Interleukin-6 Receptor Antagonists in Critically Ill Patients with Covid-19
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Abstract
BACKGROUND: The efficacy of interleukin-6 receptor antagonists in critically ill patients with coronavirus disease 2019 (Covid-19) is unclear. METHODS: We evaluated tocilizumab and sarilumab in an ongoing international, multifactorial, adaptive platform trial. Adult patients with Covid-19, within 24 hours after starting organ support in the intensive care unit (ICU), were randomly assigned to receive tocilizumab (8 mg per kilogram of body weight), sarilumab (400 mg), or standard care (control). The primary outcome was respiratory and cardiovascular organ support-free days, on an ordinal scale combining in-hospital death (assigned a value of -1) and days free of organ support to day 21. The trial uses a Bayesian statistical model with predefined criteria for superiority, efficacy, equivalence, or futility. An odds ratio greater than 1 represented improved survival, more organ support-free days, or both. RESULTS: Both tocilizumab and sarilumab met the predefined criteria for efficacy. At that time, 353 patients had been assigned to tocilizumab, 48 to sarilumab, and 402 to control. The median number of organ support-free days was 10 (interquartile range, -1 to 16) in the tocilizumab group, 11 (interquartile range, 0 to 16) in the sarilumab group, and 0 (interquartile range, -1 to 15) in the control group. The median adjusted cumulative odds ratios were 1.64 (95% credible interval, 1.25 to 2.14) for tocilizumab and 1.76 (95% credible interval, 1.17 to 2.91) for sarilumab as compared with control, yielding posterior probabilities of superiority to control of more than 99.9% and of 99.5%, respectively. An analysis of 90-day survival showed improved survival in the pooled interleukin-6 receptor antagonist groups, yielding a hazard ratio for the comparison with the control group of 1.61 (95% credible interval, 1.25 to 2.08) and a posterior probability of superiority of more than 99.9%. All secondary analyses supported efficacy of these interleukin-6 receptor antagonists. CONCLUSIONS: In critically ill patients with Covid-19 receiving organ support in ICUs, treatment with the interleukin-6 receptor antagonists tocilizumab and sarilumab improved outcomes, including survival. (REMAP-CAP ClinicalTrials.gov number, NCT02735707.).
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The record
- Venue
- New England Journal of Medicine
- Topic
- COVID-19 Clinical Research Studies
- Field
- Medicine
- Canadian institutions
- —
- Funders
- Children's Hospital of PittsburghNIHR Imperial Biomedical Research CentreHorizon 2020Health Research Council of New ZealandNational Health and Medical Research CouncilCanadian Institutes of Health ResearchUniversité de Versailles Saint-Quentin-en-YvelinesMinderoo FoundationKing Abdullah International Medical Research CenterAssistance publique-Hôpitaux de ParisUniversiteit AntwerpenUniversitätsklinikum JenaRadboud Universitair Medisch CentrumQueen's UniversityFiona Stanley HospitalInstitut National de la Santé et de la Recherche MédicaleUniversité Pierre et Marie CurieMinistère des Affaires Sociales et de la SantéSeventh Framework ProgrammeQueen's University BelfastKing Saud bin Abdulaziz University for Health ScienceEisaiUniversity of OxfordMedical Research CouncilDepartment of Health and Social CareHealth Research BoardNational Institute for Health and Care ResearchCRCMiningUniversité de SherbrookeWellcome TrustUniversity College DublinWater Environment and Reuse FoundationFP7 HealthUniversity of TorontoHelsingin YliopistoUniversity of AlbertaEuropean CommissionUniversity of PittsburghBreast Cancer Research FoundationAmgenNational Institute of General Medical SciencesUniversité Laval
- Keywords
- Interquartile rangeMedicineTocilizumabOdds ratioIntensive care unitConfidence intervalInternal medicineRheumatoid arthritis
- Has abstract in OpenAlex
- yes