Tags

Type your tag names separated by a space and hit enter

Tocilizumab in Patients Hospitalized with Covid-19 Pneumonia.
N Engl J Med. 2021 01 07; 384(1):20-30.NEJM

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.).

Authors+Show Affiliations

From Elmhurst Hospital Center-Icahn School of Medicine at Mount Sinai Hospital (C.S.), and Elmhurst Hospital Center-New York City Health and Hospitals (E.K.-L.) - both in New York; Genentech, South San Francisco (J.H., L.Y., W.G.R., B.K., B.A., J.F., S.V.M.), and Highland Hospital, Oakland (R.B.) - both in California; San Juan Oncology Associates, Farmington, NM (J.D.N); Lewis Katz School of Medicine at Temple University, Philadelphia (G.J.C.); Michael E. DeBakey Houston VA Medical Center, Houston (L.P.); Holy Cross Health, Silver Spring, MD (M.L.C.); Ochsner Clinic Foundation, New Orleans (J.G.-D.); Central Military Hospital, Lima, Peru (V.C.); Stellenbosch University, Cape Town, South Africa (M.M.-R); BR Trials-Clinical Research, São Paulo (F.L.M.); Aga Khan University Hospital, Nairobi (R.S.); and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (M.F.G.-L.).From Elmhurst Hospital Center-Icahn School of Medicine at Mount Sinai Hospital (C.S.), and Elmhurst Hospital Center-New York City Health and Hospitals (E.K.-L.) - both in New York; Genentech, South San Francisco (J.H., L.Y., W.G.R., B.K., B.A., J.F., S.V.M.), and Highland Hospital, Oakland (R.B.) - both in California; San Juan Oncology Associates, Farmington, NM (J.D.N); Lewis Katz School of Medicine at Temple University, Philadelphia (G.J.C.); Michael E. DeBakey Houston VA Medical Center, Houston (L.P.); Holy Cross Health, Silver Spring, MD (M.L.C.); Ochsner Clinic Foundation, New Orleans (J.G.-D.); Central Military Hospital, Lima, Peru (V.C.); Stellenbosch University, Cape Town, South Africa (M.M.-R); BR Trials-Clinical Research, São Paulo (F.L.M.); Aga Khan University Hospital, Nairobi (R.S.); and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (M.F.G.-L.).From Elmhurst Hospital Center-Icahn School of Medicine at Mount Sinai Hospital (C.S.), and Elmhurst Hospital Center-New York City Health and Hospitals (E.K.-L.) - both in New York; Genentech, South San Francisco (J.H., L.Y., W.G.R., B.K., B.A., J.F., S.V.M.), and Highland Hospital, Oakland (R.B.) - both in California; San Juan Oncology Associates, Farmington, NM (J.D.N); Lewis Katz School of Medicine at Temple University, Philadelphia (G.J.C.); Michael E. DeBakey Houston VA Medical Center, Houston (L.P.); Holy Cross Health, Silver Spring, MD (M.L.C.); Ochsner Clinic Foundation, New Orleans (J.G.-D.); Central Military Hospital, Lima, Peru (V.C.); Stellenbosch University, Cape Town, South Africa (M.M.-R); BR Trials-Clinical Research, São Paulo (F.L.M.); Aga Khan University Hospital, Nairobi (R.S.); and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (M.F.G.-L.).From Elmhurst Hospital Center-Icahn School of Medicine at Mount Sinai Hospital (C.S.), and Elmhurst Hospital Center-New York City Health and Hospitals (E.K.-L.) - both in New York; Genentech, South San Francisco (J.H., L.Y., W.G.R., B.K., B.A., J.F., S.V.M.), and Highland Hospital, Oakland (R.B.) - both in California; San Juan Oncology Associates, Farmington, NM (J.D.N); Lewis Katz School of Medicine at Temple University, Philadelphia (G.J.C.); Michael E. DeBakey Houston VA Medical Center, Houston (L.P.); Holy Cross Health, Silver Spring, MD (M.L.C.); Ochsner Clinic Foundation, New Orleans (J.G.-D.); Central Military Hospital, Lima, Peru (V.C.); Stellenbosch University, Cape Town, South Africa (M.M.-R); BR Trials-Clinical Research, São Paulo (F.L.M.); Aga Khan University Hospital, Nairobi (R.S.); and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (M.F.G.-L.).From Elmhurst Hospital Center-Icahn School of Medicine at Mount Sinai Hospital (C.S.), and Elmhurst Hospital Center-New York City Health and Hospitals (E.K.-L.) - both in New York; Genentech, South San Francisco (J.H., L.Y., W.G.R., B.K., B.A., J.F., S.V.M.), and Highland Hospital, Oakland (R.B.) - both in California; San Juan Oncology Associates, Farmington, NM (J.D.N); Lewis Katz School of Medicine at Temple University, Philadelphia (G.J.C.); Michael E. DeBakey Houston VA Medical Center, Houston (L.P.); Holy Cross Health, Silver Spring, MD (M.L.C.); Ochsner Clinic Foundation, New Orleans (J.G.-D.); Central Military Hospital, Lima, Peru (V.C.); Stellenbosch University, Cape Town, South Africa (M.M.