tbuckley/cabot-search huggingface dataset:
THU0760-HPR Patient advice line - the potential clinical and financial benefits to a rheumatology department
Authors: A Mason, C Beevor, J Ledingham
Journal: Annals of the Rheumatic Diseases (2017)

<h3>Background</h3> EULAR recommendation 3 for the role of the nurse in the management of chronic inflammatory arthritis states that patients should have access to nurse-led telephone services to enhance continuity of care and to provide ongoing support (1). In the UK quality standard 6 of the National Institute for Health and Care Excellence guidelines for the care of rheumatoid arthritis (RA) recommends that people with RA and disease flares, or possible drug related side effects should receive advice within 1 working day of contacting the rheumatology service. In 2016 audit data from England and Wales show that 96% of trusts report being able to provide patients with a telephone advice line but no further detail on these services was available (2). <h3>Objectives</h3> Data from our patient advice line were collected over a 6 month period. The objective was to understand who was using the helpline, the speed of our response, how much of the workload could be managed by nursing staff and the clinical and financial impact. <h3>Methods</h3> All patient calls made to our patient helpline were recorded and data were collected prospectively on patient demographics, disease, purpose of call, response time and the cost and revenue produced. Patient feedback was collected via a questionnaire. Data were collected from April 2016 to November 2016. <h3>Results</h3> 150 patient calls were responded to. 108 calls were from females and were 42 from males. The majority of patients had RA (75/150). Other conditions are displayed in the graph below. The majority of calls were regarding a flare of their condition or medication queries (79/180 and 39/180 respectively) with some patients calling for more than one reason. 83% of calls were answered within 24 hours. A clinical nurse specialist is available to respond to calls over weekends. Income generated from responding to calls by the department was £ 1900 per month. Expenditure was £ 1650 per month. Patient satisfaction was high with 130/150 stating the main reason for the call was answered to their satisfaction (7 stating no, 13 not stated). <h3>Conclusions</h3> Our advice line gives patients easy access to specialist advice. Patient satisfaction is high. Responses are timely and fast. Multiple concerns are commonly addressed, such as advice regarding flare of disease and medication queries. This service will be <h3>References</h3> Van Eijk-Hustings et al. EULAR recommendations fo the role of the nurse in the management of chronic inflammatory arthritis. Ann Rheum Dis 2012;71:13–19. BSR Rheumatoid and Early Arthritis 2nd Annual Report 2016. Available http://www.hqip.org.uk/resources/rheumatoid-and-early-inflammatory-arthritis-2016/. <h3>Disclosure of Interest</h3> None declared
THU0410 Gout and the risk of incident erectile dysfunction: a body mass index-matched population-based study
Authors: N Schlesinger, N Lu, HK Choi
Journal: Annals of the Rheumatic Diseases (2017)

<h3>Background</h3> Gout is the most common inflammatory arthritis. Erectile dysfunction is common in the general population; however, evidence regarding erectile dysfunction among gout patients is limited. <h3>Objectives</h3> Our purpose was to study whether there was an increased risk of erectile dysfunction among gout patients, as compared with the general population. <h3>Methods</h3> We conducted a cohort study using The Health Improvement Network, an electronic medical record database in the United Kingdom. Up to five individuals without gout were matched to each case of incident gout by age, enrolment time, and body mass index. Multivariate Hazard Ratios for erectile dysfunction were calculated after adjusting for smoking, alcohol consumption, comorbidities and medication use. <h3>Results</h3> We identified 2290 new cases of