Rheumatoid Arthritis Impact Of Disease Research Articles

Rheumatoid Arthritis disease activity assessment in routine care: performance of the most widely used composite disease activity indices and patient-reported outcome measures.

Background and aim:To evaluate the convergent and discriminative validity of many continuous composite disease activity indices and patient-reported outcome measures (PROMs) in rheumatoid arthritis (RA).Methods:In consecutive RA patients in moderate or high disease activity, according to the Simplified Disease Activity Index (SDAI) definition, were computed four additional composite disease activity indices, the 28-joint Disease Activity Score – erythrocyte sedimentation rate (DAS28-ESR), the Clinical Disease Activity Index (CDAI), the Chronic Arthritis Systemic Index (CASI), and the Mean Overall Index for RA (MOI-RA), and five PROMs, the Patients’ Activity Scale (PAS), the Rheumatoid Arthritis Impact of Disease (RAID), the 5-item RA Disease Activity Index (RADAI-5), the Routine Assessment of Patient Index Data (RAPID3), and the Clinical Arthritis Activity (PRO-CLARA). Spearman’s rho correlation coefficients were determined to assess their convergent validity, and discriminative performance was calculated by the area under the receiver-operating curve (AUC-ROC). The patients’ opinion of their symptomatic status (PASS) was used as the external criterion.Results:246 RA patients with moderate (29.3%) or high disease activity (70.7%) have been assessed. The indices all showed a significant correlation (p <0.0001 for all). Among the composite disease activity indices, the CDAI was the one that showed the best discriminating ability compared to the PASS (AUC = 0.962), while among the PROMs the RAID was the most performing (AUC = 0.879).Conclusions:CDAI as composite index of disease activity, and RAID as PROM, are the two instruments with the best performances in relation to PASS. The use of validated disease activity measures can help in clinical practice to adopt treat-to-target strategies in RA patients. (www.actabiomedica.it)

Trajectories of fatigue in actively treated patients with established rheumatoid arthritis starting biologic DMARD therapy

ObjectivesTo define fatigue trajectories in patients with rheumatoid arthritis (RA) who initiate biological DMARD (bDMARD) treatment, and explore baseline predictors for a trajectory of continued fatigue.MethodsOne-hundred and eighty-four patients with...

Attainment of the Patient-acceptable Symptom State in 548 patients with rheumatoid arthritis: Influence of demographic factors.

To explore the clinical and socio-demographic factors associated with Patient Acceptable Symptom Status (PASS) in Rheumatoid Arthritis (RA). In a post-hoc analyses of a cross-sectional study, RA patients from 11 countries were included. PASS was assessed as acceptable/not acceptable status by the patient. Variables collected included socio-economic (gender, age and country gross domestic product (GDP) per capita) and clinical variables: DAS28-3vESR (28 joint counts and Erythrocyte Sedimentation Rate), the patient-reported Rheumatoid Arthritis Impact of Disease (RAID) score and its seven domains (scored 0 to 10). Patients in PASS or not were compared through univariable tests and factors associated with PASS assessed by multivariable forward conditional logistic regression. A similar analysis was performed in the subgroup patients in DAS28 remission (n=168). A total of 548 patients were included: 80.5% female, mean (±SD) age 55.8±12.8years, disease duration 13.6±10.6years, DAS28 3.6±1.5. Overall, 360 (65.7%) considered themselves to be in PASS. Independent factors positively associated with being in PASS were age>50years [odds ratio, OR 1.67; (95% confidence Interval: 1.04-2.67)], a lower DAS28 [OR: 1.28 (1.08-1.52)], lower pain [OR:1.45 (1.27-1.64)] and better emotional well-being [OR:1.28 (1.13-1.45)]. Among patients in remission, being in PASS was positively associated with less severe pain [OR: 2.50 (1.79-3.84)], age>50 years [OR 3.30 (1.03 to10.87)] and living in a country of the low GDP category [OR: 5.08; (1.34-19.23)]. Being in PASS is related to many factors besides disease activity, including age, perceived impact of the disease and national GDP.

Patients’ experiences regarding self-monitoring of the disease course: an observational pilot study in patients with inflammatory rheumatic diseases at a rheumatology outpatient clinic in The Netherlands

ObjectivesSelf-monitoring the disease course is a relatively new concept in the management of patients with inflammatory rheumatic diseases (IRDs). The aims of this pilot study were to obtain patients’ experiences...

