Japanese Journal of Thrombosis and Hemostasis
Online ISSN : 1880-8808
Print ISSN : 0915-7441
ISSN-L : 0915-7441
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Original article
  • Hiroshi INABA, Keiko SHINOZAWA, Kagehiro AMANO, Ei KINAI
    Type: Original article
    2021 Volume 32 Issue 3 Pages 330-338
    Published: 2021
    Released: June 22, 2021
    JOURNALS FREE ACCESS FULL-TEXT HTML

    In recent years, PEGylated factor VIII (FVIII) has become one of the mainstay therapeutic agents for hemophilia A. In the present study, the frequency and characteristics of anti-PEG IgG antibodies were investigated in 177 hemophilia A patients in Japan. Twenty-five patients (14.1%) were determined to be anti-PEG IgG antibody-positive by ELISA using three PEGylated proteins (Rurioctocog alfa pegol, Damoctocog alfa pegol, and PEGylated BSA) as antigens. The anti-PEG IgG antibody-positive rates in the groups with and without administration of PEGylated therapeutic drugs for hepatitis were 8.2% and 16.4%, respectively. Similarly, the antibody-positive rates in the groups with and without administration of Rurioctocog alpha pegol were 8.7% and 14.9%, respectively, and a causal relationship with history of PEGylated agent use could not be confirmed. The results suggested that anti-PEG IgG antibodies were more commonly observed in younger patients than in older patients, and may be continuously retained. Anti-PEG IgG antibodies did not inhibit the activity of FVIII. In one patient with anti-PEG IgG antibody positivity, the expected recovery rate and half-life-prolonging effect of Rurioctocog alfa pegol were not obtained.

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