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Article: Real-World Effectiveness and Safety of Tixagevimab–Cilgavimab: A Target Trial Emulation Study
Title | Real-World Effectiveness and Safety of Tixagevimab–Cilgavimab: A Target Trial Emulation Study |
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Authors | |
Issue Date | 25-Jun-2024 |
Publisher | Springer Nature |
Citation | Drug Safety, 2024 How to Cite? |
Abstract | Background: Immunocompromised individuals are at high risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and subsequent severe or fatal coronavirus disease 2019 (COVID-19), yet they have suboptimal responses to mRNA and inactivated COVID-19 vaccines. The efficacy of tixagevimab–cilgavimab in reducing symptomatic SARS-CoV-2 infection was demonstrated in phase III clinical trials. Nevertheless, real-world data on the effectiveness and safety of tixagevimab–cilgavimab remain limited. Objective: The aim was to evaluate the effectiveness and safety of tixagevimab–cilgavimab among immunocompromised individuals. Methods: Adults who were immunocompromised or receiving immunosuppressive therapies were included in this target trial emulation using territory-wide electronic health records in Hong Kong. A sequential trial emulation approach was adopted to compare effectiveness and safety outcomes between individuals who received tixagevimab–cilgavimab and individuals who did not. Results: A total of 746 tixagevimab–cilgavimab recipients and 2980 controls were included from 1 May 2022 to 30 November 2022. Tixagevimab–cilgavimab significantly reduced the risk of COVID-19 infection (hazard ratio [HR] 0.708, 95% confidence interval [CI] 0.527–0.951) during a median follow-up of 60 days. No significant difference was observed in the risk of COVID-19-related hospitalisation. Zero versus eight COVID-19 mortality cases and zero versus two severe COVID-19 cases were observed in tixagevimab–cilgavimab recipients and controls, respectively. Notably, significant risk reduction in COVID-19 infection was also observed among immunocompromised individuals who had been previously vaccinated with three or more doses of COVID-19 vaccine, or had no prior COVID-19 infection history. Conclusions: Tixagevimab–cilgavimab was effective in reducing COVID-19 infection among immunocompromised patients during the Omicron wave. Findings were consistent among individuals who previously received three or more doses of COVID-19 vaccine, or had no previous history of COVID-19 infection. |
Persistent Identifier | http://hdl.handle.net/10722/345938 |
ISSN | 2023 Impact Factor: 4.0 2023 SCImago Journal Rankings: 1.204 |
DC Field | Value | Language |
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dc.contributor.author | Yan, Vincent Ka Chun | - |
dc.contributor.author | Yang, Yu | - |
dc.contributor.author | Wan, Eric Yuk Fai | - |
dc.contributor.author | Lai, Francisco Tsz Tsun | - |
dc.contributor.author | Chui, Celine Sze Ling | - |
dc.contributor.author | Li, Xue | - |
dc.contributor.author | Wong, Carlos King Ho | - |
dc.contributor.author | Hung, Ivan Fan Ngai | - |
dc.contributor.author | Lau, Chak Sing | - |
dc.contributor.author | Wong, Ian Chi Kei | - |
dc.contributor.author | Chan, Esther Wai Yin | - |
dc.date.accessioned | 2024-09-04T07:06:38Z | - |
dc.date.available | 2024-09-04T07:06:38Z | - |
dc.date.issued | 2024-06-25 | - |
dc.identifier.citation | Drug Safety, 2024 | - |
dc.identifier.issn | 0114-5916 | - |
dc.identifier.uri | http://hdl.handle.net/10722/345938 | - |
dc.description.abstract | Background: Immunocompromised individuals are at high risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and subsequent severe or fatal coronavirus disease 2019 (COVID-19), yet they have suboptimal responses to mRNA and inactivated COVID-19 vaccines. The efficacy of tixagevimab–cilgavimab in reducing symptomatic SARS-CoV-2 infection was demonstrated in phase III clinical trials. Nevertheless, real-world data on the effectiveness and safety of tixagevimab–cilgavimab remain limited. Objective: The aim was to evaluate the effectiveness and safety of tixagevimab–cilgavimab among immunocompromised individuals. Methods: Adults who were immunocompromised or receiving immunosuppressive therapies were included in this target trial emulation using territory-wide electronic health records in Hong Kong. A sequential trial emulation approach was adopted to compare effectiveness and safety outcomes between individuals who received tixagevimab–cilgavimab and individuals who did not. Results: A total of 746 tixagevimab–cilgavimab recipients and 2980 controls were included from 1 May 2022 to 30 November 2022. Tixagevimab–cilgavimab significantly reduced the risk of COVID-19 infection (hazard ratio [HR] 0.708, 95% confidence interval [CI] 0.527–0.951) during a median follow-up of 60 days. No significant difference was observed in the risk of COVID-19-related hospitalisation. Zero versus eight COVID-19 mortality cases and zero versus two severe COVID-19 cases were observed in tixagevimab–cilgavimab recipients and controls, respectively. Notably, significant risk reduction in COVID-19 infection was also observed among immunocompromised individuals who had been previously vaccinated with three or more doses of COVID-19 vaccine, or had no prior COVID-19 infection history. Conclusions: Tixagevimab–cilgavimab was effective in reducing COVID-19 infection among immunocompromised patients during the Omicron wave. Findings were consistent among individuals who previously received three or more doses of COVID-19 vaccine, or had no previous history of COVID-19 infection. | - |
dc.language | eng | - |
dc.publisher | Springer Nature | - |
dc.relation.ispartof | Drug Safety | - |
dc.rights | This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. | - |
dc.title | Real-World Effectiveness and Safety of Tixagevimab–Cilgavimab: A Target Trial Emulation Study | - |
dc.type | Article | - |
dc.identifier.doi | 10.1007/s40264-024-01450-4 | - |
dc.identifier.scopus | eid_2-s2.0-85196861361 | - |
dc.identifier.eissn | 1179-1942 | - |
dc.identifier.issnl | 0114-5916 | - |