BREAKING! Tocilizumab (Actemra): Roche’s Rheumatoid Arthritis Drug Fails To Treat COVID-19 Patients In Italian Study
: Pharma giant Roche’s rheumatoid arthritis drug, Actemra (Tocilizumab) failed to help COVID-19 patients in Italian study according to the clinical trial findings released today.
The drug failed to help patients with early-stage COVID-19 pneumonia in an Italian study, the latest instance in another an anti-inflammatory drug has fallen through in a coronavirus trial.( Sanofi and Regeneron’s arthritis drug Kevzara failed in an earlier trial)
Even with the setback, the Swiss pharmaceutical giant said that it is pressing ahead with testing Actemra in another trial against COVID-19, the disease caused by the SARS-CoV-2 coronavirus.
Tocilizumab or Actemra did not reduce severe respiratory symptoms, intensive care visits, or death any better than standard treatments, the Italian Medicines Agency (Aifa), Italy’s drugs regulator which authorized the study, said in a media statement on Wednesday.
The clinical trial, which enrolled 126 patients, about a third of the intended number, was stopped early after an interim analysis raised doubts about the anti-inflammatory medicine’s effectiveness.
Aifa said, “Although not effective in all patients with COVID-19 pneumonia, it is possible that selected subgroups of patients may have a better respons.”
Orders of Actemra jumped 30% in the first quarter, Roche said in April, on hopes it would help in the fight against the new coronavirus.
However its failure to do so in the Italian study now adds to questions about the role of drugs like Actemra, which are designed to inhibit interleukin-6 (IL-6) proteins associated with dangerous inflammation, in treating COVID-19.
Another IL-6 inhibitor, Sanofi and Regeneron’s arthritis drug Kevzara, failed in a trial in April to help a group comprised of severely ill and critically ill patients, leading the drugmakers to continue to test high doses of Kevzara only in those considered critically ill with COVID-19.
The research findings and data from the Italian Actemra study, which involved 24 medical centres, will be sent to a scientific journal.
However Roche has completed enrolment of its own Actemra study in patients hospitalized with severe COVID-19 pneumonia. That “will provide robust evidence about the benefit/ risk profile”, a Roche spokesman said, with data expected in the next few months.
In May, Roche also announced plans to study whether combining Actemra with Gilead Sciences Inc’s antiviral treatment remdesivir works better against severe COVID-19 pneumonia than remdesivir alone.
So far Remdesivir has no real proven efficacy against the SAR-CoV-2 coronavirus except that it shortened hospital stays of COVID-19 patients. However the Trump administration granted approval to the drug to treat COVID-19 despite there being no studies actually done on the safety of the drug.
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