{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T11:15:24Z","timestamp":1793531724572,"version":"4.5.0"},"reference-count":24,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2023,1,28]],"date-time":"2023-01-28T00:00:00Z","timestamp":1674864000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2023,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Polyethylene glycol (PEG) is a polymer covalently attached to proteins to improve their half\u2010life and efficacy. We previously reported that the PEGylated granulocyte colony\u2010stimulating factor (PEG\u2010G\u2010CSF) is immunogenic, which could adversely impact drug efficacy and safety in animal models. Here, we analyzed the relationship between anti\u2010PEG antibody titers and the clinical impact of PEG\u2010G\u2010CSF in 19 hematological patients. A gradual decrease of anti\u2010PEG antibody titers from baseline was observed after PEG\u2010G\u2010CSF administration. Of the 19 participants, 10 were assessed for noninfectious fever after the first administration of PEG\u2010G\u2010CSF and three experienced this reaction. The receiver operating characteristic curve revealed that the cut\u2010off values of pretreated anti\u2010PEG IgM and IgG titers for noninfectious fever were set at 5.0 and 96.6\u00a0U\/mL, respectively. All patients who experienced noninfectious fever had anti\u2010PEG antibody titers above this cut\u2010off value (<jats:italic>P<\/jats:italic>\u00a0=\u00a0.033). An enzyme\u2010linked immunosorbent assay revealed that some anti\u2010PEG antibodies in patients with anti\u2010PEG antibody titers above the cut\u2010off value reacted with the PEGylated liposome. These results indicate the reactivity of the anti\u2010PEG antibodies to PEGylated therapeutics observed in hematologic patients and the possibility of the relationship between high titers of anti\u2010PEG antibodies and the development of adverse events after PEG\u2010G\u2010CSF administration.<\/jats:p>","DOI":"10.1002\/cpdd.1225","type":"journal-article","created":{"date-parts":[[2023,1,28]],"date-time":"2023-01-28T08:25:14Z","timestamp":1674894314000},"page":"826-831","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Clinical Impact of Antipolyethylene Glycol (PEG) Antibody in Hematological Patients Administered PEGylated\u2010Granulocyte Colony\u2010Stimulating Factor"],"prefix":"10.1002","volume":"12","author":[{"given":"Naoto","family":"Okada","sequence":"first","affiliation":[{"name":"Department of Pharmacy Tokushima University Hospital  Tokushima Japan"},{"name":"Pharmacy Department Yamaguchi University Hospital  Yamaguchi Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shimizu","family":"Taro","sequence":"additional","affiliation":[{"name":"Department of Pharmacokinetics and Biopharmaceutics, Institute of Biomedical Sciences Tokushima University Graduate School  Tokushima Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hidenori","family":"Ando","sequence":"additional","affiliation":[{"name":"Department of Pharmacokinetics and Biopharmaceutics, Institute of Biomedical Sciences Tokushima University Graduate School  Tokushima Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shingen","family":"Nakamura","sequence":"additional","affiliation":[{"name":"Department of Community Medicine and Medical Science Tokushima University Graduate School of Biomedical Sciences  Tokushima 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