Adherence to Mediterranean diet and patient perception of rheumatoid arthritis

ObjectiveTo evaluate the association between the adherence to Mediterranean diet (MD) and disease impact, activity, and comorbidities in patients with rheumatoid arthritis (RA). DesignConsecutive patients with RA were enrolled in this cross-sectional study. For each patient, Disease Activity Score on 28 joints (DAS28), Simple Disease Activity Index (SDAI), RA Impact of Disease (RAID), Health Assessment Questionnaire (HAQ), patient global assessment (PGA) and general health (GH) and a self-reported questionnaire called MD score were recorded. Results205 RA patients (median age 53 years, female 80.49 %) were enrolled. An association between MD score and HAQ (p-value = 0.033), PGA and GH (p-value 0.023 both) was observed. RAID total score had a statistically significant negative relationship with MD score (p-value = 0.016). A statistically significant negative association was found for pain (p-value = 0.025), functional disability (p-value<0.001), sleep (p-value = 0.041), physical well-being (p-value = 0.027) and coping (p-value = 0.008). Multiple regression analysis to evaluate the relationship between significant RAID items and MD score did not show any statistical significance as all items are strongly related to each other. A negative trend, although not statistically significant was found for DAS28 and SDAI. The only comorbidity associated with MD score was arterial hypertension (OR = 0.94). ConclusionsIn this Italian RA cohort, the adherence to MD was significantly associated with a better RAID, PGA and GH, but higher MD score was not significantly associated with lower disease activity. Our study suggests an overall potential beneficial effect of MD in RA patients.

THU0129 SLEEP DISTURBANCE AND LOW INFLAMMATION PREDICT A PATTERN OF CHRONIC FATIGUE IN ACTIVELY TREATED PATIENTS WITH ESTABLISHED RA.

Background:Fatigue is common among patients with rheumatoid arthritis (RA) and has major impact on the burden of disease. There is little knowledge regarding the factors predicting the longitudinal development of chronic fatigue.Objectives:To identify baseline predictors for the development of chronic fatigue in patients with RA who initiate biological DMARD (bDMARD) treatment, and to compare disease courses across categories of fatigue for 12 months follow-up.Methods:Different trajectories of fatigue were calculated from a cohort of 209 established RA patients initiating bDMARDs. Fatigue was assessed by use of the fatigue Numeric Rating Scale (0-10) from the Rheumatoid Arthritis Impact of Disease (RAID) questionnaire. The patients were assessed at 0, 1, 2, 3, 6 and 12 months. We defined three groups: no fatigue (≤3 at all visits), improved fatigue (&gt;3 at baseline but ≤3 at follow-up) and chronic fatigue (≥ 4 at all visits). All patients had clinical/subjective assessments (28 tender/swollen joint count, assessor’s/patient’s global VAS, RAID score, widespread pain, pain catastrophizing, the Hospital Anxiety and Depression Scale and inflammatory markers (ESR, CRP and calprotectin (a major granulocyte protein sensitive for inflammation in RA patients)). All patients were assessed by ultrasound (grey scale (GS) and power Doppler (PD)) of 36 joints and 4 tendons with semi-quantitative scoring (0-3). Differences between groups at baseline was assessed by bivariate analyses, and logistic regression models adjusted for age and gender were used to explore baseline predictors of chronic vs improved fatigue. Trajectories of different groups were plotted as estimated marginal means in figures, and differences between groups assessed by mixed models with maximum likelihood random effects, adjusted for age and sex.Results:Table 1 describes demographics and clinical factors of the three groups with significant differences shown in bold. Logistic regression with multivariate assessments found anti-CCP and low inflammation (calprotectin) to be predictors of chronic versus improved fatigue. Sleep disturbance was highly predictive of chronic fatigue. Figure 1 illustrates the trajectories for the three groups at all visits, showing the chronic fatigue group to have significantly higher DAS28, level of widespread pain, depression and sleep disturbance in contrast to no higher level of inflammation assessed by CRP and ultrasound PD.Table 1.No fatigueImproved fatigueChronicfatigueNo fatigue vs Improved fatigueImproved fatigue vs chronic fatigueNo fatigue vs. chronic fatigue482943pppAge, mean (SD) years51 (2)48 (2)54 (2)0.280.090.28Female gender (%)35 (73)24 (83)38 (88)0.400.500.09Higher Education (%)31 (65)23 (79)20 (47)0.170.010.17Anti-CCP positive (%)29 (60)20 (69)36 (84)0.720.010.002RF positive (%)27 (56)17 (59)30 (70)0.760.110.15Disease duration, mean (SD) years7 (1)8 (1)11 (1)0.810.110.03RA disease activityDAS28CRP3.2 (0.1)3.9 (0.2)4.7 (0.2)0.0030.004&lt;0.001Swollen joints (28)5.7 (0.7)5.6 (1.0)6.2 (0.7)0.900.600.63CRP mg/L mean (SD)9.4 (2.4)15.6 (4.1)11.0 (2.6)0.020.020.58Calprotectin mg/L mean (SD)1.6 (0.3)2.0 (0.4)1.5 (0.2)0.440.200.92Sum score PD mean (SD)14.3 (1.8)13.8 (2.5)12.3 (1.9)0.850.620.43Sum score GS mean (SD)31.6 (2.8)29.3 (3.4)28.2 (2.7)0.610.810.39Psychosocial factorsRAID sleep (VAS 0-10)1.2 (0.3)4.3 (0.6)6.7(0.4)&lt;0.001&lt;0.001&lt;0.001RAID fatigue (VAS 0-10)1.4 (0.2)5.6 (0.3)7.1 (0.3)&lt;0.0010.003&lt;0.001Widespread pain (0-25)4.3 (0.4)7.0 (0.8)8.6 (0.7)0.0010.16&lt;0.001HADS anxiety1.5 (0.3)1.4 (0.6)3.4 (0.7)0.260.580.10HADS depression0.8 (0.2)0.9 (0.4)3.0 (0.8)0.980.360.05Pain Catastrophizing (0-6)1.0 (0.2)2.5 (0.3)2.9 (0.3)&lt;0.0010.31&lt;0.001Conclusion:Sleep disturbance is a modifiable factor presently found to predict chronic versus improved fatigue. Thus, attention should be given to RA patients with sleep problems to seek to avoid development of chronic fatigue. This issue should be explored in further studies.Disclosure of Interests:Hilde Berner Hammer Consultant of: Has received fees as consultant from Roche, AbbVie and Novartis., Speakers bureau: Has received fees for speaking from AbbVie, BMS, Pfizer, UCB, Roche, MSD and Novartis, Brigitte Michelsen Grant/research support from: Research support from Novartis, Consultant of: Consulting fees Novartis, Joe Sexton: None declared, Till Uhlig Consultant of: Lilly, Pfizer, Speakers bureau: Grünenthal, Novartis, Sella Aarrestad Provan Consultant of: Novartis

