Background: Composite measures of disease activity have been developed for use in Psoriatic Arthritis (PsA) to capture the wide spectrum of disease but there is a lack of consensus regarding which to adopt for routine practice. It is recognised that more data is required to understand the measurement properties of existing instruments and consider the impact of modifications that may improve face validity, responsiveness or feasibility. It is important to have an estimate of a measurement instrument’s reliability in the setting of stable disease in order to understand measurement error and responsiveness. To our knowledge no data exists on the stability of composite measures in PsA. Objectives: To measure test re-test reliability of composite measures of disease activity in PsA. Methods: Clinical and patient reported outcomes to enable the calculation of composite measures were administered to 141 patients with PsA at five time points in a UK multicentre observational study. All patients fulfilled the CASPAR criteria. Twenty-nine patients with clinically stable disease and receiving no treatment intervention underwent repeat assessment by the same examiner within 2 weeks. Patients in high and low disease were included. Reliability was evaluated by intra-class correlation coefficient (ICC) and Bland Altman plots. Results: Of the 29 patients included 15 were male, the mean age was 52.4 years (SD 13.39), mean disease duration at T 0 was 9.2yrs (SD 8.11). The mean swollen joint count was 3.4 (SD 5.1), tender joint count 11.3 (SD 15.03) and PASI 1.0 (SD1.04). The ICC (95% CI) for tender and swollen joint counts were 0.94 (0.87-0.97) and 0.91 (0.80-0.96) respectively. The ICC for PASI was 0.95 (0.90-0.98). All composite measures demonstrated high levels of test-retest reliability with ICC >0.85, table. The most reliable measure was the PADAS ICC 0.98 (95% CI 0.954-0.991). The individual ICC for each composite measures are reported in the table and Bland Altman plots, figure. Conclusion: All composite measures show high levels of test-retest reliability in this cohort. The PASDAS was the most stable measure. Modifications to these instruments can now be tested and the impact compared to the original versions. Table. Test Re-Test reliability of each composite measure Intraclass Correlation Coefficient (95% Confidence Interval) GRACE 0.929 (0.842-0.968) * CPDAI 0.852 (0.635-0.940) * PASDAS 0.978 (0.954-0.991) * DAPSA 0.922 (0.831-0.964) * 3VAS 0.915 (0.815-0.960) * RAPID3 0.899 (0.782-0.953) * Disease Activity Index for PsA (DAPSA), PsA Disease Activity Score (PASDAS), Composite Psoriatic Disease Activity Index (CPDAI), GRAppa Composite Exercise (GRACE), 3 Visual Analogue Scale (3VAS), Routine Assessment of Patient Index (RAPID3), * P<0.001 Figure. Bland Altman plots for each composite measure Funding: This report is independent research funded by the National Institute for Health Research, Programme Grants for Applied Research [Early detection to improve outcome in patients with undiagnosed PsA (‘PROMPT’), RP-PG-1212-20007]. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Disclosure of Interests: William Tillett Grant/research support from: AbbVie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc, UCB, Consultant of: AbbVie, Amgen, Celgene, Lilly, Janssen, Novartis, MSD, Pfizer Inc, UCB, Speakers bureau: AbbVie, Amgen, Celgene, Lilly, Janssen, Novartis, Pfizer Inc, UCB, Philip Helliwell: None declared, Oliver FitzGerald: None declared, Robin Waxman: None declared, Anna Antony: None declared, Laura C Coates: None declared, Deepak Jadon: None declared, Paul Creamer: None declared, Suzanne Lane: None declared, Marco Massarotti: None declared, Charlotte Cavill: None declared, Mel Brooke: None declared, Jonathan Packham: None declared, Eleanor Korendowych: None declared, Anya Lissina: None declared, Neil McHugh: None declared
