title: Anti-PEG antibody bioanalysis: a clinical case study with PEG-IFN-λ-1a and PEG-IFN-α2a in naive patients.
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.
  
  
  CONCLUSIONS
  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.forename: Heather
authors.initials: H
authors.lastname: Myler
authors.forename: Matthew W
authors.initials: MW
authors.lastname: Hruska
authors.forename: Subasree
authors.initials: S
authors.lastname: Srinivasan
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Cooney
authors.forename: George
authors.initials: G
authors.lastname: Kong
authors.forename: Robert
authors.initials: R
authors.lastname: Dodge
authors.forename: Murli
authors.initials: M
authors.lastname: Krishna
authors.affiliation: 2WuXi AppTec (Shanghai) Co., Ltd 288 Fute Zhong Road, Waigaoqiao Free Trade Zone, Shanghai 200131, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Zhu
authors.affiliation: 3LabCorp, 115 Silvia Street, West Trenton, NJ 08628, USA.
authors.forename: Tonya
authors.initials: T
authors.lastname: Felix
authors.forename: Carol
authors.initials: C
authors.lastname: Gleason
authors.forename: Steven P
authors.initials: SP
authors.lastname: Piccoli
authors.forename: Binodh
authors.initials: B
authors.lastname: DeSilva
mesh_terms: D003429:Cross Reactions; D006526:Hepatitis C / Q000097:blood; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D007075:Immunoglobulin M / Q000032:analysis* / Q000097:blood / Q000276:immunology; D007136:Immunoglobulins / Q000032:analysis* / Q000097:blood / Q000276:immunology; D016898:Interferon-alpha / Q000737:chemistry* / Q000276:immunology*; D008968:Molecular Conformation; D011092:Polyethylene Glycols / Q000737:chemistry*; D015203:Reproducibility of Results
chemical_list: D007075:Immunoglobulin M; D007136:Immunoglobulins; D016898:Interferon-alpha; C038767:immunoglobulin B; D011092:Polyethylene Glycols