Efficacy of Tocilizumab in Patients Hospitalized with Covid-19
Open accessAbstract
BACKGROUND: The efficacy of interleukin-6 receptor blockade in hospitalized patients with coronavirus disease 2019 (Covid-19) who are not receiving mechanical ventilation is unclear. METHODS: We performed a randomized, double-blind, placebo-controlled trial involving patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, hyperinflammatory states, and at least two of the following signs: fever (body temperature >38°C), pulmonary infiltrates, or the need for supplemental oxygen in order to maintain an oxygen saturation greater than 92%. Patients were randomly assigned in a 2:1 ratio to receive standard care plus a single dose of either tocilizumab (8 mg per kilogram of body weight) or placebo. The primary outcome was intubation or death, assessed in a time-to-event analysis. The secondary efficacy outcomes were clinical worsening and discontinuation of supplemental oxygen among patients who had been receiving it at baseline, both assessed in time-to-event analyses. RESULTS: We enrolled 243 patients; 141 (58%) were men, and 102 (42%) were women. The median age was 59.8 years (range, 21.7 to 85.4), and 45% of the patients were Hispanic or Latino. The hazard ratio for intubation or death in the tocilizumab group as compared with the placebo group was 0.83 (95% confidence interval [CI], 0.38 to 1.81; P = 0.64), and the hazard ratio for disease worsening was 1.11 (95% CI, 0.59 to 2.10; P = 0.73). At 14 days, 18.0% of the patients in the tocilizumab group and 14.9% of the patients in the placebo group had had worsening of disease. The median time to discontinuation of supplemental oxygen was 5.0 days (95% CI, 3.8 to 7.6) in the tocilizumab group and 4.9 days (95% CI, 3.8 to 7.8) in the placebo group (P = 0.69). At 14 days, 24.6% of the patients in the tocilizumab group and 21.2% of the patients in the placebo group were still receiving supplemental oxygen. Patients who received tocilizumab had fewer serious infections than patients who received placebo. CONCLUSIONS: Tocilizumab was not effective for preventing intubation or death in moderately ill hospitalized patients with Covid-19. Some benefit or harm cannot be ruled out, however, because the confidence intervals for efficacy comparisons were wide. (Funded by Genentech; ClinicalTrials.gov number, NCT04356937.).
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In a randomized trial, tocilizumab did not prevent intubation or death in moderately ill patients.
“A randomized clinical trial assessing tocilizumab, an anti-IL-6 antibody (Stone et al., 2020), showed no benefit for moderately ill patients concerning effectiveness of preventing intubation or death.”
From COVID-19 and the human innate immune system (2021) · cites this paper as Stone et al., 2020
Two large, randomized, controlled trials of anti-interleukin-6 receptor antibody therapies did not show a survival benefit in hospitalized patients with Covid-19.
“Despite positive anecdotal reports, two large, randomized, controlled trials of anti–interleukin-6 receptor antibody therapies did not show a survival benefit in hospitalized patients with Covid-19.97,98”
From Cytokine storm (2020) · cites this paper as [98]
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- Authors
- Stone, J. H., Frigault, M. J., Serling-Boyd, N. J., Fernandes, A. D., Harvey, L., Foulkes, A. S., Horick, N. K., Healy, B. C., Shah, R., Bensaci, A. M., Woolley, A. E., Nikiforow, S., Lin, N., Sagar, M., Schrager, H., Huckins, D. S., Axelrod, M., Pincus, M. D., Fleisher, J., Sacks, C. A., Dougan, M., North, C. M., Halvorsen, Y.-D., Thurber, T. K., Dagher, Z., Scherer, A., Wallwork, R. S., Kim, A. Y., Schoenfeld, S., Sen, P., Neilan, T. G., Perugino, C. A., Unizony, S. H., Collier, D. S., Matza, M. A., Yinh, J. M., Bowman, K. A., Meyerowitz, E., Zafar, A., Drobni, Z. D., Bolster, M. B., Kohler, M., D’Silva, K. M., Dau, J., Lockwood, M. M., Cubbison, C., Weber, B. N., & Mansour, M. K.
- Affiliations
- Brigham and Women's Hospital (US)
- From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women’s Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton–Wellesley Hospital, Newton (H.S., D.S...
- Corresponding author
- Stone, John H.
- ORCID
- Stone, John H.
- Frigault, Matthew J.
- Fernandes, Ana D.
- Foulkes, Andrea S.
- Horick, Nora K.
- Healy, Brian C.
- Woolley, Ann E.
- Nikiforow, Sarah
- Lin, Nina
- Sagar, Manish
- Fleisher, Jorge
- Sacks, Chana A.
- Dougan, Michael
- North, Crystal M.
- Halvorsen, Yuan-Di
- Dagher, Zeina
- Scherer, Allison
- Wallwork, Rachel S.
- Kim, Arthur Y.
- Neilan, Tomas G.
- Perugino, Cory A.
- Unizony, Sebastian H.
- Matza, Mark A.
- Bowman, Kathryn A.
- Meyerowitz, Eric
- Zafar, Amna
- Bolster, Marcy B.
- Kohler, Minna
- D’Silva, Kristin M.
- Lockwood, Megan M.
- Weber, Brittany N.
- Mansour, Michael K.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2020-12-10
- Volume
- 383
- Issue
- 24
- Pages
- 2333-2344
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC7646626
- OpenAlex
- W3093604087
- Cited by
- 1,362
- References
- 40
- Citations by year
- 2026: 17 · 2025: 39 · 2024: 80 · 2023: 149 · 2022: 305 · 2021: 684 · 2020: 86 · 2012: 1
- FWCI
- 40.22
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Genentech (ML42488)
- Topics
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Respiratory Support and Mechanisms
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Keywords
- tocilizumab, COVID-19 pandemic, SARS-CoV-2, IL-6 receptor inhibition, hyperinflammation, hospitalized patients, intubation, mortality, supplemental oxygen, disease worsening, cytokine storm, mechanical ventilation avoidance, safety, adverse events
- MeSH terms
- COVID-19, COVID-19 Drug Treatment, Adult, Aged, Aged, 80 and over, Boston, Double-Blind Method, Female, Humans, Intubation, Male, Middle Aged, Respiratory Therapy, Treatment Failure, Disease Progression, Receptors, Interleukin-6, Young Adult, Antibodies, Monoclonal, Humanized
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