According to COVID-19 patients receiving the anti-inflammatory monoclonal antibody tocilizumab, they are less likely to die or require invasive mechanical ventilation, according to preliminary results from the UK RECOVERY trial published today on the medRxiv preprint server is.
Under the guidance of Oxford University researchers, the ongoing Randomized Evaluation of COVID-19 Therapy (RECOVERY) trial involved 4,116 severely ill coronavirus patients assigned to receive intravenous tocilizumab, a rheumatoid arthritis remedy, or regular care. Most (82%) of the participants also received a systemic corticosteroid such as dexamethasone.
Greater chance of leaving the hospital alive
Of the 2022 patients who received tocilizumab from 23 April 2020 to 25 January 2021, 596 (29%) died within 28 days of hospitalization, compared with 694 of 2094 (33%) of the patients receiving regular care (rate ratio [RR], 0.86), for an absolute difference of 4%. The drug also increased the chance of being released alive from the hospital within 28 days from 47% to 54% (RR, 1.22).
Patients in the tocilizumab group who did not receive invasive mechanical ventilation were also less likely to require that treatment (from 38% to 33%; RR, 0.85) and fewer required dialysis (5% vs. 7% ).
However, the medication had no effect on the successful weaning of mechanical ventilation or the subsequent need for non-invasive or invasive respiratory support among those who did not need such support at study enrollment. The authors said that the benefits of tocilizumab are particularly evident in those who also receive a systemic corticosteroid, but add that it could possibly be accidental.
All patients’ subgroups have benefits, including those that require supplemental oxygen with a face mask and those that require mechanical ventilation in an intensive care unit. Mean age of participants was 63.6 years.
Among the 4,116 participants, 562 (14%) received invasive mechanical ventilation, 1,686 (41%) received non-invasive respiratory support, and 1868 (45%) received no respiratory support other than supplemental oxygen. All patients have low oxygen levels and signs of inflammation.
Three serious adverse effects have been attributed to tocilizumab, including ear infection, Staphylococcus aureus bloodstream infection, and lung abscesses. All conditions were resolved after treatment.
One third to half fewer deaths
RESTORATORY researchers have been testing different possible treatments for coronavirus since March 2020, with tocilizumab being added to the trial in April. Recently, on February 3, the U.S. National Institutes of Health said the data recommended for or against the use of tocilizumab in patients requiring invasive or non-invasive mechanical ventilation or oxygen were insufficient, but the researchers said their findings requires an update from those. guidelines, as well as actions to increase tocilizumab’s worldwide availability and affordability.
“Our data suggest that treatment with a combination of a systemic corticosteroid plus tocilizumab in COVID-19 patients who are hypoxic and have evidence of systemic inflammation would be expected to reduce the mortality rate by approximately one-third for patients receiving simple oxygen. “and receive almost one oxygen, half for those who receive invasive mechanical ventilation,” the researchers wrote.
The authors noted that seven previous randomized trials of tocilizumab in COVID-19 patients yielded mixed results that, together, did not suggest a significant reduction in mortality rates.
However, they said the RECOVERY trial has more than three times as many deaths to study as in previous trials combined. Thus, they added, all eight trials together showed that the drug was linked to a 13% drop in death by 28 days (RR, 0.87).
Lead author Peter Horby, PhD, at the University of Oxford, called the findings of the benefits of tocilizumab plus dexamethasone in a news article on the RECOVERY website ‘impressive and very welcome’. “Previous trials with tocilizumab have shown mixed results, and it was unclear which patients would benefit from the treatment,” he said. “We now know that the benefits of tocilizumab extend to all COVID patients with low oxygen levels and significant inflammation.”
According to the authors, the results will be submitted to a medical journal.