Objectives To see if a group course delivered by rheumatology teams using cognitive-behavioural approaches, plus usual care, reduced RA fatigue impact more than usual care alone. Methods Multicentre, 2-year randomised controlled trial in RA adults (fatigue severity >= 6/10, no recent major medication changes). RAFT (Reducing Arthritis Fatigue: clinical Teams using CB approaches) comprises seven sessions, codelivered by pairs of trained rheumatology occupational therapists/nurses. Usual care was Arthritis Research UK fatigue booklet. Primary 26-week outcome fatigue impact (Bristol RA Fatigue Effect Numerical Rating Scale, BRAF-NRS 0-10). Intention-to-treat regression analysis adjusted for baseline scores and centre. Results 308/333 randomised patients completed 26 week data (156/175 RAFT, 152/158 Control). Mean baseline variables were similar. At 26 weeks, the adjusted difference between arms for fatigue impact change favoured RAFT (BRAF-NRS Effect -0.59, 95% CI -1.11 to -0.06), BRAF Multidimensional Questionnaire (MDQ) Total -3.42 (95% CI -6.44 to -0.39), Living with Fatigue -1.19 (95% CI -2.17 to -0.21), Emotional Fatigue -0.91 (95% CI -1.58 to -0.23); RA Self-Efficacy (RASE, +3.05, 95% CI 0.43 to 5.66) (14 secondary outcomes unchanged). Effects persisted at 2 years: BRAF-NRS Effect -0.49 (95% CI -0.83 to -0.14), BRAF MDQ Total -2.98 (95% CI -5.39 to -0.57), Living with Fatigue -0.93 (95% CI -1.75 to -0.10), Emotional Fatigue -0.90 (95% CI -1.44, to -0.37); BRAF-NRS Coping +0.42 (95% CI 0.08 to 0.77) (relevance of fatigue impact improvement uncertain). RAFT satisfaction: 89% scored >= 8/10 vs 54% controls rating usual care booklet (p<0.0001). Conclusion Multiple RA fatigue impacts can be improved for 2 years by rheumatology teams delivering a group programme using cognitive behavioural approaches.
Objectives To assess predictive factors for rheumatoid arthritis interstitial lung disease (RA-ILD) in two early rheumatoid arthritis (RA) inception cohorts with a focus on methotrexate (MTX) exposure. Design Multicentre prospective early RA inception cohort studies; the early RA study (ERAS) and the early RA network (ERAN). Setting Secondary care, ERAS nine centres, ERAN 23 centres in England, Wales and Ireland. Participants Patients with new diagnosis of RA, n=2701. Standardised data including demographics, drug therapies and clinical outcomes including the presence of RA-ILD were collected at baseline, within 3-6 months, at 12 months and annually thereafter. Primary and secondary outcome measures Primary outcome was the association of MTX exposure on RA-ILD diagnosis. Secondary outcomes were the association of demographic, comorbid and RA-specific factors on RA-ILD diagnosis and the association of MTX exposure on time to RA-ILD diagnosis. Results Of 92 eligible ILD cases, 39 occurred in 1578 (2.5%) MTX exposed and 53 in 1114 (4.8%) non-MTX exposed cases. The primary analysis of RA-ILD cases only developing after any conventional synthetic disease-modifying antirheumatic drug treatment (n=67) showed MTX exposure not to be associated with incident RA-ILD (OR 0.85, 95% CI 0.49 to 1.49, p=0.578) and a nonsignificant trend for delayed ILD diagnosis (OR 0.54, 95% CI 0.28 to 1.06, p=0.072). In an extended analysis including RA-ILD cases present at RA diagnosis (n=92), MTX exposure was associated with a significantly reduced risk of incident RA-ILD (OR 0.48, 95% CI 0.3 to 0.79, p=0.004) and longer time to ILD diagnosis (OR 0.41, 95% CI 0.23 to 0.75, p=0.004). Other independent baseline associations with incident RA-ILD were higher age of RA onset, ever smoking, male gender, rheumatoid nodules and longer time from first RA symptom to first outpatient visit. Conclusions MTX treatment was not associated with an increased risk of RA-ILD diagnosis. On the contrary, evidence suggested that MTX may delay the onset of ILD.
