Intra-articular haemorrhage caused by reduced recovery of PEGylated recombinant factor VIII due to an anti-PEG antibody developed after mRNA-1273 SARS-CoV-2 vaccination in haemophilia A

HaemophiliaVolume 29, Issue 3 p. 935-938 LETTER TO THE EDITOR Intra-articular haemorrhage caused by reduced recovery of PEGylated recombinant factor VIII due to an anti-PEG antibody developed after mRNA-1273 SARS-CoV-2 vaccination in haemophilia A Yuto Nakajima, Yuto Nakajima orcid.org/0000-0001-5422-2782 Department of Paediatrics, Nara Medical University, Kashihara, Nara, Japan Advanced Medical Science of Thrombosis and Haemostasis, Nara Medical University, Kashihara, Nara, JapanSearch for more papers by this authorKenichi Ogiwara, Corresponding Author Kenichi Ogiwara [email protected] orcid.org/0000-0002-3046-6915 Department of Paediatrics, Nara Medical University, Kashihara, Nara, Japan Correspondence Kenichi Ogiwara, Department of Paediatrics, Nara Medical University, 840 Shijo-cho, Kashihara, Nara 634-8522, Japan. Email: [email protected]Search for more papers by this authorNaruto Shimonishi, Naruto Shimonishi orcid.org/0000-0002-0157-5215 Department of Paediatrics, Nara Medical University, Kashihara, Nara, Japan The Course of Thrombosis and Haemostasis Molecular Pathology, Nara Medical University, Kashihara, Nara, JapanSearch for more papers by this authorShoko Furukawa, Shoko Furukawa orcid.org/0000-0002-4786-8945 Department of Paediatrics, Nara Medical University, Kashihara, Nara, JapanSearch for more papers by this authorMasahiro Takeyama, Masahiro Takeyama orcid.org/0000-0002-9348-9815 Department of Paediatrics, Nara Medical University, Kashihara, Nara, JapanSearch for more papers by this authorKeiji Nogami, Keiji Nogami orcid.org/0000-0002-2415-2194 Department of Paediatrics, Nara Medical University, Kashihara, Nara, JapanSearch for more papers by this author Yuto Nakajima, Yuto Nakajima orcid.org/0000-0001-5422-2782 Department of Paediatrics, Nara Medical University, Kashihara, Nara, Japan Advanced Medical Science of Thrombosis and Haemostasis, Nara Medical University, Kashihara, Nara, JapanSearch for more papers by this authorKenichi Ogiwara, Corresponding Author Kenichi Ogiwara [email protected] orcid.org/0000-0002-3046-6915 Department of Paediatrics, Nara Medical University, Kashihara, Nara, Japan Correspondence Kenichi Ogiwara, Department of Paediatrics, Nara Medical University, 840 Shijo-cho, Kashihara, Nara 634-8522, Japan. Email: [email protected]Search for more papers by this authorNaruto Shimonishi, Naruto Shimonishi orcid.org/0000-0002-0157-5215 Department of Paediatrics, Nara Medical University, Kashihara, Nara, Japan The Course of Thrombosis and Haemostasis Molecular Pathology, Nara Medical University, Kashihara, Nara, JapanSearch for more papers by this authorShoko Furukawa, Shoko Furukawa orcid.org/0000-0002-4786-8945 Department of Paediatrics, Nara Medical University, Kashihara, Nara, JapanSearch for more papers by this authorMasahiro Takeyama, Masahiro Takeyama orcid.org/0000-0002-9348-9815 Department of Paediatrics, Nara Medical University, Kashihara, Nara, JapanSearch for more papers by this authorKeiji Nogami, Keiji Nogami orcid.org/0000-0002-2415-2194 Department of Paediatrics, Nara Medical University, Kashihara, Nara, JapanSearch for more papers by this author First published: 11 April 2023 https://doi.org/10.1111/hae.14786Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinkedInRedditWechat REFERENCES 1Tiede A. Half-life extended factor VIII for the treatment of hemophilia A. J Thromb Haemost. 2015; 13(Suppl 1): S176-S179. 2Schoenmaker L, Witzigmann D, Kulkarni JA, et al. mRNA-lipid nanoparticle COVID-19 vaccines: structure and stability. Int J Pharm. 2021; 601:120586. 3Yang Q, Jacobs TM, McCallen JD, et al. Analysis of pre-existing IgG and IgM antibodies against polyethylene glycol (PEG) in the general population. Anal Chem. 2016; 88(23): 11804-11812. 4Valsecchi C, Gualtierotti R, Arcudi S, et al. Reduced FVIII recovery associated with anti-FVIII PEG antibodies after BNT162b2 SARS-CoV-2 vaccination. Blood Adv. 2023; 7(1): 174-177. 5Ju Y, Lee WS, Pilkington EH, et al. Anti-PEG antibodies boosted in humans by SARS-CoV-2 lipid nanoparticle mRNA vaccine. ACS Nano. 2022; 16(8): 11769-11780. 6Tiede A, Brand B, Fischer R, et al. Enhancing the pharmacokinetic properties of recombinant factor VIII: first-in-human trial of glycoPEGylated recombinant factor VIII in patients with hemophilia A. J Thromb Haemost. 2013; 11: 670-678. 7Reding MT, Ng HJ, Poulsen LH, et al. Safety and efficacy of BAY 94–9027, a prolonged-half-life factor VIII. J Thromb Haemost. 2017; 15: 411-419. 8Oh Y, Niijima H, Kawahara Y, et al. An immediate hypersensitivity reaction induced by PEGylated recombinant factor VIII. Haemophilia. 2020; 26: e236-e239. 9Male C, Königs C, Dey S, et al. The safety and efficacy of N8-GP (turoctocog alfa pegol) in previously untreated pediatric patients with hemophilia A. Blood Adv. 2023; 7(4): 620-629. 10Carreño JM, Singh G, Tcheou J, et al. mRNA-1273 but not BNT162b2 induces antibodies against polyethylene glycol (PEG) contained in mRNA-based vaccine formulations. Vaccine. 2022; 40(42): 6114-6124. Volume29, Issue3May 2023Pages 935-938 ReferencesRelatedInformation