Guidance 1.1 Etanercept and infliximab (infliximab only in combination with methotrexate) are recommended as options for the treatment of adults who have continuing clinically active rheumatoid arthritis that has not responded adequately to at least two disease-modifying anti-rheumatic drugs, including methotrexate (unless contraindicated).
1.2 Both etanercept and infliximab should be prescribed in accordance with relevant sections of the British Society for Rheumatology (BSR) guidelines, April 2001 (see Appendix D), which set 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 In particular, treatment should be withdrawn in the event of severe drug-related toxicity or because of lack of response at 3 months.
1.3 Prescription of these agents and follow-up of treatment response and adverse events should be undertaken only by a consultant rheumatologist specialising in their use. The choice of which of the two agents is used should be determined by consultation between the patient and the clinician responsible, taking into account differences in treatment schedules and patient preferences.
1.4 Maintenance therapy with these agents in those who respond to treatment initially should be at the lowest licensed dose compatible with continuing clinical response.
1.5 All clinicians prescribing etanercept or infliximab should (with the patient's consent) register the patient with the Biologics Registry established by the BSR and forward information on dosage, outcome and toxicity on a 6-monthly basis.
1.6 There is currently no evidence to support treatment beyond 4 years. A decision to continue therapy should therefore be contingent on ongoing monitoring of disease activity and clinical effectiveness in individual cases. Outcomes from the BSR Biologics Registry will help inform such decisions.
1.7 There is no evidence for the consecutive use of these agents, and therefore this is not recommended.