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.
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.
Authors: Christian Lubich; Peter Allacher; Maurus de la Rosa; Alexander Bauer; Thomas Prenninger; Frank Michael Horling; Jürgen Siekmann; Johannes Oldenburg; Friedrich Scheiflinger; Birgit Maria Reipert Journal: Pharm Res Date: 2016-06-07 Impact factor: 4.200
Authors: Huijin Dong; Johanna R Mora; Catherine Brockus; Shannon D Chilewski; Robert Dodge; Colin Merrifield; W Matthew Dickerson; Binodh DeSilva Journal: AAPS J Date: 2015-07-03 Impact factor: 4.009
Authors: Rachel E Rau; ZoAnn Dreyer; Mi Rim Choi; Wei Liang; Roman Skowronski; Krishna P Allamneni; Meenakshi Devidas; Elizabeth A Raetz; Peter C Adamson; Susan M Blaney; Mignon L Loh; Stephen P Hunger Journal: Pediatr Blood Cancer Date: 2017-11-01 Impact factor: 3.167
Authors: Da Shi; Damian Beasock; Adam Fessler; Janos Szebeni; Julia Y Ljubimova; Kirill A Afonin; Marina A Dobrovolskaia Journal: Adv Drug Deliv Rev Date: 2021-12-10 Impact factor: 15.470