What is the effect of Actemra on patients with COVID-19?

Actemra does not directly target the SARS-COV-2 virus (the virus that causes COVID-19), rather it reduces inflammation by blocking the interleukin-6 receptor, which is on interleukin-6, one of the main proinflammatory cytokines (these are cell-to-cell signaling proteins that stimulate an immune response). In some cases of COVID-19 infection, the immune system can become hyperactive, which may result in worsening disease.

Actemra has been approved by the FDA to be used as a treatment for hospitalized adults with COVID-19 who are receiving corticosteroids plus supplemental oxygen, on non-invasive or invasive mechanical ventilation, or receiving extracorporeal membrane oxygenation (ECMO). This was based on the results of four trials that showed that giving Actemra to people with COVID-19 decreased their risk of dying. The use of Actemra to treat hospitalized people aged 2 to 18 years old remains under Emergency Use Authorization (EUA) and is not FDA-approved.

Four trials support using Actemra for COVID-19 and two showed that using Actemra significantly decreased the risk of people dying from COVID-19, to a modest extent. The RECOVERY [Randomized Evaluation of COVID-19 Therapy] trial was a randomized, controlled, open-label trial of 4,116 hospitalized patients with severe COVID-19 pneumonia who were randomized to receive Actemra in addition to usual care (n=2,022) or usual care alone (n=2,094). The probabilities of death by day 28 were estimated to be 30.7% for patients receiving Actemra and 34.9% for patients receiving usual care alone. The median time to hospital discharge was 19 days for patients receiving Actemra and more than 28 days for patients receiving usual care alone.

In the EMPACTA trial, 389 hospitalized patients with COVID-19 pneumonia received Actemra (249 patients) or a placebo (128 patients). 12.0% of patients receiving Actemra required mechanical ventilation or died by day 28 compared with 19.3% of those receiving a placebo.

In both the COVACTA trial (n=452) and REMDACTA trial (n=649 no statistically significant differences were observed between Actemra and placebo; however, both trials contributed to the assessment of the safety of Actemra when used for the treatment of COVID-19.

Actemra is also FDA-approved for the treatment of rheumatoid arthritis and other inflammatory conditions, such as cytokine release syndrome.