Development of anti-PEG IgG/IgM/IgE ELISA assays for profiling anti-PEG immunoglobulin response in PEG-sensitized individuals and patients with alpha-gal allergy

免疫球蛋白E 免疫学 PEG比率 过敏 抗体 免疫球蛋白G 免疫球蛋白M 医学 化学 财务 经济
作者
Zhongbo Li,Alice Ma,Ian F. Miller,Rachel Starnes,Anne Talkington,Cosby A. Stone,Elizabeth J. Phillips,Shailesh K. Choudhary,Scott P. Commins,Samuel K. Lai
出处
期刊:Journal of Controlled Release [Elsevier BV]
卷期号:366: 342-348 被引量:4
标识
DOI:10.1016/j.jconrel.2024.01.003
摘要

Polyethylene glycol (PEG) is frequently used in various protein and nanomedicine therapeutics. However, various studies have shown that select PEGylated therapeutics can induce production of anti-PEG antibodies (APA), potentially culminating in rapid clearance from the systemic circulation, loss of efficacy and possibly increased risks of allergic reactions. Although IgE is a frequent cause of immediate hypersensitivity reactions (IHR), the role of IgE APA in PEG-related IHR is not well understood, due in part to a lack of standardized assays for measuring IgE APA. Here, we developed a rigorous competitive ELISA method to measure the concentrations of various APA isotypes, including IgE, with picomolar sensitivities. In a small number of serum samples from patients with known PEG allergy, the assay allowed us to detect a strong correlation between IgG and IgE APA in individuals with history of allergic reactions to PEG or PEGylated drugs, but not between IgM and IgE APA. We detected appreciable levels of IgG and IgM APA in individuals with history of alpha-gal allergy, however, they were not elevated relative to those detected in other healthy controls, and we found no pre-existing IgE APA. While preliminary and should be further investigated, these results suggest that differences in the route and mechanism of PEG exposure may drive variability in APA response.
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