Swiss drugmaker Roche said that a recent study has shown that Tocilizumab reduced the need for mechanical ventilation in patients with Covid-19 associated pneumonia.
Giving details on the findings, Roche said, its late phase-III EMPACTA study met the primary endpoint showing that patients with Covid-19 associated pneumonia who received Tocilizumab plus standard of care “were 44 per cent less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care.”
The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2 per cent in the Tocilizumab arm versus 19.3 per cent in the placebo arm, the note said, adding that the study had not identified any new safety signals for the product.
The injectable product sold under the brand names Actemra/RoActemra is used to treat rheumatoid arthritis and is presently being repurposed as a potential drug to treat Covid-19. It has, however, not been approved by any health authority for Covid-19 associated pneumonia.
“The EMPACTA trial demonstrated that Actemra/RoActemra can reduce the need for mechanical ventilation in patients with Covid-19 associated pneumonia, an important outcome in this serious disease,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. The company intended to share the data with the US Food and Drug Administration and other international health authorities, he said.
In India, drugmaker Cipla has an alliance with Roche to sell the product that is reportedly witnessing supply shortages. Roche told BusinessLine that it was in touch with its global supply-chain teams to ensure that demands were met.
Two studies, two findings
Incidentally, Roche had in July shared findings from its advanced phase-III COVACTA study of Tocilizumab which found that it had not met the primary endpoint of improved clinical status in hospitalised adult patients with severe Covid-19 associated pneumonia.
Explaining the difference between the two studies, the company said they were done in different patient populations and had different primary endpoints.
“COVACTA enrolled hospitalised adult patients with Covid-19 pneumonia across a broader range of disease severity. EMPACTA only included patients earlier in the progression of disease who did not require mechanical ventilation at the time of enrolment,” the company said, adding that they were working to understand the data from both studies.
Further, it added, “the studies were designed differently, conducted at different sites in different regions, so they are not completely comparable with regard to ethnic or racial breakdown.”
More inclusive study
The EMPACTA trial is the first global phase-III Covid-19 clinical trial to primarily enrol patient populations that are often underrepresented in clinical studies and have been disproportionately affected by the Covid-19 pandemic, Roche said.
Approximately 85 per cent of the 389 patients were from minority racial and ethnic groups. A majority of patients were Hispanic, with significant representation of Native American and Black populations. The trial was conducted in the US, South Africa, Kenya, Brazil, Mexico and Peru.
“We have been striving to improve inclusion and diversity in our trials,” said Jamie Freedman, Head of US Medical Affairs. “During the Covid-19 pandemic, we saw how high the stakes were for many communities of colour and made diversity the centerpiece of this trial.”
There are several independent trials of Actemra/RoActemra, Roche said, including one in combination with an antiviral in the phase-III REMDACTA clinical trial.