Anti-Erythropoietin Antibody-Mediated Pure Red Cell Aplasia after Treatment with Recombinant Erythropoietin Products

Cournoyer, Denis; Toffelmire, Edwin B.; Wells, George A.; Barber, Dwayne L.; Barrett, Brendan; Delage, Robert; Forrest, Donna L.; Gagnon, Raymonde F.; Harvey, Elizabeth; Laneuville, Pierre; Patterson, Bruce; Poon, Man‐Chiu; Posen, Gerald A.; Messner, Hans A.

doi:10.1097/01.asn.0000140219.28618.9f

Cited by 71 publications

(43 citation statements)

References 19 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…There are reports of PRCA caused by formulations other than EPREX®: 0.02-0.16 per 10,000 patients for subcutaneous administration and 0.02 per 10,000 patients for intravenous administration [189]. Patients with PRCA were reported following the administration of epoetin-α and epoetin-β, which are commercially available in Japan, although the number of such patients was extremely small [190][191][192].…”

Section: Prcamentioning

confidence: 99%

2015 Japanese Society for Dialysis Therapy: Guidelines for Renal Anemia in Chronic Kidney Disease

Yamamoto¹,

et al. 2017

View full text Add to dashboard Cite

Section: Prcamentioning

confidence: 99%

2015 Japanese Society for Dialysis Therapy: Guidelines for Renal Anemia in Chronic Kidney Disease

Yamamoto¹,

et al. 2017

View full text Add to dashboard Cite

“…For NSF, reports of a gadodiamide-NSF relationship from Austria and Denmark were published three months apart and for PRCA, reports from the United States/Europe and Canada were published on the same day. 5,43,50,51 For RS, a preliminary report of the Arizona case-control study in the Morbidity and Mortality Weekly Report in July 1980 was followed by preliminary and final reports of Michigan and Ohio studies with similar findings six and 18 months later, respectively. 22-25 Regulatory responses were delayed and uncoordinated.…”

Section: Discussionmentioning

confidence: 99%

“…Independently, Cournoyer et al reported subcutaneous administration of epoetin alfa with polysorbate 80 had the highest PRCA incidence rates. 50 In 2005, the groups collaboratively reported that epoetinassociated PRCA disappeared following renal transplantation. 51 In 2009, epoetin-associated PRCA resolved in 13 of 14 patients who received a novel peptide-based erythropoietin-receptor agonist.…”

Section: Pure Red Cell Aplasiamentioning

confidence: 99%

“…53 Exposure-adjusted PRCA incidence rates with subcutaneous administration of this formulation increased in France, England, and Spain between 1998 and 2001 and in Canada until 2002 to 18 cases per 100,000 epoetin alfa with polysorbate 80 treated CKD patients. 7,50 After regulatory advisories warned against disrupting cold chain storage conditions or administering epoetin alfa with polysorbate 80 subcutaneously, and Teflon-coated rubber stoppers were added to prefilled epoetin alfa syringes, PRCA incidence subsequently decreased by 90 % in France, the United Kingdom, and Spain and by 80 % in Canada. 7,53 …”

Section: Pure Red Cell Aplasiamentioning

confidence: 99%

See 1 more Smart Citation

Linking Drugs to Obscure Illnesses: Lessons from Pure Red Cell Aplasia, Nephrogenic Systemic Fibrosis, and Reye’s Syndrome. A Report From the Southern Network on Adverse Reactions (SONAR)