SAT0072 THE IMPACT OF COMORBIDITIES ON ABSENTEEISM, PRESENTEEISM AND EMPLOYMENT STATUS IN PEOPLE LIVING WITH RHEUMATOID ARTHRITIS

Background:Many people with rheumatoid arthritis (RA) have comorbidities. However, there is limited research on the impact of multimorbidity on absenteeism (e.g. sick leave) and presenteeism (i.e. reduced productivity while at work due to ill health) in people with RA.Objectives:i) to explore the impact of comorbidities on absenteeism and presenteeism in patients with RA and ii) to evaluate the association between multimorbidity and employment status.Methods:A cross-sectional survey was conducted by the National Rheumatoid Arthritis Society (NRAS), UK, collecting information on: demographics, education, employment status (i.e. employed (Empl), stopped/retired early because of RA (Stop_RA), stopped/retired early because of other health issues (Stop_Health)), and disease related variables (e.g. symptom duration, rheumatoid arthritis impact of disease (RAID) questionnaire). Participants were asked to report whether they had or were treated for any of 15 predefined comorbidities (categorised into 0, 1, 2, 3, or ≥4 (Table)). Percentage of number of hours missed due RA (i.e. absenteeism) and presenteeism (10-point Likert scale) were assessed using the Work Productivity and Activity Impairment Questionnaire (WPAI-RA). For the purpose of this study both absenteeism and presenteeism outcomes were dichotomized (no presenteeism/absenteeism versus any) and only patients aged &lt;65yrs were included. Logistic regression analysis were applied to assess the association between number of comorbidities and absenteeism/presenteeism, adjusting for the categorical variables age, gender and education. Chi2-square test was applied to assess frequencies of individual comorbidities between the three employment status groups.Results:868 participants were included; 91.7% women with a median symptom duration of 8.3 years [IQR 4.4-13.7]. The average RAID score was 5.2 (SD 2.2). 80.4% were in paid employment, including those currently on sick leave, 16.9% stopped early because of their RA and 2.7% reported stopping early because of other health reasons. In those employed most commonly occurring comorbidities were: back pain (28.8%%), osteoarthritis (21.5%), depression (26.3%) and anxiety (22.6%). Compared to people with RA with no comorbidities, the odds associated with time off work due to RA increased from 1.7 up to 3.4 with increasing number of comorbidities (Table). Although a similar trend was observed for presenteeism, the effect sizes were smaller. Significant differences (p&lt;0.05) in frequencies of the following comorbidities were observed between the three employment status groups (Empl, Stop_RA, Stop_Health, respectively): heart disease (3.9%, 7.9%, 20.0%), blood pressure (18.0%, 29.5%, 36.7%), lung disease (5.7%, 16.3%, 26.7%), diabetes (4.4%, 4.2%, 26.7%), ulcer (6.1%, 11.1%, 13.3%), cancer (3.3%, 2.6%, 13.3%), depression (26.3%, 33.6%, 50.0%), OA (21.5%, 44.7%, 63.33%), and back pain (28.8%, 48.4%, 60.0%).Absenteeism (yes/no)Presenteeism (yes/no)Number of comorbiditiesNOR95%CIOR95%CI0206Ref.Ref.11741.701.06-2.711.661.00-2.7321361.771.08-2.921.991.13-2.863851.751.00-3.081.530.82-2.864-15max863.381.98-5.782.641.28-5.44OR=odds ratio; 95%CI=95% confidence interval; Comorbidities included: heart disease, blood pressure, lung disease, diabetes, ulcer or stomach disease, kidney disease, liver disease, anaemia or other blood disease, cancer, depression, anxiety, OA, back pain, osteoporosis and Sjögren. Bold figuresP&lt;0.05.Conclusion:Although the study is cross-sectional and no temporal association can be determined, this study shows that not only personal and work related contextual factors should be considered when preventing worker productivity loss, but also other comorbidities.Disclosure of Interests:A. Bradshaw: None declared, Ailsa Bosworth Speakers bureau: a number of pharmaceutical companies for reasons of inhouse training, advisory boards etc., K. Walker-Bone: None declared, Laura Lunt: None declared, Suzanne Verstappen Grant/research support from: BMS, Consultant of: Celltrion, Speakers bureau: Pfizer

