Sanofi and Regeneron Pharmaceuticals reported that a Phase III clinical trial of rheumatoid arthritis medication Kevzara (sarilumab) failed to meet its key primary and secondary endpoints in Covid-19 patients who required mechanical ventilation in the U.S.
The study compared the 400 mg dose of the drug plus the best supportive care with the best supportive care alone.
Minor positive trends were demonstrated in the primary prespecified test group, but did not reach statistical significance. Furthermore, these trends were offset by negative trends in a subgroup of critically ill patients who were not on mechanical ventilation at the start of the study.
In the primary analysis group, adverse events were reported in 80% of patients treated with Kevzara and 77% of those receiving placebo.
The most common adverse events in at least 3% of patients, most common among Kevzara patients, were multiorgan dysfunction syndrome and hypotension.
According to the data, companies have stopped this trial in the US, which includes a second cohort of patients who received a higher 800-mg dose of the drug.
The primary analysis included 194 patients who were seriously ill and under mechanical ventilation at enrollment.
Loading …Sanofi and Regeneron designed the Phase III trial based on the findings of a small single-arm study in China that involved hospitalized, mostly severe, feverish Covid-19 patients with elevated levels of IL-6.
The study findings indicated that blocking this pathway with the IL-6 blocker tocilizumab rapidly decreased fever and improved oxygenation in severe patients.
In addition to this Kevzara trial, Sanofi is conducting a Phase III study outside the US in hospitalized patients with severe and critical Covid-19 using a different dosage regimen.
Both trials are overseen by the same Independent Data Monitoring Committee (IDMC), which recommended that the trial being conducted outside of the US be continued.
Data from the trial are expected outside the US in the third quarter of this year.
