Biological medicines are a newer type of medicine, used to ease the symptoms of rheumatoid arthritis (RA) and reduce the damaging effect of the disease on the joints. They are usually prescribed when you have tried older medicines called disease-modifying antirheumatic drugs (DMARDs) and these have not worked so well. If a biological medicine is going to work, you will usually feel better within 12 weeks of starting one. Biological medicines make you more prone to infections and sometimes damage the blood-producing cells. You should carry a biological therapy alert card with you at all times. This is to make sure that any doctors or nurses who are treating you know that you are taking a biological medicine and that you are at increased risk of developing a serious infection.
What are biological medicines?
Biological medicines are a group of newer medicines that are used to ease the symptoms of rheumatoid arthritis (RA) and reduce the damaging effect of the disease on the joints. Biological medicines mimic substances produced by the human body, such as antibodies. They are made by living organisms such as cloned human white blood cells. This is unlike most medicines which are made by chemical processes.
There are quite a few biological medicines available to treat RA. They include adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, anakinra, abatacept, rituximab and tocilizumab. They come in various different brand names. Some biological medicines are sometimes called cytokine modulators or monoclonal antibodies.
There is another group of medicines called disease-modifying antirheumatic drugs (DMARDs) which can also be used to treat RA. Like biological medicines they have a disease-modifying effect against RA. See separate leaflet called Disease-modifying Antirheumatic Drugs (DMARDs) for more details.
Biological medicines are also used to treat other conditions - for example, some other forms of arthritis, and chronic inflammatory skin or bowel disease. However, the rest of this leaflet is only about biological medicines when they are used to treat RA.
What is rheumatoid arthritis?
Arthritis means inflammation of joints. Rheumatoid arthritis (RA) is a common form of arthritis. The main symptoms are pain and stiffness of affected joints. RA is thought to be an autoimmune disease. The immune system normally makes small proteins (antibodies) to attack bacteria, viruses, and other germs. In people with autoimmune diseases, the immune system makes antibodies against tissues of the body. It is not clear why this happens. In people with RA, antibodies are formed against the tissue that surrounds each joint (synovium). This causes inflammation in and around affected joints. Over time this can damage the joint, the cartilage, and parts of the bone near to the joint. The most commonly affected joints are the small joints of the fingers, thumbs, wrists, feet and ankles. See separate leaflet called Rheumatoid Arthritis for more details.
How do biological medicines work?
Biological medicines work in rheumatoid arthritis (RA) by blocking chemicals in the body that are involved in inflammation. For example, some of these biological medicines block a chemical called tumour necrosis factor alpha (TNF-alpha) which plays an important role in causing inflammation in the joints. Medicines that block TNF include adalimumab, certolizumab pegol, etanercept, golimumab, and infliximab. The other biological medicines (anakinra, abatacept, rituximab and tocilizumab) work in slightly different ways to each other, and to medicines that block TNF, but they all reduce inflammation.
When are biological medicines usually prescribed?
Biological medicines are usually prescribed when you have taken at least two DMARDs for six months and your rheumatoid arthritis (RA) has not improved. They are only prescribed by doctors in a hospital who specialise in treating RA (consultant rheumatologists).
If your doctor thinks that a biological medicine would work for you then you are usually asked to take a DMARD called methotrexate at the same time. Some people cannot take methotrexate and they may be asked to take a different DMARD.
Which biological medicines are usually prescribed?
Biological medicines that block TNF (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab) are usually tried first. Sometimes people have side-effects to these medicines in the first three months of treatment. If this happens, your doctor may try you on one of the other medicines that block TNF, or you may be given one of the other biological medicines that work in a slightly different way (usually rituximab). Your doctor will advise.
Biological medicines cannot be taken as a tablet or a liquid to swallow because they would be broken down in the gut and would not work. Some biological medicines are given by an injection under the skin - for example, etanercept. You can either learn to inject yourself, or a nurse in the hospital will do it for you. Other biological medicines are given in the hospital by a drip into a vein in the arm. How often they are given depends on which one you are prescribed - it can vary from once a week to once every eight weeks.
