University of Modena and Reggio Emilia, Modena; Clinical and Experimental Medicine PhD program, University of Modena and Reggio Emilia, Modena; and Rheumatology Unit, Azienda USL-IRCCS di Reggio Emilia, Italy.
University of Modena and Reggio Emilia, Modena, and Infectious Disease Unit, Azienda USL-IRCCS di Reggio Emilia, Italy.
Clin Exp Rheumatol. 2020 Nov-Dec;38(6):1215-1222. Epub 2020 Dec 3.
To identify predictors of clinical improvement and intubation/death in tocilizumab-treated severe COVID19, focusing on IL6 and CRP longitudinal monitoring.
173 consecutive patients with severe COVID-19 pneumonia receiving tocilizumab in Reggio Emilia province Hospitals between 11 March and 3 June 2020 were enrolled in a prospective cohort study. Clinical improvement was defined as status improvement on a six-category ordinal scale or discharge from the hospital, whichever came first. A composite outcome of intubation/death was also evaluated. CRP and IL-6 levels were determined before TCZ administration (T0) and after 3 (T3), and 7 (T7) days.
At multivariate analysis T0 and T3 CRP levels were negatively associated with clinical improvement (OR 0.13, CI 0.03-0.55 and OR 0.11, CI 0.0-0.46) (p=0.006 and p=0.003) and positively associated with intubation/death (OR 17.66, CI 2.47-126.14 and OR 5.34, CI: 1.49-19.12) (p=0.01 and p=0.004). No significant associations with IL-6 values were observed. General linear model analyses for repeated measures showed significantly different trends for CRP from day 3 to day 7 between patients who improved and those who did not, and between patients who were intubated or died and those who were not (p<0.0001 for both). ROC analysis identified a baseline CRP level of 15.8 mg/dl as the best cut-off to predict intubation/death (AUC = 0.711, sensitivity = 0.67, specificity = 0.71).
CRP serial measurements in the first week of TCZ therapy are useful in identifying patients developing poor outcomes.
确定托珠单抗治疗严重 COVID19 患者临床改善和插管/死亡的预测因素,重点关注 IL6 和 CRP 的纵向监测。
2020 年 3 月 11 日至 6 月 3 日,雷焦艾米利亚省医院连续收治了 173 例接受托珠单抗治疗的严重 COVID-19 肺炎患者,他们参加了一项前瞻性队列研究。临床改善定义为六类等级量表上的状态改善或最早出院。还评估了插管/死亡的复合结局。在 TCZ 给药前(T0)和第 3 天(T3)和第 7 天(T7)测定 CRP 和 IL-6 水平。
多变量分析显示,T0 和 T3 CRP 水平与临床改善呈负相关(OR 0.13,CI 0.03-0.55 和 OR 0.11,CI 0.0-0.46)(p=0.006 和 p=0.003),与插管/死亡呈正相关(OR 17.66,CI 2.47-126.14 和 OR 5.34,CI:1.49-19.12)(p=0.01 和 p=0.004)。未观察到与 IL-6 值的显著关联。重复测量的一般线性模型分析显示,在改善和未改善的患者之间,以及在插管或死亡和未插管或未死亡的患者之间,第 3 天至第 7 天的 CRP 趋势有显著差异(p<0.0001)。ROC 分析确定基线 CRP 水平为 15.8mg/dl 为预测插管/死亡的最佳截断值(AUC=0.711,敏感性=0.67,特异性=0.71)。
在 TCZ 治疗的第一周内连续测量 CRP 有助于识别出现不良结局的患者。