The question of whether seriously ill COVID-19 patients could benefit from anti-inflammatories such as Roche Actemra and Sanofi and Regeneron’s Kevzara has weighed heavily on practitioners in the United States thanks to conflicting clinical trial results.
In contrast, the UK has reached definite answers for both drugs, both of which are IL-6 inhibitors: These drugs significantly reduce the risk of death in COVID-19 patients requiring intensive care, and they must be used to relieve the stress that hospitals face when this is because the coronavirus pandemic continues to escalate, the country’s National Institute of Health Research (NIHR) said Thursday.
The recommendations came after data from an NIHR-sponsored study showed that Actemra and Kevzara could cut hospital stay for COVID-19 patients in intensive care by 10 days and could reduce the risk of death by 24% in patients receiving one of the drugs. in the day of entry. The findings prompted the UK government to recommend to the National Health Service (NHS) that IL-6 blockers be launched for the treatment of COVID-19.
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“We have worked swiftly to ensure this care is available to NHS patients without delay,” UK Secretary of Health and Social Care Matt Hancock said in a statement. statement, adding that the trial results mark “an important development in finding a way out of this pandemic.”
Trial data, which have not been peer reviewed, are published (PDF) on the preprint site medRxiv.
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Actemra and Kevzara may have received acceptance in the UK, but their paths to success in COVID-19 in the US are less clear. An observational study published last fall in JAMA Internal Medicine reported that Actemra was associated with a 29% reduced risk of death in critically ill COVID-19 patients.
But randomized clinical trials of Roche’s drug in Italy concluded that it did not result in improvements in disease progression or mortality. A similar trial in France reported that Actemra’s effectiveness in moderate to severe COVID-19 patients was mixed.
As for Sanofi and Regeneron, they are also struggling to make a strong case for Kevzara in COVID-19. During the summer, firm turn off drug trials after finding it did not help patients in ventilating. Then they released data from a Kevzara study in several countries showing that the drug failed to produce a statistically significant difference in length of hospital stay or symptom improvement.
RELATED: After the other Kevzara failed COVID-19, Sanofi and Regeneron turned their attention elsewhere
The potential benefits of IL-6 inhibitors in coronavirus patients were recognized by scientists early on during the pandemic. When the immune system fights off viruses, often it releases a flood of inflammatory molecules that can cause organ failure. Controlling IL-6 seems like an immediate way to control that reaction, so many experts remain confused as to why Actemra and Kevzara, both approved to treat rheumatoid arthritis, have not consistently performed well in COVID-19 trials.
Roche continues to study Actemra on COVID-19, launching a clinical trial last summer of the drug in combination with Gilead’s Veklury (remdesivir). The study is ongoing and recruiting patients in 73 hospitals worldwide.
