Access to the next wave of biologic therapies (Abatacept and Tocilizumab) for the treatment of rheumatoid arthritis in England and Wales: addressing treatment outside the current NICE guidance.

Patients in England and Wales with rheumatoid arthritis (RA) receive treatment from the National Health Service (NHS) with therapies approved by the European Medicines Agency (EMA), under guidance from the National Institute for Health and Clinical Excellence (NICE). This document overviews the current NICE guidelines for the treatment of RA and identifies scenarios when such guidance may not represent the optimum management strategy for individual patients. Specifically, we consider the use of tocilizumab or abatacept as the most appropriate treatments for some patients. In such scenarios, it may be possible for the clinician to secure access to the required therapy through an application procedure known as an 'individual funding request', the process of which is described in detail here. At present, it is unclear the extent to which the proposed reform of the NHS will affect the role of NICE in providing guidance and setting standards of care. Until the full impact of the proposed changes are realized, individual funding requests will remain a valuable way of securing the optimal treatment for all patients suffering from RA.

The composite DAS Score is impractical to use in daily practice: evidence that physicians use the objective component of the DAS in decision making.

INTRODUCTION AND BACKGROUND: The disease activity score for 28 joints (DAS28) is widely used for assessing disease activity in rheumatoid arthritis and its use is recommended for establishing the need for anti- tumor necrosis factor drugs, according to British Society for Rheumatology guidelines. However, calculation of the score requires a laboratory measurement of inflammation (either erythrocyte sedimentation rate or C-reactive protein) so that it is not possible to have the actual score when the patient seen in the clinic and, therefore, it is not possible to make immediate treatment decisions based on the DAS28 score. METHODS: This is an audit of clinic-based treatment decisions, collecting data for the DAS28 on consecutive patients with rheumatoid arthritis. The nonlaboratory elements of the DAS score were completed along with a physician global assessment and any treatment decisions were recorded. RESULTS: Data on 100 patients were collected. Even when the patients were judged to have active disease by DAS28 treatment switches or increases were not always made. In logistic regression analyses, using treatment increase or switch as the dependent variable, only the swollen joint count was significant. CONCLUSION: There is evidence from this study that the DAS score is limited in daily clinical practice. In this audit of practice treatment, changes seem to be made on objective physician assessments rather than patient recorded assessments.

Revised British Isles Lupus Assessment Group 2004 index: a reliable tool for assessment of systemic lupus erythematosus activity.

OBJECTIVE: To test the interrater reliability of the revised British Isles Lupus Assessment Group 2004 (BILAG-2004) index for the assessment of systemic lupus erythematosus (SLE) activity. METHODS: Patients with SLE were recruited from 11 centers. Two physician raters separately assessed the patients' disease activity using the BILAG-2004 index in routine clinical practice. Scores ranged from A (for very active disease) to E (for inactivity). Two reliability exercises were performed. Changes were made to the index after the first exercise (E1), and additional training was provided to the raters before the second exercise (E2). E1 and E2 involved 12 and 14 raters, respectively. Interrater reliability was assessed using kappa statistics and intraclass correlation coefficients. Levels of agreement and the extent of major disagreement were also examined. Major disagreement was defined as a score difference between raters of A versus C, D, or E or B versus D or E. RESULTS: For each exercise, 97 patients were recruited. In E1, the mean age of the patients was 42.3 years (range 18.5-82.2 years), 89.7% were women, and 74.2% were white, 8.2% were Afro-Caribbean, and 13.4% were South Asian, and in E2, the mean age was 43.7 years (range 17.7-75 years), 90.7% were women, and 68% were white, 15.5% were Afro-Caribbean, and 11.3% were South Asian. The mean disease duration was 9.4 years (range 0-32.1 years) for patients in E1 and 10 years (range 0-34.8 years) in E2. There was improvement in the interrater reliability and the level of agreement from E1 to E2. Further improvement was achieved after removal of poorly performing items. CONCLUSION: The BILAG-2004 index is a reliable tool to assess SLE activity. The use of a well-defined glossary and training of raters are essential to ensure the optimal performance of the index.

Pharmacological management of transient synovitis.

Synovitis is a painful and, occasionally, disabling disease. Patients with synovitis, especially new onset synovitis, should be referred to a rheumatologist urgently so that they can be assed and treated as quickly as possible. Clinical assessment and investigations are required to help differentiate between transient (< 3 months) and persistent (> 3 months) synovitis. This differentiation is important, as persistent synovitis can lead to joint damage and disability. Septic arthritis is a rheumatological emergency requiring immediate assessment and specific treatment. The earlier synovitis is treated, the more effective treatment is likely to be. If treated very early, there is potential to prevent the move from transient to persistent synovitis. Transient synovitis can be treated with painkillers, NSAIDs and/or corticosteroids, depending on severity. Persistent synovitis may also require disease-modifying drugs. Clinical indicators of persistence include symptom duration at first visit, early morning stiffness for > 1 h, arthritis in more than three joints, bilateral compression pain in metatarsophalangeal joints, rheumatoid factor positivity, anti-cyclic citrullinated peptide antibody positivity, erosions on hand or feet X-rays and a family history of rheumatoid arthritis. Disease-modifying drugs need to be considered early to achieve clinical remission before damage and disability occur. Despite emerging new treatments for synovitis, especially persistent synovitis, full clinical remission is still not achieved in most patients, and more research into disease processes and targeted therapies is required.

A comparison of the performance characteristics of classification criteria for the diagnosis of psoriatic arthritis.

OBJECTIVE: To compare the accuracy of published classification criteria for the diagnosis of psoriatic arthritis (PsA) and to see whether data-derived classification criteria would be more accurate. METHODS: Data were abstracted from case-note review and radiographic review of patients identified with PsA or rheumatoid arthritis (RA) from 2 clinical disease registers. Each patient was classified according to 7 criteria sets. The test performance characteristics were compared using conditional logistic regression analysis. In an attempt to overcome the problems of the diagnostic gold standard, latent class analysis also was used to calculate test-performance characteristics. Classification and regression-tree methodology was used to derive new criteria and to indicate the diagnostic importance of particular data items, especially rheumatoid factor (RF). RESULTS: Four hundred ninety-nine patients were identified with RA (n=156) or PsA (n=343). Excluding the criteria of Fournie, which could not be applied in 24% of subjects, 446 cases could be classified by all of the other 6 methods. The most sensitive criteria for the diagnosis of PsA were those of Vasey and Espinoza, McGonagle, and Gladman (99%), whereas the others were significantly less sensitive (between 56% and 94%). The specificity of the criteria was high and statistically similar (between 93% and 99%). The Fournie criteria were the most difficult to use, whereas the Vasey and Espinoza and Moll and Wright criteria were the easiest (98% of subjects were able to be classified). A 2-latent class model found very similar test-performance characteristics. Logistic regression and classification and regression-tree models suggested that negative RF was not necessary for diagnosis in the presence of other characteristic features of PsA. CONCLUSIONS: Apart from the Bennett and European Spondyloarthropathy Study Group criteria, which have inadequate sensitivity, the published classification criteria for PsA have similar test-performance characteristics. These data suggest that the criteria proposed by Vasey and Espinoza, Gladman, or McGonagle are the most accurate and feasible in distinguishing between PsA and RA. Relevance International agreement about classification criteria for PsA will assist the interpretation of clinical and epidemiologic research. However, further prospective studies on unselected patients with and without PsA, including controls with non-rheumatoid inflammatory arthritis, are required to confirm these findings.