Clinical Impact of Antipolyethylene Glycol (PEG) Antibody in Hematological Patients Administered PEGylated‐Granulocyte Colony‐Stimulating Factor

PEG比率 医学 效价 抗体 聚乙二醇 抗体效价 粒细胞集落刺激因子 免疫学 聚乙二醇化 药理学 内科学 化学 生物化学 化疗 财务 经济
作者
Naoto Okada,Taro Shimizu,Hidenori Ando,Shingen Nakamura,Mitsuhiro Goda,Masahiro Abe,Takashi Kitahara,Tatsuhiro Ishida,Keisuke Ishizawa
出处
期刊:Clinical pharmacology in drug development [Wiley]
卷期号:12 (8): 826-831 被引量:8
标识
DOI:10.1002/cpdd.1225
摘要

Abstract Polyethylene glycol (PEG) is a polymer covalently attached to proteins to improve their half‐life and efficacy. We previously reported that the PEGylated granulocyte colony‐stimulating factor (PEG‐G‐CSF) is immunogenic, which could adversely impact drug efficacy and safety in animal models. Here, we analyzed the relationship between anti‐PEG antibody titers and the clinical impact of PEG‐G‐CSF in 19 hematological patients. A gradual decrease of anti‐PEG antibody titers from baseline was observed after PEG‐G‐CSF administration. Of the 19 participants, 10 were assessed for noninfectious fever after the first administration of PEG‐G‐CSF and three experienced this reaction. The receiver operating characteristic curve revealed that the cut‐off values of pretreated anti‐PEG IgM and IgG titers for noninfectious fever were set at 5.0 and 96.6 U/mL, respectively. All patients who experienced noninfectious fever had anti‐PEG antibody titers above this cut‐off value ( P = .033). An enzyme‐linked immunosorbent assay revealed that some anti‐PEG antibodies in patients with anti‐PEG antibody titers above the cut‐off value reacted with the PEGylated liposome. These results indicate the reactivity of the anti‐PEG antibodies to PEGylated therapeutics observed in hematologic patients and the possibility of the relationship between high titers of anti‐PEG antibodies and the development of adverse events after PEG‐G‐CSF administration.
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