NICE technology appraisal guidance
Issued: October 2007
TA130

Adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis

This is an extract from the guidance. The complete guidance is available at guidance.nice.org.uk/ta130

1 Guidance

This guidance partially replaces 'Guidance on the use of etanercept and infliximab for the treatment of rheumatoid arthritis' (NICE technology appraisal guidance 36) issued in March 2002.

For details, see 'About this guidance'.

1.1 The tumour necrosis factor alpha (TNF-α) 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-α 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-α 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 Treatment should be withdrawn if an adequate response (as defined in 1.3) is not maintained.

1.5 An alternative TNF-α inhibitor may be considered for patients in whom treatment is withdrawn due to an adverse event before the initial 6-month assessment of efficacy, provided the risks and benefits have been fully discussed with the patient and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-α 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-α 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-α 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.