Aifa: no benefit from Tocilizumab, drug study stopped

2020-06-17T18:16:56.117Z

"The randomized study to evaluate the efficacy of tocilizumab, administered at an early stage, compared to standard therapy in patients with Covid-19 pneumonia ended after the enrollment of 126 patients (one third of the expected cases) of recent onset requiring hospital care, but not invasive or semi-invasive mechanical ventilation procedures. " This was announced by the Italian drug agency, reporting that "the study did not show any benefit in treated patients neither in terms of aggravation (entry into intensive care) nor as regards survival". And therefore - motivates Aifa - "in this population of patients in a less advanced stage of disease the study can be considered important and conclusive, while in patients of greater severity we expect the results of other studies still in progress". The study was promoted by the Local Health Unit - Irccs of Reggio Emilia (Principal investigators professors Carlo Salvarani and Massimo Costantini) and was conducted with the collaboration of 24 centers. This is the first randomized study concluded internationally on tocilizumab, entirely made in Italy. Of the 126 randomized patients, three were excluded from the analyzes because they withdrew consent. The analysis of the 123 remaining patients showed a similar percentage of aggravations in the first two weeks in patients randomized to receive tocilizumab and in patients randomized to receive standard therapy (28.3% versus 27.0%). No significant difference was observed in the total number of ICU accesses (10.0% versus 7.9%) and 30-day mortality (3.3% versus 3.2%). "In the context of the treatment of patients with Covid-19 - concludes Aifa, tocilizumab must therefore be considered as an experimental drug, the use of which must be limited only in the context of randomized clinical trials".