Colaneri Marta, Bogliolo Laura, Valsecchi Pietro, Sacchi Paolo, Zuccaro Valentina, Brandolino Fabio, Montecucco Carlomaurizio, Mojoli Francesco, Giusti Emanuele Maria, Bruno Raffaele
Division of Infectious Diseases I, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy.
Division of Rheumatology, IRCCS Policlinico San Matteo Foundation, 27100 Pavia, Italy.
Microorganisms. 2020 May 9;8(5):695. doi: 10.3390/microorganisms8050695.
This study aimed to assess the role of Tocilizumab therapy (TCZ) in terms of ICU admission and mortality rate of critically ill patients with severe COVID-19 pneumonia. Patients with COVID-19 pneumonia were prospectively enrolled in SMAtteo COvid19 REgistry (SMACORE). A retrospective analysis of patients treated with TCZ matched using propensity score to patients treated with Standard Of Care (SOC) was conducted. The study was conducted at IRCCS Policlinico San Matteo Hospital, Pavia, Italy, from March 14, 2020 to March 27, 2020. Patients with a confirmed diagnosis of COVID-19 hospitalized in our institution at the time of TCZ availability. TCZ was administered to 21 patients. The first administration was 8 mg/kg (up to a maximum 800 mg per dose) of Tocilizumab intravenously, repeated after 12 h if no side effects were reported after the first dose. ICU admission and 7-day mortality rate. Secondary outcomes included clinical and laboratory data. There were 112 patients evaluated (82 were male and 30 were female, with a median age of 63.55 years). Using propensity scores, the 21 patients who received TCZ were matched to 21 patients who received SOC (a combination of hydroxychloroquine, azithromycin and prophylactic dose of low weight heparin). No adverse event was detected following TCZ administration. This study found that treatment with TCZ did not significantly affect ICU admission (OR 0.11; 95% CI between 0.00 and 3.38; p = 0.22) or 7-day mortality rate (OR 0.78; 95% CI between 0.06 and 9.34; p = 0.84) when compared with SOC. Analysis of laboratory measures showed significant interactions between time and treatment regarding C-Reactive Protein (CRP), alanine aminotransferase (ALT), platelets and international normalized ratio (INR) levels. Variation in lymphocytes count was observed over time, irrespective of treatment. TCZ administration did not reduce ICU admission or mortality rate in a cohort of 21 patients. Additional data are needed to understand the effect(s) of TCZ in treating patients diagnosed with COVID-19.
本研究旨在评估托珠单抗治疗（TCZ）对重症新型冠状病毒肺炎（COVID-19）患者入住重症监护病房（ICU）情况及死亡率的影响。COVID-19肺炎患者被前瞻性纳入圣马泰奥COVID-19注册研究（SMACORE）。对接受TCZ治疗的患者进行回顾性分析，并使用倾向评分法与接受标准治疗（SOC）的患者进行匹配。本研究于2020年3月14日至2020年3月27日在意大利帕维亚的IRCCS圣马泰奥综合医院进行。在有TCZ可用时，对我院确诊为COVID-19并住院的患者进行研究。21例患者接受了TCZ治疗。首次给药为静脉注射8 mg/kg托珠单抗（每剂最大800 mg），如果首剂后未报告副作用，则在12小时后重复给药。观察指标为ICU入住情况和7天死亡率。次要结局包括临床和实验室数据。共评估了112例患者（82例男性，30例女性，中位年龄63.55岁）。使用倾向评分法，将接受TCZ治疗的21例患者与接受SOC（羟氯喹、阿奇霉素和预防剂量的低分子量肝素联合使用）治疗的21例患者进行匹配。TCZ给药后未检测到不良事件。本研究发现，与SOC相比，TCZ治疗对ICU入住情况（比值比[OR]0.11；95%置信区间[CI]为0.00至3.38；p = 0.22）或7天死亡率（OR 0.78；95% CI为0.06至9.34；p = 0.84）无显著影响。实验室指标分析显示，在C反应蛋白（CRP）、丙氨酸转氨酶（ALT）、血小板和国际标准化比值（INR）水平方面，时间与治疗之间存在显著交互作用。无论治疗情况如何，淋巴细胞计数随时间均有变化。在21例患者队列中，TCZ给药并未降低ICU入住率或死亡率。需要更多数据来了解TCZ在治疗COVID-19确诊患者中的作用。
