title: Anti-polyethyleneglycol antibody response to PEGylated substances.
abstract: In contrast to the general assumption that polyethyleneglycol (PEG)-conjugated substances lack immunogenicity and antigenic, it has been reported that they can elicit antibodies against PEG (mainly anti-PEG immunoglobulin M (IgM)). In patients, the presence of anti-PEG antibodies may limit therapeutic efficacy of PEGylated substances as a consequence of inducing rapid clearance of and neutralizing biological activity of the substances. Here, we introduce specific examples of PEGylated substances including several PEGylated proteins and PEGylated particles (PEGylated nanocarriers) which induce anti-PEG antibody responses. Finally, we emphasize that the immunogenicity of PEGylated substances should be tested in the development stage and that the titer of anti-PEG antibodies in patients should be pre-screened and monitored prior to and throughout a course of treatment with a PEGylated substance.
authors.affiliation: Department of Pharmacokinetics and Biopharmaceutics, Subdivision of Biopharmaceutical Sciences, Institute of Health Biosciences, The University of Tokushima, Tokushima, Japan. ishida@tokushima-u.ac.jp
authors.forename: Tatsuhiro
authors.initials: T
authors.lastname: Ishida
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kiwada
mesh_terms: D000818:Animals; D004337:Drug Carriers / Q000737:chemistry; D006801:Humans; D007075:Immunoglobulin M / Q000276:immunology*; D053758:Nanoparticles / Q000737:chemistry; D004364:Pharmaceutical Preparations / Q000737:chemistry; D011092:Polyethylene Glycols / Q000737:chemistry; D011506:Proteins / Q000737:chemistry
chemical_list: D004337:Drug Carriers; D007075:Immunoglobulin M; D004364:Pharmaceutical Preparations; D011506:Proteins; D011092:Polyethylene Glycols