Background The treat-to-target (T2T) approach, with earlier, aggressive treatment has resulted in improvements in rheumatoid arthritis (RA) outcomes1,2. Whether these improvements have translated into improvements in patient reported outcomes is less clear. Studies have indicated declines in pain and function as well as depression and anxiety. However, these studies are limited to short follow-up periods or were restricted to cross-sectional, rather than longitudinal analyses. Objectives To assess changes in 5 year progression rates for disease activity and patient reported outcomes in a prospective cohort of early RA patients between 2002 and 2011. Methods The Early RA Network (ERAN) is a longitudinal prospective cohort study that recruited 1236 early RA patients from 2002 to 2011. DAS-28 and SF-36 were measured at baseline, 6 months, 12 months and then yearly. Multi-level linear regression were used to model 5 year progression rates of both DAS-28 and SF-36 in patients recruited between 2002–2011. Models controlled for sex and age and seropostivity at baseline. DMARD use at baseline was controlled for using propensity score weighting. Year of diagnosis was entered as a continuous variable, allowing for the mean of the outcome variables to be estimated for 2002 and 2011. Restricted cubic splines were used to account for non-linear progression over time. Results Disease activity for patients diagnosed in 2011 demonstrated a statistically significant decrease at year 5 compared to patients diagnosed in 2002 (5 year estimated mean difference −0.35; 95% CI 0.22–0.49, p<0.001). Using the SF-36 measure, Physical Function, Bodily Pain, Vitality (indicating fatigue) and Mental Health indicated similar levels at year-5 between those patients diagnosed in 2011 to those diagnosed in 2002 (p>0.05). Mental health was similar to the normalised population mean of 50, irrespective of year diagnosed. However, levels of vitality/fatigue, function and pain remain less favourable for all early RA patients over the first 5 years. Conclusions Although disease activity has shown a marked decline at 5 years between 2002 and 2011, there is little evidence that this has led to improvements of an equivalent magnitude in function, pain, fatigue and mental health. Treatment should also focus on improved function, pain management, fatigue and mental health as part of the T2T protocol. References [1] Twigg S, et al. Fatigue, older age, higher body mass index and female gender predict worse disability in early rheumatoid arthritis despite treatment to target: A comparison of two observational cohort studies from the United Kingdom. Arthritis Care Res. (Hoboken). 2017. doi:10.1002/acr.23281 [2] Carpenter L, et al. Reductions in Radiographic Progression in Early Rheumatoid Arthritis Over Twenty-Five Years: Changing Contribution from Rheumatoid Factor in Two Multicenter UK Inception Cohorts. Arthritis Care Res. 2017;69. Disclosure of Interest None declared
Background Biologic therapies (eg, tumour necrosis factor inhibitors (TNFi)) used in the management of inflammatory arthritis are associated with potential risks (including local reactions, infections and possible malignancy). Increasing RCT evidence suggests stable patients can dose reduce without increased disease activity and a previous patient engagement event explored patient perceptions of dose reduction. There are no clear guidelines or strategies reported in the literature to facilitate implementation in clinical practice. Purpose For 2 years at the local NHS Trust, stable patients (out of the 460 patients on subcutaneous TNFi) were offered the opportunity to reduce their dose on an ad hoc basis with variable regimens. The purpose of this pilot study was to develop a structured programme for standardising dose reduction of subcutaneous TNFi therapy to support implementation among clinicians and patients. Material and methods An inflammatory arthritis TNFi 5 step dose reduction programme was developed (30% interval extension for 3 steps, followed by a 60% extension, before stopping treatment), with a patient information and compliance record (informing of treatment escalation following a disease flare up). The programme was reviewed by a consultant rheumatologist and patient representative group, and presented to the clinical team, and treatment checklists were updated to include a prompt. Patients started on dose reduction schemes were recorded. Results In the 2 years preceding the pilot, 27 patients attempted TNFi dose reduction (average rate of 1.1/month). In the first 6 months following introduction of the programme, an additional 42 patients (56% increase) were initiated on dose reduction schemes (average rate of 7/month). Of the 42 additional patients, 31 (74%) were initiated on the formal BTRIM programme and 11 (26%) were extended via an alternative schedule. Conclusion The pilot showed that adopting a structured dose reduction programme increased implementation in clinical practice. It is unclear whether this was attributable to increased patient and/or clinician confidence or raised clinician awareness. Reasons for opting out were not assessed. Further work has been identified following the pilot, including potential gainshare discussions with commissioners and approval of a research grant to conduct a qualitative study assessing patient perceptions of biologic therapy dose reduction. References and/or acknowledgements Rheumatology patient representative group, Local Trust. No conflict of interest
