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Antidrug antibodies against the polyethylene glycol moiety inhibit the procoagulant activity of therapeutic polyethylene glycolated factor VIII by Behnaz Pezeshkpoor; Nadja Sereda; Ann-Cristin Berkemeier; Isabell Matuschek; Nadine Schwarz; Peter L. Turecek; Silvia Horneff; Claudia Klein; Georg Goldmann; Natascha Marquardt; Thilo Albert; Jens Müller; Johannes Oldenburg is a Medicine article available to read on EtoBox.
What is Antidrug antibodies against the polyethylene glycol moiety inhibit the procoagulant activity of therapeutic polyethylene glycolated factor VIII about?
Background The standard therapy for hemophilia A (HA) patients is the replacement with Factor VIII (FVIII) therapeutics. To overcome the limitation of the short half-life of wild-type FVIII protein, polyethylene glycol (PEG) can be coupled to therapeutic FVIII to improve pharmacokinetics. Objectives To characterize antibodies developed against a FVIII therapeutic PEGylated with a 40 kDa PEG (40PEG-BDDFVIII) in two mild HA patients. Methods An in-house bead-based immunoassay was developed to characterize and confirm the specificity of detected antibodies. The neutralizing nature of the antibodies towards PEGylated therapeutics was determined by a modified Nijmegen Bethesda Assay (NBA). Results Two out of 46 patients treated with 40PEG-BDDFVIII developed inhibitory antibodies towards the drug. Switching to a non-PEGylated FVIII successfully increased the FVIII activity in both patients. In Patient 1, antibodies were raised against FVIII and PEG. Anti-FVIII antibodies were of IgG isotype, whereas anti-PEG antibodies were of IgG, IgM, and IgA isotype. In Patient 2, antibodies of IgG and IgA isotype were directed only against the PEG moiety. Competitive assays confirmed the specificity
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- Author
- Behnaz Pezeshkpoor; Nadja Sereda; Ann-Cristin Berkemeier; Isabell Matuschek; Nadine Schwarz; Peter L. Turecek; Silvia Horneff; Claudia Klein; Georg Goldmann; Natascha Marquardt; Thilo Albert; Jens Müller; Johannes Oldenburg
- Publisher
- Elsevier BV
- Published
- 2023
- Language
- EN
- Field
- Medicine (Health Sciences)