A big slap. This is what has just received the researchers from the AP-HP in charge of conducting a clinical trial on Tocilizumab, a monoclonal antibody commonly used in the treatment of rheumatoid arthritis. On April 27, in a press release, the AP-HP welcomed the fact that in view of the first conclusions of the study, this treatment “significantly improves patient prognosis “ severely affected by the Covid. And the hospital group to justify this premature announcement with regard to scientific requirements, by “ethical reasons “.
Resignation of the monitoring committee
Patatras. As the latest edition of the Duck chained, the dissemination of this information was not at all to the liking of the members of the independent data monitoring and follow-up committee, who alone were able to validate the results of the test. Who made it known immediately. In an email to the boss of the AP-HP on the evening of April 27, the scientists then expressed their “Deep reservation on the results communicated“ and their “Concern about the way research works on this trial“ More specifically, the conduct of the study suffers, according to them, from “many malfunctions“, such as a suspicious modification of the criteria along the way … Small scientifically inadmissible arrangements. To mark its disapproval, the monitoring committee resigned on April 30.
End of the adventure for Tocilizumab? Not really. It’s even the opposite. Since mid-April, this anti-inflammatory treatment has been widely imposed in Paris hospitals, which now prescribe it very often on a “compassionate basis”“ (for lack of anything better) to patients with severe pneumonia in intensive care or about to be admitted. “It’s a shame what happened with the AP-HP clinical trial because the clinicians who use it believe in this molecule“, sighs Yasdan Yasdanpanah, head of the infectious diseases department at Bichat Hospital. And the Italians long before the French.
Decrease in intensive care transfers
As early as the end of March, Professor Paolo Ascierto of the Pasquale Institute in Naples had reported the clinically observed benefits of Tocilizumab on severe patients. It is in this context that the AP-HP launched a large clinical trial “randomized“ (with control group) covering 129 patients, according to a methodology that meets the criteria of the international scientific community.
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On a smaller scale and with a claim to less publication, the private Foch hospital in Suresnes (Ile-de-France) had also decided to test the molecule on 29 serious patients. However, on April 24, the latter establishment was pleased to have obtained promising results, Tocilizumab having halved its need for resuscitation transfers. From where can be the precipitation of the AP-HP to want to communicate on its own test, even not finalized … The backlash is severe. However, this is undoubtedly only a postponement for Tocilizumab. Last weekend, the AP-HP installed a new independent follow-up committee on its test. With a mission to put it back on track.
Nathalie Raulin
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