The Patient Experienced Symptom State (PESS): a patient-reported global outcome measure that may better reflect disease remission status

In RA, Patient Acceptable Symptom State assesses disease from the patient's perspective, which does not correspond either to disease remission or to full control of disease impact. This study aims to explore the properties of a novel multilevel Patient Experienced Symptom State (PESS). This was a cross-sectional analysis of two datasets of patients with RA. PESS was assessed through the question: 'Consider how your RA has affected you. If you remain in the coming months as you have been the last week, how would you rate your condition?', with five levels (from 'very bad' to 'very good'). Construct validity of PESS was assessed against validated disease activity [DAS28, Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI)] and impact measures [RA Impact of Disease (RAID) and modified HAQ]. Multiple pairwise comparisons between groups and receiver-operating characteristic curves with Youden Index were performed. A total of 1407 patients [74% female, mean (S.d.) age 53.5 (13.4) years, mean disease duration 14.3 (12.0) years and mean DAS28 3.0 (1.5)] were analysed. Overall, 16.3% considered themselves as being in 'very good', 21.6% in 'good' and 31.9% in 'acceptable' state. Disease activity and impact measures differed significantly across the five levels (P < 0.01). Cut-off values corresponding to 'good' and 'very good' PESS states were in the range of low disease activity/remission (for 'good' and 'very good': DAS28-ESR-4v ≤2.6/≤2.3; CDAI ≤5.0/≤3.1; SDAI ≤5.1/≤3.8, respectively) and very low disease impact (RAID domains all ≤1). PESS 'very good' status corresponds to currently recommended targets for RA management and reflects full control of disease impact. PESS appears to be an easy-to-use and relevant measure in the evaluation of patients with RA.

Use of rheumatoid arthritis impact of disease (RAID) in routine care; identification of DAS28 remission and unmet patient-reported outcomes.

ObjectiveThe aim was to assess how the patient-reported outcome RA impact of disease (RAID) relates to DAS28 categories in routine care, its utility in identifying patients in DAS28 remission (RDAS) or low disease activity (LDAS) and the burden of unmet patient-reported needs in those achieving RDAS/LDAS.MethodsDAS28 and RAID scores were collected from patients with established RA attending for routine review. The relationship between RAID and DAS28 was assessed with univariate pairwise correlation and mixed-effects linear regression analyses. RAID <2 was defined as a patient-acceptable state.ResultsOne hundred and ninety-eight patients were assessed, with 220 observations, using DAS28-CRP categories: 47.5% RDAS, 14.1% LDAS, 31.8% moderate DAS (MDAS) and 6.6% high DAS (HDAS). Both patient visual analog scale score and tender joint count exhibited a high statistical association with RAID using linear regression (P < 0.0001). The mean RAID score per DAS28-CRP category was RDAS 1.84, LDAS 4.78, MDAS 5.60 and HDAS 7.68, with a statistically significant increase in RAID per unit increase in DAS-CRP or DAS28-ESR on linear regression (P < 0.001). Of 66 patients with RAID <2, 64 (97%) were in RDAS and 65 (98.5%) in RDAS/LDAS. Of 134 patients in RDAS/LDAS, RAID was ≥2 in 69 (51.5%), with fatigue and sleep being the worst-scoring domains.ConclusionRAID functions well as a patient-reported outcome in routine care. Patients with RAID <2 have a high likelihood of being in RDAS/LDAS and, if pre-screened, could avoid a clinic visit. Analysis of RAID domains provides individualized targets for holistic care in RA management, with fatigue and sleep problems dominating unmet needs in those in RDAS/LDAS.