"Monitoring patients with ankylosing spondylitis on anti-TNF monotherapy: too much too often?." Scandinavian Journal of Rheumatology, 46(4), pp. 330–331
Background: Sacroiliac joints (SJ) involvement is a distinctive and charasteristic feature of Spondyloarthritis (SpA) and x-ray is the test routinely used to make a diagnosis. However, x-ray reveals late structural damage but cannot detect active inflammation. The objective of this study was to assess the validity of Doppler ultrasound in SJ. Methods: Prospective blinded and controlled study of SJ, in which three populations were compared. We studied 106 consecutive cases, who were divided into three groups: a) 53 patients diagnosed with SpA who had inflammatory lumbar and gluteal pain assessed by a rheumatologist; b) 26 patients diagnosed with SpA who didn’t have SJ tenderness and had normal physical examination; c) control group of 27 subjects (healthy subjetcs or with mechanical lumbar pain). All patients included that were diagnosed with SpA met almost the European Spondyloarthropathy Study Group (ESSG) classification criteria. Physical examination of the SJ included: sacral sulcus tenderness, iliac gapping, iliac compression, midline sacral thrust test, Gaenslen’s test, and Patrick s test were used as gold standard. Both SJ were examined with Doppler ultrasound (General Electric Logiq 9, Wauwatosa WI, USA) fitted with a 9-14 Mhz lineal probe. The ultrasonographer was blinded to clinical data. Doppler in SJ was assessed as positive when both Doppler colour and resistance index (RI) < 0.75 within the SJ area were present. Statistical analysis was performed estimating sensitivity and specificity against gold standard. The Kappa correlation coefficient was used for reliability study. Results: 106 cases (53 female, 55 male; mean age 36 10 years) were studied. There were no statistical differences between groups related to age or sex. Physical examination of SJ was positive in 38 patients (59 sacroiliac joints). US detected Doppler signal within SJ in 37 patients (58 SJ): 33 of them were symptomatic SpA (52 SJ), one of them were asymptomatic SpA (1 SJ) and one was a healthy control (1 SJ). The accuracy of US when compared to clinical data as gold standard at subject level in the overall group was: sensitivity of 68.6% and specificity of 85.7%, positive predictive value of 70.5% and negative predictive value of 84.5%. A positive likelihood ratio of 4.8, a negative likelihood ratio of 0.36 and a kappa coefficient of 0.55 were achieved. Conclusions: Doppler US of SJ seems to be a valid method to detect active SJ inflammation. Disclosure statement: The authors have declared no conflicts of interest.
The pathophysiological relationship between scleroderma and malignancy remains poorly understood. Although some previous studies have demonstrated an increased malignancy risk in patients with scleroderma, others have been inconclusive. We aimed to determine if patients with scleroderma had an increased risk of malignancy compared to an age- and sex-matched local South West England population, and if there were any important differences between scleroderma patients with and without malignancy. Methods of this study are as follows. Notes were obtained on all local scleroderma patients ( n = 68) locally, and those diagnosed with malignancy verified by contacting each patient’s general practitioner. Expected malignancy figures were obtained from age- and sex-stratified regional prevalence data provided by the South West Cancer Intelligence Service registry. Among the patients, 22.1% with scleroderma were identified with concurrent malignancy. Affected sites were of the breast ( n = 5), haematological system ( n = 5), skin ( n = 4), and unknown primary ( n = 1). Overall, malignancy risk was found to be increased in scleroderma (RR = 3.15, 95% CI 1.77–5.20, p = 0.01). In particular, this risk was the highest for haematological malignancies (RR = 18.5, 95% CI 6–43, p = 0.03), especially for non-Hodgkin’s lymphoma (RR = 25.8, 95% CI 5–75, p = 0.10). The majority of patients (86.7%) developed malignancy after the onset of scleroderma (mean = 6.9 years). Age of >70 and patients with limited scleroderma were significant risk factors for a patient with scleroderma to have a concurrent malignancy; however, no increased risk was found in patients with any particular pattern of organ involvement, cytotoxic usage or serology. To conclude, in this small patient cohort, we have found that scleroderma is associated with an increased risk of malignancy. This risk is statistically significant in patients with limited scleroderma. Patients who are elderly and those with limited disease should be closely scrutinized at follow-up appointments.
