Technology Appraisal Guidance No. 130
Source: National Institute for Health and Care Excellence
NOTE: This guidance replaces ‘NICE technology appraisal guidance 36’ issued in March 2002.
The Institute reviews each piece of guidance it issues.
This review and re-appraisal has additionally included adalimumab for the treatment of rheumatoid arthritis, and has taken into account changes in the marketing authorisations for infliximab and etanercept.
1.1 The tumour necrosis factor alpha (TNF-alpha) inhibitors adalimumab, etanercept and infliximab are recommended as options for the treatment of adults who have both of the following characteristics.
- Active rheumatoid arthritis as measured by disease activity score (DAS28) greater than 5.1 confirmed on at least two occasions, 1 month apart.
- Have undergone trials of two disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate (unless contraindicated). A trial of a DMARD is defined as being normally of 6 months, with 2 months at standard dose, unless significant toxicity has limited the dose or duration of treatment.
1.2 TNF-alpha inhibitors should normally be used in combination with methotrexate. Where a patient is intolerant of methotrexate or where methotrexate treatment is considered to be inappropriate, adalimumab and etanercept may be given as monotherapy.
1.3 Treatment with TNF-alpha inhibitors should be continued only if there is an adequate response at 6 months following initiation of therapy. An adequate response is defined as an improvement in DAS28 of 1.2 points or more.
1.4 After initial response, treatment should be monitored no less frequently than 6-monthly intervals with assessment of DAS28. Treatment should be withdrawn if an adequate response (as defined in 1.3) is not maintained.
1.5 An alternative TNF-alpha inhibitor may be considered for patients in whom treatment is withdrawn due to an adverse event before the initial 6-month assessment of efficacy, provided the risks and benefits have been fully discussed with the patient and documented.
1.6 Escalation of dose of the TNF-alpha inhibitors above their licensed starting dose is not recommended.
1.7 Treatment should normally be initiated with the least expensive drug (taking into account administration costs, required dose and product price per dose). This may need to be varied in individual cases due to differences in the mode of administration and treatment schedules.
1.8 Use of the TNF-alpha inhibitors for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate or other DMARDs is not recommended.
1.9 Initiation of TNF-alpha inhibitors and follow-up of treatment response and adverse events should be undertaken only by a specialist rheumatological team with experience in the use of these agents.
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://guidance.nice.org.uk/TA130
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 N1397. It is also available on the Internet at http://guidance.nice.org.uk/TA130/quickrefguide/pdf/English
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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Enquiries concerning the guidance should be addressed to: National Institute for Health and Care Excellence, MidCity Place, 71 High Holborn, London WC1V 6NA. email: firstname.lastname@example.org
Adalimumab, Etanercept and Infliximab for the Treatment of Rheumatoid Arthritis
Issue Date: October 2007
Review Date: September 2010