Translation and cross-cultural adaptation into Italian of the self-administered FLARE-RA questionnaire for rheumatoid arthritis

The aim was to provide a translation into Italian with cross-cultural adaptation of the French FLARE-Rheumatoid Arthritis (RA) questionnaire, and to test its acceptability, feasibility, reliability and construct validity in a single-centre cohort study. The French version of the FLARE-RA questionnaire was cross-culturally adapted and translated into Italian following an established forward-backward translation procedure, with independent translations and backtranslations. To validate the Italian version we tested the internal validity with Cronbach's alpha, test-retest reliability with the intraclass correlation coefficient, agreement between assessments with Bland-Altman plots and construct validity with Spearman's correlation coefficients. The questionnaire was tested on 283 consecutive RA outpatients (mean age 56.1±13.9 years, 226/283 females, median disease duration 12.6 years ranging from 0.2 to 70.6). For the global score (11 items) the Cronbach's alpha coefficient was 0.94. The intraclass correlation coefficient was 0.87 (95% CI, 0.76-0.96). The correlation of FLARE-RA global score was 0.59 (95% CI, 0.50-0.66) with the Disease Activity Score on 28 joints, 0.63 (95% CI, 0.55-0.71) with the Simplified Disease Activity Index, 0.77 (95% CI, 0.71-0.83) with the RA Impact of Disease and 0.67 (95% CI, 0.59-0.73) with the Health Assessment Questionnaire. The Italian version of the FLARE-RA is feasible, brief and easy to administer. The translated and cross-cultural adapted showed accordingly to be valid and reliable. This questionnaire has some practical advantages, such as clarity, comprehensiveness, simplicity, and a minimum filling time. The development of cross-cultural adapted questionnaires in different languages is of pivotal importance to obtain standardized and comparable data across countries.

P227 Remote monitoring of patients with RA: a user-centred design approach

Abstract Background Patients with rheumatoid arthritis are generally seen at arbitrary intervals in secondary care. Patients with active disease may not always be seen at the most appropriate time and those with low disease activity may be seen more frequently than necessary. The NHS Long Term Plan expects outpatient appointments to be reduced by up to a third, with digital transformation a key enabler. The remote capture of patient-reported outcome measures (PROMs) has the potential to facilitate more flexible and responsive outpatient services. Methods This project aimed to design a digital remote monitoring platform to test the hypothesis that PROMs can be used to proactively monitor and trigger consultations when patients need them most. The Rheumatoid Arthritis Impact of Disease (RAID) questionnaire, a validated multidimensional PROM, was used. Waiting room testing with patients informed the design of an acceptable mobile device format of the RAID. Recruitment criteria and acceptable cut-offs for defining flare were agreed by the rheumatology multidisciplinary team. Patients in low disease activity or remission (DAS &amp;lt;3.2) were invited to the service via SMS. All patients were informed regarding the governance of handling patient data and an opt-out option was offered. Patients were sent an automated monthly SMS with a PROM link and weekly reminder SMS if required. They also had the option to send in SMS messages at other times or add free text comments. Patients submitting a RAID score of ≥ 4 received a SMS with a link to the rheumatology advice service advising a remote consultation. The SMS-based service went live in January 2019 and all incoming communication was monitored on a daily basis. Results 104 RA patients are currently using the remote monitoring service with 10.3% (13/117) opting-out. 847 monthly PROMs have been sent via SMS. The PROM completion rate has been 68.9% (range 59.0-85.1%). 120 RAID (21.8%) scored 2-≤4 indicating low disease activity and 136 RAID (24.7%) ≤ 2 indicating disease remission. 480 SMS have been sent manually to patients who have engaged in two-way communication or returned a RAID score ≥4. 44 telephone advice appointments were triggered through the remote monitoring service by patients in disease flare. 80% (35/44) of remote consultation were considered to have to have averted a face to face consultation with the remaining 20% providing advice alone. Interviews have been conducted with PROM ‘non-completers’ to learn and inform further service design. Conclusion This project has demonstrated how a user-centred design approach to utilising technology can support access to rheumatology care when patients need it most, such as disease flare. The identification of patients self-reporting low disease activity using multidimensional PROMs may enable more efficient utilisation of clinical capacity through patient-initiated appointment deferment and lead to improved patient-centred care. Disclosures M.J. Martin: Honoraria; Novartis, Abbvie. Grants/research support; National Ankylosing Spondylitis Society. N. Ng None. L. Blackler None. T. Garrood None.

Patient Perceptions of Unmet Medical Need in Rheumatoid Arthritis: A Cross-Sectional Survey in the USA.

