The rheumatoid arthritis drug Actemra failed to reduce severe respiratory symptoms, intensive care visits or deaths in a recent Italian study. Roche is nonetheless pushing forward with another COVID-19 trial for the drug.
The study was authorized by the Italian Medicines Agency (Aifa), who said the study was the first randomized test in the world of Actemra’s effectiveness against COVID-19. The trial enrolled 126 patients and was stopped early because an interim analysis found that Actemra’s effectiveness was doubtful.
Aifa said the study should be considered “important and conclusive” with regards to early-stage COVID-19 pneumonia.
“Although not effective in all patients with COVID-19 pneumonia, it is possible that selected subgroups of patients may have a better response,” Aifa said.
Actemra has been looked into as a COVID-19 treatment because of its anti-inflammatory properties. Many patients with severe COVID-19 infections experience cytokine release syndrome, a.k.a. a “cytokine storm.” This is a runaway inflammation response caused by an out of control immune system, and it can be fatal. It was thought that Actemra’s anti-inflammatory properties might lessen the inflammation caused by cytokine release syndrome.
Actemra is an IL-6 inhibitor. IL-6 is an inflammatory cytokine. Another IL-6 inhibitor, Kevzara, failed to help severely ill and critically ill patients in a trial in April. That result and the recent Italian result raise questions about the role of IL-6 inhibitors in treating COVID-19.
Detailed Italian Actemra study data will be sent to a scientific journal.
Roche has completed enrollment in its own study into patients in the hospital with severe COVID-19 pneumonia. A Roche spokeswoman said the study “will provide robust evidence about the benefit/risk profile,” and said data is expected within a few months.
“There are currently no approved medicines for COVID-19 pneumonia,” the spokeswoman said. “The fact that many companies and institutions are now working together to fight this complex disease will hopefully increase the collective scientific understanding of COVID-19 and translate to more options for patients.”
Roche announced plans last month to study whether Actemra combined with remdesivir works better against COVID-19 than remdesivir alone.
Actemra was in the news in 2017 because an investigation found that use of the medication might be linked to an increased risk of pancreatitis, heart failure, stroke, interstitial lung disease and heart attack.