bebetelovimab与Nirmatrelvir/Ritonavir在COVID-19门诊患者中的实际疗效

IF 2.3 Q2 RESPIRATORY SYSTEM

Pulmonary Therapy Pub Date : 2024-12-25 DOI:10.1007/s41030-024-00284-w

Christopher G Rowan, Russell M Nichols, Neil Dhopeshwarkar, Jennifer M Alyea, Baojin Zhu, Sengwee Toh, K Arnold Chan, Elsie L Grace

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引用次数: 0

摘要

这项现实世界的研究评估了贝特洛维单抗（bebetelovimab， BEB）与尼马特韦/利托那韦（nirmatrelvir/ritonavir， NR）在欧米克隆变异时代门诊COVID-19患者中的有效性。方法：我们进行了一项队列研究，评估了2022年2月至8月（研究期间）接受BEB或NR治疗的患者。治疗后第1天开始随访，持续30天。使用来自TriNetX Dataworks USA的去识别电子健康记录数据构建队列。该研究使用风险差异（RD）和95%置信区间（95% CI）评估30天全因住院或死亡（复合）。结果：未匹配的队列包括12,920名BEB治疗患者和70,741名nr治疗患者。在对关键基线协变量（年龄0 ~ 65岁、免疫功能低下、近期急诊就诊和COVID-19疫苗接种）进行精确匹配后，在更广泛的协变量集上进行高维倾向评分匹配（1:1），每个队列纳入5827例患者。与匹配前的nr治疗患者相比，beb治疗的患者年龄更大，有更多的合并症。匹配后，基线特征平衡良好。BEB和NR的主要结局（住院或死亡）累积发生率分别为2.0%和1.8% (RD为0.2%；95% ci - 0.3%, 0.7%)。RD 95% CI的上界（0.7%）排除了非劣效性边际（1.795%），表明BEB并不逊于NR。次要结局的RD为（BEB vs NR）：住院(RD 0.1%；95% ci - 0.4%, 0.6%)；ED探访(RD 0.5%；95% ci - 0.3%, 1.3%)；死亡率为0.09%；95% ci - 0.003%, 0.2%)。亚组、敏感性和关联分析（EHR +索赔+死亡率数据）的结果与主要结果一致。结论：在30天全因住院或死亡方面，BEB治疗不低于NR治疗。与NR相比，BEB患者的次要结局风险没有差异。

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Real-World Effectiveness of Bebtelovimab Versus Nirmatrelvir/Ritonavir in Outpatients with COVID-19.

Introduction: This real-world study assessed the effectiveness of bebtelovimab (BEB) versus nirmatrelvir/ritonavir (NR) among outpatients with COVID-19 during the Omicron variant era.

Methods: We conducted a cohort study evaluating patients treated with BEB or NR from February to August 2022 (study period). Follow-up began the day after treatment and continued for 30 days. Cohorts were constructed using de-identified electronic health record data from TriNetX Dataworks USA. The study assessed 30-day all-cause hospitalization or death (composite) using the risk difference (RD) and 95% confidence interval (95% CI).

Results: Unmatched cohorts included 12,920 BEB- and 70,741 NR-treated patients. After exact matching on key baseline covariates (age > 65 years, immunocompromised, recent emergency department [ED] visit, and COVID-19 vaccination) and high-dimensional propensity score matching (1:1) on a broader set of covariates, 5827 patients were included in each cohort. BEB-treated patients were older and had more comorbidities compared to NR-treated patients prior to matching. After matching, baseline characteristics were well balanced. The cumulative incidence of the primary outcome (hospitalization or death) was 2.0% and 1.8% for BEB and NR, respectively (RD 0.2%; 95% CI - 0.3%, 0.7%). The upper bound of the RD 95% CI (0.7%) excluded the noninferiority margin (1.795%), demonstrating that BEB was not inferior to NR. The RDs of the secondary outcomes were (BEB vs NR): hospitalization (RD 0.1%; 95% CI - 0.4%, 0.6%); ED visit (RD 0.5%; 95% CI - 0.3%, 1.3%); and death (RD 0.09%; 95% CI - 0.003%, 0.2%). Results from subgroup, sensitivity, and linked analyses (EHR + claims + mortality data) were consistent with the main results.

Conclusion: Treatment with BEB was not inferior to NR with respect to 30-day all-cause hospitalization or death. The risk of secondary outcomes was not different for patients treated with BEB compared to NR.

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来源期刊

Pulmonary Therapy Medicine-Pulmonary and Respiratory Medicine

CiteScore

5.20

自引率

3.30%

发文量

审稿时长

6 weeks

期刊介绍： Aims and Scope Pulmonary Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from pre-clinical, clinical (all phases), observational, real-world, and health outcomes research around the use of pulmonary therapies, devices, and surgical techniques. Areas of focus include, but are not limited to: asthma; chronic obstructive pulmonary disease; idiopathic pulmonary fibrosis; pulmonary hypertension; cystic fibrosis; lung cancer; respiratory tract disorders; allergic rhinitis and other respiratory allergies; influenza, pneumococcal infection, respiratory syncytial virus and other respiratory infections; and inhalers and other device therapies. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/series, trial protocols and short communications such as commentaries and editorials. Pulmonary Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. Rapid Publication The journal’s publication timelines aim for a rapid peer review of 2 weeks. If an article is accepted it will be published 3–4 weeks from acceptance. The rapid timelines are achieved through the combination of a dedicated in-house editorial team, who manage article workflow, and an extensive Editorial and Advisory Board who assist with peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid, efficient communication of the latest research and reviews, fostering the advancement of pulmonary therapies. Open Access All articles published by Pulmonary Therapy are open access. Personal Service The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning authors will always have an editorial contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE, GPP and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research. 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