OBJECTIVE To investigate the variability between different high-field scanners in magnetic resonance imaging (MRI) measurement of knee cartilage volume in healthy female volunteers. METHODS Five volunteers had both knees scanned using three different MRI scanners. Cartilage volume in each compartment was measured from the images by image segmentation. The data were analysed using analysis of variance models. RESULTS The mean total cartilage volume of the 10 knees scanned at three different centres was 16.15, 16.40 and 15.63 ml for the Siemens, GE and Philips scanners respectively. Small systematic differences were seen in the total knee cartilage volume results. CONCLUSIONS Although there were small systematic differences in knee cartilage volume, the three MRI scanners gave broadly similar results.
X-ray of the hands is the most valuable imaging modality in rheumatology. Joint disease may be identified by individual features such as joint space narrowing, erosions, new bone formation, subluxation and deformity, which may be diagnostic. In diseases such as rheumatoid arthritis presence of erosions on hand X-ray give a valuable measure of disease progression and response to therapy.
Rheumatologists in the former South West RegionalHealth Authority (SWRHA) have undertaken regionalaudits of their out-patient workloads on five occasionsfrom 1988 w1x to 1994 w2x. These spanned the introduc-tion of the NHS reforms of 1991 w3x, for which properevaluation was not undertaken either before or duringtheir introduction. The rheumatology audits recorded allout-patient referrals during the month of November,together with the diagnostic category and (for newpatients) the time waiting from referral to consultation.These data represent the NHS rheumatology serviceprovision for approximately 3.2 million people. Inessence, and contrary to fears expressed previously w4x,they showed that the rheumatology workload hadincreased substantially during the time of the surveys.Most of this increase had occurred following the intro-duction of NHS reforms in April 1991 and representedprimarily an increase in the workload of existing con-sultants rather than the investment of new resources‘following the patient’ w3x. Furthermore, there was a clearincrease in the time patients had to wait between referralto a specialist and their first consultation w2x. Referralhad increased, the opposite of what might have beenexpected w5x, and contrary to the intentions of provi-ding a more accessible service w1x. In order to monitorthe continuing trend, to verify the assumptions aboutchanges in working practices and to test the hypothesisthat variations in clinical practice might indicateopportunities for improving patient throughput, afurther survey was undertaken in November 2000.
Pain is the most important symptom of osteoarthritis (OA) and the reason why individuals seek medical treatment. The anatomic cause is unclear and is likely to vary between individuals. Recent work confirms the heterogeneity of pain in OA with differences in severity, location, precipitating and relieving factors, and response to intra-articular anesthetic. Nonpharmacologic treatment of OA is important and evidence is now accumulating for interventions such as aerobic exercise, quadriceps exercises, footwear modification, education, and social support. Analgesia remains the first choice drug therapy: compounds more potent than acetaminophen are now available and effective. New cyclooxygenase-2 (COX-2) inhibitors may have a role in subjects for whom simple analgesia is inadequate. Glucosamine is a simple, safe product that appears to have a weak pain-relieving effect, and intra-articular hyaluronate injections may also have a limited role. Recent community studies confirm the benefit of joint replacement in OA, though a number of questions remain about the timing, indications, and alternatives to surgery.