An Italian study did not observe a benefit for early COVID-19 pneumonia patients who were given tocilizumab, Roche’s rheumatoid arthritis drug marketed as Actemra. The study, authorized by the Italian Medicines Agency (Aifa), was stopped early. However, Roche is still reportedly moving ahead with its own phase III clinical trial of the drug.
According to a translated press release from Aifa, “The study showed no benefit in treated patients neither in terms of aggravation (entry into intensive care) nor in terms of survival. In this population of patients in a less advanced stage of disease, the study can be considered important and conclusive, while in more serious patients the results of other studies still underway are expected.”
The Italian trial, a collaborative effort of 24 centers, randomized 126 patients initially; final analyses included 123, after three patients withdrew consent. The rate of two-week aggravations was similar between those who received tocilizumab versus those who received standard therapy (28.3% vs. 27.0%), as were rates of those who required intensive care (10.0% vs. 7.9%) and 30-day mortality (3.3% vs. 3.2%).
Based on these results, Aifa said tocilizumab should “be considered as an experimental drug” and only be used in randomized trials.
Meanwhile, according to a report from Reuters, Roche still plans to move forward with its own trial of the drug. Roche reportedly completed enrollment for COVACTA, which is evaluating the safety and efficacy of tocilizumab plus standard of care compared to placebo plus standard of care in hospitalized adults with severe COVID-19 pneumonia. The first patient was enrolled on April 3 and 450 patients are currently enrolled.
Last month Roche announced their phase III, randomized double-blind REMDACTA study, assessing the drug’s safety and efficacy when used in combination with remdesivir compared to placebo plus remdesivir in patients hospitalized with severe COVID-19 pneumonia.