Sanofi and Regeneron Pharmaceuticals have announced that the US Phase III trial of rheumatoid arthritis drug Kevzara (sarilumab) in COVID-19 patients requiring mechanical ventilation did not meet its main goals.
Minor positive trends were observed in the primary pre-specified analysis group (critical patients on Kevzara 400mg who were mechanically ventilated at baseline) that did not reach statistical significance and these were countered by negative trends in a subgroup of critical patients who were not mechanically ventilated at baseline. In the primary analysis group, adverse events were experienced by 80% of Kevzara patients and 77% of placebo patients. Serious adverse events that occurred in at least 3% of patients and more frequently among Kevzara patients were multi organ dysfunction syndrome (6% Kevzara, 5% placebo) and hypotension (4% Kevzara, 3% placebo).
Based on the results, the US-based trial has been stopped, including in a second cohort of patients who received a higher dose of Kevzara (800mg). Detailed results will be submitted to a peer-reviewed publication later this year.
A separate Sanofi-led trial outside of the US in hospitalised patients with severe and critical COVID-19 using a different dosing regimen is ongoing. The same Independent Data Monitoring Committee (IDMC) is overseeing both the Regeneron-led US trial and the Sanofi-led trial outside of US, which has recommended that the trial outside of the US continues.
Image credit: SJ Objio
