Biosimilars
Biosimilar medicines are developed to be highly similar to a biologic medicine
Read moreThis information is for anyone with axial spondyloarthritis (axial SpA) including people with ankylosing spondylitis (AS)
Biologic therapy has changed the way axial SpA (AS) is managed
What is a biologic?
Unlike medications like paracetamol or ibuprofen, which are small chemical agents, biologic medicines are complex proteins.
Biologic medicines are manufactured within a living system and target specific molecules believed to be involved in axial SpA (AS). They are made up of genetically engineered proteins and are very large, complex molecules.
The most common forms are called monoclonal antibodies. This gives many of these drug names their ‘mab’ ending.
Most biologics are designed to block specific aspects of the immune system and can be thought of as ‘targeted therapies’. Because these therapies are proteins, they do not work as tablets and have to be given as injections into the skin. Biologics are made up of genetically-engineered proteins from living organisms and are very large, complex molecules. They work by blocking aspects of the immune system to slow down the attack on your joints and spine.
| Biologic Medicine | Pharmaceutical Medicine |
|---|---|
| Very large and complex medicine | Smaller with a less complex structure |
| Made through a biological process | Made through a chemical process |
| Because they are so large and complex, copies can never be identical. | Exact copies can be made by using the same chemical componnts and processes |
| Copies known as biosimiliars | Copies known as generics |
When can biologic therapy be used
Many people with axial SpA (AS) do not need biologic therapy because they can manage their condition well with a combination of physiotherapy and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen.
However, some people still have active or progressive symptoms despite these treatments and they may require biologic therapies.
Your rheumatology consultant or nurse might talk to you about biologic therapy if:
- You have tried NSAIDs but you feel they aren’t helping.
- You are not able to take NSAIDs because they cause problems with your stomach or other medical conditions.
- You still have high pain levels and stiffness which are thought to be due to inflammation from your axial SpA (AS).
- Your axial SpA (AS) is having a big impact on your life. It might be affecting your ability to work, enjoy your family life or have a good quality of life.
Biologic therapy can only be prescribed by a consultant rheumatologist. Your GP cannot offer it to you. If you are not under the care of a rheumatologist do ask your GP to refer you.
The National Institute for Health and Care Excellence (NICE) has produced written national guidelines about prescribing anti TNF therapy and anti IL-17A that must be followed. Your rheumatologist will advise you if you meet the criteria for biologic therapy and they are safe for you.
You may not be suitable for biologic therapy if:
- You have had tuberculosis (TB) in the past (in which case you may first need treatment for this). Your rheumatology doctor or nurse will test you for TB before prescribing a biologic
- You have had recent, repeated or serious infections, or are at very high risk of infections
- You have multiple sclerosis (MS) – this applies to anti TNF therapy
- You have had cancer within the past 5 years
- You have heart failure
- Your pain is due to causes other than inflammation
Biologic therapies are available to treat axial SpA (AS)
The current biologics licensed for axial SpA (AS) and approved by NICE target one of two specific inflammatory molecules, namely TNF and IL-17A.
Both work by reducing the abnormal inflammation produced by the body.
There are more drugs currently in development and going through clinical trials which target these and other pathways, which should become available in future if effective and safe.
Anti TNF therapy
Anti TNF therapy is used to treat a range of inflammatory conditions including non radiographic axial SpA (no changes on x-ray) and ankylosing spondylitis (AS) (changes on x-ray), as well as other conditions such as inflammatory bowel disease, rheumatoid arthritis and psoriasis.
These treatments interfere with the action of a protein called tumour necrosis factor (TNF) which is over-active in people with inflammatory arthritis, including axial SpA (AS).
Too much TNF can cause inflammation and damage to bones, cartilage and tissue. Anti TNF therapy blocks the action of TNF and can reduce the amount of inflammation present in your body and joints.
Anti TNF medications currently available include:
Adalimumab (Amgevita, Hulio, Humira, Hyrimoz and Imraldi)
- Self administered by an injection pen device
- Once fortnightly dosing
Certolizumab pegol (Cimzia)
- Self administered by an injection pen device
- When you start certolizumab pegol you need to do two injections every two weeks for the first 6 weeks. You then move to one injection every two weeks, or two injections every 4 weeks
Etanercept (Enbrel, Benepali and Erelzi)
- Self administered by an injection pen device or pre-filled syringe
- Once or twice weekly dosing
Golimumab (Simponi)
- Self administered by an injection pen device
- Once monthly dosing
Infliximab (Remicade, Remsima, Flixabi and Inflectra)
- Administered by an infusion (drip), often in a day unit clinic
- Dosing varies by individual but is commonly every 6 to 8 weeks
Anti IL-17A
Anti IL-17A therapy is currently licensed to treat ankylosing spondylitis, as well as psoriasis and psoriatic arthritis. We anticipate it will also become available in the future for people with non-radiographic axial spondyloarthritis.
It works by neutralising the activity of a protein in the body called IL-17A.
IL-17A is a key protein in the skin inflammation in psoriasis. Research has shown that people with axial SpA (AS) have very high levels of IL-17A in their body and that IL-17A plays a very important role in causing the inflammation associated with axial SpA (AS). By decreasing the IL-17A, this biologic reduces inflammation in your body and joints.
The first anti IL 17A secukinumab (Cosentyx) was approved by NICE and the Scottish Medicines Consortium in 2016.
- Self administered by an injection pen device
- Treatment starts with 4 ‘loading’ doses. After your first dose (week 0) you inject your medication weekly at weeks 1, 2 and 3. On week 4 you will receive the first of your monthly injections. After that you will continue to inject monthly.
How biologic therapy can help
Biologic therapy works to reduce inflammation in your body and that means you should get less pain, less stiffness and more movement. Hopefully this will mean you can get moving more quickly in the morning, find it easier to carry out your daily activities, be able to exercise more and sleep better.
In short, biologic therapy should give you a better quality of life.
It is still important to continue with your regular exercises, whatever treatment you take.
Biologic therapy cannot reverse any damage or fusion of the spine and sacroiliac joints that has already occurred, but research has shown than many people with long-standing disease can still have significant improvement with biologic therapies.
There is some early evidence that biologic therapies may prevent new bone formation in the long-term. We hope to see more evidence for this over the coming years.
It appears that people generally tolerate these treatments well, but occasionally have to stop them due to side effects. Your rheumatologist should explain these possible side effects.
Unfortunately, not everyone with axial SpA (AS) will respond to biologic therapies. The reasons for this are still not fully known and cannot be clearly predicted in advance.
It is thought that approximately 8 people out of every 10 will have a meaningful response, justifying ongoing use.
People who do not respond sufficiently (it may take 3-6 months to be certain), or who get serious side effects, will usually be recommended to stop their biologic therapy. If it is safe and appropriate to do so, your rheumatologist may suggest trying an alternative biologic therapy.
