1. Tofacitinib in Patients Hospitalized with Covid-19 Pneumonia.
- Author
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Guimarães PO, Quirk D, Furtado RH, Maia LN, Saraiva JF, Antunes MO, Kalil Filho R, Junior VM, Soeiro AM, Tognon AP, Veiga VC, Martins PA, Moia DDF, Sampaio BS, Assis SRL, Soares RVP, Piano LPA, Castilho K, Momesso RGRAP, Monfardini F, Guimarães HP, Ponce de Leon D, Dulcine M, Pinheiro MRT, Gunay LM, Deuring JJ, Rizzo LV, Koncz T, and Berwanger O
- Subjects
- Adult, Aged, Antiviral Agents therapeutic use, Brazil, COVID-19 complications, COVID-19 mortality, COVID-19 therapy, Double-Blind Method, Drug Therapy, Combination, Female, Hospitalization, Humans, Incidence, Janus Kinase 3 antagonists & inhibitors, Janus Kinase Inhibitors adverse effects, Male, Middle Aged, Oxygen Inhalation Therapy, Piperidines adverse effects, Pyrimidines adverse effects, Respiratory Insufficiency epidemiology, Respiratory Insufficiency etiology, Glucocorticoids therapeutic use, Janus Kinase Inhibitors therapeutic use, Piperidines therapeutic use, Pyrimidines therapeutic use, COVID-19 Drug Treatment
- Abstract
Background: The efficacy and safety of tofacitinib, a Janus kinase inhibitor, in patients who are hospitalized with coronavirus disease 2019 (Covid-19) pneumonia are unclear., Methods: We randomly assigned, in a 1:1 ratio, hospitalized adults with Covid-19 pneumonia to receive either tofacitinib at a dose of 10 mg or placebo twice daily for up to 14 days or until hospital discharge. The primary outcome was the occurrence of death or respiratory failure through day 28 as assessed with the use of an eight-level ordinal scale (with scores ranging from 1 to 8 and higher scores indicating a worse condition). All-cause mortality and safety were also assessed., Results: A total of 289 patients underwent randomization at 15 sites in Brazil. Overall, 89.3% of the patients received glucocorticoids during hospitalization. The cumulative incidence of death or respiratory failure through day 28 was 18.1% in the tofacitinib group and 29.0% in the placebo group (risk ratio, 0.63; 95% confidence interval [CI], 0.41 to 0.97; P = 0.04). Death from any cause through day 28 occurred in 2.8% of the patients in the tofacitinib group and in 5.5% of those in the placebo group (hazard ratio, 0.49; 95% CI, 0.15 to 1.63). The proportional odds of having a worse score on the eight-level ordinal scale with tofacitinib, as compared with placebo, was 0.60 (95% CI, 0.36 to 1.00) at day 14 and 0.54 (95% CI, 0.27 to 1.06) at day 28. Serious adverse events occurred in 20 patients (14.1%) in the tofacitinib group and in 17 (12.0%) in the placebo group., Conclusions: Among patients hospitalized with Covid-19 pneumonia, tofacitinib led to a lower risk of death or respiratory failure through day 28 than placebo. (Funded by Pfizer; STOP-COVID ClinicalTrials.gov number, NCT04469114.)., (Copyright © 2021 Massachusetts Medical Society.)
- Published
- 2021
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