New data means that IL-6 drugs from Roche and Sanofi that had been all-but written off as coronavirus therapies will now be offered routinely to COVID-19 patients in intensive care in the UK.
The renaissance of the two therapies comes on the back of the REMAP-CAP trial, which found that the IL-6 inhibitors RoActemra (tocilizumab) and Kevzara (sarilumab) reduced the relative risk of death by 24% when administered to COVID-19 patients within 24 hours of entering intensive care, and reduce the time spent in hospital by seven to ten days.
Both RoActemra and Kevzara have failed to hit their objectives in earlier studies, leading to speculation that inhibiting IL-6 wasn’t a valid approach to treat severe COVID-19, but the new independent study turns that view on its head.
Crucially, their benefits seem to stack with that of the corticosteroid dexamethasone, the first drug to be shown to improve survival in seriously-ill COVID-19 patients in the RECOVERY trial.
The death rate for those in intensive care units on dexamethasone and respiratory support alone was 35%, but reduced to 28% when RoActemra was administered as well.
“The data shows that tocilizumab, and likely sarilumab, speed up and improve the odds of recovery in intensive care, which is crucial for helping to relieve pressure on intensive care and hospitals and saving lives,” said UK deputy chief medical officer Prof Jonathan Van-Tam.
The data has emerged as the government unveiled figures showing there are currently around 30,000 COVID-19 patients in hospitals, up nearly 40% on the previous peak during the first wave of the pandemic in April.
There are already ample supplies of RoActemra in the UK, so that drug in particular will be recommended for use “immediately” in patients admitted to intensive care with the virus, it said, saying that could potentially save “hundreds of lives”.
Roche welcomed the results, saying it was still in the process of analysing data from the COVACTA and EMPACTA trials, which generated negative and positive results for its drug respectively in patients hospitalised with COVID-19 associated pneumonia.
“Previous trials using IL-6 receptor agonists have showed no clear benefit on either disease progression or survival in COVID-19 patients, but those studies included less severely ill patients and started treatment at different stages in the disease course,” said Professor Anthony Gordon of Imperial College London, the trial’s lead investigator in the UK.
“A crucial difference may be that in our study, critically ill patients were enrolled within 24 hours of starting organ support. This highlights a potential early window for treatment where the sickest patients may gain the most benefit from immune modulation treatment,” he added.
REMAP-CAP has been running since 2016, with the aim of putting dozens of drugs through their paces to see if they can improve the prospects of people with severe community-acquired pneumonia (CAP) caused by influenza, but was expanded to include COVID-19 patients after the pandemic took hold.
It included more than 800 pneumonia patients in intensive care with suspected or proven COVID-19, of which around three-quarters were recruited from UK NHS trusts, but hasn’t yet been subjected to the scrutiny of peer review.
“This news is a positive step in the fight against COVID-19, giving doctors and the NHS another weapon in their armoury to treat critically ill patients,” said Marius Scholtz, chief medical officer at Roche Products Ltd. “It also increases the collective scientific understanding of COVID-19.”
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