scholarly journals POS0583 ENGINEERED GLOVE TO EVALUATE THE SPEED OF THE HANDS’ MOVEMENTS IN RHEUMATOID ARTHRITIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 524.3-525
Author(s):  
M. Patanè ◽  
L. Carmisciano ◽  
E. Hysa ◽  
E. Gotelli ◽  
A. Signori ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Health Assessment ◽  
Continuous Variable ◽  
Test System ◽  
Movement Speed ◽  
Healthy Controls ◽  
Activity Class ◽  
Patient Reported ◽  
Opposition Movements

Background:Rheumatoid arthritis (RA) is a long-term, progressive, and disabling autoimmune disease1. The disease activity can be quantified by the Disease Activity Score 28-joint count – C reactive protein (DAS28crp)2; the evaluation of disability function (DF) is actually mainly performed only by subjective Patient Reported Outcomes (PROs) like Health Assessment Questionnaire (HAQ)3; to investigate the functional aspects of RA hands it is usually used the grip strength (GS)4. However, in the scientific literature no tool, which objectively evaluates movement speed, has been reported. The Hand Test System (HTS, ETT) is an engineered glove (RAGLOVE), nowadays applied for neuroscience studies to evaluate hand motility5Objectives:To objectively evaluate the RA hand’s speed of the fine movements, through the HTS and to compared with a group of age and sex matched healthy controls. To verify the correspondence with the HAQ, DAS28, GS.Methods:55 consecutives RA patients (pts) (6 males, age 61 ± 16 years, mean duration of disease 12 ± 8 years), classified according to 2010 ACR/EULAR criteria6, and 50 matched healthy controls (HCs) were enrolled. After consent, all participants undergone HTS test that recognizes the touches between the finger tips during the opposition movements of the hands in standard sequences of movements, after dressed the glove. A multiple finger evaluation (MFE) and a single finger evaluation (SFE) were performed using a dedicated software that provided the physician the following quantitative parameters: Touch Duration (TD), Inter Tapping Interval (ITI) and Movement Rate (MR). Average time for hand 2 minutes. RA pts compiled the HAQ, performed the GS and a DAS28cpr was performed.The student’s t-test was used to compare the glove’s parameters between the groups whereas the analysis of variance (ANOVA) was utilized to verify potential differences between the populations. In order to evaluate the single correlations, the r and p values of Pearson were employed.Results:For MFE, glove parameters TD and ITI were significantly higher in RA pts than HCs, whereas; MR was significantly lower in RA pts compared to HCs (all p <0.001).For SFE non-affected fingers (not swollen and not tender) of RA pts performed better than a clinically affected fingers, but in any case significantly worse than average HCs fingers (p < 0.001).There is a statistically significant correlation between the GS and MR (r= 0.39 p=0.003) and TD (r=-0.33 p=0.015).TD, ITI e MR of RA pts showed a significant correlation with the total score of the HAQ (r = 0.56, r = 0.39, r = -0.56, all p < 0.001;). DAS28, considered as a continuous variable, proved to be significantly correlated with the TD (r = 0.36, p = 0.009). When the RA patients were grouped according to the disease activity by DAS28cpr7, there was an increase of one third of the TD’s logarithm for each increase in the activity class (linear regression with ordinal predictors, beta = 0.33; 95%CI 0.03, 0.63,p < 0.0297). Finally, even RA pts in remission showed a TD significantly higher compared with HCs (p= 0.034).Conclusion:The RAGLOVE is shown as a new safe and fast tool to evaluate a new objective parameter in the hand’s functionality: the speed of finger movements. In RA pts, an inversely proportional correlation emerges between the speed of movement and disease activity.The significant correlation found with HAQ, highlights the loss of motility of the hands as one of the main determinant of disability. The RAGLOVE is now tested in RA patients undergoing treatment.References:[1]Hakkinen et al Ann Rheum Dis. 2005;[2]Van Der Heijde et al J of Rheum. 1993;[3]Fries et al Arthritis Rheum. 1980;[4]Mathiowetz et al J Hand Surg Am. 1984;[5]Carmisciano et al Eur J Neurol. 2020;[6]Aletaha et al. Ann Rheum Dis. 2010;[7]Aletaha et al Arthritis Rheum 2005.Disclosure of Interests:None declared

scholarly journals FRI0020 CLINICAL TREATMENT RESPONSE STILL DOES NOT MATCH PATIENT REPORTED IMPROVEMENT, EVEN IN EARLY RHEUMATOID ARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 582.1-582
Author(s):  
S. Pazmino ◽  
A. Lovik ◽  
A. Boonen ◽  
D. De Cock ◽  
V. Stouten ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Early Rheumatoid Arthritis ◽  
Health Assessment ◽  
Sustained Remission ◽  
Research Support ◽  
Early Ra ◽  
Severity Scores ◽  
Patient Reported ◽  
Over Time

