Real-World Effectiveness and Safety of Tixagevimab–Cilgavimab: A Target Trial Emulation Study

Vincent Ka Chun Yan, Yu Yang, Eric Yuk Fai Wan, Francisco Tsz Tsun Lai, Celine Sze Ling Chui, Xue Li, Carlos King Ho Wong, Ivan Fan Ngai Hung, Chak Sing Lau, Ian Chi Kei Wong () and Esther Wai Yin Chan ()
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Vincent Ka Chun Yan: The University of Hong Kong
Yu Yang: The University of Hong Kong
Eric Yuk Fai Wan: The University of Hong Kong
Francisco Tsz Tsun Lai: The University of Hong Kong
Celine Sze Ling Chui: Hong Kong Science and Technology Park
Xue Li: The University of Hong Kong
Carlos King Ho Wong: The University of Hong Kong
Ivan Fan Ngai Hung: The University of Hong Kong
Chak Sing Lau: The University of Hong Kong
Ian Chi Kei Wong: The University of Hong Kong
Esther Wai Yin Chan: The University of Hong Kong

Drug Safety, 2024, vol. 47, issue 10, No 6, 1025-1037

Abstract: 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.

Date: 2024
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DOI: 10.1007/s40264-024-01450-4

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