erectile dysfunction among 38,438 patients with gout (mean age 63.6 years) and 8447 cases among 154,332 individuals in the comparison cohort over a 5-year median follow up (11.9 vs. 10.5 per 1000 person-years, respectively). Univariate (age, entry time and body mass index-matched) and multivariate Hazard Ratios for erectile dysfunction among patients with gout were 1.13 (95% CI, 1.08 to 1.19) and 1.15 (95% CI, 1.09 to 1.21), respectively. In our sensitivity analysis, restricting gout cases to those receiving anti-gout treatment (n=31,227) the magnitude of relative risk was stronger than the primary analysis; (multivariate Hazard Ratios =1.29; 95% CI, 1.22 to 1.37). <h3>Conclusions</h3> This population-based study suggests an increased risk of erectile dysfunction among gout patients, supporting a possible role for hyperuricemia and inflammation as independent risk factors for erectile dysfunction. <h3>References</h3> Jackson G, et al. Int J Clin Pract 2002; 56: 663. Clarson L, et al. Ann Rheum Dis 2015; 74: 4642. Schlesinger N, et al. J Rheumatol 2015; <i>42</i>: 1893. Vlachopoulos C, et al. Eur Urol 2007; <i>2</i>:1590. <h3>Disclosure of Interest</h3> N. Schlesinger Grant/research support from: Astra Zeneca, Consultant for: Astra Zeneca, Horizon, Celgene, ProteoThera, Pfizer, N. Lu: None declared, H. Choi Grant/research support from: Astra Zeneca, Consultant for: Takeda, Selecta
SAT0046 TNF antagonist drug safety assessment by pharmacovigilance signaling and post-marketing adverse event reports
Authors: M Cavaco, F Araujo, J Eurico Fonseca, J Goncalves
Journal: Annals of the Rheumatic Diseases (2017)

<h3>Background</h3> TNF antagonists have been equally effective in the treatment of immunoinflammatory diseases. However, differences in their characteristics and the introduction of biosimilars may be associated with different safety profiles. <h3>Objectives</h3> The main goal of this study is to compare the safety of infliximab (IFX), etanercept (ETN), and adalimumab (ADA), as well as of IFX-biosimilar. <h3>Methods</h3> We assessed the adverse events reported in the EudraVigilance database between 2004 and 2016. The MEdDRA® system was used to classify the adverse events according to the primary system organ class. For a direct comparison of the data obtained, the adverse events reported for each drug were normalized using the number of treatments for the same period. The reporting odds ratio (ROR) and its 95% confidence intervals (CI) were calculated regarding the different categories of adverse events. The incidence of serious adverse events, serious infections, withdrawals due to adverse events and deaths were also calculated. <h3>Results</h3> The EudraVigilance database contains 851 882 adverse events reported for IFX, ETN, and ADA. During this period, the different TNF antagonists have shown almost the same safety profile. The reported adverse events were classified by systems organ class (SOC) and the most frequent were administration site conditions (28.8%) and infections and infestations (11.2%), Safety was not statistically different. The comparison between IFX originator and its biosimilar did not show statistically significant differences in safety (ROR 1.08 [0.80, 1.46]) during the initial 3-years after launch for both drugs. However, a small non-significant increase in immune reactions during administration was reported for IFX-biosimilar, which might reflect increasing attention for this class of drugs. <h3>Conclusions</h3> The comparison of reference IFX and IFX-biosimilar did not demonstrate statistically significant differences in safety. This pharmacovigilance study provides the first analysis of TNF antagonists from the EudraVigilance database and offers a framework for safety comparison between originators and biosimilar TNF antagonists. <h3>Acknowledgements</h3> We would like to acknowledge Eudravigilance for providing access to the database. <h3>Disclosure of Interest</h3> None declared
SAT0644 Is ankle involvement important in rheumatoid arthritis?