Background:Commonly used disease activity scores in rheumatoid arthritis (RA) include one patient reported outcome (PRO) -the patient’s global health assessment (PGA). Exploratory factor analysis (EFA) was performed on data from the 2 year Care in early Rheumatoid Arthritis (CareRA) trial to explain the evolution of disease burden extracting 3 factors.1Objectives:To assess the evolution and relative responsiveness over time of clinical, laboratory and patient assessments included in composite scores, together with other PROs like pain, fatigue and functionality in patients with early RA (≤1 year) treated to target (T2T) within the CareRA trial.Methods:DMARD naïve patients with early RA (n=379) were included, randomized to remission induction with COBRA-like treatment schemes (n=332) or MTX monotherapy (n=47) and T2T.Components of disease activity scores (swollen/tender joint count (S/TJC), C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR), and physician (PhGH) or patient (PGA) global health assessment), pain and fatigue (both on 0-100 scale) and HAQ were recorded at every visit.Missing data was handled with multiple imputation (n=15). Clustering was removed with multiple outputation (n=1000), then each of the 15 000 datasets was analyzed by EFA with principal component extraction and oblimin rotation. The analyses were combined after re-ordering the factors by maximizing factor congruence. The 3 extracted factors and their individual components (with their loadings) were: 1. Patient containing PGA (0.87), pain (0.86), fatigue (0.90) and HAQ (0.5) 2.Clinical with SJC (0.92), TJC (0.89) and PhGH (0.76) and 3.Laboratory with CRP(0.87) and ESR (0.78).1(Pazmino, ACR 2019 abstract, Table 3)Afterwards, variables were first normalized to a 0-1 scale, then multiplied -weighted- by the factor loadings previously obtained.1For each Patient, Clinical and Laboratory severity score, the weighted variables belonging to each score were summed together and then re-scaled to 0-1 (higher values suggest more burden).The percentage (%) improvement from baseline to week 104 and the area under the curve (AUC) across time points were calculated per factor.Differences in % improvement and AUC were compared between patients not achieving and achieving early and sustained (week 16 to 104) disease activity score remission (DAS28CRP <2.6) with ANOVA. Bonferroni correction was used for multiple testing.Results:Severity scores of Patient, Clinical and Laboratory factors improved rapidly over time (Figure 1). In patients achieving sustained remission (n=122), Patient, Clinical and Laboratory scores improved 56%, 90% and 27% respectively. In patients not achieving sustained remission (n=257) the improvement was 32%, 78% and 9% respectively (p<0.001 only for clinical improvement).Patients in CareRA who achieved sustained remission had an AUC of 15.1, 3.4 and 4.7 in Patient, Clinical and Laboratory scores respectively, compared to 32.3, 10.0, and 7.2 in participants not achieving sustained remission (p<0.001 for all comparisons).Conclusion:Patient, Clinical and Laboratory severity scores improved rapidly over time in patients achieving rapid and sustained disease control. However, overall, Patient burden seemed not to improve to the same extent as Clinical burden. Patient’s unmet needs in terms of pain, fatigue, functionality and overall well-being should thus be given more attention, even in patients in sustained remission.References:[1]Pazmino S,et al.Including Pain, Fatigue and Functionality Regularly in the Assessment of Patients with Early Rheumatoid Arthritis Separately Adds to the Evaluation of Disease Status [abstract]. ACR. 2019.Disclosure of Interests:Sofia Pazmino: None declared, Anikó Lovik: None declared, Annelies Boonen Grant/research support from: AbbVie, Consultant of: Galapagos, Lilly (all paid to the department), Diederik De Cock: None declared, Veerle Stouten: None declared, Johan Joly: None declared, Delphine Bertrand: None declared, Rene Westhovens Grant/research support from: Celltrion Inc, Galapagos, Gilead, Consultant of: Celltrion Inc, Galapagos, Gilead, Speakers bureau: Celltrion Inc, Galapagos, Gilead, Patrick Verschueren Grant/research support from: Pfizer unrestricted chair of early RA research, Speakers bureau: various companies

Reevaluation of the Role of Duration of Morning Stiffness in the Assessment of Rheumatoid Arthritis Activity

2009 ◽  
Vol 36 (11) ◽  
pp. 2435-2442 ◽  
Author(s):  
NASIM A. KHAN ◽  
YUSUF YAZICI ◽  
JAIME CALVO-ALEN ◽  
JOLANTA DADONIENE ◽  
LAURE GOSSEC ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Roc Curve ◽  
Morning Stiffness ◽  
Health Assessment ◽  
Analysis Of Covariance ◽  
Interactive Effects ◽  
Moderate Correlation ◽  
Mixed Effect ◽  
Patient Reported

