Abstract

These guidelines have been developed for use by prescribing secondary-care rheumatologists. They are intended to indicate which adult patients with rheumatoid arthritis (RA) may benefit from the anti-tumour necrosis factor (anti-TNF) therapies, precautions that need to be taken in their use and to highlight potential side-effects from these therapies. The previous guidelines applied to the then available anti-TNF therapies (etanercept and infliximab) [1]. These current guidelines would apply to these two products together with adalimumab, which is a newly licensed anti-TNF therapy for RA. This is a rapidly changing field with new data emerging each month, so that it is vital that clinicians keep up to date with this area of practice. These guidelines can only incorporate information that was available to the authors at the time of their completion. The guidelines have been drawn up by the above working party and have been approved by the British Society for Rheumatology (BSR) Standards, Guidelines and Audit Working Group (SGAWG). National Institute of Clinical Excellence (NICE) guidelines, Medline literature searches for published data on the anti-TNF drugs and data from the pharmaceutical companies producing anti-TNF agents have been used to draw together the updated guidelines. The guidelines were subject to a consultation process at the BSR Annual Meeting 2004 and feedback was received from BSR members, allied health professionals, patient representatives and members of the pharmaceutical industry. The BSR SGAWG will be responsible for initiating a further update of these guidelines in the future and for auditing their use. The anti-TNF therapies are not necessarily the only treatment option available to patients who are eligible for treatment according to these guidelines—the potential risks versus the benefits need to be considered for each individual case. There will be circumstances in which rheumatologists will feel that there are other drugs that may be equally likely to produce a good clinical response. In the UK all patients commenced on the following anti-TNF therapies need to be registered on the BSR biologics register (BSRBR): etanercept, infliximab, adalimumbab and anakinra. It is currently intended that data be collected on 4000 patients per antiTNF therapy. Thereafter the BSR would recommend continued data collection, in the same format as for the BSRBR, at a local level. These guidelines will be updated as other anti-TNF treatments are included in the register. For further clarification before registration, please contact Dr Kath Watson, BSRBR Study Co-ordinator, arc Epidemiology Unit, Stopford Building, The University of Manchester, Oxford Road, Manchester M13 9PT, UK (Tel: 0161 275 1613, E-mail: biologics.register@ man.ac.uk). Adverse incidents/serious side-effects arising whilst on antiTNF therapy should be notified immediately via the yellow card system, but also to the BSRBR via the 6-monthly review sheets. Rheumatologists have responsibility for supplying updated information to the BSRBR as required and as requested. Written consent will be sought from patients for their participation in this study via the BSRBR.

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