et al. 2012

View full text Add to dashboard Cite

Identification of serious adverse drug reactions (sADRS) associated with commonly used drugs can elude detection for years. Reye’s syndrome (RS), nephrogenic systemic fibrosis (NSF), and pure red cell aplasia (PRCA) among chronic kidney disease (CKD) patients were recognized in 1951, 2000, and 1998, respectively. Reports associating these syndromes with aspirin, gadodiamide, and epoetin, were published 29, 6, and 4 years later, respectively. We obtained primary information from clinicians who identified causes of these sADRs and reviewed factors contributing to delayed identification of these toxicities. Overall, 3,500 aspirin-associated RS cases in the United States, 1,605 gadolinium-associated NSF cases, and 181 epoetin-associated PRCA cases were reported. Delays in FDA regulation of over-the- counter medications and administration of aspirin to children contributed to development of RS. For NSF, in 1996, the Danish Medicine Agency approved high-dose gadodiamide administration to chronic kidney disease (CKD) patients undergoing MR scans. Overall, 88 % of Danish NSF cases were from two hospitals and 97 % of United States’ NSF cases were from 60 hospitals. These hospitals frequently administered high-doses of gadodiamide to CKD patients. Another factor was the decision to administer linear chelated contrast agents versus lower risk macrocyclic chelated agents. For PRCA, increased use of subcutaneous epoetin formulations to CKD patients, in part due to convenience and cost-savings considerations, and a European regulatory requirement requiring removal of albumin as a stabilizer, led to toxicity. Overall, 81, 13, and 17 years elapsed between drug introduction into practice and identification of a causal relationship for aspirin, erythropoietin, and gadodiamide, respectively. A substantial decline in new cases of these sADRs occurred within two years of identification of the offending drug. Clinicians should be vigilant for sADRs, even for frequently-prescribed pharmaceuticals, particularly in settings where formulation or regulatory changes have occurred, or when over-the-counter, off-label, or pediatric use is common

show abstract

“…The development of anti-EPO antibodies is a very rare but serious complication of treatment with erythropoietic agents. From 1998 to 2004, it was apparent that there was a significant increase in the number of patients who developed pure red-cell aplasia (PRCA) secondary to the appearance of neutralizing anti-EPO antibodies [76,77] . PRCA is characterized by severe anemia, high transfusion requirement and a total lack of response to increasing doses of rHuEPO.…”

Section: Side Effects Of Esasmentioning

confidence: 99%

Use of agents stimulating erythropoiesis in digestive diseases

López¹,

Sicilia²,

García³

2009

WJG

View full text Add to dashboard Cite

Anemia is the most common complication of inflammatory bowel disease (IBD). Control and inadequate treatment leads to a worse quality of life and increased morbidity and hospitalization. Blood loss, and to a lesser extent, malabsorption of iron are the main causes of iron deficiency in IBD. There is also a variable component of anemia related to chronic inflammation. The anemia of chronic renal failure has been treated for many years with recombinant human erythropoietin (rHuEPO), which significantly improves quality of life and survival. Subsequently, rHuEPO has been used progressively in other conditions that occur with anemia of chronic processes such as cancer, rheumatoid arthritis or IBD, and anemia associated with the treatment of hepatitis C virus. Erythropoietic agents complete the range of available therapeutic options for treatment of anemia associated with IBD, which begins by treating the basis of the inflammatory disease, along with intravenous iron therapy as first choice. In cases of resistance to treatment with iron, combined therapy with erythropoietic agents aims to achieve near-normal levels of hemoglobin/hematocrit (11-12 g/dL). New formulations of intravenous iron (iron carboxymaltose) and the new generation of erythropoietic agents (darbepoetin and continuous erythropoietin receptor activator) will allow better dosing with the same efficacy and safety.

show abstract

Anti-Erythropoietin Antibody-Mediated Pure Red Cell Aplasia after Treatment with Recombinant Erythropoietin Products

Abstract: Abstract. Since 1998, there has been a marked increase in incidence of pure red cell aplasia secondary to development of anti-

Cited by 71 publications

References 19 publications

2015 Japanese Society for Dialysis Therapy: Guidelines for Renal Anemia in Chronic Kidney Disease

2015 Japanese Society for Dialysis Therapy: Guidelines for Renal Anemia in Chronic Kidney Disease

Linking Drugs to Obscure Illnesses: Lessons from Pure Red Cell Aplasia, Nephrogenic Systemic Fibrosis, and Reye’s Syndrome. A Report From the Southern Network on Adverse Reactions (SONAR)

Use of agents stimulating erythropoiesis in digestive diseases

Contact Info

Product

Resources

About