Anti TNF therapy, also known as biologic therapy, is one of a new class of drugs for AS.

In people with AS, along with some other forms of inflammatory arthritis, a protein called tumour necrosis factor (TNF) is over-produced in the body. This causes inflammation and damage to bones, cartilage and tissue. Anti TNF therapy blocks the action of TNF and so can reduce inflammation.

Four anti TNF drugs have now received a Europe-wide license. They were first used in rheumatoid arthritis (RA) simply because there are more people with RA than AS, therefore, not unnaturally the first trials were on patients with RA.

Subsequent trials of these anti TNF drugs in AS have demonstrated conclusively, that in many cases, there are both clinical improvements and in a few studies, improvements in Magnetic Resonance Imaging (MRI) parallel to the clinical improvement. The evidence suggests that there is reason to suspect that in AS, the drug is even more effective than it is in RA, especially as it is recognised that AS has a limited response to anti -inflammatory drugs.

One of our NASS members has written about how anti TNF therapy helped her AS. To read Anya`s story please click here.

The four anti TNF drugs licensed for the treatment of AS are:

Currently  adalimumab, etanercept and golimumab have been approved by the National Insitute for Clinical Excellence (NICE) for use in AS. NICE issued their guidance on the use of adalimumab, entanercept and infliximab in May 2008. Infliximab was turned down on the grounds of cost, rather than effectiveness or side effects. Golimumab was approved by NICE for AS in September 2011.

The three anti TNF drugs currently approved by NICE should be available to patients who meet the prescribing criteria laid down by NICE where anti TNF therapy is recommended by their rheumatologist.　

If you have any problems gaining access to an anti TNF drug and you have the support of your rheumatologist in prescribing it, then please contact NASS for further help and advice. 　

The NICE recommendations are:

For more details you can look at the full NICE guidelines. You can also look at a quick reference guide and a version aimed at patients. However, the main points are as follows:

Your AS must meet the modified New York criteria for AS

After taking reasonable measures to ensure that the symptoms are not due to alternative causes such as spinal fracture, disc disease and fibromyalgia. This means that you will have:

  • Low back pain and stiffness for more than 3 months that improves with exercise but is not relieved by rest
  • Limitation of motion of the lumbar spine in the sagittal and frontal planes
  • Limitation of chest expansion relative to normal values correlated by age and sex

Additionally, the radiological (x-ray) criteria is:

  • Sacroiliitis grade>2 bilaterally (one both sides) or grade 3-4 unilaterally (on one side)

You must have failed on standard medications

The doctor must also be of the opinion that all other forms of medication have failed. For AS this means that you have tried at least two anti-inflammatory drugs. You do not need to have tried a disease modifying agent, such as methotrexate.

You must meet the BASDAI and VAS requirements

The patient must also have reached a score of more than 4 on what is known as the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and spinal pain score during the previous week, measuring more than 4 on the Visual Analogue Scale (VAS). Click here for more information on these measures.

It is the recommendation that everybody should be tested and treated for the TB germ if they have previously had TB or been in contact with other people who have had the disease. This is because, in very few cases, there is evidence that TB has been reactivated as a result of this treatment.

It is recommended that pregnant women should not be treated but this is only a precaution, as nothing is known.

It is recommended that the response to adalimumab, etanercept or golimumab treatment should be assessed 12 weeks after treatment is initiated, and that treatment should be discontinued in the absence of an adequate response.

Patients who have an adequate response to anti TNF treatment should have their condition monitored at three monthly intervals. If the response to treatment, is not maintained, a repeat assessment should be made after a further six weeks. If at this six week assessment the response has not been maintained, treatment should be discontinued.

Prescription of an alternative anti TNF is currently not recommended in patients who have either not achieved an adequate initial response to treatment or who experience loss of the initially adequate response during treatment.

It is recommended that the use of adalimumab, etanercept and golimumab for severe AS should be initiated and supervised only by specialist physicians experienced in the diagnosis and treatment of this condition, that is, a rheumatologist.

Last reviewed: March 2012

 

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