TY - JOUR
T1 - Phenotype Algorithms for the Identification and Characterization of Vaccine-Induced Thrombotic Thrombocytopenia in Real World Data
T2 - A Multinational Network Cohort Study
AU - Shoaibi, Azza
AU - Rao, Gowtham A.
AU - Voss, Erica A.
AU - Ostropolets, Anna
AU - Mayer, Miguel Angel
AU - Ramírez-Anguita, Juan Manuel
AU - Maljković, Filip
AU - Carević, Biljana
AU - Horban, Scott
AU - Morales, Daniel R.
AU - Duarte-Salles, Talita
AU - Fraboulet, Clement
AU - Le Carrour, Tanguy
AU - Denaxas, Spiros
AU - Papez, Vaclav
AU - John, Luis H.
AU - Rijneek, Peter R.
AU - Minty, Evan
AU - Alshammari, Thamir M.
AU - Makadia, Rupa
AU - Blacketer, Clair
AU - DeFalco, Frank
AU - Sena, Anthony G.
AU - Suchard, Marc A.
AU - Prieto-Alhambra, Daniel
AU - Ryan, Patrick B.
N1 - Funding Information:
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.
© 2022. The Author(s).
PY - 2022/6
Y1 - 2022/6
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85131308910&partnerID=8YFLogxK
U2 - 10.1007/s40264-022-01187-y
DO - 10.1007/s40264-022-01187-y
M3 - Article
C2 - 35653017
SN - 0114-5916
VL - 45
SP - 685
EP - 698
JO - Drug Safety
JF - Drug Safety
ER -