-R); BR Trials-Clinical Research, São Paulo (F.L.M.); Aga Khan University Hospital, Nairobi (R.S.); and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (M.F.G.-L.).From Elmhurst Hospital Center-Icahn School of Medicine at Mount Sinai Hospital (C.S.), and Elmhurst Hospital Center-New York City Health and Hospitals (E.K.-L.) - both in New York; Genentech, South San Francisco (J.H., L.Y., W.G.R., B.K., B.A., J.F., S.V.M.), and Highland Hospital, Oakland (R.B.) - both in California; San Juan Oncology Associates, Farmington, NM (J.D.N); Lewis Katz School of Medicine at Temple University, Philadelphia (G.J.C.); Michael E. DeBakey Houston VA Medical Center, Houston (L.P.); Holy Cross Health, Silver Spring, MD (M.L.C.); Ochsner Clinic Foundation, New Orleans (J.G.-D.); Central Military Hospital, Lima, Peru (V.C.); Stellenbosch University, Cape Town, South Africa (M.M.-R); BR Trials-Clinical Research, São Paulo (F.L.M.); Aga Khan University Hospital, Nairobi (R.S.); and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (M.F.G.-L.).From Elmhurst Hospital Center-Icahn School of Medicine at Mount Sinai Hospital (C.S.), and Elmhurst Hospital Center-New York City Health and Hospitals (E.K.-L.) - both in New York; Genentech, South San Francisco (J.H., L.Y., W.G.R., B.K., B.A., J.F., S.V.M.), and Highland Hospital, Oakland (R.B.) - both in California; San Juan Oncology Associates, Farmington, NM (J.D.N); Lewis Katz School of Medicine at Temple University, Philadelphia (G.J.C.); Michael E. DeBakey Houston VA Medical Center, Houston (L.P.); Holy Cross Health, Silver Spring, MD (M.L.C.); Ochsner Clinic Foundation, New Orleans (J.G.-D.); Central Military Hospital, Lima, Peru (V.C.); Stellenbosch University, Cape Town, South Africa (M.M.-R); BR Trials-Clinical Research, São Paulo (F.L.M.); Aga Khan University Hospital, Nairobi (R.S.); and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (M.F.G.-L.).From Elmhurst Hospital Center-Icahn School of Medicine at Mount Sinai Hospital (C.S.), and Elmhurst Hospital Center-New York City Health and Hospitals (E.K.-L.) - both in New York; Genentech, South San Francisco (J.H., L.Y., W.G.R., B.K., B.A., J.F., S.V.M.), and Highland Hospital, Oakland (R.B.) - both in California; San Juan Oncology Associates, Farmington, NM (J.D.N); Lewis Katz School of Medicine at Temple University, Philadelphia (G.J.C.); Michael E. DeBakey Houston VA Medical Center, Houston (L.P.); Holy Cross Health, Silver Spring, MD (M.L.C.); Ochsner Clinic Foundation, New Orleans (J.G.-D.); Central Military Hospital, Lima, Peru (V.C.); Stellenbosch University, Cape Town, South Africa (M.M.-R); BR Trials-Clinical Research, São Paulo (F.L.M.); Aga Khan University Hospital, Nairobi (R.S.); and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (M.F.G.-L.).From Elmhurst Hospital Center-Icahn School of Medicine at Mount Sinai Hospital (C.S.), and Elmhurst Hospital Center-New York City Health and Hospitals (E.K.-L.) - both in New York; Genentech, South San Francisco (J.H., L.Y., W.G.R., B.K., B.A., J.F., S.V.M.), and Highland Hospital, Oakland (R.B.) - both in California; San Juan Oncology Associates, Farmington, NM (J.D.N); Lewis Katz School of Medicine at Temple University, Philadelphia (G.J.C.); Michael E. DeBakey Houston VA Medical Center, Houston (L.P.); Holy Cross Health, Silver Spring, MD (M.L.C.); Ochsner Clinic Foundation, New Orleans (J.G.-D.); Central Military Hospital, Lima, Peru (V.C.); Stellenbosch University, Cape Town, South Africa (M.M.-R); BR Trials-Clinical Research, São Paulo (F.L.M.); Aga Khan University Hospital, Nairobi (R.S.); and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (M.F.G.-L.).From Elmhurst Hospital Center-Icahn School of Medicine at Mount Sinai Hospital (C.S.), and Elmhurst Hospital Center-New York City Health and Hospitals (E.K.-L.) - both in New York; Genentech, South San Francisco (J.H., L.Y., W.G.R., B.K., B.A., J.F., S.V.M.), and Highland Hospital, Oakland (R.B.) - both in California; San Juan Oncology Associates, Farmington, NM (J.D.N); Lewis Katz School of Medicine at Temple University, Philadelphia (G.J.C.); Michael E. DeBakey Houston VA Medical Center, Houston (L.P.); Holy Cross Health, Silver Spring, MD (M.L.C.); Ochsner Clinic Foundation, New Orleans (J.G.-D.); Central Military Hospital, Lima, Peru (V.C.); Stellenbosch University, Cape Town, South Africa (M.M.