner, Hans A ^d   Yarnold, Paul R ^d   Trifilio, Steven M ^d   Raisch, Dennis W ^d   Kuzel, Timothy M ^d   Nissenson, Allen ^d   Lim, Lay Cheng ^d   Tallman, Martin S ^d   Casadevall, Nicole ^c   more..

^a NORTHWESTERN UNIVERSITY   (United States)

^b AMGEN INC   (United States)

^c JOHNSON AND JOHNSON   (United States)

^d NONE

Author keywords

[No Author keywords available]

Indexed keywords

CORTICOSTEROID; CYCLOPHOSPHAMIDE; CYCLOSPORIN; ERYTHROPOIETIN ANTIBODY; IMMUNOGLOBULIN; IMMUNOSUPPRESSIVE AGENT; PREDNISONE; PROTEIN ANTIBODY; RECOMBINANT ERYTHROPOIETIN; TACROLIMUS; UNCLASSIFIED DRUG;

ADULT; AGED; CHRONIC KIDNEY DISEASE; CONTROLLED STUDY; CONVALESCENCE; DRUG EFFICACY; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; KIDNEY TRANSPLANTATION; MAJOR CLINICAL STUDY; MALE; PATIENT INFORMATION; PRIORITY JOURNAL; PURE RED CELL ANEMIA; REVIEW; TREATMENT OUTCOME;

EID: 27744500483     PISSN: 00064971     EISSN: 00064971     Source Type: Journal    
DOI: 10.1182/blood-2005-02-0508     Document Type: Review

References (42)

