RECOVERY trial: Tocilizumab reduces death among seriously ill COVID-19 patients
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Compared with usual care, tocilizumab reduced deaths by an absolute difference of 4% among patients with COVID-19 who required oxygen and had evidence of inflammation, investigators from the RECOVERY trial reported Thursday.
Data suggested that, among patients with hypoxia and significant inflammation, tocilizumab in combination with a systemic corticosteroid like dexamethasone reduced mortality “by about one-third for patients requiring simple oxygen and nearly one-half for those requiring invasive mechanical ventilation,” according to a news release from the investigators.
The RECOVERY trial previously showed that dexamethasone reduced death among patients with COVID-19 who were ventilated or receiving oxygen. In the current trial, investigators said the benefits of tocilizumab were “clearly seen to be in addition to those of steroids.”
“Previous trials of tocilizumab had shown mixed results, and it was unclear which patients might benefit from the treatment,” Peter Horby, MD, PhD, professor of emerging infectious diseases at the University of Oxford and joint chief investigator for the RECOVERY trial, said in a statement. “We now know that the benefits of tocilizumab extend to all COVID patients with low oxygen levels and significant inflammation. The double impact of dexamethasone plus tocilizumab is impressive and very welcome.”
The RECOVERY trial — RECOVERY stands for Randomized Evaluation of COVID-19 Therapy — has been assessing numerous potential treatments for the disease for almost a year. Last month, investigators announced the end of a trial evaluating convalescent plasma as a treatment for COVID-19 after the independent data monitoring committee determined there was no evidence that it benefited patients.
Investigators added tocilizumab, an arthritis drug, to the trial last April. The data reported Thursday were based on more than 4,000 patients randomly assigned in an equal ratio to receive either an IV infusion of tocilizumab or usual care. Among all patients, 82% were taking dexamethasone or another systemic steroid, the investigators said.
Among patients in the treatment arm, 596 (29%) died within 28 days compared with 694 (33%) patients in the usual care arm (RR = 0.86; 95% CI 0.77-0.96) — an absolute difference of 4%, the investigators reported.
Tocilizumab had other benefits, including increasing the probability of being alive at discharge within 28 days from 47% to 54% (RR = 1.23; 95% CI 1.12-1.34).
“These benefits were seen in all patient subgroups, including those requiring oxygen via a simple face mask through to those requiring mechanical ventilators in an intensive care unit,” the news release said.
Patients who were not mechanically ventilated also were less likely to progress to invasive mechanical ventilation if they received tocilizumab, or to die, but the trial did not find evidence that tocilizumab helped get patients off mechanical ventilation, the investigators said.
“The results from the RECOVERY trial clearly show the benefits of tocilizumab and dexamethasone in tackling the worst consequences of COVID-19 — improving survival, shortening hospital stay, and reducing the need for mechanical ventilators,” Martin Landray, MB. ChB, PhD, professor of medicine and epidemiology at the University of Oxford and joint chief investigator for the trial, said in a statement.
“Used in combination, the impact is substantial,” Landray said. “This is good news for patients and good news for the health services that care for them in the U.K. and around the world.”
As of Wednesday, when it updated its literature review on tocilizumab, the Infectious Diseases Society of America still recommended against the routine use of the drug in patients hospitalized with COVID-19. An IDSA spokesperson told Healio that a guidelines panel is reviewing the data from the RECOVERY trial but could not say whether any changes to the guidelines were forthcoming.
(Editor's note: This story was updated to include a response from the IDSA.)
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