How well or quickly do biological medicines work?
It is thought that biological medicines work better than DMARDs at slowing damage to the joints. Unfortunately, they do not work for everyone and it is not possible before treatment starts to tell who will respond to them. If a biological medicine is going to work, you will probably feel better within 12 weeks.
How long are biological medicines prescribed for?
Biological medicines are normally prescribed for six months. If your symptoms have not improved after six months then these medicines are usually stopped. Your doctor will discuss other treatments that you can try.
If biological medicines improve your rheumatoid arthritis (RA), the specialist may consider keeping you on this medication in the long term. Once your RA is under control, the specialist may decide to try to reduce your dose and eventually stop your biological medicine. But the decision to continue or stop treatment will depend upon your symptoms and what the specialist feels is best for you.
What are the possible side-effects?
It is not possible to list all of the adverse effects of each biological medicine in this leaflet. However, as with all medicines, there are a number of side-effects that have been reported with each of the biological medicines. If you want more information specific to your biological medicine then you should read the information leaflet that comes with your medicine.
Most biological medicines make you more prone to infections. These can be quite serious and some people have had severe infections such as infection of the blood (septicaemia), as well as tuberculosis (TB) and hepatitis B reactivation. Screening for hepatitis B is now recommended before starting rituximab, whether you are at risk of infection or not. If the screen shows you are carrying hepatitis B you will be referred to a liver specialist. The specialist will do more tests to help decide if rituximab is right for you.
Some biological medicines may also cause damage to the blood-producing cells.
You should tell your doctor or nurse straightaway if you develop any of the following after starting a biological medicine:
- A sore throat.
- A high temperature (fever).
- Any other symptoms of infection.
- Unexplained bruising.
These are all signs that you may be having side-effects to your medicine.
Other side-effects that have been reported include:
- Feeling sick (nauseated).
- Tummy (abdominal) pain.
- Itching (pruritus).
- Injection site reactions.
Most hospitals will give you a biological therapy alert card to carry with you at all times. This is important because, if you become unwell, the doctor or nurse treating you needs to know you are being treated with a biological medicine, making you more at risk of infection.
These medicines sometimes react with other medicines that you may take. For example, people who are being treated with biological medicines cannot have certain types of vaccines called live vaccines. So, make sure your doctor knows of any other medicines that you are taking, including ones that you have bought rather than been prescribed. See the leaflet that comes with your particular brand for a full list of possible side-effects and cautions.
Do I need any tests before starting a biological medicine?
Most people will have a chest X-ray and blood tests before starting a biological medicine. These tests are done to make sure you do not have TB and hepatitis B (as above) and that you do not have any problems with your blood-producing cells.
During treatment you will be monitored for any signs of TB, hepatitis B and other infections. You may also have further blood tests to see if your treatment is working.
Can I buy biological medicines?
You cannot buy biological medicines. They are only available with a doctor's prescription.
Who cannot take biological medicines?
Doctors do not prescribe biological medicines if you:
- Are pregnant or breast-feeding.
- Have an infection.
There are a number of other conditions which, if you have them, may make your doctor decide against prescribing a biological medicine. For example, if you have had TB in the past, if you have active hepatitis B, if you are prone to infections, or if you have serious problems with your heart.
How to use the Yellow Card Scheme
If you think you have had a side-effect to one of your medicines you can report this on the Yellow Card Scheme. You can do this online at www.mhra.gov.uk/yellowcard.
The Yellow Card Scheme is used to make pharmacists, doctors and nurses aware of any new side-effects that medicines or any other healthcare products may have caused. If you wish to report a side-effect, you will need to provide basic information about:
- The side-effect.
- The name of the medicine which you think caused it.
- The person who had the side-effect.
- Your contact details as the reporter of the side-effect.
It is helpful if you have your medication - and/or the leaflet that came with it - with you while you fill out the report.
Further reading and references
EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update; European League Against Rheumatism (Dec 2013)
Management of early rheumatoid arthritis; Scottish Intercollegiate Guidelines Network - SIGN (February 2011)
Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed; NICE Technology Appraisal, January 2016