Authors: L Enache, C Mogosan, C Popescu, G Gutoiu, C Codreanu
Journal: Annals of the Rheumatic Diseases (2017)

<h3>Background</h3> The ankles may be affected by rheumatoid arthritis (RA). In daily evaluation of RA patients, the ankles are often neglected by clinical examinations, while composite activity scores do not include them <h3>Objectives</h3> The aim of the study is to assess the inflammatory lesions in RA ankles, regarding frequency and possible correlation with activity disease <h3>Methods</h3> The study included 76 RA patients fulfilling the 2010 ACR/EULAR classification criteria. In every patient we recorded clinical ankle involvement (ankle swelling and/or tenderness on physical examination); both ankles were evaluated by gray scale (GS) and Power Doppler (PD) ultrasound examination, graded from 0–3. In each joint we assessed: tibio-talar joint (TT); tibialis anterior (TA) tendon; extensor hallux (EH) and extensor digitorum (ED) tendons; talo-navicular joint (TN); tibialis posterior (TP) tendon; flexor digitorum (FD) and flexor hallux (FH) tendons; peroneus brevis (PB) and longus (PL) tendons; Achilles tendon (AT); subtalar joints (SJ; posterior, lateral, medial recesses); plantar fascia (PL). We recorded the following abnormalities: synovitis, tenosynovitis, bursitis, entesopathy and rupture. Activity scores (DAS28, DAS44, SDAI), inflammatory markers (ESR, CRP), serology (FR, ACPA) and HAQ were also assessed <h3>Results</h3> The mean age was 57.2±14.2 years; 88% were women; mean disease duration was 12.2±9.2 years; 56.6% had symptomatic ankles; 81.6% had ultrasound ankle abnormalities. The most frequent ultrasound pathology encountered was ST synovitis (56.6%), followed by TT synovitis (48.7%), TN synovitis (38.2%), TP tenosynovitis (30.3%), PL tenosynovitis (15.8%). Ultrasound abnormalities were recorded in 93% of the symptomatic ankle patients and in 66.7% of the asymptomatic ankle patients (p=0.008). Overall, 43% had positive PD signals, but the prevalence of positive PD signals was significantly higher in symptomatic ankle patients than in asymptomatic ankle patients (60.5% compared to 21.2%, p=0.011). Statistically significant correlations were found between ultrasound inflammatory pathology (synovitis and tenosynovitis), activity disease markers and quality of life (Table 1). <h3>Conclusions</h3> Musculoskeletal ultrasound detected a high prevalence of inflammatory abnormalities in rheumatoid arthritis ankles, in both symptomatic and asymptomatic patients, while power Doppler signal was present mostly in symptomatic patients. The ultrasound pathology was highly correlated with activity disease markers and quality of life <h3>References</h3> M Backhaus, G-R Burmester, T Gerber et al., Guidelines for musculoskeletal ultrasound in rheumatology, Ann Rheum Dis 2001,; 60:641–649. M Alsuwaidi, B Ehrenstein, M Fleck et al., Ankle Joint in Rheumatoid Arthritis. An Ultrasound Study Using High Resolution- and Clour Doppler Ultrasound, 2013 ACR/ARHP Annual Meeting, Abstract No 1969. <h3>Disclosure of Interest</h3> None declared
THU0319 Mr angiography for evaluation of vascular inflammation in elder patients with large vessel vasculitis
Authors: I Smitienko, P Novikov, E Atyasova
Journal: Annals of the Rheumatic Diseases (2017)

<h3>Objectives</h3> The aim of the study was to evaluate the feasibility of MR angiography (MRA) for evaluation of vascular inflammation in elder patients with large vessel vasculitis. <h3>Methods</h3> 16 patients with established on PET with 18F-FDG large vessel vasculitis (14 female and 2 male; average age 66 years) were enrolled in our study. 14 patients had got giant cell arteritis (just only 3 biopsy-proven cases), 2 patients with isolated aortitis of thorax aorta and 2 cases of PMR-associated arteritis. The average duration of any disease was 8 months. All patients underwent MRA with or without contrast enhancement of aorta and its branches at 1.5 Tesla (Siemens Magnetom Essenza). All patients had repeated MRA at 6 and 12 months. All images were studied by one specialist. We evaluated the role of mural oedema as a sign of activity of vasculitis. The results of MR-angiography were compared with clinical and laboratory data, ultrasound and PET with 18F-FDG. <h3>Results</h3> A total of 42 MRA were obtained in 16 patients. Significant mural oedema of thorax aorta or large arteries was shown by imaging in 20 of 42 cases (48.0%) and correlated with clinical and laboratory signs of vasculitis activity, progressive arterial stenosis detected by ultrasound and increased uptake of 18F-FDG on PET. 12 patients with high degree of inflammation on MRA