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April 22, 2021 VOL. 384 NO. 16 1491-1502

Interleukin-6 Receptor Antagonists in Critically Ill Patients with Covid-19

By the REMAP-CAP Investigators.

The efficacy of interleukin-6 receptor antagonists, such as tocilizumab and sarilumab, in critically ill patients with Covid-19 is unclear. In this ongoing international, adaptive platform trial, adult patients with Covid-19, within 24 hours after starting organ support therapy in the intensive care unit (ICU), were randomly assigned to receive tocilizumab, sarilumab, or standard care. The primary outcome was respiratory and cardiovascular organ support−free days, on an ordinal scale that combined in-hospital death and days free of organ support to day 21. 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 in the tocilizumab group, 11 in the sarilumab group, and 0 in the control group. The median adjusted cumulative odds ratios were 1.64 for tocilizumab and 1.76 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 and a posterior probability of superiority of more than 99.9%. All secondary analyses supported efficacy of these interleukin-6 receptor antagonists. 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.

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