Biological medicines and COVID-19 FAQs

Biological medicines are made of, or contain, substances from living cells and can be used to treat serious diseases affecting the immune system. They are a type of treatment known as disease-modifying anti-rheumatic drugs or DMARDs.¹ 

DMARDs

DMARDs reduce the activity of the immune system, the body’s defence system that fights infections and diseases. This is called immunosuppression.¹

They are usually prescribed for people with autoimmune disorders, when the immune system attacks the body’s own cells. This includes rheumatological conditions such as rheumatoid arthritis (RA), psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis) and systemic lupus erythematosus (SLE). These medicines are also used to treat people diagnosed with Crohn disease, ulcerative colitis, psoriasis, and some types of cancers.^1,2

There are three types of DMARDs:³

• conventional synthetic (csDMARD)
• targeted synthetic (tsDMARD)
• biological (bDMARD).

Each type affects the immune system in a different way.³

Biological medicines

Biological medicines target and reduce the activity of specific molecules or molecular pathways in the immune system. For people with RA, for example, these medicines are usually taken together with other medicines to control disease activity. This reduces inflammation, preventing joint damage, and eases symptoms such as pain and swelling.^1,3

Biological medicines are being repurposed and tested in clinical studies in a number of countries to see if they are safe and effective for people with COVID-19. Medicines tested include:^4,5

• tocilizumab (Actemra)
• anakinra (Kineret)
• sarilumab (Kevzara).

Tocilizumab is the biological medicine that has received the greatest clinical attention for COVID-19. It is being used in some countries and tested in clinical studies as a treatment added to a standard group of treatments for people with severe COVID who are critically ill in hospital.^4,6

Tocilizumab is a biological medicine used in Australia by people who have:^7,8

• rheumatoid arthritis (RA)
• juvenile idiopathic arthritis (JIA)
• giant cell arteritis (GCA)
• cytokine release syndrome (CRS) induced by chimeric antigen receptor T cell (CAR-T) therapy, for adults and children aged 2 years and older who have specific cancers.

Tocilizumab reduces the activity of a cytokine called interleukin-6 (IL-6).^7,8

Cytokines are small proteins released by many different cells in the body. In the immune system cytokines coordinate the body’s defence response against infection and trigger inflammation. The cytokine IL-6 has been found to have a role in autoimmune disorders such as rheumatoid arthritis.^7-9

When the SARS-CoV-2 virus (that causes the disease called COVID-19) enters the lungs, it triggers an immune response. This attracts immune cells to the region to attack the virus, resulting in inflammation in the lungs.⁹

But for some people with COVID-19 the immune system goes into overdrive. This causes excessive and uncontrolled levels of cytokines, called a cytokine storm, that leads to hyperinflammation. This situation is similar to cytokine release syndrome (CRS), a condition that is characterised by fever and multiple organ dysfunction.^5,9 The end result can be serious harm or even death.¹⁰

IL-6 is considered a leading cause of this cytokine storm.¹⁰ It’s believed that reducing IL-6 with tocilizumab in people with severe COVID-19 who are critically ill may help bring the cytokine storm back under control.^4,6

Tocilizumab is currently conditionally recommended for people hospitalised with COVID-19 who require supplemental oxygen. This means that the benefits of treatment with tocilizumab probably outweigh the possible harms, but not for everyone.¹¹

For people with severe COVID-19 who are in hospital, tocilizumab probably decreases the likelihood of needing treatment with a ventilator, and probably reduces the risk of death. It may also reduce the length of time the person needs intensive care and hospital care.¹¹

Studies are underway in the United States and other countries that will provide further evidence and certainty about the benefits and harms, and the safety and effectiveness of tocilizumab as a treatment for people with severe COVID-19.^4,5

Other biological medicines such as anakinra (Kineret) and medicines that affect the immune system, including baricitinib (Olumiant), are currently not recommended for people with COVID-19 as there is not enough evidence about their potential benefits and harms.^4,5,11 Some of these medicines may be used by people who give informed consent to be part of a clinical study on the safety and effectiveness of the medicine.¹¹

Studies have started in the United States and other countries that will provide clearer evidence on whether these medicines can be recommended.^4,5,11

Hydroxychloroquine is a csDMARD, which is also used as an antimalarial medicine and has been tested unsuccessfully as a treatment for COVID-19.

Find out more about hydroxychloroquine

It’s understandable that people with rheumatoid arthritis (RA) and other autoimmune disorders who are already taking medicines that reduce the activity of the immune system may feel vulnerable and anxious about COVID-19.¹²

Current evidence suggests that people with RA and other autoimmune disorders may be at higher risk of infection and serious illness from COVID-19. This could be a result of the underlying disease or of taking some of the medicines that reduce the activity of the immune system.¹³

However the Australian Rheumatology Association recommends that people with these conditions who are well should not stop taking their medicines.¹²

In particular, stopping glucocorticoids (also known as corticosteroids) suddenly may cause patients to become very unwell.¹²

They also point out that patients who stop their medicines may experience a flare and may need to restart and have to take more intensive treatment with glucocorticoids.¹²

Although some DMARDs, such as tocilizumab, are being trialled as treatments for severe COVID-19, they do not protect against infection. People taking these medicines should take the same precautions as all members of the community.¹⁴

COVID-19 vaccination is recommended for people with autoimmune diseases, like RA, who are taking medicines that affect the immune system.¹³ Two COVID-19 vaccines are available in Australia and both are suitable for people taking medicines that suppress the immune system.^13,14 Currently the Pfizer vaccine is recommended  for adults aged under 60 years and the AstraZeneca vaccine is the preferred vaccine for adults aged 60 years and over.¹⁵ The benefit of early vaccination with the Astra Zeneca vaccine may outweigh the risks for some people under 60 years of age who are taking medicines that reduce the activity of the immune system. Talk to your doctor about the choice and timing of vaccine for your situation.¹³

People taking rituximab should speak to their doctor to discuss the timing of the COVID-19 vaccination and their rituximab infusion.¹⁴

There is some evidence that methotrexate may lower the effectiveness of the COVID-19 vaccination. For some people taking methotrexate, who have stable disease with a low risk of flare, their doctor may consider holding methotrexate for one or two doses following vaccination. This decision should be made in discussion with their doctor, taking into account the risks and their individual circumstances.¹⁴

There is currently no clear evidence whether taking other DMARDs reduces protection from the COVID-19 vaccine but further research is underway to provide a better understanding for people taking these medicines.^13,14

If you have questions about disease-modifying treatments, including biological medicines, contact your doctor for advice.