-R); BR Trials-Clinical Research, São Paulo (F.L.M.); Aga Khan University Hospital, Nairobi (R.S.); and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (M.F.G.-L.).From Elmhurst Hospital Center-Icahn School of Medicine at Mount Sinai Hospital (C.S.), and Elmhurst Hospital Center-New York City Health and Hospitals (E.K.-L.) - both in New York; Genentech, South San Francisco (J.H., L.Y., W.G.R., B.K., B.A., J.F., S.V.M.), and Highland Hospital, Oakland (R.B.) - both in California; San Juan Oncology Associates, Farmington, NM (J.D.N); Lewis Katz School of Medicine at Temple University, Philadelphia (G.J.C.); Michael E. DeBakey Houston VA Medical Center, Houston (L.P.); Holy Cross Health, Silver Spring, MD (M.L.C.); Ochsner Clinic Foundation, New Orleans (J.G.-D.); Central Military Hospital, Lima, Peru (V.C.); Stellenbosch University, Cape Town, South Africa (M.M.-R); BR Trials-Clinical Research, São Paulo (F.L.M.); Aga Khan University Hospital, Nairobi (R.S.); and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (M.F.G.-L.).From Elmhurst Hospital Center-Icahn School of Medicine at Mount Sinai Hospital (C.S.), and Elmhurst Hospital Center-New York City Health and Hospitals (E.K.-L.) - both in New York; Genentech, South San Francisco (J.H., L.Y., W.G.R., B.K., B.A., J.F., S.V.M.), and Highland Hospital, Oakland (R.B.) - both in California; San Juan Oncology Associates, Farmington, NM (J.D.N); Lewis Katz School of Medicine at Temple University, Philadelphia (G.J.C.); Michael E. DeBakey Houston VA Medical Center, Houston (L.P.); Holy Cross Health, Silver Spring, MD (M.L.C.); Ochsner Clinic Foundation, New Orleans (J.G.-D.); Central Military Hospital, Lima, Peru (V.C.); Stellenbosch University, Cape Town, South Africa (M.M.-R); BR Trials-Clinical Research, São Paulo (F.L.M.); Aga Khan University Hospital, Nairobi (R.S.); and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (M.F.G.-L.).From Elmhurst Hospital Center-Icahn School of Medicine at Mount Sinai Hospital (C.S.), and Elmhurst Hospital Center-New York City Health and Hospitals (E.K.-L.) - both in New York; Genentech, South San Francisco (J.H., L.Y., W.G.R., B.K., B.A., J.F., S.V.M.), and Highland Hospital, Oakland (R.B.) - both in California; San Juan Oncology Associates, Farmington, NM (J.D.N); Lewis Katz School of Medicine at Temple University, Philadelphia (G.J.C.); Michael E. DeBakey Houston VA Medical Center, Houston (L.P.); Holy Cross Health, Silver Spring, MD (M.L.C.); Ochsner Clinic Foundation, New Orleans (J.G.-D.); Central Military Hospital, Lima, Peru (V.C.); Stellenbosch University, Cape Town, South Africa (M.M.-R); BR Trials-Clinical Research, São Paulo (F.L.M.); Aga Khan University Hospital, Nairobi (R.S.); and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (M.F.G.-L.).From Elmhurst Hospital Center-Icahn School of Medicine at Mount Sinai Hospital (C.S.), and Elmhurst Hospital Center-New York City Health and Hospitals (E.K.-L.) - both in New York; Genentech, South San Francisco (J.H., L.Y., W.G.R., B.K., B.A., J.F., S.V.M.), and Highland Hospital, Oakland (R.B.) - both in California; San Juan Oncology Associates, Farmington, NM (J.D.N); Lewis Katz School of Medicine at Temple University, Philadelphia (G.J.C.); Michael E. DeBakey Houston VA Medical Center, Houston (L.P.); Holy Cross Health, Silver Spring, MD (M.L.C.); Ochsner Clinic Foundation, New Orleans (J.G.-D.); Central Military Hospital, Lima, Peru (V.C.); Stellenbosch University, Cape Town, South Africa (M.M.-R); BR Trials-Clinical Research, São Paulo (F.L.M.); Aga Khan University Hospital, Nairobi (R.S.); and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (M.F.G.-L.).From Elmhurst Hospital Center-Icahn School of Medicine at Mount Sinai Hospital (C.S.), and Elmhurst Hospital Center-New York City Health and Hospitals (E.K.-L.) - both in New York; Genentech, South San Francisco (J.H., L.Y., W.G.R., B.K., B.A., J.F., S.V.M.), and Highland Hospital, Oakland (R.B.) - both in California; San Juan Oncology Associates, Farmington, NM (J.D.N); Lewis Katz School of Medicine at Temple University, Philadelphia (G.J.C.); Michael E. DeBakey Houston VA Medical Center, Houston (L.P.); Holy Cross Health, Silver Spring, MD (M.L.C.); Ochsner Clinic Foundation, New Orleans (J.G.-D.); Central Military Hospital, Lima, Peru (V.C.); Stellenbosch University, Cape Town, South Africa (M.M.-R); BR Trials-Clinical Research, São Paulo (F.L.M.); Aga Khan University Hospital, Nairobi (R.S.); and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (M.F.G.