Immunogenicity of branched polyethylene glycol modified interferon alpha

Immunopharmacology and Immunotoxicology
Weidong ZhouLi Sun

Abstract

To assess the immunogenicity of Peginterferon alpha-2 b(Pegberon) and its effect on the efficacy and safety in phase III clinical trial, by comparing it with the control drug Pegasys. 770 patients were recruited in total. 509 were treated with Pegberon plus ribavirin and 261 were treated with Pegasys plus ribavirin. After treatment of 12 and 24 weeks, plasma samples were collected from individual patients for detecting the anti-therapeutic antibodies (ATA) and hepatitis C RNA(HCV RNA), to evaluate the production of antibodies and their adverse effect on the efficacy and safety of the treatments. With data obtained from the treatments with Pegberon or Pegasys, gross comparison analysis was performed. The incidence of treatment-induced neutralizing antibodies (NAb) of Pegberon group (0.7%, 3/454) was significantly lower than Pegasys group (5.0%,12/238)(p < .001). Among all patients, the rates of sustained virological response 24 (SVR24) were significantly different between baseline ATA positive (60.7%,34/56) and baseline ATA negative patients (76.2%,544/714)(p = .010), between baseline NAb positive (36.0%,9/25) and baseline NAb negative patients (76.4%,569/745)(p < .001) and between induced ATA positive (72.7%,40/55) and sustaine...Continue Reading

References

Jul 1, 1994·Journal of Hepatology·P BonettiA Alberti
Mar 24, 2006·The New England Journal of Medicine·Annemiek A van der EijkBart L Haagmans
Nov 11, 2008·Journal of Pharmaceutical and Biomedical Analysis·Gopi ShankarEugen Koren

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