Increased Reporting of Venous and Arterial Thromboembolic events reported with Tixagevimab-Cilgavimab for COVID-19.
Clin Microbiol Infect
; 2022 Dec 01.
Article
in English
| MEDLINE | ID: covidwho-2243443
ABSTRACT
OBJECTIVES:
Since in two phase 3 clinical trials, there were a disproportion of number of thromboembolic events in the tixagevimab/cilgavimab group than in placebo group, there is a cardiovascular safety concerns with the use of this Anti-SARS-COV-2 Monoclonal Antibody. Whether tixagevimab/cilgavimab use in real life context increases the risk for of thromboembolic events is unclear.METHODS:
We used VigiBase, the World Health Organization's individual case safety reports database, to assess the risk of reporting arterial or venous thromboembolic events in COVID-19 patients (≥12 years) exposed to tixagevimab/cilgavimab compared with COVID-19 patients exposed to other anti-SARS-CoV-2 mAbs, including casirivimab/imdevimab, bamlanivimab/etesevimab and sotrovimab.RESULTS:
Among the 8,952 reports of patients with an anti-SARS-CoV-2 mAb, 31 reports of thromboembolic events associated with tixagevimab/cilgavimab, mainly deep vein thrombosis (10), pulmonary embolism (8) and myocardial infarction (7). Compared with other anti-SARS-CoV-2 mAbs, the use of tixagevimab/cilgavimab was associated with an increased risk of reporting arterial thromboembolic events (Reporting Odds Ratio (ROR) 3.25; 95%CI 1.73, 6.10). Concerning venous thromboembolic events, a significant increase in the risk of reporting was observed with use of tixagevimab/cilgavimab (ROR 3.59; 95%CI 2.16, 5.96).CONCLUSIONS:
This observational study corroborate in a real-world setting, the cardiovascular safety signal already found with tixagevimab/cilgavimab in two clinical trials. Owing these thromboembolic safety concerns and considering the lack of clinical trials supporting a protection against the omicron variant, there is an urgent need to improve knowledge on the effectiveness of tixagevimab/cilgavimab with new COVID-19 variants.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Type of study:
Observational study
/
Prognostic study
/
Randomized controlled trials
Topics:
Variants
Language:
English
Journal subject:
Communicable Diseases
/
Microbiology
Year:
2022
Document Type:
Article
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