Objective.To evaluate the utility of the duration of morning stiffness (MS), as a patient-reported outcome (PRO), in assessing rheumatoid arthritis (RA) disease activity.Methods.We acquired information on 5439 patients in QUEST-RA, an international database of patients with RA evaluated by a standard protocol. MS duration was assessed from time of waking to time of maximal improvement. Ability of MS duration to differentiate RA activity states, based on Disease Activity Score (DAS)28, was assessed by analysis of variance; and a receiver-operating characteristic (ROC) curve was plotted for discriminating clinically active (DAS28 > 3.2) from less active (DAS28 ≤ 3.2) RA. Mixed-effect analysis of covariance (ANCOVA) models were used to assess the utility of adding MS duration to Routine Assessment of Patient Index Data (RAPID)3, a PRO index based on physical function, pain, and general health (GH), in predicting the 3-variable DAS28 (DAS28v3).Results.MS duration had moderate correlation (r = 0.41–0.48) with pain, Health Assessment Questionnaire, and GH; and weak correlation (r = 0.23–0.39) with joint counts and erythrocyte sedimentation rate. MS duration differed significantly among patients with different RA activity (p < 0.001). The area under the ROC curve of 0.74 (95% CI 0.72–0.75) showed moderate ability of MS duration to differentiate clinically active from less active RA. ANCOVA showed significant interactive effects between RAPID3 and the MS duration categories (p = 0.0005) in predicting DAS28v3. The effect of MS was found to be clinically important in patients with the low RAPID3 scores (< 6) in whom the presence of MS may indicate clinically active disease (DAS28v3 > 3.2).Conclusion.MS duration has a moderate correlation with RA disease activity. Assessment of MS duration may be clinically helpful in patients with low RAPID3 scores.

Proposed Metrics for the Determination of Rheumatoid Arthritis Outcome and Treatment Success and Failure

2009 ◽  
Vol 36 (1) ◽  
pp. 27-33 ◽  
Author(s):  
FREDERICK WOLFE ◽  
KALEB MICHAUD
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Recursive Partitioning ◽  
Treatment Success ◽  
Health Assessment ◽  
Comorbid Condition ◽  
Regression Methods ◽  
Visual Analog Scales ◽  
Patient Reported ◽  
Definition Of

ObjectivePatients with rheumatoid arthritis (RA) and their physicians often disagree as to the success of RA treatment or RA outcomes. However, guidelines (such as EULAR criteria for DAS scores) are heavily weighted toward joint counts and laboratory tests, and no guidelines exist for patient reported outcomes. Our aims were (1) to provide a patient-based definition of successful RA outcome or of treatment success and failure; (2) to describe the characteristics of patients meeting this definition; (3) to describe how external states such as disability and comorbidity influence definitions of health outcome; and (4) to derive surrogate-measure cutpoints for the definition.MethodsA total of 20,268 patients with RA (5132 without comorbidity) were studied by recursive partitioning and regression methods to determine best dividing points between RA treatment and outcome success and non-success using 0–10 visual analog scales (VAS) for patient global assessment, pain, fatigue, and RA activity, and a Health Assessment Questionnaire (HAQ) scale.Results14.5% of all patients and 22.9% of those without comorbidity were very satisfied with their health (success). Patient global at a level ≤ 1.25 best separated success from failure. Mean and median scores for those who were very satisfied were HAQ (0–3 scale) 0.36, 0.12; pain (0–10) 1.1, 0.5; global (0–10) 0.9, 0.5; and fatigue (0–10) 1.5, 1.0. VAS scores increased by approximately 0.5 units for each comorbid condition.ConclusionPatient global at a level ≤ 1.25 best separates patients who are very satisfied with their health from those not very satisfied, regardless of the presence of comorbidity. All scores increase with increasing comorbidity, which must be accounted for when assessing individual patients. Values identified here suggest patients require better outcomes than are found in patients who are in Disease Activity Score-28 remission or OMERACT low disease activity states.

scholarly journals The efficacy, safety and cost-effectiveness of hydroxychloroquine, sulfasalazine, methotrexate triple therapy in preventing relapse among patients with rheumatoid arthritis achieving clinical remission or low disease activity: the study protocol of a randomized controlled clinical Trial (ESCoRT study)

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Juan Zhao ◽  
Wei Zhou ◽  
Yangfeng Wu ◽  
Ping Ji ◽  
Li Yang ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Short Form ◽  
Treatment Options ◽  
Health Assessment ◽  
Disease Activity Index ◽  
Controlled Clinical Trial ◽  
Disease Relapse ◽  
Patient Reported

