National Institute for Health and Clinical Excellence (NICE)
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NICE issues guidance on treatments for ankylosing spondylitis

The National Institute for Health and Clinical Excellence (NICE) yesterday (May 28) issued guidance on the use of adalimumab, etanercept and infliximab in the treatment of severe active ankylosing spondylitis in adults.

The recommendations include:

• Adalimumab or etanercept are recommended as treatment options for adults with severe active ankylosing spondylitis only if all of the specified clinical criteria are fulfilled. This includes:

o having active spinal disease as assessed on two separate occasions 12 weeks apart

o failure of conventional treatment with at least two non-steroidal anti-inflammatory drugs taken sequentially at maximum tolerated or recommended dosage to control symptoms

• Infliximab is not recommended for the treatment of ankylosing spondylitis

• People currently receiving infliximab for treating ankylosing spondylitis should have the option to continue therapy until they and their clinicians consider it appropriate to stop.

Further recommendations are given on how the response to treatment should be monitored and the use of an alternative treatment in the case of intolerance. It is also
recommended that treatment should be supervised only by specialist physicians experienced in the diagnosis and management of this condition.

Andrew Dillon, Executive Lead for the appraisal, said:
“Ankylosing spondylitis is a progressive and irreversible condition causing a great deal of pain and discomfort and impacting on an individual’s ability to go about their daily life. NICE’s guidance on the use of adalimumab and etanercept is positive news for people with this disabling condition and offers them access to treatments that have previously been subject to postcode prescribing.”

For more information call Dr Tonya Gillis on 0207 045 2174 or the NICE press office on 0845 003 7782 or 07775 583 813.

Notes to Editors

About the guidance

1. Ankylosing spondylitis is an inflammatory disease of unknown cause. The principal feature of ankylosing spondylitis is inflammation of the sacroiliac joint at the base of the spine followed by inflammation rising along the spine. The result is back pain and stiffness. Inflammation at the sites where ligaments and tendons attach to bone can lead to new bone development and joint fixation (ankylosis).

2. Where assessment methods are not suitable because of a patient’s circumstances (such as learning disabilities or communication difficulties), healthcare professionals should use another appropriate assessment method, which may include adapting the questionnaire to the patient’s needs.

3. Publication of this appraisal follows a meeting of the Appeal Panel on 31 March 2008, where appeals against the draft guidance from Schering - Plough Ltd and The National Ankylosing Spondylitis Society were heard but subsequently not upheld.

About NICE

4. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.

5. NICE produces guidance in three areas of health:

public health – guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector

health technologies – guidance on the use of new and existing medicines, treatments and procedures within the NHS

clinical practice – guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

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