BSR and BHPR rheumatoid arthritis guidelines on eligibility criteria for the first biological therapy

Abstract

The 2000 BSR recommendations on eligibility for anti-TNF agents had a limited evidence base [1], but were accepted unchanged in the first National Institute of Health and Clinical Excellence (NICE) guidelines [2]. This included the criteria of a 28-joint version of the disease activity score (DAS-28) being >5.1 on two occasions 1 month apart in patients having failed on two DMARDs (one being MTX), and a drop in DAS-28 of 1.2 to demonstrate response. The updated BSR guidelines in 2005 did not consider that there was sufficient evidence to enable a change in eligibility or response criteria [3]. An editorial in 2006 discussed the shortcomings of these guidelines, and established an agenda for their regular review [4]. Updated NICE anti-TNF in RA guidelines have been published recently [5] and have left eligibility criteria unchanged. Response criteria have become more exacting, not only requiring initial evidence of response, but also 6-monthly assessments demonstrating maintenance of response for patients to remain on therapy [5]. The arguments over the cost-effectiveness of anti-TNF therapy in RA will be revisited in 2010, and it is important that robust evidence-based arguments improve the current NICE guidelines on biological therapies in RA, and ensure the identification of those patients who are most likely to gain benefit, in a manner that NICE deems to be cost-effective.