Abstract Background Tumor necrosis factor α inhibitors (TNFi) is effective for rheumatoid arthritis (RA) patients who fail to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs). Because of high cost, the discontinuation is common but often lead to disease relapse. The study aims to investigate, if the combination therapy of csDMARDs is more effective in reducing disease relapse than methotrexate (MTX) monotherapy, and more cost-effective than continuing TNFi and MTX. Methods It will be a two-stage trial. In the first stage, all RA patients who failed to csDMARDs treatment [disease activity score 28 (DAS28)-CRP > 3.2] will receive MTX plus TNFi for no more than 12 weeks. Patients achieving DAS28-CRP < 3.2 during the first stage will be randomized into three groups at 1:1:1 ratio: (A) add hydroxychloroquine (HCQ) and sulfasalazine (SSZ) for the first 12 weeks and then remove TNFi but continue other treatments for the next 48 weeks; (B) maintain TNFi + MTX for 60 weeks; and (C) maintain TNFi + MTX for the first 12 weeks and then remove TNFi but continue MTX monotherapy for the next 48 weeks. The primary outcome will be disease relapse (DAS28-CRP increases by at least 0.6 and > 3.2). Secondary outcomes will include the incremental cost per reducing 1 case of relapse; patient reported intolerance to the treatment; adverse events; change of mean disease activity measured by DAS28, clinical disease activity index (CDAI) and simplified disease activity index (SDAI); the proportion of modified Sharp score increase < 0.3; ultrasound-detected remission in hands; Health Assessment Questionnaire Disability Index (HAQ-DI) and health related quality of life [the five-level EuroQol-5D (EQ-5D-5L) and short form-6D (SF-6D)]. Discussion The aim of this trail will be to seek effective treatment options of preventing relapse of RA. The results of the current study may provide an instructive recommendation for more economical application of TNFi treatment in RA. Trial registration NCT, NCT02320630. Registered on 16 December 2014. https://register.clinicaltrials.gov/prs/app/action/LoginUser?ts=3&cx=-jg9qo2.

scholarly journals Progranulin Is Associated with Disease Activity in Patients with Rheumatoid Arthritis

2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Lucie Andrés Cerezo ◽  
Markéta Kuklová ◽  
Hana Hulejová ◽  
Zdeňka Vernerová ◽  
Nikola Kaspříková ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Synovial Fluid ◽  
Disease Activity ◽  
Health Assessment ◽  
Immunohistochemical Analysis ◽  
Healthy Controls ◽  
Reactive Protein ◽  
Synovial Tissues ◽  
Inflammatory Infiltrates ◽  
Fluid Levels

Objective. Progranulin (PGRN) is implicated in the pathogenesis of rheumatoid arthritis (RA). The aim of this study was to assess the relationship between PGRN and disease activity in RA.Methods.PGRN levels were evaluated in patients with RA (n=47) and OA (n=42) and healthy controls (n=41). Immunohistochemical analysis of PGRN in synovial tissues was performed. The association between PGRN and C-reactive protein (CRP), disease activity score (DAS28-CRP), and health assessment questionnaire (HAQ) was studied.Results. Circulating PGRN was elevated in patients with RA and OA compared to healthy controls (227.1±100.2and221.5±102.5versus128.1±34.7 ng/mL;P<0.001). Synovial fluid levels of PGRN were higher in patients with RA compared to OA (384.5±275.3versus241.4±165.2 ng/mL;P=0.002). PGRN expression was significantly upregulated in the synovial tissue of RA patients particularly in the inflammatory infiltrates. Serum PGRN levels correlated with DAS28 (r=0.327,P=0.049) and HAQ score (r=0.323,P=0.032), while synovial fluid PGRN correlated only with HAQ (r=0.310,P=0.043) in patients with RA. PGRN levels were not associated with CRP or autoantibodies.Conclusions. This study demonstrates increased PGRN expression at local sites of inflammation and association between PGRN levels, disease activity, and functional impairment in patients with RA.

scholarly journals AB0330 HIGH REMISSION RATES IN RA – REAL LIFE DATA FROM BARITICINIB

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1463.2-1464
Author(s):  
S. Bayat ◽  
K. Tascilar ◽  
V. Kaufmann ◽  
A. Kleyer ◽  
D. Simon ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Cox Regression ◽  
Real Life ◽  
Inadequate Response ◽  
Research Support ◽  
Das 28 ◽  
Patient Reported ◽  
One Year