-L.).From Elmhurst Hospital Center-Icahn School of Medicine at Mount Sinai Hospital (C.S.), and Elmhurst Hospital Center-New York City Health and Hospitals (E.K.-L.) - both in New York; Genentech, South San Francisco (J.H., L.Y., W.G.R., B.K., B.A., J.F., S.V.M.), and Highland Hospital, Oakland (R.B.) - both in California; San Juan Oncology Associates, Farmington, NM (J.D.N); Lewis Katz School of Medicine at Temple University, Philadelphia (G.J.C.); Michael E. DeBakey Houston VA Medical Center, Houston (L.P.); Holy Cross Health, Silver Spring, MD (M.L.C.); Ochsner Clinic Foundation, New Orleans (J.G.-D.); Central Military Hospital, Lima, Peru (V.C.); Stellenbosch University, Cape Town, South Africa (M.M.-R); BR Trials-Clinical Research, São Paulo (F.L.M.); Aga Khan University Hospital, Nairobi (R.S.); and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (M.F.G.-L.).From Elmhurst Hospital Center-Icahn School of Medicine at Mount Sinai Hospital (C.S.), and Elmhurst Hospital Center-New York City Health and Hospitals (E.K.-L.) - both in New York; Genentech, South San Francisco (J.H., L.Y., W.G.R., B.K., B.A., J.F., S.V.M.), and Highland Hospital, Oakland (R.B.) - both in California; San Juan Oncology Associates, Farmington, NM (J.D.N); Lewis Katz School of Medicine at Temple University, Philadelphia (G.J.C.); Michael E. DeBakey Houston VA Medical Center, Houston (L.P.); Holy Cross Health, Silver Spring, MD (M.L.C.); Ochsner Clinic Foundation, New Orleans (J.G.-D.); Central Military Hospital, Lima, Peru (V.C.); Stellenbosch University, Cape Town, South Africa (M.M.-R); BR Trials-Clinical Research, São Paulo (F.L.M.); Aga Khan University Hospital, Nairobi (R.S.); and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (M.F.G.-L.).From Elmhurst Hospital Center-Icahn School of Medicine at Mount Sinai Hospital (C.S.), and Elmhurst Hospital Center-New York City Health and Hospitals (E.K.-L.) - both in New York; Genentech, South San Francisco (J.H., L.Y., W.G.R., B.K., B.A., J.F., S.V.M.), and Highland Hospital, Oakland (R.B.) - both in California; San Juan Oncology Associates, Farmington, NM (J.D.N); Lewis Katz School of Medicine at Temple University, Philadelphia (G.J.C.); Michael E. DeBakey Houston VA Medical Center, Houston (L.P.); Holy Cross Health, Silver Spring, MD (M.L.C.); Ochsner Clinic Foundation, New Orleans (J.G.-D.); Central Military Hospital, Lima, Peru (V.C.); Stellenbosch University, Cape Town, South Africa (M.M.-R); BR Trials-Clinical Research, São Paulo (F.L.M.); Aga Khan University Hospital, Nairobi (R.S.); and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (M.F.G.-L.).From Elmhurst Hospital Center-Icahn School of Medicine at Mount Sinai Hospital (C.S.), and Elmhurst Hospital Center-New York City Health and Hospitals (E.K.-L.) - both in New York; Genentech, South San Francisco (J.H., L.Y., W.G.R., B.K., B.A., J.F., S.V.M.), and Highland Hospital, Oakland (R.B.) - both in California; San Juan Oncology Associates, Farmington, NM (J.D.N); Lewis Katz School of Medicine at Temple University, Philadelphia (G.J.C.); Michael E. DeBakey Houston VA Medical Center, Houston (L.P.); Holy Cross Health, Silver Spring, MD (M.L.C.); Ochsner Clinic Foundation, New Orleans (J.G.-D.); Central Military Hospital, Lima, Peru (V.C.); Stellenbosch University, Cape Town, South Africa (M.M.-R); BR Trials-Clinical Research, São Paulo (F.L.M.); Aga Khan University Hospital, Nairobi (R.S.); and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (M.F.G.-L.).From Elmhurst Hospital Center-Icahn School of Medicine at Mount Sinai Hospital (C.S.), and Elmhurst Hospital Center-New York City Health and Hospitals (E.K.-L.) - both in New York; Genentech, South San Francisco (J.H., L.Y., W.G.R., B.K., B.A., J.F., S.V.M.), and Highland Hospital, Oakland (R.B.) - both in California; San Juan Oncology Associates, Farmington, NM (J.D.N); Lewis Katz School of Medicine at Temple University, Philadelphia (G.J.C.); Michael E. DeBakey Houston VA Medical Center, Houston (L.P.); Holy Cross Health, Silver Spring, MD (M.L.C.); Ochsner Clinic Foundation, New Orleans (J.G.-D.); Central Military Hospital, Lima, Peru (V.C.); Stellenbosch University, Cape Town, South Africa (M.M.-R); BR Trials-Clinical Research, São Paulo (F.L.M.); Aga Khan University Hospital, Nairobi (R.S.); and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (M.F.G.-L.).

