Is tocilizumab (Actemra) effective for treating COVID-19?
Yes Actemra (tocilizumab) may improve outcomes in COVID-19 patients who are receiving corticosteroids and requiring supplemental oxygen or breathing support. Actemra is FDA approved to be used to treat COVID-19 in hospitalized adult patients, who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Actemra has a emergency use authorisation (EUA) for ages 2 years to less than 18 years old to treat COVID-19 in patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Results from four studies (RECOVERY trial, EMPACTA, COVACTA and REMDACTA) showed that Actemra may improve COVID-19 outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support. The FDA approval for Actemra use in COVID-19 is based on the results from the RECOVERY trial and the EMPACTA trial, which was the first global, Phase III study in COVID-19 to focus on patients from underrepresented racial and ethnic groups.
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)
- COVID-19 in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Actemra has an EUA for treatment of hospitalized COVID-19 patients aged 2 years to less than 18 years old, who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)..
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.
- Actemra FDA approved to be used to treat adult COVID-19 patients who are hospitalized, are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)
- Tocilizumab has an EUA to treat COVID-19 for patients who are 2 years and less than 18 years old, 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).
- Actemra is also 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.
- COVID-19: consider cytokine storm syndromes and immunosuppression: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30628-0/fulltext
- Therapeutic strategies to fight COVID-19: Which is the status artis?: https://bpspubs.onlinelibrary.wiley.com/doi/full/10.1111/bph.15452
- Tocilizumab in COVID-19: some clarity amid controversy: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00712-1/fulltext
- Effectiveness of Tocilizumab in Patients Hospitalized With COVID-19, A Follow-up of the CORIMUNO-TOCI-1 Randomized Clinical Trial: https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2780021
- What is the role of the IL-6 inhibitor tocilizumab (Actemra) in the treatment of coronavirus disease 2019 (COVID-19)?: https://www.medscape.com/answers/2500114-197457/what-is-the-role-of-the-il-6-inhibitor-tocilizumab-actemra-in-the-treatment-of-coronavirus-disease-2019-covid-19
- Coronavirus (COVID-19) Update: FDA Authorizes Drug for Treatment of COVID-19: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-drug-treatment-covid-19?utm_medium=email&utm_source=govdelivery
- Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00676-0/fulltext
- Tocilizumab in Patients Hospitalized with Covid-19 Pneumonia: https://www.nejm.org/doi/full/10.1056/NEJMoa2030340
- Tocilizumab in Hospitalized Patients with Severe Covid-19 Pneumonia: https://www.nejm.org/doi/full/10.1056/NEJMoa2028700
- Roche provides update on the phase III REMDACTA trial of Actemra/RoActemra plus Veklury in patients with severe COVID-19 pneumonia: https://www.roche.com/investors/updates/inv-update-2021-03-11.htm
- FDA Frequently Asked Questions on the Emergency Use Authorization for Actemra (Tocilizumab) for Treatment of COVID-19 https://www.fda.gov/media/150345/download
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