Rheumatoid Arthritis: Gadsby K

Rajakulendran S, Gadsby K, Deighton C. · Department of Rheumatology, Derbyshire Royal Infirmary, Derby, UK. · Musculoskeletal Care. · Pubmed #18702106 No free full text.

Abstract: INTRODUCTION: The summary of product characteristics for leflunomide and methotrexate recommend avoiding alcohol. By contrast, the latest British Society for Rheumatology (BSR) guidelines suggest that alcohol should be 'well within national limits'. A postal survey was performed of rheumatoid arthritis (RA) patients to address their alcohol consumption, and assess whether this influenced any rise in alanine transaminase (ALT) levels while on leflunomide or methotrexate. METHODS: RA patients commenced on methotrexate or leflunomide within the preceding two years were identified using the departmental database. A total of 200 patients on methotrexate or leflunomide were sent questionnaires covering demographics, disease details, duration of disease-modifying anti-rheumatic drug (DMARD) use, previous medical and drug history, alcohol advice recalled, and alcohol consumption while on the drug. ALT levels at drug commencement and the highest level on the drug were recorded. RESULTS: Replies were received from 69.5% of methotrexate and 57.5% of leflunomide patients. 68.6% of patients recalled receiving alcohol advice. 55.8% of leflunomide patients did not drink alcohol prior to taking the DMARD, compared with 39.4% of methotrexate patients. 27.7% of leflunomide patients continued to drink alcohol compared with 64.3% on methotrexate. For both drugs, no patterns emerged to suggest that baseline or highest ALT levels were influenced by higher levels of alcohol consumption. DISCUSSION: No differences were found with either methotrexate or leflunomide for self-reported alcohol consumption influencing ALT levels. It is appropriate to give similar alcohol advice to patients beginning therapy with either methotrexate or leflunomide. This research has not found any evidence to contradict the relaxation of advice on alcohol consumption with methotrexate and leflunomide in the updated BSR guidelines.

Smith N, Ding T, Butt S, Gadsby K, Deighton C. · Department of Rheumatology, Derbyshire Royal Infirmary, London Road, Derby, DE1 2QY, UK. · Rheumatology (Oxford). · Pubmed #18603597 No free full text.

Abstract: 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.

Barry RJ, Sutcliffe N, Isenberg DA, Price E, Goldblatt F, Adler M, Canavan A, Hamburger J, Richards A, Regan M, Gadsby K, Rigby S, Jones A, Mathew R, Mulherin D, Stevenson A, Nightingale P, Rauz S, Bowman SJ. · Academic Unit of Ophthalmology, University of Birmingham, UK. · Rheumatology (Oxford). · Pubmed #18524804 No free full text.

Abstract: OBJECTIVE: To validate a tool for assessment of accumulated damage in patients with Primary SS (PSS). METHODS: Of the total 114 patients fulfilling American-European Consensus Group (AECG) criteria for PSS 104 were included in the study and assessed by rheumatologists at T (time) = 0 months and T = 12 months. On each occasion, damage and activity data, and autoantibody status were collected. SF-36 and Profile of Fatigue and Discomfort-Sicca Symptoms Inventory (PROFAD-SSI) questionnaires were completed. Cross-sectional analysis of this data was subject to a process of expert validation by 11 ophthalmologists, 14 oral medicine specialists and 8 rheumatologists. Items were removed from the index if >or= 50% of respondents recommended exclusion. Statistical validation was performed on remaining items. Spearman's rank analysis was used to investigate associations between damage scores and other disease status measures and Wilcoxon matched-pair analysis to assess sensitivity to change in the damage score. RESULTS: Based on the expert validation, a 29-item damage score was agreed incorporating ocular, oral and systemic domains. Total damage score correlated with disease duration at study entry (r = 0.436; P < 0.001), physical function as measured by SF-36 (r = 0.250, T = 0 months; r = 0.261 T = 12 months) and activity as measured by the Sjögren's Systemic Clinical Activity Index (r = 0.213, T = 0 months; r = 0.215, T =12 months). Ocular damage score correlated with the 'eye dry' domain of PROFAD-SSI (r = 0.228, T = 0 months; r = 0.365, T = 12 months). Other associations not present on both assessments were considered clinically insignificant. On Wilcoxon analysis, the index was sensitive to change over 12 months (z = -3.262; P < 0.01). CONCLUSION: This study begins validation of a tool for collection of longitudinal damage data in PSS. We recommend further trial in both the experimental and clinical environment.

Jerram S, Butt S, Gadsby K, Deighton C. · Department of Rheumatology, Derbyshire Royal Infirmary, London Road, Derby, DEI 2QY, UK. · Rheumatology (Oxford). · Pubmed #18160419 No free full text.