IntroductionMany rheumatoid arthritis (RA) patients do not achieve their treatment goals and experience symptoms that affect psychosocial outcomes and daily activities. This study aimed to identify and quantify the unmet needs perceived by US patients with RA currently taking a disease-modifying antirheumatic drug (DMARD).MethodsA cross-sectional, web-based survey was conducted with RA patients recruited through CreakyJoints, an online patient support community, and ArthritisPower®, an online patient research registry, from December 2017 to January 2018. Participant patients were aged ≥ 21 years, failed ≥ 1 DMARDs, and were receiving their current DMARD(s) for ≥ 6 months; they answered 50 questions about treatment history, RA symptoms, and flares and completed the Rheumatoid Arthritis Impact of Disease (RAID) questionnaire and the Treatment Satisfaction Questionnaire for Medication (TSQM). Treatment satisfaction was defined by a TSQM global satisfaction score ≥ 80.ResultsOf 415 patients screened, 258 (62%) were eligible and completed the survey; 87% were women, and 87% white, with mean (SD) age of 54.5 (11.4) years. A total of 232 patients (90%) had current or past biologic DMARD (bDMARD) use, with 67% currently on a bDMARD, 65% on ≥ 1 conventional synthetic DMARD, and 40% on methotrexate. Forty-three percent of patients reported daily/almost daily use of prescription pain medications, and 44% reported a current flare. Mean (SD) TSQM scores were 59 [20] for effectiveness, 59 [26] for side effects, 72 [18] for convenience, and 65 [21] for global satisfaction. The mean (SD) RAID overall score was 5.1 (2.0) on a 0–10 scale. Only 26% (67 patients) were satisfied with their RA treatment. Patients not satisfied with treatment reported higher RAID scores overall and by domain, and approximately half reported a current flare.ConclusionsResults from this real-world survey suggest that three-fourths of RA patients are not satisfied with treatments, which include bDMARDs. Patients continued to experience bothersome symptoms that impacted their daily activities and life. There remains a need for improved disease management among currently treated RA patients.FundingEli Lilly and Company (Indianapolis, IN, USA).Electronic Supplementary MaterialThe online version of this article (10.1007/s40744-019-00168-5) contains supplementary material, which is available to authorized users.

New insights into the prevalence of depressive symptoms and depression in rheumatoid arthritis - Implications from the prospective multicenter VADERA II study.

ObjectivesTo investigate the prevalence of depressive symptoms in rheumatoid arthritis (RA) patients using two previously validated questionnaires in a large patient sample, and to evaluate depressive symptoms in the context of clinical characteristics (e.g. remission of disease) and patient-reported impact of disease.MethodsIn this cross-sectional study, the previously validated Patient Health Questionnaire (PHQ-9) and Beck-Depression Inventory II (BDI-II) were used to assess the extent of depressive symptoms in RA patients. Demographic background, RA disease activity score (DAS28), RA impact of disease (RAID) score, comorbidities, anti-rheumatic therapy and antidepressive treatment, were recorded. Cut-off values for depressive symptomatology were PHQ-9 ≥5 or BDI-II ≥14 for mild depressive symptoms or worse and PHQ-9 ≥ 10 or BDI-II ≥ 20 for moderate depressive symptoms or worse. Prevalence of depressive symptomatology was derived by frequency analysis while factors independently associated with depressive symptomatology were investigated by using multiple logistic regression analyses. Ethics committee approval was obtained, and all patients provided written informed consent before participation.ResultsIn 1004 RA-patients (75.1% female, mean±SD age: 61.0±12.9 years, mean disease duration: 12.2±9.9 years, DAS28 (ESR): 2.5±1.2), the prevalence of depressive symptoms was 55.4% (mild or worse) and 22.8% (moderate or worse). Characteristics independently associated with depressive symptomatology were: age <60 years (OR = 1.78), RAID score >2 (OR = 10.54) and presence of chronic pain (OR = 3.25). Of patients classified as having depressive symptoms, only 11.7% were receiving anti-depressive therapy.ConclusionsMild and moderate depressive symptoms were common in RA patients according to validated tools. In routine clinical practice, screening for depression with corresponding follow-up procedures is as relevant as incorporating these results with patient-reported outcomes (e.g. symptom state), because the mere assessment of clinical disease activity does not sufficiently reflect the prevalence of depressive symptoms.Clinical trial registration numberThis study is registered in the Deutsches Register Klinischer Studien (DRKS00003231) and ClinicalTrials.gov (NCT02485483).

Comorbidities in Patients with Rheumatoid Arthritis and Their Association with Patient-reported Outcomes: Results of Claims Data Linked to Questionnaire Survey.

To investigate the prevalence of comorbidities in a population-based cohort of persons with rheumatoid arthritis (RA) compared to matched controls and to examine their association with patient-reported outcomes in a survey sample. Data of 96,921 persons with RA [International Classification of Diseases, 10th ed (ICD-10) M05/M06] and 484,605 age- and sex-matched controls without RA of a German statutory health fund were studied regarding 26 selected comorbidities (ICD-10). A self-reported questionnaire, comprising joint counts [(tender joint count (TJC), swollen joint count (SJC)], functional status (Hannover Functional Ability Questionnaire), effect of the disease (Rheumatoid Arthritis Impact of Disease), and well-being (World Health Organization 5-item Well-Being Index; WHO-5) was sent to a random sample of 6193 persons with RA, of whom 3184 responded. For respondents who confirmed their RA (n = 2535), associations between comorbidities and patient-reported outcomes were analyzed by multivariable linear regression. Compared to controls, all investigated comorbidities were more frequent in persons with RA (mean age 63 yrs, 80% female). In addition to cardiovascular risk factors, the most common were osteoarthritis (44% vs 21%), depression (32% vs 20%), and osteoporosis (26% vs 9%). Among the survey respondents, 87% of those with 0-1 comorbidity but only 77% of those with ≥ 8 comorbidities were treated by rheumatologists. Increasing numbers of comorbidities were associated with poorer values for TJC, SJC, function, and WHO-5. Compared to a matched population, persons with RA present with increased prevalence of numerous comorbidities. Patients with RA and multimorbidity are at risk of insufficient rheumatological care and poorer patient-reported outcomes.