Background:Recent developments of targeted treatments such as targeted synthetic DMARDs (tsDMARDs) increase the chances of a sustained low disease activity (LDA) or remission state for patients suffering rheumatoid arthritis (RA). tsDMARDs such as baricitinib, an oral inhibitor of the Janus Kinases (JAK1/JAK2) was recently approved for the treatment of RA with an inadequate response to conventional (cDMARD) and biological (bDMARD) therapy. (1, 2).Objectives:Aim of this study is to analyze the effect of baricitinb on disease activity (DAS28, LDA) in patients with RA in real life, to analyze drug persistance and associate these effects with various baseline characteristics.Methods:All RA patients were seen in our outpatient clinic. If a patient was switched to a baricitinib due to medical reasons, these patients were included in our prospective, observational study which started in April 2017. Clinical scores (SJC/TJC 76/78), composite scores (DAS28), PROs (HAQ-DI; RAID; FACIT), safety parameters (not reported in this abstract) as well as laboratory biomarkers were collected at each visit every three months. Linear mixed effects models for repeated measurements were used to analyze the time course of disease activity, patient reported outcomes and laboratory results. We estimated the probabilities of continued baricitinib treatment and the probabilities of LDA and remission by DAS-28 as well as Boolean remission up to one year using survival analysis and explored their association with disease characteristics using multivariable Cox regression. All patients gave informed consent. The study is approved by the local ethics.Results:95 patients were included and 85 analyzed with available follow-up data until November 2019. Demographics are shown in table 1. Mean follow-up duration after starting baricitinib was 49.3 (28.9) weeks. 51 patients (60%) were on monotherapy. Baricitinib survival (95%CI) was 82% (73% to 91%) at one year. Cumulative number (%probability, 95%CI) of patients that attained DAS-28 LDA at least once up to one year was 67 (92%, 80% to 97%) and the number of patients attaining DAS-28 and Boolean remission were 31 (50%, 34% to 61%) and 12(20%, 9% to 30%) respectively. Median time to DAS-28 LDA was 16 weeks (Figure 1). Cox regression analyses did not show any sufficiently precise association of remission or LDA with age, gender, seropositivity, disease duration, concomitant DMARD use and number of previous bDMARDs. Increasing number of previous bDMARDs was associated with poor baricitinib survival (HR=1.5, 95%CI 1.1 to 2.2) while this association was not robust to adjustment for baseline disease activity. Favorable changes were observed in tender and swollen joint counts, pain-VAS, patient and physician disease assessment scores, RAID, FACIT and the acute phase response.Conclusion:In this prospective observational study, we observed high rates of LDA and DAS-28 remission and significant improvements in disease activity and patient reported outcome measurements over time.References:[1]Keystone EC, Taylor PC, Drescher E, Schlichting DE, Beattie SD, Berclaz PY, et al. Safety and efficacy of baricitinib at 24 weeks in patients with rheumatoid arthritis who have had an inadequate response to methotrexate. Annals of the rheumatic diseases. 2015 Feb;74(2):333-40.[2]Genovese MC, Kremer J, Zamani O, Ludivico C, Krogulec M, Xie L, et al. Baricitinib in Patients with Refractory Rheumatoid Arthritis. The New England journal of medicine. 2016 Mar 31;374(13):1243-52.Figure 1.Cumulative probability of low disease activity or remission under treatment with baricitinib.Disclosure of Interests:Sara Bayat Speakers bureau: Novartis, Koray Tascilar: None declared, Veronica Kaufmann: None declared, Arnd Kleyer Consultant of: Lilly, Gilead, Novartis,Abbvie, Speakers bureau: Novartis, Lilly, David Simon Grant/research support from: Else Kröner-Memorial Scholarship, Novartis, Consultant of: Novartis, Lilly, Johannes Knitza Grant/research support from: Research Grant: Novartis, Fabian Hartmann: None declared, Susanne Adam: None declared, Axel Hueber Grant/research support from: Novartis, Lilly, Pfizer, EIT Health, EU-IMI, DFG, Universität Erlangen (EFI), Consultant of: Abbvie, BMS, Celgene, Gilead, GSK, Lilly, Novartis, Speakers bureau: GSK, Lilly, Novartis, Georg Schett Speakers bureau: AbbVie, BMS, Celgene, Janssen, Eli Lilly, Novartis, Roche and UCB

scholarly journals AB0140 A HIGH-CONFIDENCE DEFINITION OF THERAPEUTIC RESPONSE IN RHEUMATOID ARTHRITIS USING A MONTE CARLO SIMULATION APPROACH

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1097.2-1098
Author(s):  
V. Strand ◽  
S. Cohen ◽  
L. Zhang ◽  
T. Mellors ◽  
A. Jones ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Monte Carlo ◽  
Disease Activity ◽  
Health Assessment Questionnaire ◽  
Health Assessment ◽  
High Confidence ◽  
Response Status ◽  
Definition Of ◽  
Fidelity Score ◽  
Assessment Questionnaire

