The New England Journal of Medicine

Stopcovid 

Tofacitinib in Patients Hospitalized with Covid-19 Pneumonia

Patrícia O. Guimarães, M.D., Ph.D., Daniel Quirk, M.D., M.P.H.,
Remo H. Furtado, M.D., Ph.D., Lilia N. Maia, M.D., Ph.D., José F. Saraiva, M.D., Ph.D., Murillo O. Antunes, M.D., Ph.D., Roberto Kalil Filho, M.D., Ph.D.,
Vagner M. Junior, M.D., Alexandre M. Soeiro, M.D., Alexandre P. Tognon, M.D., Ph.D., Viviane C. Veiga, M.D., Ph.D., Priscilla A. Martins, M.D., Diogo D.F. Moia, Pharm.D., Bruna S. Sampaio, B.Sc., Silvia R.L. Assis, M.S., Ronaldo V.P. Soares, Pharm.D., Luciana P.A. Piano, Ph.D., Kleber Castilho, M.B.A., Roberta G.R.A.P. Momesso, Ph.D., Frederico Monfardini, M.Sc., Helio P. Guimarães, M.D., Ph.D.,
Dario Ponce de Leon, M.D., Majori Dulcine, M.D., Marcia R.T. Pinheiro, M.D., Levent M. Gunay, M.D., J. Jasper Deuring, Ph.D., Luiz V. Rizzo, M.D., Ph.D., Tamas Koncz, M.D., Ph.D., and Otavio Berwanger, M.D., Ph.D.,
for the STOP-COVID Trial Investigators*

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 pneumo- nia 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 cumula- tive incidence of death or respiratory failure through day 28 was 18.1% in the to- facitinib 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 pla- cebo 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 to- facitinib 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.)

The authors’ affiliations are listed in the Appendix. Address reprint requests to Dr. Berwanger at the Hospital Israelita Albert Einstein, Av. Albert Einstein 627, São Paulo 05620-900, Brazil, or at otavioberwanger@gmail.com.

*A list of the STOP-COVID Trial Investi- gators is provided in the Supplemen- tary Appendix, available at NEJM.org.

This article was published on June 16, 2021, at NEJM.org.

DOI: 10.1056/NEJMoa2101643

Copyright © 2021 Massachusetts Medical Society.