Vita-Salute San Raffaele University, Milan, Italy; Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele Scientific Institute, Milan, Italy.
Vita-Salute San Raffaele University, Milan, Italy; Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele Scientific Institute, Milan, Italy.
Eur J Intern Med. 2020 Jun;76:43-49. doi: 10.1016/j.ejim.2020.05.021. Epub 2020 May 22.
Tocilizumab (TCZ), a humanized monoclonal antibody targeting the interleukin-6 (IL-6) receptor, has been proposed for the treatment of COVID-19 patients; however, limited data are available on the safety and efficacy.
We performed a retrospective study on severe COVID-19 patients with hyper-inflammatory features admitted outside intensive care units (ICUs). Patients treated with intravenous TCZ in addition to standard of care were compared to patients treated with standard of care alone. Safety and efficacy were assessed over a 28-day follow-up.
65 patients were included. Among them, 32 were treated with TCZ. At baseline, all patients were on high-flow supplemental oxygen and most (78% of TCZ patients and 61% of standard treatment patients) were on non-invasive ventilation. During the 28-day follow-up, 69% of TCZ patients experienced a clinical improvement compared to 61% of standard treatment patients (p = 0.61). Mortality was 15% in the tocilizumab group and 33% in standard treatment group (p = 0.15). In TCZ group, at multivariate analysis, older age was a predictor of death, whereas higher baseline PaO2:FiO2 was a predictor of clinical improvement at day 28. The rate of infection and pulmonary thrombosis was similar between the two groups.
At day 28, clinical improvement and mortality were not statistically different between tocilizumab and standard treatment patients in our cohort. Bacterial or fungal infections were recorded in 13% of tocilizumab patients and in 12% of standard treatment patients. Confirmation of efficacy and safety will require ongoing controlled trials.
托珠单抗(TCZ)是一种针对白细胞介素 6(IL-6)受体的人源化单克隆抗体,已被提议用于治疗 COVID-19 患者;然而,关于其安全性和疗效的数据有限。
我们对在重症监护病房(ICU)外住院的伴有炎症反应特征的严重 COVID-19 患者进行了回顾性研究。将接受 TCZ 静脉治疗联合标准治疗的患者与仅接受标准治疗的患者进行比较。在 28 天的随访期间评估安全性和疗效。
共纳入 65 例患者。其中 32 例接受 TCZ 治疗。在基线时,所有患者均接受高流量补充氧气治疗,大多数(78%的 TCZ 患者和 61%的标准治疗患者)接受无创通气。在 28 天的随访期间,与标准治疗组(61%)相比,TCZ 组(69%)的患者临床改善更多(p=0.61)。TCZ 组的死亡率为 15%,标准治疗组为 33%(p=0.15)。在 TCZ 组中,多变量分析显示,年龄较大是死亡的预测因素,而较高的基线 PaO2:FiO2 是第 28 天临床改善的预测因素。两组之间感染和肺血栓形成的发生率相似。
在本队列中,在第 28 天,TCZ 组和标准治疗组患者的临床改善和死亡率没有统计学差异。在 TCZ 组中,有 13%的患者记录了细菌或真菌感染,在标准治疗组中,有 12%的患者记录了细菌或真菌感染。疗效和安全性的确证需要进行正在进行的对照试验。