Baricitinib vs tocilizumab treatment for hospitalized adult patients with severe COVID-19 and associated cytokine storm: a prospective, investigational, real-world study

• Published in: International journal of infectious diseases Vol. 125; pp. 233 - 240
• Main Authors: Lakatos, Botond, Szabó, Bálint Gergely, Bobek, Ilona, Kiss-Dala, Noémi, Gáspár, Zsófia, Riczu, Alexandra, Petrik, Borisz, Farkas, Balázs Ferenc, Sebestyén, Gabriella, Gopcsa, László, Bekő, Gabriella, Sinkó, János, Reményi, Péter, Szlávik, János, Mathiász, Dóra, Vályi-Nagy, István
• Format: Journal Article
• Language: English
• Published: Canada Elsevier Ltd 01.12.2022; Elsevier
• Subjects: Adult; Baricitinib; COVID-19; COVID-19 - complications; Cytokine Release Syndrome - drug therapy; Cytokine storm; Humans; Prospective Studies; SARS-CoV-2; Tocilizumab; Treatment Outcome; COVID-19; SARS-CoV-2; Tocilizumab; Cytokine storm; Baricitinib
• ISSN: 1201-9712; 1878-3511; 1878-3511
• DOI: 10.1016/j.ijid.2022.10.037

•Treatment of adults with severe COVID-19 and cytokine storm were compared.•In all, 102/463 patients received tocilizumab, and 361 of 463 received baricitinib.•At 28 days, there was no difference in all-cause mortality between subgroups.•No differences regarding side effects were observed between groups. Our aim was to compare outcomes of hospitalized adults with severe COVID-19 and cytokine storm treated with tocilizumab or baricitinib. A prospective, investigational, real-world study was performed from April 2020 to April 2021 at our center. COVID-19 severity was classified by World Health Organization criteria, and cytokine storm was documented along predefined criteria. Eligible patients were enrolled at diagnosis if they fulfilled a priori inclusion criteria and received standard-of-care plus tocilizumab or baricitinib for >48 hours. Patients were followed per protocol for 28 days post-diagnosis. The primary outcome was all-cause mortality; secondary outcomes were invasive mechanical ventilation and major infectious complications. Of 463 patients, 102/463 (22.1%) received tocilizumab, and 361/463 (77.9%) baricitinib. Baseline characteristics were balanced. At 28 days, there was no difference in all-cause mortality (22/102, 21.6% vs 64/361, 17.7%; P-value = 0.38). Requirement for invasive mechanical ventilation was more frequent after tocilizumab (52/102, 50.9% vs 96/361, 26.6%; P <0.01), rate of major infectious complications was similar (32/102, 31.4% vs 96/361, 26.6%; P-value = 0.34). In logistic regression, the immunomodulatory drug was not retained as a predictor of all-cause mortality. Kaplan–Meier analysis revealed statistically similar survival distributions. All-cause mortality was similar between adults treated with baricitinib or tocilizumab for severe COVID-19 with cytokine storm.