Tocilizumab plus standard care is not superior to standard care alone for improving clinical outcomes among patients with severe or critical COVID-19 and may increase mortality, according to a study published online Jan. 20 in The BMJ.
Viviane C. Veiga, M.D., Ph.D., from the BP-A Beneficência Portuguesa de São Paulo in Brazil, and colleagues conducted a randomized trial in nine hospitals in Brazil involving adults with confirmed COVID-19 who were receiving supplemental oxygen or mechanical ventilation and had abnormal levels of at least two biomarkers. One hundred twenty-nine patients were enrolled: 65 to tocilizumab plus standard care and 64 to standard care alone.
At the recommendation of the data monitoring committee, the trial was stopped early, after enrollment of 129 patients, due to a greater number of deaths in the tocilizumab group. The researchers found that 28 and 20 percent of patients in the tocilizumab and standard care groups, respectively, were receiving mechanical ventilation or died at day 15 (odds ratio, 1.54; 95 percent confidence interval, 0.66 to 3.66; P = 0.32). Death at 15 days occurred in 17 and 3 percent of patients in the tocilizumab and standard care groups, respectively (odds ratio, 6.42; 95 percent confidence interval, 1.59 to 43.2). Adverse events were reported in 43 and 34 percent of patients who received and did not receive tocilizumab, respectively.
“Identifying a population that would likely benefit from tocilizumab has not been possible so far,” the authors write.
Several authors disclosed financial ties to the biopharmaceutical and medical device industries.