Roche’s Actemra for Rheumatoid Arthritis Reduces Need for Mechanical Ventilation in Hospitalized COVID-19 Patients

Roche’s (Basel, Switzerland) Phase 3 EMPACTA study has shown that Actemra/RoActemra reduced the likelihood of needing mechanical ventilation in hospitalized patients with COVID-19 associated pneumonia.

Actemra/RoActemra was the first approved anti-IL-6 receptor biologic available in both intravenous (IV) and subcutaneous (SC) formulations for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA). Actemra/RoActemra is currently being investigated as a potential treatment for COVID-19 associated pneumonia, including in combination with an antiviral in the Phase 3 REMDACTA clinical trial. EMPACTA (Evaluating Minority Patients with Actemra) is a Phase 3, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of Actemra in the treatment of hospitalized COVID-19 associated pneumonia among patients that are often underrepresented in clinical trials.

The study is the first global, Phase 3 COVID-19 clinical trial to primarily enroll patient populations that are often underrepresented in clinical studies and have been disproportionately affected by the COVID-19 pandemic. Approximately 85% of the 389 patients were from minority racial and ethnic groups. The 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. The trial enrolled hospitalized patients older than 18 years with confirmed SARS-CoV-2 (COVID-19) infection with SpO2 <94% while on ambient air who did not require noninvasive or invasive mechanical ventilation. The primary endpoint is the cumulative proportion of participants dying or requiring mechanical ventilation by Day 28.

Roche has announced that the Phase 3 EMPACTA study met its primary endpoint, showing that patients with COVID-19 associated pneumonia who received Actemra/RoActemra (tocilizumab) plus standard of care were 44% less likely to progress to mechanical ventilation or death, as 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% in the Actemra/RoActemra arm versus 19.3% in the placebo arm. The EMPACTA study did not identify any new safety signals for Actemra/RoActemra.

“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, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We plan to share this important data with the US Food and Drug Administration (FDA) and other health authorities around the world.”