Phenotype Algorithms for the Identification and Characterization of Vaccine-Induced Thrombotic Thrombocytopenia in Real World Data: A Multinational Network Cohort Study

Azza Shoaibi (), Gowtham A. Rao, Erica A. Voss, Anna Ostropolets, Miguel Angel Mayer, Juan Manuel Ramírez-Anguita, Filip Maljković, Biljana Carević, Scott Horban, Daniel R. Morales, Talita Duarte-Salles, Clement Fraboulet, Tanguy Carrour, Spiros Denaxas, Vaclav Papez, Luis H. John, Peter R. Rijneek, Evan Minty, Thamir M. Alshammari, Rupa Makadia, Clair Blacketer, Frank DeFalco, Anthony G. Sena, Marc A. Suchard, Daniel Prieto-Alhambra and Patrick B. Ryan
Additional contact information
Azza Shoaibi: Janssen Research & Development, LLC
Gowtham A. Rao: Janssen Research & Development, LLC
Erica A. Voss: Janssen Research & Development, LLC
Anna Ostropolets: OHDSI Collaborators
Miguel Angel Mayer: Hospital del Mar Medical Research Institute (IMIM)
Juan Manuel Ramírez-Anguita: Hospital del Mar Medical Research Institute (IMIM)
Filip Maljković: Heliant Ltd
Biljana Carević: University Clinical Center of Serbia
Scott Horban: University of Dundee
Daniel R. Morales: University of Dundee
Talita Duarte-Salles: Fundació Institut Universitari per a la recerca a l’Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol)
Clement Fraboulet: Assistance Publique - Hôpitaux de Marseille
Tanguy Carrour: Easter-eggs
Spiros Denaxas: University College London, Institute of Health Informatics
Vaclav Papez: University College London, Institute of Health Informatics
Luis H. John: Erasmus University Medical Center
Peter R. Rijneek: Erasmus University Medical Center
Evan Minty: Stanford University
Thamir M. Alshammari: OHDSI Collaborators
Rupa Makadia: Janssen Research & Development, LLC
Clair Blacketer: Janssen Research & Development, LLC
Frank DeFalco: Janssen Research & Development, LLC
Anthony G. Sena: Janssen Research & Development, LLC
Marc A. Suchard: OHDSI Collaborators
Daniel Prieto-Alhambra: University of Oxford
Patrick B. Ryan: Janssen Research & Development, LLC

Drug Safety, 2022, vol. 45, issue 6, No 8, 685-698

Abstract: 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.

Date: 2022
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DOI: 10.1007/s40264-022-01187-y

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