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

33332779

Citation

Salama, Carlos, et al. "Tocilizumab in Patients Hospitalized With Covid-19 Pneumonia." The New England Journal of Medicine, vol. 384, no. 1, 2021, pp. 20-30.
Salama C, Han J, Yau L, et al. Tocilizumab in Patients Hospitalized with Covid-19 Pneumonia. N Engl J Med. 2021;384(1):20-30.
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. The New England Journal of Medicine, 384(1), 20-30. https://doi.org/10.1056/NEJMoa2030340
Salama C, et al. Tocilizumab in Patients Hospitalized With Covid-19 Pneumonia. N Engl J Med. 2021 01 7;384(1):20-30. PubMed PMID: 33332779.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Tocilizumab in Patients Hospitalized with Covid-19 Pneumonia. AU - Salama,Carlos, AU - Han,Jian, AU - Yau,Linda, AU - Reiss,William G, AU - Kramer,Benjamin, AU - Neidhart,Jeffrey D, AU - Criner,Gerard J, AU - Kaplan-Lewis,Emma, AU - Baden,Rachel, AU - Pandit,Lavannya, AU - Cameron,Miriam L, AU - Garcia-Diaz,Julia, AU - Chávez,Victoria, AU - Mekebeb-Reuter,Martha, AU - Lima de Menezes,Ferdinando, AU - Shah,Reena, AU - González-Lara,Maria F, AU - Assman,Beverly, AU - Freedman,Jamie, AU - Mohan,Shalini V, Y1 - 2020/12/17/ PY - 2020/12/18/pubmed PY - 2021/1/13/medline PY - 2020/12/17/entrez SP - 20 EP - 30 JF - The New England journal of medicine JO - N Engl J Med VL - 384 IS - 1 N2 - 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.). SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/33332779/Tocilizumab_in_Patients_Hospitalized_with_Covid_19_Pneumonia_ L2 - https://www.nejm.org/doi/10.1056/NEJMoa2030340?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -