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Войти в исследования Interleukin-6 Receptor Antagonists in Critically Ill Patients with Covid-19.
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REMAP-CAP Investigators, Gordon Anthony C, Mouncey Paul R, Al-Beidh Farah, Rowan Kathryn M, Nichol Alistair D, Arabi Yaseen M, Annane Djillali, Beane Abi, van Bentum-Puijk Wilma, Berry Lindsay R, Bhimani Zahra, Bonten Marc J M, Bradbury Charlotte A, Brunkhorst Frank M, Buzgau Adrian, Cheng Allen C, Detry Michelle A, Duffy Eamon J, Estcourt Lise J, Fitzgerald Mark, Goossens Herman, Haniffa Rashan, Higgins Alisa M, Hills Thomas E, Horvat Christopher M, Lamontagne Francois, Lawler Patrick R, Leavis Helen L, Linstrum Kelsey M, Litton Edward, Lorenzi Elizabeth, Marshall John C, Mayr Florian B, McAuley Daniel F, McGlothlin Anna, McGuinness Shay P, McVerry Bryan J, Montgomery Stephanie K, Morpeth Susan C, Murthy Srinivas, Orr Katrina, Parke Rachael L, Parker Jane C, Patanwala Asad E, Pettilä Ville, Rademaker Emma, Santos Marlene S, Saunders Christina T, Seymour Christopher W, Shankar-Hari Manu, Sligl Wendy I, Turgeon Alexis F, Turner Anne M, van de Veerdonk Frank L, Zarychanski Ryan, Green Cameron, Lewis Roger J, Angus Derek C, McArthur Colin J, Berry Scott, Webb Steve A, Derde Lennie P G
Аннотация
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.).