353 patients randomized to #tocilizumab, 48 to #sarilumab, and 402 to control.
Adjusted odds ratio for improvement on organ-support free days at day 21 was 1.64 (CrI 1.25 - 2.18) and 1.89 (1.24 - 3.48), respectively. (2/10)
Mortality was 28% with tocilizumab, 22.2% for sarilumab (combined 27.3%), and 35.8% for control, with benefit of IL-6 blockade on all secondary outcomes collected. (3/10)
At the time of randomization, 28.8% were on high-flow nasal cannulae, 41% were on non-invasive ventilation, and 29.4% were invasively ventilated. 32.8% received remdesivir. (4/10)
Why different than the other Il-6 studies in COVID19? Exclusively critically ill population and the possibly additive effect of steroids may explain (majority received steroids) (5/10)
There was no difference observed based on CRP tercile at time of randomization.
There was no increase in adverse events in the IL-6 antagonism group, in the open-label design (6/10)
These results have been submitted for peer review and should be considered preliminary; minor changes may occur with further follow-up and analysis (7/10)
On the recommendation of the data safety and monitoring board, @REMAP_CAP is declaring efficacy of #tocilizumab with an OR of 1.87 for benefit on a combination of survival and length of time patients received organ support in ICU, compared with standard care [...]
This finding has a high degree of statistical certainty, with 99.75% probability of benefit for tocilizumab compared to no immune modulation […]
This conclusion is based on the first 303 critically ill patients randomized in the #COVID19 immune modulation domain; due to rapid recruitment since that interim analysis, the final analysis will have hundreds more patients included [...]