Evaluation of the safety and immunogenicity of subcutaneous HX575 epoetin alfa in the treatment of anemia associated with chronic kidney disease in predialysis and dialysis patients

Clinical Nephrology

Volumn 88, Issue 4, 2017, Pages 190-197

  Casadevall, Nicole ^a   Dobronravov, Vladimir ^b   Eckardt, Kai Uwe ^c   Ertürk, Sehsuvar ^d   Martynyuk, Liliya ^e   Schmitt, Susanne ^f   Schaffar, Gregor ^f   Rudy, Anita ^f   Krendyukov, Andriy ^f   Ode, Marité ^f  

^a HÔPITAL SAINT ANTOINE   (France)

^b PAVLOV FIRST SAINT PETERSBURG STATE MEDICAL UNIVERSITY   (Russian Federation)

^c UNIVERSITY OF ERLANGEN NUREMBERG   (Germany)

^d ANKARA UNIVERSITY   (Turkey)

^e I HORBACHEVSKY TERNOPIL NATIONAL MEDICAL UNIVERSITY   (Ukraine)

^f Sandoz Biopharmaceuticals   (Germany)

Author keywords

Anemia; CKD; Dialysis; ESA; Hemodialysis

Indexed keywords

ERYTHROPOIETIN ANTIBODY; RECOMBINANT ERYTHROPOIETIN; ANTIANEMIC AGENT; EPO PROTEIN, HUMAN; ERYTHROPOIETIN; RECOMBINANT PROTEIN;

ADULT; ANEMIA; ANTIBODY TITER; ARTERIOVENOUS FISTULA; ARTICLE; CHRONIC KIDNEY FAILURE; DISEASE ASSOCIATION; DRUG DOSE TITRATION; DRUG FATALITY; FEMALE; GLIOMA; HEMODIALYSIS PATIENT; HUMAN; HYPERTENSION; IMMUNOGENICITY; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; OPEN STUDY; PATIENT SAFETY; PERIPHERAL EDEMA; PERITONITIS; PNEUMONIA; RADIOIMMUNOPRECIPITATION; RHINOPHARYNGITIS; THORAX PAIN; THROMBOEMBOLISM; TREATMENT DURATION; AGED; COMPLICATION; EUROPE; HEMODIALYSIS;

ADULT; AGED; ANEMIA; EPOETIN ALFA; ERYTHROPOIETIN; EUROPE; FEMALE; HEMATINICS; HUMANS; MALE; MIDDLE AGED; RECOMBINANT PROTEINS; RENAL DIALYSIS; RENAL INSUFFICIENCY, CHRONIC;

EID: 85028987211     PISSN: 03010430     EISSN: None     Source Type: Journal    
DOI: 10.5414/CN109159     Document Type: Article

References (16)

1. Macdougall IC, Casadevall N, Locatelli F, Combe C, London GM, Di Paolo S, Kribben A, Fliser D, Messner H, McNeil J, Stevens P, Santoro A, De Francisco ALM, Percheson P, Potamianou A, Foucher A, Fife D, Mérit V, Vercammen E; PRIMS study group. Incidence of erythropoietin antibodymediated pure red cell aplasia: the Prospective Immunogenicity Surveillance Registry (PRIMS). Nephrol Dial Transplant. 2015; 30: 451-460. PubMed
2. Haag-Weber M, Eckardt KU, Hörl WH, Roger SD, Vetter A, Roth K. Safety, immunogenicity and efficacy of subcutaneous biosimilar epoetin-a (HX575) in non-dialysis patients with renal anemia: a multi-center, randomized, double-blind study. Clin Nephrol. 2012; 77: 8-17
3. Seidl A, Hainzl O, Richter M, Fischer R, Böhm S, Deutel B, Hartinger M, Windisch J, Casadevall N, London GM, Macdougall I. Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity. Pharm Res. 2012; 29: 1454-1467
4. Jiang Y, Nashed-Samuel Y, Li C, Liu W, Pollastrini J, Mallard D, Wen ZQ, Fujimori K, Pallitto M, Donahue L, Chu G, Torraca G, Vance A, Mire-Sluis T, Freund E, Davis J, Narhi L. Tungsten-induced protein aggregation: solution behavior. J Pharm Sci. 2009; 98: 4695-4710
5. Bee JS, Nelson SA, Freund E, Carpenter JF, Randolph TW. Precipitation of a monoclonal antibody by soluble tungsten. J Pharm Sci. 2009; 98: 3290-3301
6. Liu W, Swift R, Torraca G, Nashed-Samuel Y, Wen ZQ, Jiang Y, Vance A, Mire-Sluis A, Freund E, Davis J, Narhi L. Root cause analysis of Tungsteninduced protein aggregation in pre-filled syringes. PDA J Pharm Sci Technol. 2010; 64: 11-19. PubMed
7. Wadhwa M, Bird C, Dougall T, Rigsby P, Thorpe R. Proposed 1st WHO Erythropoietin antibody reference panel. Available from: http://www.who. int/biologicals/expert_committee/BS2265_EPOantibody_ panel_ECBS2015-Final.pdf [accessed September 21, 2016].
8. Barger TE, Wrona D, Goletz TJ, Mytych DT. A detailed examination of the antibody prevalence and characteristics of anti-ESA antibodies. Nephrol Dial Transplant. 2012; 27: 3892-3899
9. Wu G, Wadgymar A, Wong G, Ting R, Nathoo B, Mendelssohn D, Pandeya S, Sapir D, Tam P. 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
10. Barger TE, Kuck AJ, Chirmule N, Swanson SJ, Mytych DT. Detection of anti-ESA antibodies in human samples from PRCA and non-PRCA patients: an immunoassay platform comparison. Nephrol Dial Transplant. 2012; 27: 688-693
11. Shankar G, Arkin S, Cocea L, Devanarayan V, Kirshner S, Kromminga A, Quarmby V, Richards S, Schneider CK, Subramanyam M, Swanson S, Verthelyi D, Yim S; American Association of Pharmaceutical Scientists. Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations. AAPS J. 2014; 16: 658-673
12. Schellekens H. Bioequivalence and the immunogenicity of biopharmaceuticals. Nat Rev Drug Discov. 2002; 1: 457-462
13. Schellekens H, Casadevall N. Immunogenicity of recombinant human proteins: causes and consequences. J Neurol. 2004; 251 (Suppl 2): II4-II9
14. Kessler M, Goldsmith D, Schellekens H. Immunogenicity of biopharmaceuticals. Nephrol Dial Transplant. 2006; 21 (Suppl 5): v9-v12
15. Bennett CL, Luminari S, Nissenson AR, Tallman MS, Klinge SA, McWilliams N, McKoy JM, Kim B, Lyons EA, Trifilio SM, Raisch DW, Evens AM, Kuzel TM, Schumock GT, Belknap SM, Locatelli F, Rossert J, Casadevall N. Pure red-cell aplasia and epoetin therapy. N Engl J Med. 2004; 351: 1403-1408
16. Haag-Weber M, Vetter A, Thyroff-Friesinger U; INJ-Study Group. Therapeutic equivalence, longterm efficacy and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis. Clin Nephrol. 2009; 72: 380-390. PubMed