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

IF 4 2区医学 Q1 PHARMACOLOGY & PHARMACY

Drug Safety Pub Date : 2024-10-01 Epub Date: 2024-06-25 DOI:10.1007/s40264-024-01450-4

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, Esther Wai Yin Chan

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引用次数: 0

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.

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Tixagevimab-Cilgavimab 的真实世界有效性和安全性：目标试验模拟研究

背景：免疫力低下的人极易感染严重急性呼吸系统综合征冠状病毒 2（SARS-CoV-2），继而引发严重或致命的冠状病毒病 2019（COVID-19），但他们对 mRNA 和 COVID-19 灭活疫苗的反应却不理想。tixagevimab-cilgavimab 在减少无症状 SARS-CoV-2 感染方面的疗效已在 III 期临床试验中得到证实。然而，有关 tixagevimab-cilgavimab 的有效性和安全性的实际数据仍然有限：目的：评估替沙吉单抗-西格维单抗在免疫力低下人群中的有效性和安全性：方法：利用全港范围内的电子健康记录，将免疫功能低下或正在接受免疫抑制疗法的成年人纳入目标试验模拟中。方法：利用全港电子病历将免疫功能低下或正在接受免疫抑制治疗的成年人纳入目标试验仿真，并采用顺序试验仿真法比较接受了 tixagevimab-cilgavimab 和未接受 tixagevimab-cilgavimab 的个体之间的有效性和安全性结果：结果：从2022年5月1日至2022年11月30日，共纳入了746名接受tixagevimab-cilgavimab治疗的患者和2980名对照组患者。在中位随访60天期间，tixagevimab-cilgavimab可显著降低COVID-19感染风险（危险比[HR]0.708，95%置信区间[CI]0.527-0.951）。在与COVID-19相关的住院风险方面没有观察到明显差异。在tixagevimab-cilgavimab受试者和对照组中分别观察到0例和8例COVID-19死亡病例以及0例和2例严重COVID-19病例。值得注意的是，在既往接种过三针或三针以上COVID-19疫苗或既往无COVID-19感染史的免疫力低下者中，也观察到COVID-19感染风险明显降低：结论：Tixagevimab-cilgavimab能有效降低Omicron波期间免疫力低下患者的COVID-19感染率。在之前接种过三针或三针以上COVID-19疫苗或之前没有COVID-19感染史的患者中，研究结果是一致的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drug Safety 医学-毒理学

CiteScore

7.60

自引率

7.10%

发文量

112

审稿时长

6-12 weeks

期刊介绍： Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.