Evaluation of anti‐activated protein C antibody development in patients with severe sepsis from four clinical studies with drotrecogin alfa (activated)

Abstract

To cite this article: Yan SB, Brandt JT, Correll NL, Um SL, Bourdage JS. Evaluation of anti-activated protein C antibody development in patients with severe sepsis from four clinical studies with drotrecogin alfa (activated). J Thromb Haemost 2009; 7: 1787-94.

Readministration of drotrecogin alfa (activated) in an adult with severe sepsis

“…9 A recent study evaluated the development of anti-APC antibodies among patients in four clinical studies of drotrecogin alfa. 9 The authors of that study developed an assay to detect anti-APC antibodies to immunoglobulins M, G, and A.…”

“…9 A recent study evaluated the development of anti-APC antibodies among patients in four clinical studies of drotrecogin alfa. 9 The authors of that study developed an assay to detect anti-APC antibodies to immunoglobulins M, G, and A. Overall, 2.4% of patients receiving drotrecogin alfa (n = 1855) and 2.7% of patients receiving placebo (n = 1493) had a positive assay result at any point during the four clinical studies.…”

“…Currently there is minimal evidence regarding the readministration of drotrecogin alfa in patients with repeated episodes of sepsis, [9][10][11] but the limited information available suggests that the risk of antibody formation is minimal in patients who receive single or multiple courses of drotrecogin alfa. 9 A recent study evaluated the development of anti-APC antibodies among patients in four clinical studies of drotrecogin alfa.…”

“…7 A recent study showed that the risk of the development of antibodies after administration of the agent is low 9 ; however, there are limited data to indicate whether clinical outcomes are worse in patients receiving multiple courses of drotrecogin alfa. [7][8][9][10][11] Here we report the case of a patient with severe sepsis who was successfully treated with two courses of the agent.…”

New parenteral anticoagulants in development

“…TB-402), as with all therapeutic proteins, there is a potential for immunogenicity. However, the risk for immunogenicity with DrotAA, as measured by the presence of antibodies after treatment, seems to be low [Yan et al . 2009].…”