Actemra failed a global, randomized, double-blind, placebo-controlled phase III trial investigating COVID-19 treatment, Roche announced on Wednesday.
The primary endpoint of the study was improved clinical status of adult, hospitalized patients with severe pneumonia from COVID-19. The rheumatoid arthritis medication failed to meet the primary endpoint. Key secondary endpoints such as patient mortality at week four were also not met.
Patients who were treated with Actemra did get discharged from the hospital more quickly than patients who were not. However, the study notes that “the difference cannot be considered statistically significant as the primary endpoint was not met.”
No new safety signals for the drug were found by the study, and the trial results require further analysis to be fully understood.
“People around the world are waiting for further effective treatment options for COVID-19 and we are disappointed that COVACTA did not demonstrate a benefit for patients in either clinical status or mortality at week four. We will continue to generate evidence to provide a more complete understanding of Actemra/RoActemra in COVID-19 associated pneumonia,” said Roche’s Levi Garraway, M.D., Ph.D. “We are grateful for the patients and physicians around the world who helped us to complete this study quickly during a public health crisis, while upholding the highest standards of scientific rigour. We will keep working to help combat the COVID-19 pandemic.”
The study compared the efficacy and safety of Actemra plus standard treatment compared with standard treatment plus placebo. The primary endpoint involved tracking the status of patients based on the requirement of ventilator use, intensive care and supplemental oxygen.
The study found that the difference in ventilator-free days between Actemra and placebo was not statistically significant.
Actemra is an IL-6 inhibitor. Another IL-6 inhibitor, Kevzara, saw its phase 3 COVID-19 trial halted after the trial found the drug didn’t help COVID-19 patients requiring mechanical ventilation.
IL-6 is a pro-inflammatory cytokine and it had been theorized that inhibiting it could help calm the runaway inflammation response severely ill COVID-19 patients sometimes experience.
The trial was a collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the United States Department of Health and Human Services.
Actemra has been linked with higher risks of stroke, interstitial lung disease, pancreatitis, heart attack and heart failure.
For more information on Actemra, visit https://www.personalinjurylawcal.com/cases-we-handle/actemra-side-effects/