The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2005-06

AUTHORS

Katia Boven, Scott Stryker, John Knight, Adrian Thomas, Marc van Regenmortel, David M Kemeny, David Power, Jerome Rossert, Nicole Casadevall

ABSTRACT

BACKGROUND: The incidence of pure red cell aplasia (PRCA) in chronic kidney disease patients treated with epoetins increased substantially in 1998, was shown to be antibody mediated, and was associated predominantly with subcutaneous administration of Eprex. A technical investigation identified organic compounds leached from uncoated rubber stoppers in prefilled syringes containing polysorbate 80 as the most probable cause of the increased immunogenicity. METHODS: This study investigated whether the incidence of PRCA was higher for exposure to the product form containing leachates than for leachate-free product forms. Antibody-mediated PRCA cases were classified according to indication, product form, and route of administration. Exposure estimates were obtained by country, indication, route of administration, and product form. RESULTS: For 2001 to 2003, the PRCA incidence rate for patients with subcutaneous exposure to Eprex in prefilled syringes with polysorbate 80 and uncoated rubber stoppers (leachates present) was 4.61/10,000 patient years (95% CI 3.88-5.43) versus 0.26/10,000 patient years (95% CI 0.007-1.44) for syringes with coated stoppers (leachates absent). The rate difference was 4.35/10,000 patient years (95% CI 3.44-5.26; P < 0.0001); the rate ratio was 17 (95% CI 3.14-707). A substantial rate difference remained in sensitivity analyses that adjusted for exposure to multiple product forms. CONCLUSION: The epidemiologic data, together with the chemical and immunologic data, support the hypothesis that leachates from uncoated rubber syringe stoppers caused the increased incidence of PRCA associated with Eprex. Currently, all Eprex prefilled syringes contain fluoro-resin coated stoppers, which has contributed to decreased incidence of PRCA with continued surveillance. More... »

PAGES

2346-2353

References to SciGraph publications

  • 1990. Pure Red Cell Aplasia in APLASTIC ANEMIA AND OTHER BONE MARROW FAILURE SYNDROMES
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1111/j.1523-1755.2005.00340.x

    DOI

    http://dx.doi.org/10.1111/j.1523-1755.2005.00340.x

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1019837931

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/15882278


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