Guidance on the Use of Etanercept for the Treatment of Juvenile Idiopathic Arthritis (TA35)

NOTE: This guidance has been replaced by ‘NICE technology appraisal guidance 373’.

Technology Appraisal Guidance No. 35

Source: National Institute for Health and Care Excellence

  • Etanercept is recommended for children aged 4 to 17 years with active polyarticular-course juvenile idiopathic arthritis whose condition has not responded adequately to, or who have proved intolerant of, methotrexate.

  • Etanercept should be prescribed in accordance with relevant sections of the British Paediatric Rheumatology Group (BPRG) protocol (see Appendix D of the detailed guideline), which sets out criteria for eligibility, definitions of failure of standard therapy, exclusion criteria and criteria for withdrawal of therapy. In particular, treatment should be withdrawn in the event of severe drug-related toxicity or because of lack of response at 6 months.

  • Initiation of etanercept therapy should only be undertaken by a consultant who regularly sees children and young people with juvenile idiopathic arthritis and who runs specialised paediatric rheumatology clinics. In addition, the prescribing centre should have a nurse specialist or an appropriately trained nurse who is able to teach children and parents injection techniques and who does this regularly. Follow up of treatment response and adverse events may be on a shared-care basis depending on local circumstances.

  • It is strongly recommended that all clinicians prescribing etanercept should (with the permission of the child and/or parent) register the child with the Biologics Registry established by the BPRG and forward information on dosage, outcome and toxicity on a quarterly basis.

  • There is currently no evidence to support treatment beyond 2 years and continuation of therapy is therefore contingent upon outgoing monitoring of disease activity and clinical effectiveness in individual cases.

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

Copies of the document can also be obtained by contacting 0845 003 7783 or emailing and quoting reference number N0071.

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.

© Copyright National Institute for Health and Care Excellence. All rights reserved. This material may be freely reproduced for educational and not for profit purposes within the NHS. No reproduction by or for commercial organisations is permitted without the express written permission of the Institute.

Enquiries concerning the guidance should be addressed to: National Institute for Health and Care Excellence, MidCity Place, 71 High Holborn, London WC1V 6NA. email:

Guidance on the Use of Etanercept for the Treatment of Juvenile Idiopathic Arthritis.
Issue Date: March 2002
Review Date: January 2005

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