Kate Gadsby

BSR and BHPR rheumatoid arthritis guidelines on safety of anti-TNF therapies.

Inhibitors of TNF-a represent important treatment advances for a number of inflammatory conditions, including RA. TNF-a inhibitors offer a targeted strategy that contrasts with the non-specific immunosuppressive agents traditionally used to treat most forms of systemic inflammation. Information on who benefits from these agents and on their adverse effects continues to be collected through clinical studies, case series and reports and through national registries. In 2001 and 2005, the British Society for Rheumatology (BSR) established and updated guidelines for the use of anti-TNF drugs in RA [1, 2]. These guidelines have indicated which adult patients with RA should be eligible for treatment with anti-TNF therapies, precautions that need to be taken in their use and action that should be taken in the event of adverse effects. The previous guidelines applied to the then-available anti-TNF therapies {etanercept and infliximab in 2001 [1], and etanercept, infliximab and adalimumab (first-generation anti-TNF agents) in 2005 [2]}. Due to the large volume of information now available on these agents the BSR has, in 2010, produced separate guidelines on eligibility for anti-TNF treatment in RA (in press) These current guidelines cover the safety aspects of anti-TNF treatment in RA and apply to the first-generation products but also to the newly licensed second-generation anti-TNF drugs, certolizumab pegol and golimumab. There are relatively little safety data specifically for these second-generation agents but there are no data thus far to suggest that their side-effect profile would differ significantly from the first-generation agents. This is a rapidly changing field with new data emerging each month, so it is vital that clinicians keep up to date with this area of practice. These guidelines have Rheumatology Department, Royal Derby Hospital, Derby, Rheumatology Unit, Queen Alexandra Hospital, Portsmouth, Rheumatology Department, Nuffield Orthopaedic Centre, Oxford, Rheumatology Department, Poole Hospital, Poole, ARC Epidemiology Unit, University of Manchester, Manchester, Rheumatology Department, St George’s Healthcare, London, Rheumatology Department, Royal Lancaster Infirmary, Lancaster, Rheumatology Department, St Helens Hospital, St Helens, National Rheumatoid Arthritis Society, Maidenhead, Rheumatology Department, Addenbrooke’s Hospital, Cambridge, Rheumatology Department, Trafford General Hospital, Manchester, Rheumatology Unit, Worthing and Southlands NHS Trust, Worthing and Rheumatology Department, Robert Jones and Agnes Hunt Orthopaedic Hospital, Oswestry, UK.

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

Chris Deighton1, Kimme Hyrich2, Tina Ding1, Jo Ledingham3, Mark Lunt2, Raashid Luqmani4, Patrick Kiely5, Marwan Bukhari6, Rikki Abernethy7, Andrew Ostor8, Ailsa Bosworth9, Kate Gadsby1, Frank McKenna10, Diana Finney11 and Josh Dixey12, on behalf of BSR Clinical Affairs Committee & Standards, Audit and Guidelines Working Group and the BHPR 1Rheumatology Department, Royal Derby Hospital, Derby; 2ARC Epidemiology Unit, University of Manchester, Manchester; 3Rheumatology Unit, Queen Alexandra Hospital, Portsmouth; 4Rheumatology Department, Nuffi eld Orthopaedic Centre, Oxford; 5Rheumatology Department, St George’s Healthcare, London; 6Rheumatology Department, Royal Lancaster Infi rmary, Lancaster; 7Rheumatology Department, St Helens Hospital, St Helens; 8Rheumatology Department, Addenbrooke’s Hospital, Cambridge; 9National Rheumatoid Arthritis Society, Maidenhead; 10Department of Rheumatology, Trafford General Hospital, Manchester; 11Rheumatology Unit, Worthing and Southlands NHS Trust, Worthing; 12Department of Rheumatology, Robert Jones and Agnes Hunt Orthopaedic Hospital, Oswestry, UK

BSR and BHPR guidelines on the use of rituximab in rheumatoid arthritis

The Standards, Audit and Guidelines Working Group (SAGWG) of the British Society for Rheumatology (BSR) have recently updated the guidelines on eligibility for anti-TNF drugs in RA [1] and have updated the anti-TNF safety and efficacy guidelines [2] for general use of the rheumatology community. The National Institute for Heath and Clinical Excellence (NICE) in the UK, which is the is an independent organization responsible for providing national guidance in the UK on promoting good health and preventing and treating ill health, has published a technology appraisal guidance [3] for use of rituximab in RA in 2007. Furthermore, a consensus statement from EULAR [4] was also published in 2007. Therefore, it was felt appropriate to undertake a review of the currently available data as new evidence was available. The group did not wish to duplicate the guidance in those documents, but wished to review the more recent evidence and supplement what is already known.

The importance of the baseline Disease Activity Score 28 in determining responders and non-responders to anti-TNF in UK clinical practice

OBJECTIVES The NICE re-appraisal of anti-TNF requires demonstration of ongoing response, making the baseline 28-joint Disease Activity Score (DAS28) crucially important. A retrospective analysis of all RA patients on their first anti-TNF determined predictive factors for those classified as non-responders at 6 months according to current NICE guidelines. METHODS The patients were divided into responders (DAS28 dropped by >1.2) and non-responders. These groups were compared for demographics, DAS28 at the two pre-assessments 1 month apart and at baseline. Exposure to intramuscular, oral and IA steroids in the 3 months period before the baseline DAS28 was recorded. RESULTS At 6-month assessment in 256 patients, 82.8% were responders with no demographic differences between them and non-responders. Although the first pre-assessment score was not significantly different (6.8 vs 6.6), the second pre-assessment score (7.1 vs 6.7) and the baseline DAS (7.2 vs 6.3) were lower in the non-responders (P < 0.04 and P < 0.001, respectively). Comparing the differences in DAS28 from the first pre-assessment to baseline, the responders had increased by 0.4, and the non-responders had decreased by 0.4, (P < 0.001). If the first pre-assessment score had been taken as the baseline DAS28, then 9.4% of responders would be re-classified as non-responders, and 31.8% of non-responders would be re-classified as responders. The proportion of patients who had steroid treatment within the 3 months period before the baseline DAS28 did not differ significantly between the responders and non-responders (34% vs 41%, P = 0.38). CONCLUSION Baseline DAS28 is critical in classifying responders at the 6-month assessment.