were streroid-naïve. In 22 cases (52%), MRA had showed mild or moderate oedema of the arteries9 wall. Low-moderate activity of vascular inflammation in our patients was associated with moderate or high of immunosuppressive therapy (prednisolone 40–60 mg/day). However, gradual reduction in the intensity of immunosuppression in 4 patients with mild mural oedema was associated with development of relapse of large vessel vasculitis. Notably, contrast enhancement did not improve significantly edema imaging. <h3>Conclusions</h3> Visualisation of artery wall oedema by MRA may be a usefull approach to detect persisting inflammation in elder patients with large vessel vasculitis. <h3>Disclosure of Interest</h3> None declared
FRI0372 The ducas: proposal for a digital ulcer assessment score in scleroderma
Authors: C Bruni, T Ngcozana, F Braschi, S Guiducci, S Bellando-Randone, YA Suliman, J Grotts, CP Denton, DE Furst, M Matucci-Cerinic
Journal: Annals of the Rheumatic Diseases (2017)

<h3>Background</h3> No objective measure is presently available to assess digital ulcer (DU) in SSc patients apart from "healed/non healed" and experience-based clinical judgment. <h3>Objectives</h3> The aim of the current study is to propose a composite DU clinical assessment score (DUCAS) and, to lend it, test its face validity by correlating it with commonly used disease related patient-reported outcomes (PROs) and physician evaluation. <h3>Methods</h3> SSc patients presenting at least one DU and attending the Rheumatology Wound Care Clinic of the Florence University Hospital or the London Royal Free Hospital were enrolled. Patients were assessed with HAQ-DI, Cochin scale, Visual analogic scale (VAS) for DU-related pain (DU_pain, 0–100 mm), patient VAS for global DU status (ptGDU, 0–100mm) and patient global assessment (PtGA, 0–100 mm) as PROs and physician VAS for DU status (phyGDU, 0–100mm). The DUCAS included 7 DU related variables selected by a committee of 8 SSc DU experts - they are outlined in figure 1. Each variable was weighted on a clinical basis and the DUCAS score was the sum of the values for the 7 variables (max=19.5). Spearman9s correlation tests were calculated for to examine face validity. A linear regression model with forward and backward stepwise analysis was used to determine the relationship of individual variables with the primary clinical parameter, phyGDU. <h3>Results</h3> 44 SSc patients (9 males, mean age 54,3±15,6 years, mean disease duration 9,9±5,8 years) were enrolled in the study. Mean phyGDU was 44,3±23mm, mean ptGDU was 54±30mm (Wilcoxon p=0.022, phyGDU VAS vs ptGDU) and mean DUCAS score was 4,2±2. Overall DUCAS showed significant positive correlations with all PROs, but when all the individual clinician and patient9s variables were modelled, only the overall DUCAS significantly predicted PhyGDU; after backwards stepwise analysis overall DUCAS and ptGDU best predicted PhyGDU, with an adjusted R<sup>2</sup>=0,437 and AIC=380,3 (Table 2). <h3>Conclusions</h3> DUCAS is a newly proposed clinical score for SSc related DU which has face validity and which may reflect DU status as judged by SSc experts. Further validation of this score will be undertaken. <h3>Acknowledgements</h3> Cosimo Bruni received a EULAR travel bursary to run this project in the UK. <h3>Disclosure of Interest</h3> None declared
AB1164 Rabiopred, an innovative theragnostic tool for precision medicine in rheumatoid arthritis patients
Authors: E Schordan, M Mehdi, S Danilin, M Coq, M Schumacher, T Huizinga, H Firat
Journal: Annals of the Rheumatic Diseases (2017)

<h3>Background</h3> Anti-TNF alpha biologicals are an important breakthrough in the treatment of Rheumatoid Arthritis (RA) patients. However, 30–40% of RA patients do not respond to these therapies. Therefore, there is an unmet need for a tool to predict treatment response that would help clinicians choose an optimal treatment for RA patients. <h3>Objectives</h3> Under the framework of Horizone2020 SME Instrument of European Commission, Firalis has identified and developed a panel of 2159 mRNA genes which can predict non-response to anti-TNF alpha therapy using the HTG EdgeSeq platform, an innovative combination of a nuclease protection assay &amp; next generation sequencing (NGS). <h3>Methods</h3> RABIOPRED assay is a proprietary panel of Firalis signatures, which also includes targets selected by the <i>BTCure consortium</i>, to predict treatment response of anti-TNF alpha biologicals. In total 2175 targets were selected for the development and 2159 are successfully included in the panel. Each oligonucleotide is a 100-mer comprising a 25-mer "wing" at