A clinical trial in France evaluating the drug anakinra in the management of Covid-19 is being hampered by unexplained excess mortality among patients being treated according to preliminary results of the trial, notes the drug agency ANSM.
This drug, anakinra (trade name: Kineret), originally intended for rheumatoid diseases, gave “encouraging” results for severe forms of Covid-19 disease by reducing the risk of death and the need for ” placed on a ventilator in intensive care, according to a study by a French medical team from the Paris Saint-Joseph Hospital Group (GHPSJ), published in the specialist journal The Lancet Rheumatology.
This safety information does not question anakinra’s benefit / risk ratio when used in the validated signs of its marketing authorization (AMM) such as for example for rheumatoid arthritis, underlines the ANSM. . “Therefore, patients being treated for one of these pathologies can continue their treatment”.
“If symptoms suggestive of Covid-19 appear”, the health agency invites them to consult their physician.
Other clinical trials suspended
The ANACONDA-COVID-19 trial conducted by University Hospital Tours involves approximately thirty patients. The interim review of data showed excessive early deaths in the patient group treated with anakinra compared to the group who did not receive this medication. “The adverse effect of anakinra cannot be excluded to the extent that currently available information does not enable this difference to be explained” between these two groups of patients, notes the ANSM.
Anakinra targets, to block it, one of the cytokines, interleukin-1 (IL-1) involved in the “inflammatory storm” that leads to acute respiratory distress syndrome (ARDS) which seek physician assistance. artificial ventilation using an inhaler.
The other clinical trials with anakinra authorized in France at the Covid-19 indication have also been suspended. However, these clinical trials were already stopped or not yet started, the health agency notes.
Finally, the ANSM “reminds healthcare professionals that there is currently no study showing the interest of its use in the care of Covid patients”.