Comparative analyses of responsiveness between the Rheumatoid Arthritis Impact of Disease score, other patient-reported outcomes and disease activity measures: secondary analyses from the ARCTIC study

ObjectiveTo evaluate the responsiveness of the Rheumatoid Arthritis Impact of Disease (RAID) score compared with other patient-reported outcome measures (PROMs), inflammatory markers and clinical disease activity measures in patients with...

Abrief report on the clinical trial on neural mobilization exercise for joint pain in patients with rheumatoid arthritis.

In rheumatoid arthritis (RA) synovitis, activation of synoviocytes and infiltration of adaptive immune cells leads to synovial hyperplasia and joint swelling. Under the elevated extra-neural pressure, free nerve endings release neuropeptides, calcitonin gene-related peptide, and substanceP, thus promoting neurogenic inflammation. This study aimed to assess the effect of therapeutic neural mobilization (NM) exercises targeting the nervous system on disease impact in RA patients. A total of 21RA patients were randomized into NM (n = 11) and control (n = 10) groups. NM group patients performed NM exercises targeting the median, musculocutaneous, femoral, and saphenous nerve, as well as the entire nervous system twice daily for 4-8weeks. Control RA patients performed gentle joint mobilization exercises targeting the same joints. Primary outcome was the change in pre-/post-treatment score in the validated Rheumatoid Arthritis Impact of Disease (RAID). Secondary outcome was erythrocyte sedimentation rate (ESR). There were no significant differences between the groups at baseline. No adverse events were observed and compliance was over 90%. Post-treatment, favorable changes were observed in the NM group RAID score: -5.1 vs. -0.8; weighted RAID score: -0.79 vs. -0.15. ESR was reduced in the NM group, albeit non-significantly. Regarding the RAID score domains, the NM group demonstrated significant improvements in pain and coping. The current data indicate a beneficial effect of NM exercises on pain and self-efficacy in our RA patients. Larger clinical studies are warranted to determine the clinical effectiveness of NM as atreatment for pain for RA patients and simultaneously address immune and neuropeptide modulation through NM.

Validation of the Musculoskeletal Health Questionnaire in inflammatory arthritis: a psychometric evaluation

The Musculoskeletal Health Questionnaire (MSK-HQ) is a recently developed Patient Reported Outcome Measure for use across patients with musculoskeletal conditions. This study provides a validation of the MSK-HQ examining construct validity and reliability in inflammatory arthritis. 287 adults with inflammatory arthritis completed the MSK-HQ and other Patient Reported Outcome Measures at baseline and after 3 months. Construct validity was assessed using item response theory methods. Concurrent validity was considered in relation to the HAQ and EuroQol-5D in all patients, as well as the RA Impact of Disease (RAID), PsA Impact of Disease scales, and AS Quality of Life Questionnaire (ASQoL) in disease subtypes. The MSK-HQ was approximately normally distributed with no evidence of floor or ceiling effects. A unidimensional structure was confirmed. Two items were less weakly related to the latent musculoskeletal health variable, providing some evidence of multidimensionality. Reliability was high (α = 0.93). The total score correlated highly with the HAQ (r = -0.81) and EuroQol-5D index (r = 0.80) in all patients, RAID in RA patients (r = -0.88), PsA Impact of Disease in PsA patients (r = -0.88), and ASQoL in AS patients (r = -0.86). Test-retest reliability was high (rICC = 0.73). This study provides evidence for the validity and reliability of the MSK-HQ in people with inflammatory arthritis. The major advantage of the MSK-HQ is that it is not disease specific and has high content validity in rheumatological conditions. The MSK-HQ score will be of value in clinical rheumatology practice, providing a measure that can be used across disease areas.

The Portuguese Rheumatoid Arthritis Impact of Disease (RAID) score and its measurement equivalence in three countries: validation study using Rasch Models

PurposeThe Rheumatoid Arthritis Impact of Disease (RAID) score assesses seven impact domains of interest for people with RA. This study aimed to test patients’ understanding of the Portuguese RAID and evaluate its cross-cultural validity for use in Portugal.MethodsThis was a mixed methods study comprising two phases: (i) cognitive debriefing to determine patient’s comprehension of the Portuguese RAID and (ii) cross-cultural validation using Rasch analysis. Construct validity was determined by fit to the model, invariance culture (compared with France and UK datasets) and evidence of convergent and divergent validity.ResultsPatients’ input (n = 38) led to minor changes in the phrasing of two items to ensure conceptual equivalence between the Portuguese and the original RAID. In Rasch analysis (n = 288), two items ‘Sleep’ and ‘Physical well-being’ in the Portuguese dataset did not adequately fit the model specifications, suggesting multidimensionality (sleep—not necessarily associated with RA) and redundancy (physical well-being overlapping with functional disability). Despite the imperfections, the scale had high internal consistency, evidence of convergent and divergent validity and invariance to culture (compared to France n = 195 and UK n = 205 datasets). The scale was well targeted for patients with different levels of disease impact.ConclusionsThe RAID has been successfully adapted into Portuguese and it can be used with confidence in clinical practice. Further research will be required to ensure it captures the full range of sleep problems in RA. Meanwhile, data across the three countries (Portugal, France and the UK) are comparable except for the two items (sleep and physical well-being).

