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Tocilizumab in Patients Hospitalized with Covid-19 Pneumonia

Open access
Salama, Carlos, Han, Jian, Yau, Linda, Reiss, William G., Kramer, Benjamin, Neidhart, Jeffrey D., Criner, Gerard J., Kaplan-Lewis, Emma, Baden, Rachel, Pandit, Lavannya, Cameron, Miriam L., Garcia-Diaz, Julia, Chávez, Victoria, Mekebeb-Reuter, Martha, Lima de Menezes, Ferdinando, Shah, Reena, González-Lara, Maria F., Assman, Beverly, Freedman, Jamie, Mohan, Shalini V.·2021·New England Journal of Medicine

Abstract

BACKGROUND: Coronavirus disease 2019 (Covid-19) pneumonia is often associated with hyperinflammation. Despite the disproportionate incidence of Covid-19 among underserved and racial and ethnic minority populations, the safety and efficacy of the anti-interleukin-6 receptor antibody tocilizumab in patients from these populations who are hospitalized with Covid-19 pneumonia are unclear. METHODS: We randomly assigned (in a 2:1 ratio) patients hospitalized with Covid-19 pneumonia who were not receiving mechanical ventilation to receive standard care plus one or two doses of either tocilizumab (8 mg per kilogram of body weight intravenously) or placebo. Site selection was focused on the inclusion of sites enrolling high-risk and minority populations. The primary outcome was mechanical ventilation or death by day 28. RESULTS: A total of 389 patients underwent randomization, and the modified intention-to-treat population included 249 patients in the tocilizumab group and 128 patients in the placebo group; 56.0% were Hispanic or Latino, 14.9% were Black, 12.7% were American Indian or Alaska Native, 12.7% were non-Hispanic White, and 3.7% were of other or unknown race or ethnic group. The cumulative percentage of patients who had received mechanical ventilation or who had died by day 28 was 12.0% (95% confidence interval [CI], 8.5 to 16.9) in the tocilizumab group and 19.3% (95% CI, 13.3 to 27.4) in the placebo group (hazard ratio for mechanical ventilation or death, 0.56; 95% CI, 0.33 to 0.97; P = 0.04 by the log-rank test). Clinical failure as assessed in a time-to-event analysis favored tocilizumab over placebo (hazard ratio, 0.55; 95% CI, 0.33 to 0.93). Death from any cause by day 28 occurred in 10.4% of the patients in the tocilizumab group and 8.6% of those in the placebo group (weighted difference, 2.0 percentage points; 95% CI, -5.2 to 7.8). In the safety population, serious adverse events occurred in 38 of 250 patients (15.2%) in the tocilizumab group and 25 of 127 patients (19.7%) in the placebo group. CONCLUSIONS: In hospitalized patients with Covid-19 pneumonia who were not receiving mechanical ventilation, tocilizumab reduced the likelihood of progression to the composite outcome of mechanical ventilation or death, but it did not improve survival. No new safety signals were identified. (Funded by Genentech; EMPACTA ClinicalTrials.gov number, NCT04372186.).

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Metadata

Authors
Salama, C., Han, J., Yau, L., Reiss, W. G., Kramer, B., Neidhart, J. D., Criner, G. J., Kaplan-Lewis, E., Baden, R., Pandit, L., Cameron, M. L., Garcia-Diaz, J., Chávez, V., Mekebeb-Reuter, M., Lima de Menezes, F., Shah, R., González-Lara, M. F., Assman, B., Freedman, J., & Mohan, S. V.
Venue
New England Journal of Medicine
Published
2021-01-07
Volume
384
Issue
1
Pages
20-30
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W3110844195
Cited by
1,291
References
14
FWCI
33.92
Type
journal article
Language
en
Open access
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CoChat. (2026). Citation check: Tocilizumab in Patients Hospitalized with Covid-19 Pneumonia. https://app.cochat.ai/papers/10.1056/nejmoa2030340
The paper
Salama, C., Han, J., Yau, L., Reiss, W. G., Kramer, B., Neidhart, J. D., Criner, G. J., Kaplan-Lewis, E., Baden, R., Pandit, L., Cameron, M. L., Garcia-Diaz, J., Chávez, V., Mekebeb-Reuter, M., Lima de Menezes, F., Shah, R., González-Lara, M. F., Assman, B., Freedman, J., & Mohan, S. V. (2021). Tocilizumab in Patients Hospitalized with Covid-19 Pneumonia. New England Journal of Medicine. https://doi.org/10.1056/nejmoa2030340

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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