Department of Pharmacy, NewYork-Presbyterian Hospital, Columbia University Irving Medical Center, New York, New York, United States of America.
Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York, New York, United States of America.
PLoS One. 2021 Apr 8;16(4):e0249349. doi: 10.1371/journal.pone.0249349. eCollection 2021.
Tocilizumab, an interleukin-6 receptor blocker, has been used in the inflammatory phase of COVID-19, but its impact independent of corticosteroids remains unclear in patients with severe disease.
In this retrospective analysis of patients with COVID-19 admitted between March 2 and April 14, 2020 to a large academic medical center in New York City, we describe outcomes associated with tocilizumab 400 mg (without methylprednisolone) compared to a propensity-matched control. The primary endpoints were change in a 7-point ordinal scale of oxygenation and ventilator free survival, both at days 14 and 28. Secondary endpoints include incidence of bacterial superinfections and gastrointestinal perforation. Primary outcomes were evaluated using t-test.
We identified 33 patients who received tocilizumab and matched 74 controls based on demographics and health measures upon admission. After adjusting for illness severity and baseline ordinal scale, we failed to find evidence of an improvement in hypoxemia based on an ordinal scale at hospital day 14 in the tocilizumab group (OR 2.2; 95% CI, 0.7-6.5; p = 0.157) or day 28 (OR 1.1; 95% CI, 0.4-3.6; p = 0.82). There also was no evidence of an improvement in ventilator-free survival at day 14 (OR 0.8; 95% CI, 0.18-3.5; p = 0.75) or day 28 (OR 1.1; 95% CI, 0.1-1.8; p = 0.23). There was no increase in secondary bacterial infection rates in the tocilizumab group compared to controls (OR 0.37; 95% CI, 0.09-1.53; p = 0.168).
There was no evidence to support an improvement in hypoxemia or ventilator-free survival with use of tocilizumab 400 mg in the absence of corticosteroids. No increase in secondary bacterial infections was observed in the group receiving tocilizumab.
白细胞介素-6 受体阻滞剂托珠单抗已用于 COVID-19 的炎症期,但在重症患者中,其独立于皮质类固醇的影响尚不清楚。
本研究回顾性分析了 2020 年 3 月 2 日至 4 月 14 日期间在纽约市一家大型学术医疗中心住院的 COVID-19 患者,描述了与单独使用 400mg 托珠单抗(无甲泼尼龙)相关的结局与倾向评分匹配的对照。主要终点是第 14 天和第 28 天的氧合 7 点有序量表和无呼吸机生存的变化。次要终点包括细菌继发感染和胃肠穿孔的发生率。主要结果使用 t 检验进行评估。
我们确定了 33 名接受托珠单抗治疗的患者,并根据人口统计学和入院时的健康指标匹配了 74 名对照。在校正疾病严重程度和基线有序量表后,我们未发现托珠单抗组在第 14 天(OR 2.2;95%CI,0.7-6.5;p = 0.157)或第 28 天(OR 1.1;95%CI,0.4-3.6;p = 0.82)的低氧血症严重程度改善的证据。第 14 天(OR 0.8;95%CI,0.18-3.5;p = 0.75)或第 28 天(OR 1.1;95%CI,0.1-1.8;p = 0.23)无无呼吸机生存改善的证据。与对照组相比,托珠单抗组继发性细菌感染率无增加(OR 0.37;95%CI,0.09-1.53;p = 0.168)。
在没有皮质类固醇的情况下,单独使用 400mg 托珠单抗没有证据表明低氧血症或无呼吸机生存改善。接受托珠单抗治疗的组中未观察到继发性细菌感染增加。