One of the drugs that was proposed for the treatment of COVID-19, an approved drug for arthritis, has not been shown to have a significant effect in the treatment of hospitalized patients with severe or critical COVID-19, according to a trial published today by « The BMJ ».
Tocilizumab Not only did it not reduce the number of deaths, but in the group treated with this drug there were a greater number of deaths at 15 days, which caused the trial to stop prematurely.
The results contradict previous observational studies suggesting a benefit from tocilizumab. However, these studies are limited because other unknown factors may have been involved and, furthermore, some studies have not yet been peer-reviewed or published in a scientific journal.
For example, ehe randomized trial evaluating tocilizumab in critically ill patients with covid-19 (REMAP-CAP), published as a preprint earlier this month, found a beneficial effect of the drug. However, according to the authors of the study published in “BMJ” they believe that this work should be evaluated in future analyzes.
Tocilizumab blocks a specific part of the immune system (interleukin 6) that can become overloaded in some patients with COVID-19. Doctors believe this could help decrease the body’s inflammatory response to the virus and prevent some of the more serious consequences of the disease, but its effects are not well defined.
To test this theory, researchers from Centro A Beneficência Portuguesa in São Paulo (Brazil) carried out a randomized controlled trial that compared tocilizumab within standard care against another group treated only with standard therapy in 129 adult patients admitted to the hospital with severe or critical covid-19.
The patients, relatively young (mean age 57), were receiving supplemental oxygen or mechanical ventilation and had abnormal levels of at least two inflammation-related chemicals in their blood.
All patients were monitored for 15 days. After that period of time, 18 (28%) patients in the tocilizumab group and 13 (20%) in the standard care group were receiving mechanical ventilation or had died. But more died in the first group than in the second: 11 in the tocilizumab group compared to 2 in the other.
This increase in the number of deaths in the tocilizumab group raised safety concerns and the trial was stopped early. In both groups, deaths were attributed to acute respiratory failure or multiple organ dysfunction related to COVID-19.
Although the Brazilian researchers acknowledge some limitations, including the small sample size, which affects the chances of detecting a true effect, they consider the results consistent.
Therefore, they conclude, “the results raise questions about an anti-inflammatory approach in the treatment of COVID-19 beyond corticosteroids.”