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Doubtful Clinical Benefit of Casirivimab-Imdevimab Treatment for Disease Severity Outcome of High-Risk Patients with SARS-CoV-2 Delta Variant Infection
medRxiv - Emergency Medicine Pub Date : 2022-01-31 , DOI: 10.1101/2022.01.29.22270090
Noah Shopen , Michal Dekel , Michal Mizrahi , Efrat Zandberg , Nancy Bishouty , Daniel Talmud , Ben Vaknin , Shira Haberman , Malka Katz Shalhav , David Zeltser , Neta Cohen

Casirivimab/Imdevimab therapy reportedly retains neutralization potency against circulating SARS-CoV-2 variants, including Delta (B.1.617.2), but there are sparse data on its clinical benefit against the Delta variant among vaccinated and unvaccinated patients. We explored its therapeutic effect on COVID-19 severity outcome in terms of room air saturation <93% within 14 days of initial presentation and 45-day all-cause mortality among high-risk patients with SARS-CoV-2 Delta variant infection and compared its effect between vaccinated and unvaccinated patients. We conducted a retrospective cohort study at a tertiary care medical center between 6/2021 and 9/2021 and included patients who presented with a positive PCR for SARS-CoV-2 and fulfilled the criteria for Casirivimab/Imdevimab treatment. Of the 359 suitable patients (52% female, median age 63 years), 116 were treated with Casirivimab/Imdevimab and 243 were not. Two-hundred and one (56%) patients had received at least 2 SARS-CoV-2 vaccinations. Casirivimab/Imdevimab treatment was not an independent protective factor of COVID-19 severity outcome (multivariable analysis). Chronic kidney disease (aOR=3.51 [95%CI: 1.34-9.20], P=0.01), lower saturation levels (aOR=0.7 [95%CI: 0.58–0.85], P<0.01), abnormal chest x-ray findings (aOR=2.92, [95%CI: 1.24–6.87, P=0.01), and higher C-reactive protein levels (aOR=1.01 [95%CI: 1.00–1.01], P=0.008) were independent risk factors of COVID-19 severity. Positive immunization status was an independent protective factor (aOR=0.33 [95%CI: 0.14–0.77], P=0.01). A sub analysis of patients treated with Casirivimab/Imdevimab revealed no significant difference in COVID-19 severity between vaccinated and unvaccinated patients. These findings demonstrate no added benefit of Casrivimab/Imdevinab treatment for high-risk patients with the SARS-CoV-2 Delta variant infection, regardless of their vaccination status.

中文翻译:

Casirivimab-Imdevimab 治疗对 SARS-CoV-2 Delta 变异感染高危患者疾病严重程度结果的可疑临床益处

据报道,Casirivimab/Imdevimab 疗法保留了对循环 SARS-CoV-2 变体(包括 Delta (B.1.617.2))的中和效力,但在接种疫苗和未接种疫苗的患者中,关于其对 Delta 变体的临床益处的数据很少。我们探讨了其对 SARS-CoV-2 Delta 变异感染高危患者 14 天内室内空气饱和度 <93% 和 45 天全因死亡率的治疗效果,并比较它在接种疫苗和未接种疫苗的患者之间的影响。我们于 2021 年 6 月至 2021 年 9 月在一家三级医疗中心进行了一项回顾性队列研究,纳入了 SARS-CoV-2 PCR 呈阳性并符合卡西瑞单抗/艾姆德单抗治疗标准的患者。在 359 名合适的患者中(52% 为女性,中位年龄 63 岁),116 人接受了卡西瑞单抗/艾姆德单抗治疗,243 人未接受治疗。201 名 (56%) 患者至少接种了 2 次 SARS-CoV-2 疫苗。Casirivimab/Imdevimab 治疗不是 COVID-19 严重程度结果的独立保护因素(多变量分析)。慢性肾病(aOR=3.51 [95%CI: 1.34-9.20],P = 0.01),较低的饱和度(aOR=0.7 [95%CI: 0.58–0.85], P <0.01),异常的胸部 X 线检查结果(aOR=2.92, [95%CI: 1.24–6.87, P= 0.01 ) 和较高的 C 反应蛋白水平 (aOR=1.01 [95%CI: 1.00–1.01], P = 0.008) 是 COVID-19 严重程度的独立危险因素。阳性免疫状态是一个独立的保护因素(aOR=0.33 [95%CI: 0.14-0.77],P = 0.01)。对接受 Casirivimab/Imdeimab 治疗的患者进行的子分析显示,接种疫苗和未接种疫苗的患者在 COVID-19 严重程度方面没有显着差异。这些研究结果表明,无论其疫苗接种状态如何,Casrivimab/Imdevinab 治疗对 SARS-CoV-2 Delta 变异感染的高危患者没有额外的益处。
更新日期:2022-02-02
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