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Reviews of "Interleukin-6 Receptor Antagonists in Critically Ill Patients with Covid-19 – Preliminary report"

Reviewers: Manish Sagar (Boston University) | 📘📘📘📘📘 • Mike Samsonov (Sechenov Moscow Medical Academy) | 📘📘📘📘📘

Published onMar 01, 2021
Reviews of "Interleukin-6 Receptor Antagonists in Critically Ill Patients with Covid-19 – Preliminary report"
key-enterThis Pub is a Review of
Interleukin-6 Receptor Antagonists in Critically Ill Patients with Covid-19 – Preliminary report
Description

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 of commencing organ support in an intensive care unit, were randomized to receive either tocilizumab (8mg/kg) or sarilumab (400mg) or standard care (control). The primary outcome was an ordinal scale combining in-hospital mortality (assigned −1) and days free of organ support to day 21. The trial uses a Bayesian statistical model with pre-defined triggers to declare superiority, efficacy, equivalence or futility.Results Tocilizumab and sarilumab both met the pre-defined triggers for efficacy. At the time of full analysis 353 patients had been assigned to tocilizumab, 48 to sarilumab and 402 to control. Median organ support-free days were 10 (interquartile range [IQR] −1, 16), 11 (IQR 0, 16) and 0 (IQR −1, 15) for tocilizumab, sarilumab and control, respectively. Relative to control, median adjusted odds ratios were 1.64 (95% credible intervals [CrI] 1.25, 2.14) for tocilizumab and 1.76 (95%CrI 1.17, 2.91) for sarilumab, yielding >99.9% and 99.5% posterior probabilities of superiority compared with control. Hospital mortality was 28.0% (98/350) for tocilizumab, 22.2% (10/45) for sarilumab and 35.8% (142/397) for control. All secondary outcomes and analyses supported efficacy of these IL-6 receptor antagonists.Conclusions In critically ill patients with Covid-19 receiving organ support in intensive care, treatment with the IL-6 receptor antagonists, tocilizumab and sarilumab, improved outcome, including survival. (ClinicalTrials.gov number: NCT02735707)

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Summary of Reviews: IL-6 receptor inhibitor therapy likely reduces morbidity and mortality in a select group of patients if used within 24 hours of worsening clinical status. Both reviewers considered the multi-center, placebo-controlled randomized control trial results to be strong.

Reviewer 1 (Manish Sagar) | 📘📘📘📘📘

Reviewer 2 (Mike Samsonov) | 📘📘📘📘📘

RR:C19 Strength of Evidence Scale Key

📕 ◻️◻️◻️◻️ = Misleading

📙📙 ◻️◻️◻️ = Not Informative

📒📒📒 ◻️◻️ = Potentially Informative

📗📗📗📗◻️ = Reliable

📘📘📘📘📘 = Strong

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