Abstract: OBJECTIVES: A discrepancy exists between the National Institute for Health and Clinical Excellence (NICE) guidelines for continuation of TNF therapy in RA and EULAR response criteria. We performed a retrospective study of patients starting anti-TNF therapy to establish how many NICE non-responders would have met EULAR response criteria, and whether this may increase. METHOD: We calculated the percentage of NICE non-responders who would have met EULAR moderate response criteria. We then compared the mean decrease in disease activity score (DAS28) for patients with low and high baseline scores. We analysed trends for treating RA in Derby with anti-TNF to address whether we were treating less active disease over time. RESULTS: At 3 months (n = 271 patients), 7.7% of NICE non-responders would have met EULAR moderate response criteria. At 6 months (n = 240 patients) this was 23.7%. Patients starting with a higher DAS28 had a significantly greater absolute drop in score. The mean decrease between the 1st and 3rd tertiles of patients divided by baseline DAS28 was significant at 3 and 6 months (P < 0.001). Derby rheumatologists were treating less active RA over time. Comparing the mean DAS28 baseline between the 1st and 3rd tertiles of patients divided by anti-TNF commencement date was significant (P < 0.001). CONCLUSIONS: A significant minority of NICE non-responders would fall within the moderate EULAR response criteria. This is likely to increase in future due to the increasing tendency to initiate anti-TNF in patients with less active disease. Consequently, NICE guidelines should be brought in line with EULAR response criteria.

Bowman SJ, Sutcliffe N, Isenberg DA, Goldblatt F, Adler M, Price E, Canavan A, Hamburger J, Richards A, Rauz S, Regan M, Gadsby K, Rigby S, Jones A, Mathew R, Mulherin D, Stevenson A, Nightingale P. · Rheumatology Department, University Hospital Birmingham NHS Foundation Trust, Selly Oak, Birmingham B29 6JD, UK. · Rheumatology (Oxford). · Pubmed #18032543 No free full text.

Abstract: OBJECTIVE: This article describes the development of the Sjögren's Systemic Clinical Activity Index (SCAI) for the measurement of systemic disease activity in patients with primary Sjögren's syndrome (PSS). METHODS: A pilot tool was developed based on expert consensus and previous published data. One hundred and four patients with PSS were evaluated in a cross-sectional analysis, of whom 65 were reviewed at 3-monthly intervals, using this index, over a 12-month period. Factor analysis was used to evaluate the proposed domain structure. External validation was assessed by comparison with relevant domains of the Profile of Fatigue and Discomfort (PROFAD), Medical Outcomes Study Short Form-36 (SF-36) and The World Health Organization Quality of Life-Bref (WHOQOL-BREF). Sensitivity to change was assessed by comparing SCAI-derived flares with physician-designated disease flare and intention-to-treat analysis. A reliability and repeatability workshop was also held. RESULTS: Factor analysis supported the proposed domain structure. There were strong correlations between the SCAI fatigue, musculoskeletal and Raynaud's components and the PROFAD fatigue, arthralgia and vascular domains. There was a significant correlation between change in therapy and SCAI-defined flares (P = 0.01). The mean kappa-test results both for reliability of the SCAI and for physician repeatability were 0.71. CONCLUSION: This initial evaluation supports the potential for the SCAI as a tool for systemic activity assessment in patients with PSS but additional work is required to assess sensitivity to change in clinical therapeutic trials.

Smith N, Gadsby K, Butt S, Carruthers D, Deeming A, Ledingham J, Fletcher M, Mulherin D, Roskell S, Kay L, Nicholl K, Cooper R, Worsley A, Deighton C. · Department of Rheumatology, Derbyshire Royal Infirmary, London Road, Derby, England, UK DE1 2QY. · Rheumatology (Oxford). · Pubmed #17666440 No free full text.

Abstract: OBJECTIVES: National Institute for Health and Clinical Excellence (NICE) guidelines for anti-tumour necrosis factor (TNF) in rheumatoid arthritis (RA) state that two pre-assessments of Disease Activity Score (DAS28) should be performed a month apart. We performed a retrospective audit of data from six centres to determine the stability of DAS28 between assessments, and the proportion of patients still satisfying eligibility criteria at baseline. METHODS: All RA patients assessed for anti-TNF from six centres had their pre-assessment DAS28 (DAS-1) compared with their baseline DAS28 (DAS0) using paired t-tests, and a similar analysis for the components of the DAS28. Patients who were no longer eligible for anti-TNF at DAS0 were noted. RESULTS: Six hundred and seventy-nine RA patients showed no significant change in the DAS28, with a mean DAS-1 of 6.74 and DAS0 of 6.73. (P = 0.86). Of the patients, 97.2% fulfilled the UK eligibility criteria at DAS0. Comparison of the individual components of the DAS28 between the two pre-assessment dates showed that there was no significant difference between either the numbers of swollen joints or the erythrocyte sedimentation rate (ESR), but there was a significant increase in the numbers of tender joints of 1.41 (P < 0.001) and in the visual analogue scale (VAS) of 4.22 (P < 0.001). DISCUSSION: The overwhelming majority of patients who fulfil eligibility criteria for anti-TNF drugs 1 month prior to baseline also fulfil the criteria at baseline. There is no significant change in the DAS28 over the month waiting to go onto anti-TNF therapy. A single assessment of the DAS28 would suffice to enable patients to go on to anti-TNF treatment.

Wenham C, Gadsby K, Deighton C. · No affiliation provided · Rheumatology (Oxford). · Pubmed #18180249 No free full text.

This publication has no abstract.

Rajakulendran S, Gadsby K, Allen D, O'Reilly S, Deighton C. · No affiliation provided · Ann Rheum Dis. · Pubmed #17105865 No free full text.

This publication has no abstract.