Tocilizumab fails to prevent mechanical ventilation, death in moderate COVID-19
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The addition of tocilizumab to the standard of care fails to prevent mechanical ventilation or death in patients moderately ill with COVID-19, according to a speaker at ACR Convergence 2020.
“Rheumatologists played a very prominent role in this trial,” John Stone, MD, MPH, of Massachusetts General Hospital and Harvard Medical School, told attendees at the virtual meeting. “There were 17 rheumatologists in the investigators group, 16 of whom were at Massachusetts General Hospital and one at Brigham and women’s hospital. Our hypothesis was that early intervention with [interleukin]-6 receptor blockade would limit progression to Hypoxemic respiratory failure or death in patients hospitalized with COVID-19.”
To analyze the efficacy of IL-6 receptor blockade with tocilizumab (Actemra, Genentech) among hospitalized patients that have COVID-19 but are not on mechanical ventilation, Stone and colleagues conducted a randomized, double-blind, placebo-controlled trial of 243 participants across seven Boston-area hospitals. All included patients had confirmed COVID-19 with elevated serum inflammatory markers and at least two of the following: pulmonary infiltrate, supplemental oxygen required to maintain a saturation level of more than 92%, or a fever of higher than 38° Celsius.
Participants were randomized 2-to-1 to receive standard of care alongside either 8 mg/kg of intravenous tocilizumab or a placebo. The primary outcome was the time to mechanical ventilation or death during the 28-day study period. The two secondary efficacy outcomes were the time to clinical worsening and the time to resolving the need for supplemental oxygen.
According to the researchers, the hazard ratio for mechanical ventilation or death was 0.83 (95% CI, 0.38-1.81), and 1.11 (95% CI, 0.59-2.1) for disease worsening, in the tocilizumab group. At 14 days, 18% of those who received tocilizumab demonstrated disease worsening, compared with 14.9% of those in the placebo group. The median time to oxygen discontinuation was 5 days (3.8-7.6) in the tocilizumab group and 4.9 days (3.8-7.8) among those who received a placebo. Lastly, 24.6% of participants treated with tocilizumab still required oxygen at 14 days, compared with 21.2% in the placebo group. Those in the tocilizumab did, however, experience fewer serious infections.
“In conclusion, 12% of the patients in our trial were intubated or died,” Stone said. “We found no evidence, however, that tocilizumab altered any of the efficacy outcomes in the population of patients we studied. However, the confidence intervals for most of our comparisons were wide. We therefore cannot preclude the possibility that there might be some improvement or, conversely, some worsening with tocilizumab treatment in other subsets of patients with COVID-19 or in studies of larger size.”
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Stone J. Abstract L07. Presented at: ACR Convergence 2020; November 5-9, 2020 (virtual meeting).
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