Technology Appraisal Guidance No. 143
Source: National Institute for Health and Care Excellence
NOTE: This guidance has been replaced by NICE technology appraisal guidance 383.
1.1 Adalimumab or etanercept are recommended as treatment options for adults with severe active ankylosing spondylitis only if all of the following criteria are fulfilled.
- The patient’s disease satisfies the modified New York criteria for diagnosis of ankylosing spondylitis.
- There is confirmation of sustained active spinal disease, demonstrated by:
− a score of at least 4 units on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and
− at least 4 cm on the 0 to 10 cm spinal pain visual analogue scale (VAS).
These should both be demonstrated on two occasions at least 12 weeks apart without any change of treatment.
- Conventional treatment with two or more non-steroidal anti-inflammatory drugs taken sequentially at maximum tolerated or recommended dosage for 4 weeks has failed to control symptoms.
1.2 When using BASDAI and spinal pain VAS scores to inform conclusions about whether or not sustained active spinal disease is present, healthcare professionals should be mindful of the need to secure equality of access to treatment for patients with disabilities and patients from different ethnic groups. There are circumstances in which it may not be appropriate for healthcare professionals to use a patient’s BASDAI and spinal pain VAS scores to inform their conclusion about the presence of sustained active spinal disease. These are:
- where the BASDAI or spinal pain VAS score is not a clinically appropriate tool to inform a clinician’s conclusion on the presence of sustained active spinal disease because of a patient’s learning or other disabilities (for example, sensory impairments) or linguistic or other communication difficulties
- where it is not possible to administer the BASDAI or spinal pain VAS questionnaire in a language in which the patient is sufficiently fluent for it to be an appropriate tool to inform a conclusion on the presence of sustained active spinal disease, or there are similarly exceptional reasons why use of a patient’s BASDAI or spinal pain VAS score would be an inappropriate tool to inform a conclusion on the presence of sustained active spinal disease in that individual patient’s case.
In such cases, healthcare professionals should make use of another appropriate method of assessment, which may include adapting the use of the questionnaire to suit the patient’s circumstances.
The same approach should apply in the context of a decision about whether to continue the use of the drug in accordance with sections 1.3 and 1.4.
1.3 It is recommended that the response to adalimumab or etanercept treatment should be assessed 12 weeks after treatment is initiated, and that treatment should be only continued in the presence of an adequate response as defined in section 1.4.
1.4 For the purposes of this guidance, an adequate response to treatment is defined as a:
- reduction of the BASDAI score to 50% of the pre-treatment value or by 2 or more units and
- reduction of the spinal pain VAS by 2 cm or more.
1.5 Patients who have experienced an adequate response to adalimumab or etanercept treatment, as defined in section 1.4, should have their condition monitored at 12-week intervals. If the response to treatment, as defined in section 1.4, is not maintained, a repeat assessment should be made after a further 6 weeks. If at this 6-week assessment the response defined in section 1.4 has not been maintained, treatment should be discontinued.
1.6 For patients who have been shown to be intolerant of adalimumab or etanercept before the end of the 12-week initial assessment period, as in section 1.3, the other one of this pair of TNF-alpha inhibitor treatments is recommended as an alternative treatment.
1.7 Prescription of an alternative TNF-alpha inhibitor is not recommended in patients who have either not achieved an adequate initial response to treatment with adalimumab or etanercept, as defined in section 1.4, or who experience loss of the initially adequate response during treatment.
1.8 It is recommended that the use of adalimumab or etanercept for severe active ankylosing spondylitis should be initiated and supervised only by specialist physicians experienced in the diagnosis and treatment of this condition.
1.9 Infliximab is not recommended for the treatment of ankylosing spondylitis.
1.10 Patients currently receiving infliximab for the treatment of ankylosing spondylitis should have the option to continue therapy until they and their clinicians consider it appropriate to stop.
The guidance shown above constitutes Section 1 of the full document. A copy of the full document and a summary of the evidence is available on the Internet at http://www.nice.org.uk/guidance/index.jsp?action=byID&o=11992
An abridged version of this guidance (a 'quick reference guide') is also available. Printed copies of the quick reference guide can be obtained by contacting 0845 003 7783 or emailing email@example.com and quoting reference number N1570. It is also available on the Internet at http://www.nice.org.uk/guidance/index.jsp?action=download&o=40764
This guidance represents the view of the Institute which was arrived at after careful consideration of the available evidence. Health professionals are expected to fully take it into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
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Adalimumab, Etanercept and Infliximab for Ankylosing Spondylitis.
Issue Date: May 2008
Review Date: October 2010