Impact of comorbidities on fatigue in rheumatoid arthritis patients: Results from a nurse-led program for comorbidities management (COMEDRA).

To analyze the factors associated with fatigue focusing on comorbidities in a large cohort of rheumatoid arthritis (RA). Cross-sectional analyses were performed on RA patients from the French COMEDRA cohort study, a nurse-led program for comorbidities management. Fatigue was assessed using Question 3 of the Rheumatoid Arthritis Impact of Disease (RAID) score on a 0-10 numerical rating scale (NRS). Fatigue was defined as acceptable if ≤ 2, moderate if 3 or 4, or severe if ≥ 5 out of 10. Using univariate and multivariate models, the relationship between fatigue and demographics, social, disease characteristics, comorbidities (cardiovascular, infections, cancer, pulmonary, osteoporosis, and psychiatric disorders), physical activity, quality of life, and treatments was investigated. In total, 962 patients were analyzed. The mean fatigue score was 3.8 ± 2.7, 40% of patients reported severe fatigue. Patients had an average of 1.8 additional morbid conditions, with anxiety/depression the most common (52%). In univariate analysis, severe fatigue was more frequent in women, in patients not working, and in those with less physical activity. It was associated with disease duration and activity, mHAQ, pain, sleeping and emotional difficulties. Severe fatigue correlated with Multimorbidity index assessing the number of morbid conditions and was associated with obesity, hypertension, COPD, and anxiety/depression. In multivariate models, the risk of severe fatigue was associated with female gender, disease activity, mHAQ, current treatment with NSAIDs and biologics, multimorbidity, obesity and anxiety/depression. Assessment of comorbidities, psychological health and physical activity should be taken into account in order to address frequent RA-related severe fatigue.

Patient-reported outcomes from a randomized phase III trial of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis

BackgroundThe phase III MONARCH randomized controlled trial (NCT02332590) demonstrated that in patients with rheumatoid arthritis (RA), sarilumab (anti-interleukin-6 receptor monoclonal antibody) monotherapy is superior to adalimumab monotherapy in reducing disease activity and signs and symptoms of RA, as well as in improving physical function, with similar rates of adverse and serious adverse events. We report the effects of sarilumab versus adalimumab on patient-reported outcomes (PROs).MethodsPatients with active RA intolerant of, or inadequate responders to, methotrexate were randomized to sarilumab 200 mg plus placebo every 2 weeks (q2w; n = 184) or adalimumab 40 mg plus placebo q2w (n = 185). Dose escalation to weekly administration of adalimumab or matching placebo was permitted at week 16. PROs assessed at baseline and weeks 12 and 24 included patient global assessment of disease activity (PtGA), pain and morning stiffness visual analogue scales (VASs), Health Assessment Questionnaire Disability Index (HAQ-DI), 36-item Short Form Health Survey (SF-36), Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F), Rheumatoid Arthritis Impact of Disease (RAID), and rheumatoid arthritis-specific Work Productivity Survey (WPS-RA). Between-group differences in least-squares mean (LSM) changes from baseline were analyzed. p < 0.05 was considered significant for PROs in a predefined hierarchy. For PROs not in the hierarchy, nominal p values are provided. Proportions of patients reporting improvements greater than or equal to the minimal clinically important difference (MCID) and achieving normative values were assessed.ResultsAt week 24, sarilumab treatment resulted in significantly greater LSM changes from baseline than adalimumab monotherapy in HAQ-DI (p < 0.005), PtGA (p < 0.001), pain VAS (p < 0.001), and SF-36 Physical Component Summary (PCS) (p < 0.001). Greater LSM changes were reported for sarilumab than for adalimumab in RAID (nominal p < 0.001), morning stiffness VAS (nominal p < 0.05), and WPS-RA (nominal p < 0.005). Between-group differences in FACIT-F and SF-36 Mental Component Summary (MCS) were not significant. More patients reported improvements greater than or equal to the MCID in HAQ-DI (nominal p < 0.01), RAID (nominal p < 0.01), SF-36 PCS (nominal p < 0.005), and morning stiffness (nominal p < 0.05), as well as greater than or equal to the normative values in HAQ-DI (p < 0.05), with sarilumab versus adalimumab.ConclusionsIn parallel with the clinical efficacy profile previously reported, sarilumab monotherapy resulted in greater improvements across multiple PROs than adalimumab monotherapy.Trial registrationClinicalTrials.gov, NCT02332590. Registered on 5 January 2015.