Phenotype algorithms for the identification and characterization of vaccine-induced thrombotic thrombocytopenia in real world data: a multinational network cohort study

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  • dc.contributor.author Shoaibi, Azza
  • dc.contributor.author Mayer, Miguel Ángel, 1960-
  • dc.contributor.author Ramírez Anguita, Juan Manuel
  • dc.contributor.author Ryan, Patrick B.
  • dc.date.accessioned 2022-10-21T06:19:58Z
  • dc.date.available 2022-10-21T06:19:58Z
  • dc.date.issued 2022
  • dc.description.abstract Introduction: vaccine-induced thrombotic thrombocytopenia (VITT) has been identified as a rare but serious adverse event associated with coronavirus disease 2019 (COVID-19) vaccines. Objectives: in this study, we explored the pre-pandemic co-occurrence of thrombosis with thrombocytopenia (TWT) using 17 observational health data sources across the world. We applied multiple TWT definitions, estimated the background rate of TWT, characterized TWT patients, and explored the makeup of thrombosis types among TWT patients. Methods: we conducted an international network retrospective cohort study using electronic health records and insurance claims data, estimating background rates of TWT amongst persons observed from 2017 to 2019. Following the principles of existing VITT clinical definitions, TWT was defined as patients with a diagnosis of embolic or thrombotic arterial or venous events and a diagnosis or measurement of thrombocytopenia within 7 days. Six TWT phenotypes were considered, which varied in the approach taken in defining thrombosis and thrombocytopenia in real world data. Results: overall TWT incidence rates ranged from 1.62 to 150.65 per 100,000 person-years. Substantial heterogeneity exists across data sources and by age, sex, and alternative TWT phenotypes. TWT patients were likely to be men of older age with various comorbidities. Among the thrombosis types, arterial thrombotic events were the most common. Conclusion: our findings suggest that identifying VITT in observational data presents a substantial challenge, as implementing VITT case definitions based on the co-occurrence of TWT results in large and heterogeneous incidence rate and in a cohort of patints with baseline characteristics that are inconsistent with the VITT cases reported to date.
  • dc.description.sponsorship This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 806968. The JU receives support from the European Union’s Horizon 2020 research and innovation program and EFPIA. Funders had no role in the conceptualization, design, data collection, analysis, decision to publish, or preparation of the manuscript.
  • dc.format.mimetype application/pdf
  • dc.identifier.citation Shoaibi A, Rao GA, Voss EA, Ostropolets A, Mayer MA, Ramírez-Anguita JM, et al. Phenotype algorithms for the identification and characterization of vaccine-induced thrombotic thrombocytopenia in real world data: a multinational network cohort study. Drug Saf. 2022 Jun; 45(6): 685-98. DOI: 10.1007/s40264-022-01187-y
  • dc.identifier.doi http://dx.doi.org/10.1007/s40264-022-01187-y
  • dc.identifier.issn 0114-5916
  • dc.identifier.uri http://hdl.handle.net/10230/54519
  • dc.language.iso eng
  • dc.publisher SpringerOpen
  • dc.relation.projectID info:eu-repo/grantAgreement/EC/H2020/806968
  • dc.rights Copyright © Shoaibi A, Rao GA, Voss EA, Ostropolets A, Mayer MA, Ramírez-Anguita JM, 2022. Open Access. This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.
  • dc.rights.accessRights info:eu-repo/semantics/openAccess
  • dc.subject.other Vacunes -- Efectes secundaris
  • dc.subject.other Fenotip
  • dc.subject.other Trombocitopènia
  • dc.title Phenotype algorithms for the identification and characterization of vaccine-induced thrombotic thrombocytopenia in real world data: a multinational network cohort study
  • dc.type info:eu-repo/semantics/article
  • dc.type.version info:eu-repo/semantics/publishedVersion

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