Skip to main content

Is tocilizumab (Actemra) effective for treating COVID-19?

Medically reviewed by Melisa Puckey, BPharm. Last updated on June 30, 2021.

Official Answer

by Drugs.com

A number of clinical trials have been completed using tocilizumab (Actemra) to treat hospitalized COVID-19 patients. The results of the clinical trials so far have not been clear. Some trials show tocilizumab to be effective in treating COVID-19, as it reduces the time spent in hospital and decreases the risk of death, while other trials showing no significant difference in health outcomes.

After reviewing a selection of clinical trials the FDA has issued an emergency use authorization (EUA) for Actemra to be used to treat patients who are:

  • hospitalized with COVID-19
  • 2 years and older
  • being treated with corticosteroids
  • need to have supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).

What is the difference between an EUA and FDA approval?

An EUA is a way of making medical products available more quickly when there are no adequate, approved, and available treatments for a specific condition.

An EUA can be issued when the FDA has looked at the best available evidence and then balances the known and potential risk and benefits of the product, and they believe that the benefits will outweigh the risks.

For a medicine to get FDA approval the FDA needs to look at a substantial amount of evidence in the form of clinical data and other information to make sure that it is safe and effective for what it is to be used for.

Is Tocilizumab (Actemra) an FDA approved medicine ?

Actemra is FDA approved for treatment of:

  • rheumatoid arthritis (RA)
  • giant cell arteritis (GCA)
  • systemic sclerosis-associated interstitial lung disease (SSc-ILD)
  • polyarticular juvenile idiopathic arthritis (PJIA)
  • systemic juvenile idiopathic arthritis (SJIA)
  • cytokine release syndrome (CRS)

Actemra does not have a FDA approval for the treatment of COVID-19.
Acetmra has an EUA for treatment of hospitalized COVID-19 patients who fit a specific criteria.


What is Tocilizumab (Actemra) ?

Tocilizumab is a monoclonal antibody that lowers inflammation by blocking the interleukin-6 receptor.

How does Tocilizumab (Actemra) work on COVID-19?

  • Very simply it is thought to reduce the amount of inflammation in the lungs caused by coronavirus, so it may help with breathing problems in COVID-19.
  • If you become infected with coronavirus, your immune system sends useful immune chemicals to the affected areas of the lungs to help fight the infection, which is good because this is how you recover from an infection. However in some people there is an overreaction by the immune system (called a ‘cytokine storm’) causing too many immune chemicals arriving in the lungs. The lungs become very inflamed and can no longer work properly, which causes severe breathing problems and can in some cases have led to death in Covid-19 patients.
  • Tocilizumab works to reduce this rush of immune chemicals to the affected area, and means there is less inflammation and damage to the lungs. The actual way it does this is by blocking the Interleukin-6 (IL-6) receptor.
  • Once the IL-6 receptor is blocked by tocilizumab, then there will be a dampening down of the inflammation and immune response, this means the body will hopefully be able to recover better.

Clinical Trials for Actemra treatment of COVID-19

The FDA based their decision to grant an EUA for Actemra to be used as a treatment of COVID-19 (for a specific group of patients) on four clinical trials, the RECOVERY trial, EMPACTA trial, COVACTA trial and the REMDACTA trial.

RECOVERY Trial

  • Was a randomized, controlled, open-label trial with 4,116 hospitized COVID-19 patients.
  • Patients were randomized into two groups, placebo + usual care or Actemra + usual care and they were followed up over 28 days.
  • Chance of death in the Actemra + usual treatment group was 30.7% compared to the placebo + usual treatment group which was 34.9%. The Actemra group had a 4.2% less chance of dying (34.9%-30.7%=4.2%).
  • The median time spent in hospital was over 28 days for patients in the usual care group and 19 days for Actemra + usual treatment group. Therefore the Actemra+usual treatment group spent a median of 9 days less in hospital (28 days-19 days = 9 days).

EMPACTA Trial

  • Was a randomized, double-blind, placebo-controlled trial with 389 hospitalized COVID-19 patients
  • Patients were randomized into two groups, Actemra + standard care group or the placebo + standard care group and then they were followed up over 28 days.
  • The chance of death or need for mechanical ventilation over the 28 days of follow up was 19.3% for the placebo + standard care compared to 12% for Actemra + standard care.
  • This means that the Actemra + standard care were 7.3% less likely to die or required mechanical ventilation (19.3% - 12% = 7.3%) compared to the place + standard care group.


COVACTA Trial

  • Was a randomized, double-blind, placebo-controlled trial with 452 patients hospitalized with severe COVID-19 pneumonia.
  • Patients were randomized into two groups either to receive Actemra + standard care or placebo + standard care.
  • At the end of 28 days follow patients assessed and given a score based on their clinical status.
  • There was no statistical significant difference in clinical status between the two groups.

REMDACTA Trial

  • Was a randomized, double-blind, placebo-controlled trial with 649 patients hospitalized with severe COVID-19 pneumonia.
  • Patients were randomized into two groups either to receive Actemra + remdesivir + standard care or placebo + remdesivir + standard care then they were followed for 28 days.
  • The endpoint of the trial was the time it took for patients to be ready for hospital discharge.
  • There were no statistically significant differences between the two groups.

Bottom line

  • Tocilizumab has an EUA to treat COVID-19 for patients who are 2 years and older, who are are being treated in a hospital with corticosteroids and they also need to have supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
  • Tocilizumab is not currently approved by FDA for COVID-19 but Tocilizumab is FDA approved for Rheumatoid Arthritis (RA), Giant Cell Arteritis (GCA), Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD), Polyarticular Juvenile Idiopathic Arthritis (PJIA), Systemic Juvenile Idiopathic Arthritis (SJIA) and Cytokine Release Syndrome (CRS)
  • Tocilizumab is thought to benefit patients with COVID-19 by decreasing the ‘cytokine storm’ or excessive immune response.
References

 

Related Medical Questions

Drug Information

Related Support Groups