• Patrícia O Guimarães, Daniel Quirk, Remo H Furtado, Lilia N Maia, José F Saraiva, Murillo O Antunes, Roberto Kalil Filho, Vagner M Junior, Alexandre M Soeiro, Alexandre P Tognon, Viviane C Veiga, Priscilla A Martins, Diogo D F Moia, Bruna S Sampaio, Silvia R L Assis, Ronaldo V P Soares, Luciana P A Piano, Kleber Castilho, Roberta G R A P Momesso, Frederico Monfardini, Helio P Guimarães, Dario Ponce de Leon, Majori Dulcine, Marcia R T Pinheiro, Levent M Gunay, J Jasper Deuring, Luiz V Rizzo, Tamas Koncz, Otavio Berwanger, and STOP-COVID Trial Investigators.
• From the Hospital Israelita Albert Einstein (P.O.G., R.H.F., D.D.F.M., B.S.S., S.R.L.A., R.V.P.S., L.P.A.P., K.C., R.G.R.A.P.M., F.M., H.P.G., L.V.R., O.B.), the Heart Institute, InCor, University of São Paulo Medical School (R.H.F., R.K.F., V.M.J.), BP Mirante-A Beneficência Portuguesa de São Paulo (A.M.S.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), and Pfizer (M.D., M.R.T.P.), São Paulo, Centro Integrado de Pesquisa, Hospital de Base, São José do Rio Preto Medical School, São José do Rio Preto (L.N.M.), Pontifícia Universidade Católica de Campinas, Campinas (J.F.S.), Hospital Universitário São Francisco de Assis na Providência de Deus and Irmandade do Senhor Bom Jesus dos Passos da Santa Casa de Misericórida de Bragança Paulista, Bragança Paulista (M.O.A.), Hospital São Vicente de Paulo, Passo Fundo (A.P.T.), and Hospital Estadual Jayme dos Santos Neves, Vila Velha (P.A.M.) - all in Brazil; Pfizer, Collegeville, PA (D.Q.); Pfizer, Lima, Peru (D.P.L.); Pfizer, Istanbul, Turkey (L.M.G.); Pfizer, Rotterdam, the Netherlands (J.J.D.); and Pfizer, New York (T.K.).
• N. Engl. J. Med. 2021 Jul 29; 385 (5): 406-415.

BackgroundThe efficacy and safety of tofacitinib, a Janus kinase inhibitor, in patients who are hospitalized with coronavirus disease 2019 (Covid-19) pneumonia are unclear.MethodsWe 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.ResultsA 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.ConclusionsAmong 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.

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