Background:Therapy choice and therapy change depend on the ability to accurately assess patients’ disease activity. The clinical assessments used to evaluate treatment response in rheumatoid arthritis have inherent variability, normally considered as measurement error, intra-observer variability or within subject variability. Each contribute to variability in deriving response status as defined by composite measures such as the ACR or EULAR criteria, particularly when a one-time observed measurement lies near the boundary defining response or non-response. To select an optimal therapeutic strategy in the burgeoning age of precision medicine in rheumatology, achieve the lowest disease activity and maximize long-term health outcomes for each patient, improved treatment response definitions are needed.Objectives:Develop a high-confidence definition of treatment response and non-response in rheumatoid arthritis that exceeds the expected variability of subcomponents in the composite response criteria.Methods:A Monte Carlo simulation approach was used to assess ACR50 and EULAR response outcomes in 100 rheumatoid arthritis patients who had been treated for 6 months with a TNF inhibitor therapy. Monte Carlo simulations were run with 2000 iterations implemented with measurement variability derived for each clinical assessment: tender joint count, swollen joint count, Health Assessment Questionnaire disability index (HAQ-DI), patient pain assessment, patient global assessment, physician global assessment, serum C-reactive protein level (CRP) and disease activity score 28-joint count with CRP.1-3 Each iteration of the Monte Carlo simulation generated one outcome with a value of 0 or 1 indicating non-responder or responder, respectively.Results:A fidelity score, calculated separately for ACR50 and EULAR response, was defined as an aggregated score from 2000 iterations reported as a fraction that ranges from 0 to 1. The fidelity score depicted a spectrum of response covering strong non-responders, inconclusive statuses and strong responders. A fidelity score around 0.5 typified a response status with extreme variability and inconclusive clinical response to treatment. High-fidelity scores were defined as >0.7 or <0.3 for responders and non-responders, respectively, meaning that the simulated clinical response status label among all simulations agreed at least 70% of the time. High-confidence true responders were considered as those patients with high-fidelity outcomes in both ACR50 and EULAR outcomes.Conclusion:A definition of response to treatment should exceed the expected variability of the clinical assessments used in the composite measure of therapeutic response. By defining high-confidence responders and non-responders, the true impact of therapeutic efficacy can be determined, thus forging a path to development of better treatment options and advanced precision medicine tools in rheumatoid arthritis.References:[1]Cheung, P. P., Gossec, L., Mak, A. & March, L. Reliability of joint count assessment in rheumatoid arthritis: a systematic literature review. Semin Arthritis Rheum43, 721-729, doi:10.1016/j.semarthrit.2013.11.003 (2014).[2]Uhlig, T., Kvien, T. K. & Pincus, T. Test-retest reliability of disease activity core set measures and indices in rheumatoid arthritis. Ann Rheum Dis68, 972-975, doi:10.1136/ard.2008.097345 (2009).[3]Maska, L., Anderson, J. & Michaud, K. Measures of functional status and quality of life in rheumatoid arthritis: Health Assessment Questionnaire Disability Index (HAQ), Modified Health Assessment Questionnaire (MHAQ), Multidimensional Health Assessment Questionnaire (MDHAQ), Health Assessment Questionnaire II (HAQ-II), Improved Health Assessment Questionnaire (Improved HAQ), and Rheumatoid Arthritis Quality of Life (RAQoL). Arthritis Care Res (Hoboken) 63 Suppl 11, S4-13, doi:10.1002/acr.20620 (2011).Disclosure of Interests:Vibeke Strand Consultant of: Abbvie, Amgen, Arena, BMS, Boehringer Ingelheim, Celltrion, Galapagos, Genentech/Roche, Gilead, GSK, Ichnos, Inmedix, Janssen, Kiniksa, Lilly, Merck, Novartis, Pfizer, Regeneron, Samsung, Sandoz, Sanofi, Setpoint, UCB, Stanley Cohen: None declared, Lixia Zhang Shareholder of: Scipher Medicine Corporation, Employee of: Scipher Medicine Corporation, Ted Mellors Shareholder of: Scipher Medicine Corporation, Employee of: Scipher Medicine Corporation, Alex Jones Shareholder of: Scipher Medicine Corporation, Employee of: Scipher Medicine Corporation, Johanna Withers Shareholder of: Scipher Medicine Corporation, Employee of: Scipher Medicine Corporation, Viatcheslav Akmaev Shareholder of: Scipher Medicine Corporation, Employee of: Scipher Medicine Corporation

scholarly journals OP0076 HOW TO SELF-EXAMINE FOR TENDER AND SWOLLEN JOINTS: CO-DEVELOPMENT OF A TRAINING VIDEO FOR PEOPLE WITH RHEUMATOID ARTHRITIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 41.1-41
Author(s):  
C. Sharp ◽  
K. Staniland ◽  
T. Cornell ◽  
W. Dixon
Keyword(s):  
Rheumatoid Arthritis ◽  
Decision Making ◽  
Disease Activity ◽  
Remote Monitoring ◽  
British Society ◽  
Patient Report Outcome Measure ◽  
Nurse Consultant ◽  
Patient Reported ◽  
Self Examination ◽  
Remote Consultations

