TITLE

Potential Clinical Consequences of Antibodies to Animal-Derived Products in Surgery

AUTHOR(S)
Cronstein, Bruce; Mackman, Nigel; Ofosu, Frederick A.
PUB. DATE
January 2008
SOURCE
Open Surgery Journal;2008, Vol. 2, p30
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Many therapeutically effective animal-derived biopharmaceuticals and biomaterials, e.g., bovine thrombin, heparin and collagen, have been used successfully for decades during surgery, despite the potential formation of antibodies. Whether biological products are derived from human or animal sources or are recombinant proteins, an antigenic response can be provoked by many different factors inherent to biopharmaceuticals or biomaterials, including differences in amino acid sequences and glycosylation, impurities/contaminants in the biological preparations and patient-specific factors. Administration of products containing biological proteins can result in a range of reactions and the development of antibodies that can be serious but does not always have significant clinical consequences. Overall, only small proportions of treated patients develop severe reactions to these products. For example, out of the millions of patients treated with erythropoietin, 175 patients developed pure red cell aplasia, and of 4109 patients with injectable collagen implants, treatment- related adverse reactions (mostly localized swelling and erythema) occurred in 1.3% of patients. Despite their potential immunogenicity, physicians still use animal-derived products because of the beneficial effects on patient outcomes during surgery. Since retrospective clinical and immunogenicity assessments of these commonly used products is unlikely, the key for new animal-derived biopharmaceuticals is to carry out comprehensive immunogenicity assessments during clinical development before they reach the marketplace.
ACCESSION #
44290399

 

Related Articles

  • Epoetin-induced autoimmune pure red cell aplasia. Casadevall, Nicole // Hematology Journal;2004 Supplement 3, Vol. 5, pS104 

    Studies epoetin-induced autoimmune pure red cell aplasia (PRCA). Diagnostic criteria; Assays for anti-epoetin antibodies; Epidemiology of antibody-induced PRCA.

  • Anti-Erythropoietin Antibody Associated Pure Red Cell Aplasia Resolved after Liver Transplantation. Hung, Annie K.; Guy, Jennifer; Behler, Caroline M.; Lee, Eugene E. // Case Reports in Transplantation;7/9/2015, Vol. 2015, p1 

    Patients undergoing antiviral therapy for chronic hepatitis C often develop anemia secondary to ribavirin and interferon. Recombinant erythropoietin has been used to improve anemia associated with antiviral therapy and to minimize dose reductions, which are associated with decreased rates of...

  • Patients developing anti-Epo antibodies during rHuEpo treatment do not express a polymorphic variant of Epo. Kadri, Zahra; Mayeux, Patrick; Casadevall, Nicole; Chretien, Stany // Kidney International;Feb2004, Vol. 65 Issue 2, p742 

    Presents a letter to the editor regarding the development of pure red blood aplasia during treatment with recombinant human erythropoietin (EPO) citing the production of neutralizing anti-EPO antibodies as the cause of aplasia.

  • Incidence of erythropoietin antibody-mediated pure red cell aplasia: the Prospective Immunogenicity Surveillance Registry (PRIMS). Macdougall, Iain C.; Casadevall, Nicole; Locatelli, Francesco; Combe, Christian; London, Gerard M.; Di Paolo, Salvatore; Kribben, Andreas; Fliser, Danilo; Messner, Hans; McNeil, John; Stevens, Paul; Santoro, Antonio; De Francisco, Angel L.M.; Percheson, Paul; Potamianou, Anna; Foucher, Arnaud; Fife, Daniel; Mérit, Véronique; Vercammen, Els // Nephrology Dialysis Transplantation;Mar2015, Vol. 30 Issue 3, p451 

    Background Subcutaneous administration of Eprex® (epoetin alfa) in patients with chronic kidney disease (CKD) was contraindicated in the European Union between 2002 and 2006 after increased reports of anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA). The Prospective...

  • Hematide corrected anemia in patients with pure red-cell aplasia. Blazek, Nicole; DiMarcantonio, Tina; Haigh, Christen; Harris, Jason; Lawrence, Leah; Volansky, Rob // Hem/Onc Today;12/10/2009, Vol. 10 Issue 23, p56 

    The article discusses research on the benefit of the synthetic peptide-based erythropoietin-receptor agaonist, Hematide, in patients with pure red-cell aplasia caused by antierythropoietin antibodies, published in a 2009 issue of the "New England Journal of Medicine."

  • Epoetin α.  // Reactions Weekly;3/20/2010, Issue 1293, p23 

    The article describes the case of a 65-year-old woman with hepatitis C infection who developed pure red cell aplasia during epoetin α therapy.

  • Incidence of recombinant erythropoietin (EPO) hyporesponse, EPO-associated antibodies, and pure red cell aplasia in dialysis patients. Kharagjitsingh, Aantje V.; Korevaar, Joke C.; Vandenbroucke, Jan P.; Boeschoten, Elisabeth W.; Krediet, Raymond T.; Daha, Mohammed R.; Dekker, Friedo W. // Kidney International;Sep2005, Vol. 68 Issue 3, p1215 

    Incidence of recombinant erythropoietin (EPO) hyporesponse, EPO-associated antibodies, and pure red cell aplasia in dialysis patients. Background. Since 1998, an increase of anti-erythropoietin (anti-EPO) antibody–induced pure red cell aplasia (PRCA) has been reported. As data up to now...

  • Darbepoetin-α/epoetin-α/epoetin-β.  // Reactions Weekly;3/12/2011, Issue 1342, p14 

    The article describes the case of two chronic kidney diseases (CKD) patients who acquired pure red cell aplasia (PRCA) while undergoing treatment with recombinant erythropoietins.

  • Biosimilars need comparative clinical data. Casadevall, Nicole; Thorpe, Robin; Schellekens, Huub // Kidney International;Sep2011, Vol. 80 Issue 5, p553 

    A letter to the editor is presented in response to the article "Biosimilar recombinant human enthropoietin induces the production of neutralizing antibodies," by K. Praditpornsilpa and colleagues in the 2011 issue.

Share

Read the Article

Courtesy of VIRGINIA BEACH PUBLIC LIBRARY AND SYSTEM

Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics