Myriam Drysdale, Evgeniy R Galimov, Marcus James Yarwood, Vishal Patel, Bethany Levick, Daniel C Gibbons, Jonathan D Watkins, Sophie Young, Benjamin F Pierce, Emily J Lloyd, William Kerr, Helen J Birch, Tahereh Kamalati, Stephen J Brett
{"title":"伦敦西北部非住院治疗的 COVID-19 高危患者使用索托维单抗与不使用索托维单抗的疗效比较:一项回顾性队列研究","authors":"Myriam Drysdale, Evgeniy R Galimov, Marcus James Yarwood, Vishal Patel, Bethany Levick, Daniel C Gibbons, Jonathan D Watkins, Sophie Young, Benjamin F Pierce, Emily J Lloyd, William Kerr, Helen J Birch, Tahereh Kamalati, Stephen J Brett","doi":"10.1136/bmjresp-2023-002238","DOIUrl":null,"url":null,"abstract":"Background We assessed the effectiveness of sotrovimab vs no early COVID-19 treatment in highest-risk COVID-19 patients during Omicron predominance. Methods Retrospective cohort study using the Discover dataset in North West London. Included patients were non-hospitalised, aged ≥12 years and met ≥1 National Health Service highest-risk criterion for sotrovimab treatment. We used Cox proportional hazards models to compare HRs of 28-day COVID-19-related hospitalisation/death between highest-risk sotrovimab-treated and untreated patients. Age, renal disease and Omicron subvariant subgroup analyses were performed. Results We included 599 sotrovimab-treated patients and 5191 untreated patients. Compared with untreated patients, the risk of COVID-19 hospitalisation/death (HR 0.50, 95% CI 0.24, 1.06; p=0.07) and the risk of COVID-19 hospitalisation (HR 0.43, 95% CI 0.18, 1.00; p=0.051) were both lower in the sotrovimab-treated group; however, statistical significance was not reached. In the ≥65 years and renal disease subgroups, sotrovimab was associated with a significantly reduced risk of COVID-19 hospitalisation, by 89% (HR 0.11, 95% CI 0.02, 0.82; p=0.03) and 82% (HR 0.18, 95% CI 0.05, 0.62; p=0.007), respectively. Conclusions Risk of COVID-19 hospitalisation in sotrovimab-treated patients aged ≥65 years and with renal disease was significantly lower compared with untreated patients. Overall, risk of hospitalisation was also lower for sotrovimab-treated patients, but statistical significance was not reached. Data are available upon reasonable request. The Discover data that support the findings of this study are available from Imperial College Health Partners via approval from the Discover Data Research Access Group (DRAG) under certain restrictions.","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"240 1","pages":""},"PeriodicalIF":3.6000,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comparative effectiveness of sotrovimab versus no treatment in non-hospitalised high-risk COVID-19 patients in north west London: a retrospective cohort study\",\"authors\":\"Myriam Drysdale, Evgeniy R Galimov, Marcus James Yarwood, Vishal Patel, Bethany Levick, Daniel C Gibbons, Jonathan D Watkins, Sophie Young, Benjamin F Pierce, Emily J Lloyd, William Kerr, Helen J Birch, Tahereh Kamalati, Stephen J Brett\",\"doi\":\"10.1136/bmjresp-2023-002238\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Background We assessed the effectiveness of sotrovimab vs no early COVID-19 treatment in highest-risk COVID-19 patients during Omicron predominance. Methods Retrospective cohort study using the Discover dataset in North West London. Included patients were non-hospitalised, aged ≥12 years and met ≥1 National Health Service highest-risk criterion for sotrovimab treatment. We used Cox proportional hazards models to compare HRs of 28-day COVID-19-related hospitalisation/death between highest-risk sotrovimab-treated and untreated patients. Age, renal disease and Omicron subvariant subgroup analyses were performed. Results We included 599 sotrovimab-treated patients and 5191 untreated patients. Compared with untreated patients, the risk of COVID-19 hospitalisation/death (HR 0.50, 95% CI 0.24, 1.06; p=0.07) and the risk of COVID-19 hospitalisation (HR 0.43, 95% CI 0.18, 1.00; p=0.051) were both lower in the sotrovimab-treated group; however, statistical significance was not reached. In the ≥65 years and renal disease subgroups, sotrovimab was associated with a significantly reduced risk of COVID-19 hospitalisation, by 89% (HR 0.11, 95% CI 0.02, 0.82; p=0.03) and 82% (HR 0.18, 95% CI 0.05, 0.62; p=0.007), respectively. Conclusions Risk of COVID-19 hospitalisation in sotrovimab-treated patients aged ≥65 years and with renal disease was significantly lower compared with untreated patients. Overall, risk of hospitalisation was also lower for sotrovimab-treated patients, but statistical significance was not reached. Data are available upon reasonable request. The Discover data that support the findings of this study are available from Imperial College Health Partners via approval from the Discover Data Research Access Group (DRAG) under certain restrictions.