Anti-Peg Antibody Bioanalysis: A Clinical Case Study with Peg-Ifn-λ-1A and Peg-Ifn-α2A in Naive Patients

• DOI: 10.4155/bio.15.36
• Publication Date: 2015-06-03T14:59:36Z
• Authors: Heather Myler; Matthew W Hruska; Subasree Srinivasan; Elizabeth Cooney; George Kong; Robert Dodge; Murli Krishna; Jie Zhu; Tonya Felix; Carol Gleason; Steven P Piccoli; Binodh DeSilva
• Keywords: Immunoassay; 0301 basic medicine; Molecular Conformation; Immunoglobulins; Interferon-alpha; Reproducibility of Results; Cross Reactions; Hepatitis C; Polyethylene Glycols; 3. Good health; 03 medical and health sciences; Immunoglobulin M; Humans

Extensive use of polyethylene glycol (PEG) in consumer products necessitates the assessment of anti-PEG antibodies (APAb).In clinical trials comparing PEG-IFN-λ to PEG-IFN-α, conventional bridge and direct assays were assessed.The bridge assay detected IgM and IgG APAb reactive with common PEG sizes and derivatives at sufficient sensitivity, 15-500 ng/ml. Of subjects evaluated, 6% of PEG-IFN-λ and 9% of PEG-IFN-α subjects had persistent APAb while 60% of PEG-IFN-λ and 33% of PEG-IFN-α subjects had persistent anti-interferon antibodies (AIAb). Pre-existing APAb and AIAb prevalence was comparable (approximately 10% of subjects). APAb were earlier onset, less frequent, less persistent and lower titer than AIAb. No associated hypersensitivity events were reported.