Background:COVID-19 has catalysed the transformation of healthcare services, with outpatient services increasingly dependent upon remote models of care. Healthcare professionals now have to make clinical assessments based on remote patient examinations. The number of tender and swollen joints a patient has drives decision-making in RA, making it particularly important that people with RA and HCPs have a shared understanding of these examinations.Even before remote consultations became widespread, long gaps between clinic visits create challenges in enabling HCPs to form an accurate picture of disease activity over time. The REMORA (REmote MOnitoring of Rheumatoid Arthritis) app aims to address this issue by asking people with RA to track disease activity, including counting the number of tender or swollen joints, weekly(1). Data are integrated into the electronic patient record for clinicians to access with patients during clinical consultations. As part of the supporting materials for the REMORA app, we planned to develop a video to train people with RA how to examine their own joints. This video may now help meet the need created by the recent expansion in remote consultations.Objectives:To describe the co-production, implementation and evaluation of a video to train patients how to examine their own joints.Methods:The need for the video to fill a current gap in patient education was identified by the REMORA patient and public involvement and engagement (PPIE) group. A core working group comprising the PPIE lead, a nurse consultant, rheumatology clinicians, project and communications managers was formed. A storyboard was drafted and feedback gained from the PPIE group and wider REMORA team. Images were sourced from licenced suppliers, or co-developed with the PPIE group where necessary. No ethical approval was required as the PPIE group lead was acting as an equal member of the research term. Written informed consent was gained from video participants. Filming took place between two national lockdowns during the COVID-19 pandemic, providing a challenge to ensure social distancing and requiring the use of masks.Results:A 15 minute video to train people with RA to self-examine for tender and swollen joints was developed. An introduction outlining the rationale behind self-examination is followed by a nurse consultant coaching an RA patient in individual joint self-examination. Shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and knees are included, all of which are counted in disease activity scores.Early feedback from stakeholders has been overwhelmingly positive. The video will be publicly available on YouTube from February 2021. A survey of patients and HCPs aims to obtain more formal feedback on the video, with a view to a further iteration, if required. Leading national organisations in rheumatology will promote the video, as it supports national programmes including the British Society for Rheumatology national early inflammatory arthritis audit and ePROMS (electronic patient report outcome measure) platform, both of which include entry of patient reported tender and swollen joint counts.Conclusion:This video was co-designed by people with RA, aiming to support self-examination of tender and swollen joint counts. Hits on YouTube and survey responses will help assess its impact. Evaluation to assess whether the video affects patients’ ability to self-examine for tender and swollen joints before and after watching is planned. We hope the video will support remote consultations and help people with arthritis to better understand and self-manage their arthritis, and to have shared decision making conversations with their clinicians.References:[1]Austin L, Sharp CA, van der Veer SN, Machin M, Humphreys J, Mellor P, et al. Providing ‘the bigger picture’: benefits and feasibility of integrating remote monitoring from smartphones into the electronic health record: findings from the Remote Monitoring of Rheumatoid Arthritis (REMORA) study. Rheumatology. 2020;59(2):367-78.Disclosure of Interests:Charlotte Sharp: None declared, Karen Staniland: None declared, Trish Cornell Shareholder of: shares in Abbvie, Employee of: Abbvie, working as a Rheumatology Nurse Consultant, Will Dixon Consultant of: Google and Abbvie, unrelated to this work.

scholarly journals THU0106 PREDICTORS OF FLARE IN RHEUMATOID ARTHRITIS PATIENTS WITH LOW DISEASE ACTIVITY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 267.1-267
Author(s):  
K. W. Moon
Keyword(s):  
Rheumatoid Arthritis ◽  
Multivariate Analysis ◽  
Observational Study ◽  
Disease Activity ◽  
Health Assessment Questionnaire ◽  
Health Assessment ◽  
Low Disease Activity ◽  
Erythrocyte Sedimentation ◽  
Euroqol 5D ◽  
Assessment Questionnaire

