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索托维单抗治疗血液系统恶性肿瘤患者在 BA.1 奥密克戎浪潮中住院的 2019 年冠状病毒病的预测因素。

Predictors of Coronavirus Disease 2019 Hospitalization After Sotrovimab in Patients With Hematologic Malignancy During the BA.1 Omicron Surge.

机构信息

Infection Control, Memorial Sloan Kettering Cancer Center, New York, New York, USA.

Department of Pharmacy, Memorial Sloan Kettering Cancer Center, New York, New York, USA.

出版信息

Clin Infect Dis. 2023 Apr 17;76(8):1476-1482. doi: 10.1093/cid/ciac916.

Abstract

BACKGROUND

Sotrovimab is an anti-spike neutralization monoclonal antibody developed to reduce the risk of coronavirus disease 2019 (COVID-19) progression and advancement to hospitalization in high-risk patients. Currently, there is limited research describing the association of sotrovimab treatment in patients with hematologic malignancy and the predictive factors of hospitalization.

METHODS

We performed an observational study of 156 consecutive cancer patients who received sotrovimab at Memorial Sloan Kettering Cancer Center in New York City during the BA.1 Omicron surge. We evaluated the demographic, clinical, and laboratory characteristics of the patients who had subsequent COVID-19-related hospitalization(s) compared to those who did not.

RESULTS

Among the 156 study patients, 17 (11%) were hospitalized, of whom 4 were readmitted for COVID-19-related complications; 3 deaths were attributed to COVID-19. Results from multivariable logistic regression show that significant factors associated with hospitalization include patients on anti-CD20 therapy (adjusted odds ratio [aOR], 5.59 [95% confidence interval {CI}, 1.73-18.12]; P = .004) and with relapse/refractory disease (aOR, 5.69 [95% CI, 1.69-19.16]; P = .005). Additionally, whole genome sequencing of severe acute respiratory syndrome coronavirus 2 detected high occurrences of mutations in the spike gene associated with treatment-related resistance longitudinal samples from 11 patients treated with sotrovimab.

CONCLUSIONS

While sotrovimab is effective at reducing COVID-19 hospitalization and disease severity in patients with hematologic malignancy when administered early, patients who received anti-CD20 antibodies showed substantial morbidity. Due to the high potential for resistance mutation to sotrovimab and increased morbidity in patients on anti-CD20 therapy, combination treatment should be explored to determine whether it provides added benefits compared to monotherapy.

摘要

背景

Sotrovimab 是一种针对刺突的中和单克隆抗体,旨在降低 2019 年冠状病毒病(COVID-19)高危患者进展和住院的风险。目前,关于接受血液恶性肿瘤治疗的患者接受 sotrovimab 治疗的相关性以及住院的预测因素的研究有限。

方法

我们对在纽约市 Memorial Sloan Kettering 癌症中心接受 sotrovimab 治疗的 156 例连续癌症患者进行了一项观察性研究,这些患者均处于 BA.1 奥密克戎激增期间。我们评估了随后发生 COVID-19 相关住院(s)的患者与未住院的患者的人口统计学、临床和实验室特征。

结果

在 156 例研究患者中,有 17 例(11%)住院,其中 4 例因 COVID-19 相关并发症再次入院;3 例死亡归因于 COVID-19。多变量逻辑回归的结果表明,与住院相关的显著因素包括接受抗 CD20 治疗的患者(调整后的优势比[aOR],5.59[95%置信区间{CI},1.73-18.12];P =.004)和疾病复发/难治性患者(aOR,5.69[95%CI,1.69-19.16];P =.005)。此外,对 11 例接受 sotrovimab 治疗的患者的纵向样本进行了严重急性呼吸综合征冠状病毒 2 的全基因组测序,发现刺突基因中与治疗相关耐药性相关的突变发生率较高。

结论

尽管 sotrovimab 在早期给予血液恶性肿瘤患者时可有效降低 COVID-19 住院和疾病严重程度,但接受抗 CD20 抗体治疗的患者发病率较高。由于 sotrovimab 耐药性突变的高风险以及接受抗 CD20 治疗的患者发病率增加,应探索联合治疗,以确定与单药治疗相比是否具有额外的益处。

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