PDF(Pubmed)
Abstract：
OBJECTIVE: There is a scarcity of data on the outcomes and predictors of therapeutic failure of monoclonal antibodies (mAbs) in frail patients with COVID-19.
METHODS: Prospective study including consecutive COVID-19 outpatients referred by primary care physicians for mAb treatment. The outcomes evaluated were 60-day mortality, time to SARS-CoV-2 clearance, need for hospitalization, and O2 therapy.
RESULTS: Among 1026 COVID-19 patients enrolled, 60.2% received casirivamab/imdevimab and 39.8% sotrivimab. Median age was 63 years, 52.4% were males and median time from positive nasopharyngeal swab to mAbs administration was 3 days (interquartile range, 2-5). 78.1% were vaccinated. Overall, the 60-day mortality was 2.14%. No differences in outcomes were observed between the two mAbs used. No difference was observed in mortality between vaccinated and unvaccinated patients (P = 0.925); although, lower rate of hospitalization (P <0.005), less need for O2 therapy (P <0.0001) and reduced nasopharyngeal swab negativity time (P <0.0001) were observed in vaccinated patients. Early administration of mAbs was associated with lower mortality (P <0.007), whereas corticosteroid use worsened prognosis (P <0.004). The independent predictors associated with higher mortality were older age (P <0.0001), presence of active hematologic malignancies (P <0.0001), renal failure (P <0.041), and need for O2 therapy (P <0.001).
CONCLUSIONS: This study shows similar effectiveness among mAbs used, regardless of vaccination status and identifies patients with COVID-19 in whom mAbs have poor activity.
METHODS: Prospective study including consecutive COVID-19 outpatients referred by primary care physicians for mAb treatment. The outcomes evaluated were 60-day mortality, time to SARS-CoV-2 clearance, need for hospitalization, and O2 therapy.
RESULTS: Among 1026 COVID-19 patients enrolled, 60.2% received casirivamab/imdevimab and 39.8% sotrivimab. Median age was 63 years, 52.4% were males and median time from positive nasopharyngeal swab to mAbs administration was 3 days (interquartile range, 2-5). 78.1% were vaccinated. Overall, the 60-day mortality was 2.14%. No differences in outcomes were observed between the two mAbs used. No difference was observed in mortality between vaccinated and unvaccinated patients (P = 0.925); although, lower rate of hospitalization (P <0.005), less need for O2 therapy (P <0.0001) and reduced nasopharyngeal swab negativity time (P <0.0001) were observed in vaccinated patients. Early administration of mAbs was associated with lower mortality (P <0.007), whereas corticosteroid use worsened prognosis (P <0.004). The independent predictors associated with higher mortality were older age (P <0.0001), presence of active hematologic malignancies (P <0.0001), renal failure (P <0.041), and need for O2 therapy (P <0.001).
CONCLUSIONS: This study shows similar effectiveness among mAbs used, regardless of vaccination status and identifies patients with COVID-19 in whom mAbs have poor activity.
摘要：
背景：关于脆弱的COVID-19患者中mAb治疗失败的结果和预测因素的数据很少。
方法：前瞻性研究，包括由初级保健医生转诊的连续COVID-19门诊患者进行单克隆抗体治疗。评估的结果是60天死亡率，SARS-CoV-2清除时间到了，需要住院治疗，和氧气疗法。
结果：在1026例COVID-19患者中，60.2%的患者接受了卡西利瓦单抗/imdevimab和39.8%的sotrivimab。中位年龄为63岁,52.4%为男性，从鼻咽拭子阳性到单克隆抗体给药的中位时间为3天[IQR，2-5].78.1%接种疫苗。总的来说,60天死亡率为2.14%。在使用的两种mAb之间没有观察到结果的差异。接种疫苗和未接种疫苗的患者之间的死亡率没有差异（p=0.925）。虽然住院率较低(p<0.005)，在接种疫苗中观察到O2治疗的需要减少(p<0.0001)和鼻咽拭子阴性时间减少(p<0.0001).早期给予mAb与较低的死亡率相关（p<0.007），而使用皮质类固醇会使预后恶化（p<0.004）。与较高死亡率相关的独立预测因素是年龄较大（p<0.0001），存在活动性血液恶性肿瘤（p<0.0001），肾功能衰竭（p<0.041）和需要O2治疗（p<0.001）。
结论：这项研究显示，无论疫苗接种状态如何，使用的单克隆抗体的有效性相似，并确定了单克隆抗体活性较差的COVID-19患者。
方法：前瞻性研究，包括由初级保健医生转诊的连续COVID-19门诊患者进行单克隆抗体治疗。评估的结果是60天死亡率，SARS-CoV-2清除时间到了，需要住院治疗，和氧气疗法。
结果：在1026例COVID-19患者中，60.2%的患者接受了卡西利瓦单抗/imdevimab和39.8%的sotrivimab。中位年龄为63岁,52.4%为男性，从鼻咽拭子阳性到单克隆抗体给药的中位时间为3天[IQR，2-5].78.1%接种疫苗。总的来说,60天死亡率为2.14%。在使用的两种mAb之间没有观察到结果的差异。接种疫苗和未接种疫苗的患者之间的死亡率没有差异（p=0.925）。虽然住院率较低(p<0.005)，在接种疫苗中观察到O2治疗的需要减少(p<0.0001)和鼻咽拭子阴性时间减少(p<0.0001).早期给予mAb与较低的死亡率相关（p<0.007），而使用皮质类固醇会使预后恶化（p<0.004）。与较高死亡率相关的独立预测因素是年龄较大（p<0.0001），存在活动性血液恶性肿瘤（p<0.0001），肾功能衰竭（p<0.041）和需要O2治疗（p<0.001）。
结论：这项研究显示，无论疫苗接种状态如何，使用的单克隆抗体的有效性相似，并确定了单克隆抗体活性较差的COVID-19患者。
