Yan, Vincent Ka Chun, Yang, Yu, Wan, Eric Yuk Fai, Lai, Francisco Tsz Tsun, Chui, Celine Sze Ling, Wong, Carlos King Ho, Hung, Ivan Fan Ngai, Lau, Chak Sing, Wong, Ian Chi Kei and Chan, Esther Wai Yin (2024). Real-World Effectiveness and Safety of Tixagevimab-Cilgavimab: A Target Trial Emulation Study. Drug Safety ,
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.
Publication DOI: | https://doi.org/10.1007/s40264-024-01450-4 |
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Divisions: | College of Health & Life Sciences > Aston Pharmacy School |
Funding Information: | This work was supported by HMRF Research on COVID-19, the Hong Kong Special Administrative Region (HKSAR) Government (Principal Investigator (WP2): EWC; ref. no. COVID1903011). ICKW and FTTL are partially supported by the Laboratory of Data Discovery for |
Additional Information: | Copyright © 2024. The Author(s). This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit https://creativecommons.org/licenses/by-nc/4.0/ |
Publication ISSN: | 1179-1942 |
Last Modified: | 16 Aug 2024 07:18 |
Date Deposited: | 05 Aug 2024 17:01 |
Full Text Link: | |
Related URLs: |
https://link.sp ... 264-024-01450-4
(Publisher URL) http://www.scop ... tnerID=8YFLogxK (Scopus URL) |
PURE Output Type: | Article |
Published Date: | 2024-06-25 |
Published Online Date: | 2024-06-25 |
Accepted Date: | 2024-05-28 |
Authors: |
Yan, Vincent Ka Chun
Yang, Yu Wan, Eric Yuk Fai Lai, Francisco Tsz Tsun Chui, Celine Sze Ling Wong, Carlos King Ho Hung, Ivan Fan Ngai Lau, Chak Sing Wong, Ian Chi Kei ( ![]() Chan, Esther Wai Yin |