Background:Low disease activity (LDA) in patients with rheumatoid arthritis (RA) are usually recognized as stable state. In according to most guidelines for RA, monotherapy of disease modifying anti-rheumatic drug (DAMRD) was recommended for RA patents with LDA. But some of patients with LDA suffer from flare in their disease course. Until now, we don’t have enough data on factors that can predict flare in RA patients with LDA.Objectives:The aim of this study is to evaluate predictor of flare in RA patient with LDA from long-term (3 year) cohort data.Methods:Korean observational study network for arthritis (KORONA) registry is a nationwide Korean RA specific cohort registry that collecting data annually from 5,376 RA patients in 23 centers across South Korea. We include the data from 1, 801 RA patients with LDA (28 –joint disease activity score (DAS 28) < 3.2 at enrollment) who had consecutive data of DAS28 for 3 years. Flare was defined as an increase in DAS28 compared with baseline of >1.2 or >0.6 if concurrent DAS28 ≥3.2. Cox regression analysis was used to identify baseline predictors of flare.Results:Among 1,801 RA patients, 673 patients (37.4%) experienced flare in 3 years. When we compare the baseline characteristics of both flare and non-flare group, more women and more non-adherent patients for medication were observed in flare group. Flare group had longer disease duration, lower EuroQol 5D score, higher health assessment questionnaire (HAQ) score, and higher erythrocyte sedimentation rate (ESR) than non-flare group at baseline. In multivariate analysis, physician’s VAS, HAQ score, ESR, and poor adherence for medication were significant predictors of flare (Table 1).Table 1.Multivariate analysis of prediction of flare with baseline variablesMeasureHazard ratio95% Confidence IntervalP-valueFemale1.1300.906-1.4090.280Age0.9960.988-1.0050.414Physician’s VAS1.0081.002-1.013<0.01Pain VAS1.0020.998-1.0060.34EQ5D0.9520.534-1.6960.87HAQ1.4071.109-1.786<0.01ESR1.0081.002-1.014<0.01Poor adherence1.2721.047-1.545<0.05VAS: Visual Analogue Scale; EQ5D: EuroQol 5D; HAQ: Health Assessment Questionnaire; ESR: Erythrocyte Sedimentation RateConclusion:RA patient who have risk factors for flare, even though their disease activity was low, require more proactive treatment.References:[1]Bechman K, Tweehuysen L, Garrood T, Scott DL, Cope AP, Galloway JB, et al. Flares in Rheumatoid Arthritis Patients with Low Disease Activity: Predictability and Association with Worse Clinical Outcomes. J Rheumatol. 2018;45(11):1515-21.[2]Singh JA, Saag KG, Bridges SL, Jr., Akl EA, Bannuru RR, Sullivan MC, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Rheumatol. 2016;68(1):1-26.[3]Sung YK, Cho SK, Choi CB, Park SY, Shim J, Ahn JK, et al. Korean Observational Study Network for Arthritis (KORONA): establishment of a prospective multicenter cohort for rheumatoid arthritis in South Korea. Semin Arthritis Rheum. 2012;41(6):745-51.Disclosure of Interests:None declared

scholarly journals P158 Severity of hand vascular involvement as assessed by MRI Digital Artery Volume Index (DAVIX©) predicts worsening of clinical parameters and patient reported outcomes in scleroderma

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Fiammetta Danzo ◽  
Klodian Gjeloshi ◽  
Giovanni Lettieri ◽  
Giuseppina Abignano ◽  
Mark Hinton ◽  
...  
Keyword(s):  
Disease Activity ◽  
Health Assessment Questionnaire ◽  
Patient Reported Outcomes ◽  
Health Assessment ◽  
Volume Index ◽  
Vascular Involvement ◽  
Clinical Parameters ◽  
Digital Artery ◽  
Patient Reported ◽  
Assessment Questionnaire

Abstract Background Neointima proliferation is a key pathologic feature of systemic sclerosis (SSc), causing arterial vessel narrowing and being the recognised culprit pathological lesion in digital ulcers (DUs), pulmonary artery hypertension and renal crisis. Nevertheless, there are no validated imaging techniques to assess the severity of vascular involvement in SSc. We have previously shown digital artery volume index (DAVIX©) assessed with time of right MRI angiography, is a reliable measure of neointima proliferation in the hands. The purpose of our study was to identify the value of DAVIX© in predicting worsening of patient reported outcomes (PROs) and clinical parameters in SSc. Methods Cross-sectional data were available for 91 patients and complete 12 months follow-up data for 68 patients. Data collected included: modfied Rodnan skin score (mRSS), pulmonary function tests (PFTs), echocardiography, nailfold capillaroscopy, Health Assessment Questionnaire Disability Index (HAQ-DI), and Scleroderma Health Assessment Questionnaire (sHAQ). DAVIX© of the dominant hand was calculated as the % mean of the 4 fingers, employing MeVisLab software. Following analysis of distribution, Spearman or Pearson test were used to determine correlation coefficients, as appropriate (Prism 7). Results 56/68 were female and median of disease duration was 4 years (IQR 1.91-9). As previously reported DAVIX© correlated with the presence of DUs (p = 0.0093). Considering all patients, DAVIX© correlated with mRSS (r=-0.258, p = 0.017), DLCO% (r = 0.338, p = 0.008) and the pattern of capillaroscopy (r=-0.388, p = 0.001). In patients with DUs, DAVIX© showed a stronger correlation with DLCO% (r = 0.786, p = 0.048). Most importantly, DAVIX© predicted the worsening of HAQ-DI (r=-0.295, p = 0.029), sHAQ (r =-0.333, p = 0.029) and VAS pain (r=-0.269, p = 0.038) independently of the presence of DUs. Conclusion The quantitative assessment of neointima proliferation in the hand by DAVIX© is a useful imaging biomarker of vascular disease activity. The value of DAVIX© in predicting the worsening of PROs and clinical parameters in overall patients, may offer insights on the role of vascular disease activity in the global progression of SSc. The validation of our data in an independent cohort and the sensitivity to change over time of DAVIX© may aid to the implementation of hand MRI as imaging outcome measure of vascular severity in SSc. Disclosures F. Danzo None. K. Gjeloshi None. G. Lettieri None. G. Abignano None. M. Hinton None. A. Dean None. G. Cuomo None. O. Kubassova None. F. del Galdo None.

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