the 59 end and 39 end, and a 50-mer sequence in between that is complementary to the target mRNA. QC is checked for secondary structure and absence of homology with other sequences. Analytical parameters are assessed and repeatability of the RABIOPRED assay is validated on both Paxgene and purified RNA samples. Sample input is set at 32 μl for Paxgene RNA blood and 25 ng for extracted RNA. <h3>Results</h3> Mean correlation factor for 12 samples on 8 replicates for Paxgene and RNA samples are R<sup>2</sup>&gt;0.97 and R<sup>2</sup>&gt;0.99 respectively. First analysis and predictive modelling shows an AUC over 0.95 for the prediction of non-response to anti-TNF alpha. In the present work, we disclose the performance of the CE-IVD RABIOPRED assay based on more than 200 samples obtained from the prospective clinical studies, PRINT and RA-TNF. The algorithm will be further validated within the ongoing RABIOPRED Proof-of-Performance study (ClinicalTrials.gov Identifier: NCT03016260) in 720 patients treated by anti-TNF alpha biologicals (5 originators and 3 biosimilars) launched in December 2016. First version of the CE-IVD RABIOPRED assay will be available during Q2 2017 and open for testing. <h3>Conclusions</h3> We are showing that we can accurately measure mRNA expression with RABIOPRED assay using HTG-EdgeSeq NGS platform. Preliminary performance of the assay shows that it can efficiently predict treatment response to anti-TNF alpha biologicals. The algorithm will be later on validated in a multi-centric proof-of-performance clinical study. <h3>Disclosure of Interest</h3> None declared
OP0209-HPR Incidence of first cardiovascular event in spanish patients with chronic inflammatory rheumatic diseases: prospective data from the carma project
Authors: MA Martin Martinez, S Castañeda, C Gonzalez-Juanatey, F Sanchez-Alonso, S Marsal Barril, M Romera-Baures, J Santos-Rey, JA Pinto-Tasende, J Tornero-Molina, R Lopez-Gonzalez, MD Sanchez-Gonzalez, J Llorca, MA Gonzalez-Gay
Journal: Annals of the Rheumatic Diseases (2017)

<h3>Objectives</h3> To determine the incidence and risk factors implicated in the development of first cardiovascular event (CVE) in patients with chronic inflammatory rheumatic diseases (CIRD) attending rheumatology clinics after 2.5 years of follow-up. <h3>Methods</h3> Analysis of data after 2.5 years of follow-up in an observational prospective study [CARdiovascular in rheuMAtology (CARMA) project] that includes a cohort of patients with CIRD [rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA)] and another cohort of matched individuals without CIRD attending outpatient rheumatology clinics from 67 hospitals in Spain. The cumulative incidence per 1000 patients and the incidence density per 1000 patient-months of non-fatal CVE were estimated in both cohorts at 2.5 years from the start of the project. Weibull proportional hazard model was used to calculate the Hazard Ratio (HR) and 95% confidence interval (95% CI) of the risk factors involved in the development of CVD events. Losses to follow-up and their causes were also analyzed. <h3>Results</h3> The total number patient who completed the follow-up visit at 2.5 years was 2,598 (89.2% of those who started the study). Seven patients had died due to CVE and 23 because of non-CVE. The higher number of losses to follow-up was found in the control group (15.81%), because many of them were not periodically follow-up at the outpatient clinics. Cardiovascular cumulative incidence in patients with CIRD 15.30 cases per 1000 patients (95% CI: 12.93–17.67), being higher in AS patients 22.03 (95% CI: 11.01–33.04). The higher risk of developing a first CVE during the 2.5 years of follow-up was in patients with AS (HR: 4.11, 95% CI: 1.07–15.79; p: 0.04), those with older age (HR:1.09; 95% CI: 1.05–1.13, p&lt;0.001), higher systolic blood pressure (HR: 1.02; 95% CI: 1.00–1.04, p=0, 01) and longer duration of the rheumatic disease (HR: 1.07; 95% CI: 1.03–1.12), p&lt;0.01). In contrast, woman gender was a protective factor (HR: 0.43; 95% CI: 0.18–1.00, p=0.05). <h3>Conclusions</h3> Patients with AS prospectively followed-up at rheumatology outpatients clinics show higher risk of developing a first CVE than those with RA or PsA. Besides traditional CVD risk factors a longer time course of the disease is a risk factor for the development of CVD in patients with CIRD. <h3>Acknowledgements</h3> This project has been supported by an unrestricted grant from Abbvie, Spain. The design, analysis, interpretation of results and preparation of the manuscript has been done independently of Abbvie. <h3>Disclosure of Interest</h3> None declared