Effect of tocilizumab on clinical outcomes at 15 days in patients with severe or critical coronavirus disease 2019: randomised controlled trial
This Brazilian study (n=129) has been stopped early, as tocilizumab was associated with higher mortality at 15 days versus standard care (component of the primary outcome; 17% v 3%; OR 6.42, 95% CI 1.59 to 43.2), with no clinical benefit noted.
Source:
British Medical Journal
SPS commentary:
There was no difference in improvement in mechanical ventilation or death at 15 days (28% in the tocilizumab group and 20% in the standard care group; OR 1.54, 95% CI 0.66 to 3.66; P=0.32).
The results appear to contradict those from the REMAP-CAP trial, which showed that when given within 24 hours of patients entering intensive care in addition to a corticosteroid, tocilizumab (n=353) reduced mortality when compared with standard care only (including corticosteroids). The authors of the study note a number of limitations, including the fact that the level of respiratory support was lower among those randomised to tocilizumab, and its small size (the 95% confidence intervals around the primary endpoint were wide, and ranged from benefit to harm).
An expert commentator on this study, as reported in a news article in the BMJ, notes that the study was small and that it is important to consider the totality of the evidence, with over 2000 patients with Covid-19 enrolled in trials of tocilizumab to date; the results of which, taken together, suggest a modest reduction in the risk of death. They note also that it is currently uncertain as to whether the potential benefits of tocilizumab vary according to the patient circumstances.
A NICE rapid evidence summary on tocilizumab for Covid-19 was published on 15th January 2021. NHS England has published an interim position statement on interleukin-6 inhibitors (tocilizumab or sarilumab) for patients admitted to ICU with COVID-19 pneumonia (adults). A clinical commissioning policy is intended to replace this interim position statement.