Department of Pharmacy, Cleveland Clinic, Cleveland, Ohio, USA.
Respiratory Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Pharmacotherapy. 2024 Jan;44(1):28-38. doi: 10.1002/phar.2867. Epub 2023 Aug 24.
The immunomodulators tocilizumab and baricitinib improve outcomes in severely ill patients with coronavirus disease 2019 (COVID-19); however, comparative analyses of clinical outcomes related to these agents are lacking. A tocilizumab national shortage shifted treatment to baricitinib in critically ill patients, allowing for an outcome comparison in a similar population. The purpose of this study is to compare clinical outcomes in critically ill COVID-19 patients who received tocilizumab and those who received baricitinib.
Retrospective, observational cohort study using generalized estimating equation models, accounting for clustering by hospital and known confounders, to estimate the proportional odds of the ordinal World Health Organization Clinical Progression Scale (WHO-CPS) score at day 14, the primary outcome. Secondary outcomes included WHO-CPS score at day 7.
Multiple hospitals within the Cleveland Clinic Health System.
Adult patients admitted for COVID-19 between January 2021 and November 2021.
Receipt of tocilizumab, before its shortage, or baricitinib, during shortage.
In total, 507 patients were included; 217 received tocilizumab and 290 received baricitinib. Over 96% of patients required ICU admission and 98% received concomitant dexamethasone. Tocilizumab recipients had higher (worse) baseline WHO-CPS scores. After adjustment, tocilizumab use was associated with higher odds of a worse day 14 WHO-CPS score compared with baricitinib (adjusted odds ratio [OR] 1.65 [95% confidence interval (CI) 1.10-2.48]). Similarly, after adjustment, tocilizumab use was associated with higher odds of a worse day 7 WHO-CPS score (adjusted OR 1.65 [95% CI 1.22-2.24]).
Baricitinib use was associated with better WHO-CPS scores at day 14 and day 7 compared with tocilizumab in a cohort of critically ill patients with COVID-19. The odds of having a one unit increase in WHO-CPS score at day 14 was 71% higher with tocilizumab than baricitinib. No difference in mortality or adverse effects was noted.
免疫调节剂托珠单抗和巴瑞替尼可改善 2019 年冠状病毒病(COVID-19)重症患者的结局;然而,缺乏关于这些药物相关临床结局的比较分析。托珠单抗的全国短缺促使我们在危重症患者中使用巴瑞替尼进行治疗,这使得我们能够在类似人群中进行结局比较。本研究的目的是比较接受托珠单抗和巴瑞替尼治疗的 COVID-19 重症患者的临床结局。
使用广义估计方程模型进行回顾性观察队列研究,通过医院和已知混杂因素进行聚类分析,以估计主要结局(第 14 天的世界卫生组织临床进展量表(WHO-CPS)评分的有序比例优势)。次要结局包括第 7 天的 WHO-CPS 评分。
克利夫兰诊所医疗系统内的多家医院。
2021 年 1 月至 2021 年 11 月期间因 COVID-19 入院的成年患者。
接受托珠单抗治疗(在短缺之前)或巴瑞替尼治疗(在短缺期间)。
共纳入 507 例患者,其中 217 例接受托珠单抗治疗,290 例接受巴瑞替尼治疗。超过 96%的患者需要入住 ICU,98%的患者接受了同时使用地塞米松治疗。托珠单抗组患者的基线 WHO-CPS 评分更高(更差)。调整后,与巴瑞替尼相比,托珠单抗组患者第 14 天 WHO-CPS 评分更差的可能性更高(调整后的比值比 [OR] 1.65 [95%置信区间(CI)1.10-2.48])。同样,调整后,托珠单抗组患者第 7 天 WHO-CPS 评分更差的可能性更高(调整后的 OR 1.65 [95% CI 1.22-2.24])。
在 COVID-19 危重症患者队列中,与托珠单抗相比,巴瑞替尼治疗第 14 天和第 7 天的 WHO-CPS 评分更好。与巴瑞替尼相比,第 14 天 WHO-CPS 评分增加一个单位的可能性高 71%。未观察到死亡率或不良反应的差异。