\",\"PeriodicalId\":9048,\"journal\":{\"name\":\"BMJ Open Respiratory Research\",\"volume\":\"240 1\",\"pages\":\"\"},\"PeriodicalIF\":3.6000,\"publicationDate\":\"2024-04-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMJ Open Respiratory Research\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1136/bmjresp-2023-002238\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"RESPIRATORY SYSTEM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMJ Open Respiratory Research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1136/bmjresp-2023-002238","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"RESPIRATORY SYSTEM","Score":null,"Total":0}
引用次数: 0
摘要
背景 我们评估了索托维单抗与不进行早期 COVID-19 治疗的效果,索托维单抗适用于 Omicron 优势期的高风险 COVID-19 患者。方法 使用伦敦西北部的发现数据集进行回顾性队列研究。纳入的患者均未住院,年龄≥12 岁,且符合≥1 项国家卫生服务局索托维单抗治疗最高风险标准。我们使用 Cox 比例危险模型比较了最高风险索托维单抗治疗患者和未治疗患者 28 天 COVID-19 相关住院/死亡的 HRs。还进行了年龄、肾病和 Omicron 亚变量亚组分析。结果 我们纳入了 599 例索托维单抗治疗患者和 5191 例未治疗患者。与未经治疗的患者相比,索托维单抗治疗组的COVID-19住院/死亡风险(HR 0.50,95% CI 0.24,1.06;P=0.07)和COVID-19住院风险(HR 0.43,95% CI 0.18,1.00;P=0.051)均较低,但未达到统计学意义。在≥65岁和肾脏疾病亚组中,索托维单抗与COVID-19住院风险显著降低相关,分别降低了89%(HR 0.11,95% CI 0.02,0.82;P=0.03)和82%(HR 0.18,95% CI 0.05,0.62;P=0.007)。结论 与未接受治疗的患者相比,年龄≥65岁且患有肾病的索托维单抗治疗患者的COVID-19住院风险显著降低。总体而言,索托维单抗治疗患者的住院风险也较低,但未达到统计学意义。如有合理要求,可提供相关数据。在某些限制条件下,经发现数据研究访问组 (DRAG) 批准,可从帝国理工学院健康合作伙伴处获得支持本研究结果的发现数据。
Comparative effectiveness of sotrovimab versus no treatment in non-hospitalised high-risk COVID-19 patients in north west London: a retrospective cohort study
Background We assessed the effectiveness of sotrovimab vs no early COVID-19 treatment in highest-risk COVID-19 patients during Omicron predominance. Methods Retrospective cohort study using the Discover dataset in North West London. Included patients were non-hospitalised, aged ≥12 years and met ≥1 National Health Service highest-risk criterion for sotrovimab treatment. We used Cox proportional hazards models to compare HRs of 28-day COVID-19-related hospitalisation/death between highest-risk sotrovimab-treated and untreated patients. Age, renal disease and Omicron subvariant subgroup analyses were performed. Results We included 599 sotrovimab-treated patients and 5191 untreated patients. Compared with untreated patients, the risk of COVID-19 hospitalisation/death (HR 0.50, 95% CI 0.24, 1.06; p=0.07) and the risk of COVID-19 hospitalisation (HR 0.43, 95% CI 0.18, 1.00; p=0.051) were both lower in the sotrovimab-treated group; however, statistical significance was not reached. In the ≥65 years and renal disease subgroups, sotrovimab was associated with a significantly reduced risk of COVID-19 hospitalisation, by 89% (HR 0.11, 95% CI 0.02, 0.82; p=0.03) and 82% (HR 0.18, 95% CI 0.05, 0.62; p=0.007), respectively. Conclusions Risk of COVID-19 hospitalisation in sotrovimab-treated patients aged ≥65 years and with renal disease was significantly lower compared with untreated patients. Overall, risk of hospitalisation was also lower for sotrovimab-treated patients, but statistical significance was not reached. Data are available upon reasonable request. The Discover data that support the findings of this study are available from Imperial College Health Partners via approval from the Discover Data Research Access Group (DRAG) under certain restrictions.
期刊介绍:
BMJ Open Respiratory Research is a peer-reviewed, open access journal publishing respiratory and critical care medicine. It is the sister journal to Thorax and co-owned by the British Thoracic Society and BMJ. The journal focuses on robustness of methodology and scientific rigour with less emphasis on novelty or perceived impact. BMJ Open Respiratory Research operates a rapid review process, with continuous publication online, ensuring timely, up-to-date research is available worldwide. The journal publishes review articles and all research study types: Basic science including laboratory based experiments and animal models, Pilot studies or proof of concept, Observational studies, Study protocols, Registries, Clinical trials from phase I to multicentre randomised clinical trials, Systematic reviews and meta-analyses.