A new trial published Wednesday by the British Medical Journal today has found that adding tocilizumab, an arthritis drug, to standard care for hospitalized patients with severe COVID-19 illness is no better than standard care alone in improving clinical outcomes at 15 days, according to Medical Xpress.
The trial was stopped early after the researchers found that there was an increased number of deaths at 15 days in patients receiving the drug.
These results contradict earlier observational studies that suggested a benefit of adding tocilizumab.
An earlier randomized trial assessing the arthritis drug in seriously ill patients with COVID-19 found a beneficial effect of the drug on days free from organ support within 21 days and mortality.
The recent study authors said, “Reasons for these apparently contradictory effects, for example, differences between patients’ characteristics, need to be assessed in future analysis.”
Tocilizumab works by blocking a specific part of the immune system, called interleukin 6, which can go into overdrive in some patients with COVID-19. Doctors think the drug might help lessen the inflammatory response to the virus, potentially averting some of the more serious consequences of the disease. However, the drug’s effects are not well defined.
To dig deeper, Brazilian researchers conducted a randomized controlled trial comparing tocilizumab plus standard care with standard care alone in hospitalized patients with severe COVID-19 illness.
The trial included 129 relatively young adults with confirmed COVID-19 illness from May 8 to July 17.
Patients were divided into two groups – 65 received tocilizumab plus standard care, while the remaining received standard care alone. All the patients were receiving supplemental oxygen or mechanical ventilation.
By day 15, 18 patients in the tocilizumab group and 13 in the standard care group were either receiving mechanical ventilation or died. Eleven patients in the tocilizumab group and 2 patients in the standard care group died.
The trial ad to be stopped early due to the increased number of deaths in the tocilizumab group, raising safety concerns.
However, the study author pointed out that there were a few limitations, including the small size of the study, which affects the chances of detecting a true effect.
The author concluded that in patients with severe COVID-19 illness, “tocilizumab plus standard care was not superior to standard care alone in improving clinical status at 15 days and might increase mortality.”
The results “raise questions about an anti-inflammatory approach in the treatment of COVID-19 beyond corticosteroids,” they added. The article appeared on Medical Xpress.
