• National Institute for Health and Clinical Excellence (NICE). Adalimumab, etanercept and infliximab for ankylosing spondylitis. London (UK): National Institute for Health and Clinical Excellence (NICE); 2008 May. 47 p. (Technology appraisal guidance; no. 143).

This is the current release of the guideline.

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.

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

  or

• 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 the two following paragraphs.

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 below.

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.

Patients who have experienced an adequate response to adalimumab or etanercept treatment, as defined above, should have their condition monitored at 12-week intervals. If the response to treatment, is not maintained, a repeat assessment should be made after a further 6 weeks. If at this 6-week assessment the response defined above has not been maintained, treatment should be discontinued.

For patients who have been shown to be intolerant of adalimumab or etanercept before the end of the 12-week initial assessment period, the other one of this pair of TNF-alpha inhibitor treatments is recommended as an alternative treatment.

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 above, or who experience loss of the initially adequate response during treatment.

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.

Infliximab is not recommended for the treatment of ankylosing spondylitis.

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.

None provided

The type of evidence supporting the recommendations is not specifically stated.

• National Institute for Health and Clinical Excellence (NICE). Adalimumab, etanercept and infliximab for ankylosing spondylitis. London (UK): National Institute for Health and Clinical Excellence (NICE); 2008 May. 47 p. (Technology appraisal guidance; no. 143).

Not applicable: The guideline was not adapted from another source.

2008 May

National Institute for Health and Clinical Excellence (NICE) - National Government Agency [Non-U.S.]

National Institute for Health and Clinical Excellence (NICE)

Appraisal Committee

Committee Members: Dr Jane Adam Radiologist, St George's Hospital, London; Professor A E Ades MRC Senior Scientist, MRC Health Services Research Collaboration, Department of Social Medicine, University of Bristol; Dr Amanda Adler Consultant Physician, Addenbrooke's Hospital, Cambridge; Dr Tom Aslan General Practitioner, Stockwell, London; Professor David Barnett (Chair) Professor of Clinical Pharmacology, University of Leicester; Mrs Elizabeth Brain Lay Member; Dr Karl Claxton Health Economist, University of York; Dr Richard Cookson Senior Lecturer in Health Economics, School of Medicine Health Policy and Practice, University of East Anglia; Mrs Fiona Duncan Clinical Nurse Specialist, Anaesthetic Department, Blackpool Victoria Hospital, Blackpool; Professor Christopher Eccleston Director Pain Management Unit, University of Bath; Dr Paul Ewings Statistician, Taunton & Somerset NHS Trust, Taunton; Professor John Geddes Professor of Epidemiological Psychiatry, University of Oxford; Mr John Goulston Director of Finance, Barts and the London NHS Trust; Ms Linda Hands Consultant Surgeon, John Radcliffe Hospital; Dr Rowan Hillson Consultant Physician, Diabeticare, The Hillingdon Hospital; Professor Philip Home (Vice Chair) Professor of Diabetes Medicine, Newcastle University; Dr Catherine Jackson Clinical Senior Lecturer in Primary Care Medicine, University of Dundee; Dr Terry John General Practitioner, The Firs, London; Professor Richard Lilford Professor of Clinical Epidemiology, Department of Public Health and Epidemiology, University of Birmingham; Dr Simon Maxwell Senior Lecturer in Clinical Pharmacology and Honorary Consultant Physician, Queen's Medical Research Institute; Dr Simon Mitchell Consultant Neonatal Paediatrician, St Mary's Hospital, Manchester; Ms Judith Paget Chief Executive, Caerphilly Local Health Board, Wales; Dr Katherine Payne Health Economist, The North West Genetics Knowledge Park, The University of Manchester; Dr Ann Richardson Lay Member; Dr Stephen Saltissi General Manager, Clinical Support Services, Cardiff and Vale NHS Trust; Mr Mike Spencer General Manager, Clinical Support Services, Cardiff and Vale NHS Trust; Dr Debbie Stephenson Head of HTA Strategy, Eli Lilly and Company; Professor Andrew Stevens Professor of Public Health, University of Birmingham; Dr Cathryn Thomas General Practitioner & Associate Professor, Department of Primary Care & General Practice, University of Birmingham; Dr Simon Thomas Consultant Physician, General Medicine and Clinical Pharmacology, Newcastle Hospitals NHS Trust; Mr David Thomson Lay Member; Dr Luke Twelves General Practitioner, Cambridgeshire PCT; Dr Norman Vetter Reader, Department of Epidemiology, Statistics and Public Health, College of Medicine, University of Wales, Cardiff; Professor Mary Watkins Professor of Nursing, University of Plymouth; Dr Paul Watson Director of Commissioning, NHS East of England

Committee members are asked to declare any interests in the technology to be appraised. If it is considered there is a conflict of interest, the member is excluded from participating further in that appraisal.

This is the current release of the guideline.

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.