1. Casadevall N, Cournoyer D, Marsh J, et al. Recommendations on haematological criteria for the diagnosis of epoetin-induced pure red cell aplasia. Eur J Haematol. 2004;73:389-396.
2. Casadevall N, Nataf J, Viron B, et al. Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N Engl J Med. 2002;346:469-475.
3. Cournoyer D, Toffelmire E, Wells G, et al. Antierythropoietin antibody-mediated pure red cell aplasia after treatment with recombinant erythropoietin products: recommendations for minimization of risks. J Am Soc Nephrol. 2004;15:2728-2734.
4. Bennett CL, Luminari S, Nissenson AR, et al. Pure red-cell aplasia and epoetin therapy. N Engl J Med. 2004;351:1403-1408.
5. Bergrem H, Danielson BG, Eckardt KU, Kurtz A, Stridsberg M. A case of antierythropoietin antibodies following recombinant erythropoietin treatment. In: Bauer C, Koch KM, Scigalla P, Wieczorek L, eds. Erythropoietin: molecular physiology and clinical applications. New York, NY: Marcel Dekker; 1993:265-273.
6. Peces R, de la Torre M, Alcazar R, Urra JM. Antibodies against recombinant human erythropoietin in a patient with erythropoietin-resistant anemia. N Engl J Med. 1996;335:523-524.
7. Prabhakar SS, Muhlfelder T. Antibodies to recombinant human erythropoietin causing pure red cell aplasia. Clin Nephrol. 1997;47:331-335.
8. Knauss MD, Walton T, Macon EJ. Switching from intravenous to subcutaneous epoetin in hemodialysis patients. Am J Health Syst Pharm. 2002;59:1783-1784.
9. Kaufman JS, Reda DJ, Fye CL, et al. Subcutaneous compared with intravenous epoetin in patients receiving hemodialysis. N Engl J Med. 1998;339:578-583.
10. Kaufman JS. Subcutaneous erythropoietin therapy: efficacy and economic implications. Am J Kidney Dis. 1998;32(6 Suppl 4):S147-S151.
11. Hynes DM, Stroupe KT, Greer JW, et al. Potential cost savings of erythropoietin administration in end-stage renal disease. Am J Med. 2002;112:169-175.
12. Locatelli F, Del Vecchio L. Pure red cell aplasia secondary to treatment with erythropoietin. Artif Organs. 2003;27:755-758.
13. Rossert J, Casadevall N, Eckardt KU. Anti-erythropoietin antibodies and pure red cell aplasia. J Am Soc Nephrol. 2004;5:398-406.
14. Janssen-Cilag, Ltd. Summary of Product Characteristics, Eprex®. http://www.janssen-cilag.co.uk/content/extended_products/www.janssen-cilag.uk/ pdf/Eprex_SPC.pdf. Accessed June 13, 2005.
15. Bennett CL, Nebeker JR, Lyons EA, et al. The Research on Adverse Drug Events and Reports (RADAR) Project. JAMA. 2005;293:2131-2140.
16. Yarnold PR, Soltysik RC. Optimal data analysis: a guidebook with software for Windows. Washington, DC: APA Books. 2004.
17. Nigg L, Shanz U, Ambühl PM, et al. Prolonged course of pure red cell aplasia after erythropoietin therapy. Eur J Haematol. 2004;73:376-379.
18. Verhelst D, Rossert J, Casadevall N, Krüger A, Eckardt KU, Macdougall IC. Treatment of erythropoietin-induced pure red cell aplasia: a retrospective study. Lancet. 2004;363:1768-1771.
19. Gagnon RF, Unikowsky B, Lachance S, Assouline S, Cournoyer D. Diversity of the hematological manifestations of antibodies to erythropoietin in renal failure patients treated with Eprex [abstract]. Canadian Society of Nephrology. 2003;___:___. Abstract 099.
20. Praditpornsilpa K, Buranasot S, Bhokaisuwan N, et al. Recovery from anti-recombinant-human-erythropoietin associated pure red cell aplasia in end-stage renal disease patients after renal transplantation. Nephrol Dial Transplant. 2005;20:626-630.
21. Livnah O, Stura EA, Johnson DL, et al. Functional mimicry of a protein hormone by a peptide agonist: the Epo receptor complex at 2.8 Å. Science. 1996;273:464-471.
22. Qureshi SA, Kim RM, Konteatis Z, et al. Mimicry of erythropoietin by a nonpeptide molecule. Proc Natl Acad Sci U S A. 1999;96:12156-12161.
23. Therapeutic Products Directorate. Important safety information: Eprex® (epoetin alfa) sterile solution: revised prescribing information for patients with chronic renal failure. http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/ eprex3_hpc_e.html. Accessed June 13, 2005.
24. Epogen® (epoetin alfa) safety information. http://www.epogen.com/ professional/safety_info/safety_info.jsp. Accessed June 13, 2005.
25. Procrit® (epoetin alfa) full prescribing information. http://www.procrit.com/common/prescribing_ information/PROCRIT/PDF/ ProcritBooklet.pdf. Accessed June 13, 2005.
26. NeoRecormon® (epoetin beta) brief prescribing information, December 2002. http://www.rocheuk.com/ProductDB/documents/rx/spc/NeoRecormon_ Reco_Pen_SPC.pdf. Accessed June 13, 2005.
27. Tolman C, Duja S, Richardson D, et al. Four cases of pure red cell aplasia secondary to epoetin beta with strong temporal relationships. Nephrol Dial Transplant. 2004;19:2133-2136.
28. Vartia A, Asola MR, Tertti R, Kunelius P, Metsärinne KP. Two haemodialysis patients with epoetin alfa-induced pure red-cell aplasia recovered despite treatment with another epoetin preparation. Nephrol Dial Transplant. 2004;19:1313-1316.
29. Asari A, Gokal R. Pure red cell aplasia secondary to epoetin alpha responding to Darbepoetin alpha in a patient on peritoneal dialysis. J Am Soc Nephrol. 2004;15:2204-2207.
30. Wu G, Wadgymar A, Wong G, et al. A cross-sectional immunosurveillance study of anti-EPO antibody levels in CRF patients receiving epoetin alfa in 5 Ontario Renal Centers. Am J Kidney Dis. 2004;44:264-269.
31. Macdougall IC, Rosert J, Francais P, Cassadevall N. Retreatment with recombinant erythropoietic-stimulating agents (ESAs) in patients with remission from antibody-mediated pure red cell aplasia. J Am Soc Nephrol. 2004;15:543A.
32. Summers SA, Matijevic A, Almond MK. Successful re-introduction of recombinant human erythropoietin following antibody induced pure red cell aplasia. Nephrol Dial Transplant. 2004;19:2137-2139.
33. Macdougall IC, Roche A, Rossert J, Casadevall N, Francois P, Kemeny DM. Re-challenging paients who developed pure red cell aplasia with epoetin: can it be done? Nephrol Dialysis Transplant. 2004;19:2901-2905.
34. Schönholzer C, Keusch G, Nigg L, Robert D, Wauters J-P. High prevalence in Switzerland of pure red-cell aplasia due to anti-erythropoietin antibodies in chronic dialysis patients: report of five cases. Nephrol Dial Transplant. 2004;19:2121-2125.
35. Sharma B, Bader F, Templeman T, Lisi P, Ryan M, Heavner GA. Technical investigations into the cause of the increased incidence of antibody-mediated pure red cell aplasia associated with Eprex®. Eur J Hosp Pharm Practice. 2004;5:86-91.
36. Boven K, Sharma B, Bader F, et al. Indentifying the cause of the increased immunogenicity of epoetin alfa in patients with chronic kidney disease. J Am Soc Nephrol. 2004;15:230A.
37. Swanson SJ, Ferbas J, Mayeux P, Casadevall N. Evaluation of methods to detect and characterize antibodies against recombinant human erythropoietin. Nephron Clin Pract. 2004;96:88-95.
38. Swanson SJ. New technologies for the detection of antibodies to therapeutic proteins. In: Mire-Sluis AR, ed. Immunogenicity of therapeutic biological products. Vol 112. Basel, Switzerland: Karger; 2003:127-133.
39. Hoesel W, Gross Jm, Moller R, et al. Development and validation of a new ELISA for the detection and quantification of antierythropoietin antibodies for the human sera. J Immunol Methods. 2004;294:101-110.
40. Casadevall N. Antibodies against rHuEPO: native and recombinant. Nephrol Dialysis Transplant. 2002;17S:42-47.
41. Tacey R, Greway A, Smiell J, et al. The detection of anti-erythropoietin antibodies in human sera and plasma, I: validation of the protocol for a radioimmunoprecipitation assay. J Immunol Methods. 2003;283:317-329.
42. Casadevall N, Rossert J. Importance of biologic follow-ons: experience with EPO. Best Pract Res Clin Haematol. 2005;18:381-387.