Anti-PEG antibody bioanalysis: a clinical case study with PEG-IFN-λ-1a and PEG-IFN-α2a in naive patients. (May 2015)

• Record Type: Journal Article
• Authors: Myler, Heather; Hruska, Matthew W; Srinivasan, Subasree; Cooney, Elizabeth; Kong, George; Dodge, Robert; Krishna, Murli; Zhu, Jie; Felix, Tonya; Gleason, Carol; Piccoli, Steven P; DeSilva, Binodh
• Is Part Of: Bioanalysis. Volume 7:Number 9(2015)
• Page Start: 1093
• Page End: 1106
• Publication Date: 2015-05
• Subjects: Drugs -- Analysis -- Periodicals; 615.19005
• DOI: 10.4155/bio.15.36
• Languages: English
• ISSNs: 1757-6180

Abstract

Background: Extensive use of polyethylene glycol (PEG) in consumer products necessitates the assessment of anti-PEG antibodies (APAb).Methods: In clinical trials comparing PEG-IFN-λ to PEG-IFN-α, conventional bridge and direct assays were assessed.Results & Conclusion: 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.