Clinical outcomes in patients with mild to moderate coronavirus disease 2019 treated with monoclonal antibody therapy versus an untreated control cohort.

IF 1.3 4区医学 Q4 INFECTIOUS DISEASES Antiviral Therapy Pub Date : 2024-08-01 DOI:10.1177/13596535241264694

Courtney N Nichols, Mark Lustberg, Mohammed Mahdee E Sobhanie, Lucia J Niermann, Melissa Gordon, Nicholas Kman, Jonathan Parsons, Mark Conroy, Michael Dick, James Allen, Erica Reed, Joy Lehman, Carlos Malvestutto

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Abstract

Background: Monoclonal antibody therapy (MAT) received Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for mild to moderate COVID-19 treatment in adults at a high-risk for progression to severe disease in November 2020. This study assessed the impact of MAT on clinical outcomes.

Methods: We conducted a single-center, retrospective study comparing 30-day COVID-19-related emergency department (ED) visits, admissions, and mortality in patients receiving MAT (bamlanivimab, bamlanivimab-etesevimab, or casirivimab-imdevimab) between 16 November 2020 and 19 June 2021, compared to a control group of high-risk adults diagnosed with mild to moderate COVID-19 prior to MAT availability between 16 May 2020 and 15 November 2020. Statistical analysis used logistic regression analysis with backward selection to determine the odds ratios and 95% confidence interval evaluating the relationship between clinical characteristics and outcomes.

Results: 1187 patients who received MAT were compared to 1103 patients not treated with MAT. Multivariable regression model adjusted for possible confounders showed patients who received MAT had lower rates of ED visits (3.2% vs 7.4%, OR = 0.46, 95% CI = 0.31-0.70, p < .001) and hospital admissions (4.3% vs 7.8%, OR = 0.42, 95% CI = 0.29-0.62, p < .001) compared to the control group. After adjusting for confounders, MAT was associated with decreased mortality (OR = 0.36, p = .035). In the MAT group, those treated within 2 days of COVID-19 diagnosis had lower mortality than those treated more than 2 days post-diagnosis (unadjusted OR = 0.152, 95% CI = 0.031-0.734, p = .019).

Conclusions: Individuals treated with MAT had lower rates of 30-day COVID-19-related ED visits and hospital admissions compared to those not receiving MAT. Early MAT resulted in lower 30-day mortality compared to receipt >2 days post COVID-19 diagnosis.

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2019 年接受单克隆抗体疗法治疗的轻度至中度冠状病毒患者与未接受治疗的对照组患者的临床疗效对比。

背景：单克隆抗体疗法（MAT2020年11月，单克隆抗体疗法（MAT）获得了美国食品和药物管理局（FDA）的紧急使用授权（EUA），可用于轻度至中度COVID-19的治疗，适用于有发展为重症风险的成人。本研究评估了 MAT 对临床结果的影响：我们进行了一项单中心回顾性研究，比较了在 2020 年 11 月 16 日至 2021 年 6 月 19 日期间接受 MAT（bamlanivimab、bamlanivimab-etesevimab 或 casirivimab-imdevimab）治疗的患者与 2020 年 5 月 16 日至 2020 年 11 月 15 日 MAT 上市前诊断为轻度至中度 COVID-19 的高危成人对照组的 30 天 COVID-19 相关急诊就诊、入院和死亡率。统计分析采用反向选择的逻辑回归分析，以确定评估临床特征与结果之间关系的几率比和95%置信区间：1187 名接受 MAT 治疗的患者与 1103 名未接受 MAT 治疗的患者进行了比较。根据可能的混杂因素调整后的多变量回归模型显示，与对照组相比，接受 MAT 治疗的患者的急诊室就诊率（3.2% vs 7.4%，OR = 0.46，95% CI = 0.31-0.70，p < .001）和住院率（4.3% vs 7.8%，OR = 0.42，95% CI = 0.29-0.62，p < .001）较低。在对混杂因素进行调整后，MAT 与死亡率下降有关（OR = 0.36，p = 0.035）。在 MAT 组中，COVID-19 诊断后 2 天内接受治疗者的死亡率低于诊断后 2 天以上接受治疗者（未调整 OR = 0.152，95% CI = 0.031-0.734，p = .019）：结论：与未接受 MAT 治疗的患者相比，接受 MAT 治疗的患者 30 天内 COVID-19 相关的急诊就诊率和住院率较低。与 COVID-19 诊断后 2 天以上接受 MAT 治疗的患者相比，早期接受 MAT 治疗的患者 30 天死亡率较低。

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

Antiviral Therapy 医学-病毒学

CiteScore

2.60

自引率

8.30%

发文量

审稿时长

4-8 weeks

期刊介绍： Antiviral Therapy (an official publication of the International Society of Antiviral Research) is an international, peer-reviewed journal devoted to publishing articles on the clinical development and use of antiviral agents and vaccines, and the treatment of all viral diseases. Antiviral Therapy is one of the leading journals in virology and infectious diseases. The journal is comprehensive, and publishes articles concerning all clinical aspects of antiviral therapy. It features editorials, original research papers, specially commissioned review articles, letters and book reviews. The journal is aimed at physicians and specialists interested in clinical and basic research.