Rheumatoid Arthritis Impact Of Disease Research Articles

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.

216 Relationship between DAS28 categories and rheumatoid arthritis impact of disease (RAID) patient reported outcome in rheumatoid arthritis: significant advantage of targeting DAS remission

216 Relationship between DAS28 categories and rheumatoid arthritis impact of disease (RAID) patient reported outcome in rheumatoid arthritis: significant advantage of targeting DAS remission

Validity of the rheumatoid arthritis impact of disease (RAID) score and definition of cut-off points for disease activity states in a population-based European cohort of patients with rheumatoid arthritis

ObjectivesTo assess the validity of the rheumatoid arthritis impact of disease (RAID) for measuring disease activity of rheumatoid arthritis (RA) and to determine cut-off values for defining the disease activity states. MethodsA total of 622 RA patients from an European database have been included. Cross-validation was based on assessment of convergent and discriminant validity. Optimal cut-offs were determined against external criteria by calculating the respective 25th and 75th percentiles mean values of RAID. External criteria included definitions for remission (REM), low disease activity (LDA), moderate disease activity (MDA) and high disease activity (HDA), cut-offs of the 28-joint disease activity score-C-reactive protein (DAS28-CRP) score. ResultsThe RAID showed a moderate degree of correlation with respect to DAS28-CRP (rho=0.417; P<0.0001). The receiver operating characteristic (ROC) curves to discriminate the ability of RAID to distinguish patients with active and non-active disease was very good with an area under the curve (AUC) of 0.847 (95% confidence interval [CI]: 0.816 to 0.878; P<0.0001). Based on the distributions of RAID in the different disease activity groups, we propose the following cut-off values for REM: RAID ≤3; for LDA: RAID >3 and ≤4; for MDA: RAID >4 and ≤6; for HDA: RAID >6. Mean RAID differed significantly between patients classified as REM, LDA, MDA or HDA (P=0.001). ConclusionsThe cut-offs revealed good measurement characteristics in cross-validation analysis, had great discriminatory performance in distinguishing patients with different levels of disease activity and are suited for widespread use in everyday practice application and research.

Sarilumab improves patient-reported outcomes in rheumatoid arthritis patients with inadequate response/intolerance to tumour necrosis factor inhibitors

ObjectiveTo evaluate effects of the anti-interleukin-6 receptor monoclonal antibody sarilumab administered with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) on patient-reported outcomes (PROs) in the TARGET trial in patients with rheumatoid...

Validation of FLARE-RA, a Self-Administered Tool to Detect Recent or Current Rheumatoid Arthritis Flare.

To validate the measurement properties and the detection performance of the FLARE-RA questionnaire in a longitudinal prospective study. To validate the FLARE-RA self-administered questionnaire, we conducted a prospective trial in rheumatoid arthritis (RA) patients to document: 1) content and construct validity by factor analysis, convergent validity by Pearson's correlation with routine assessment of patient index data (Routine Assessment of Patient Index Data 3 [RAPID-3] questionnaire), RA Impact of Disease (RAID) score, Disease Activity Score in 28 joints (DAS28), and Health Assessment Questionnaire (HAQ), 2) reliability (intraclass correlation coefficient [ICC] and Bland-Altman plot), and 3) feasibility of use. Patients were examined and questionnaires were collected at baseline and 3 months, and every week in between for RAPID-3. We recruited 138 patients from 13 centers: 81.9% women, mean age 57.4 years, mean DAS28 2.9, mean C-reactive protein level 6.2 mg/liter, 84.4% rheumatoid factor positive, 78.0% anti-citrullinated protein antibody positive, and 78.8% with erosive disease. At baseline, the mean ± SD FLARE-RA score was 2.3 ± 2.3. The content and construct validity of FLARE-RA was good. A substantial floor effect, but no ceiling effect, was observed. Principal components analysis revealed 1 domain disentangled in 2 subdomains: physical and emotional. The FLARE-RA total score was correlated with the DAS28 (r = 0.63, P < 0.001), RAID (r = 0.80, P < 0.001), RAPID-3 (r = 0.77, P < 0.001), and HAQ (r = 0.53, P < 0.001). The ICC for reliability was 0.94 (95% confidence interval 0.92-0.96). The FLARE-RA self-administered questionnaire represents a valid and valuable instrument to detect RA flare between visits to the physician.

Patient-reported outcomes in Asia: evaluation of the properties of the Rheumatoid Arthritis Impact of Disease (RAID) score in multiethnic Asian patients with rheumatoid arthritis.

Patient-reported outcomes (PROs) such as the Europe-developed Rheumatoid Arthritis Impact of Disease (RAID) are important to assess patients' quality of life. Their interpretation may be culture-dependent. To evaluate the potential utility of RAID in multiethnic Asian rheumatoid arthritis (RA) patients. Cross-sectional study of English-speaking RA patients in a Singapore tertiary center. Validity of RAID (scored between 0 and 10 with higher score indicating worse status) was assessed by Spearman's correlation with patient global assessment (PGA), DAS28 and short form 12 (SF-12). Consistency was assessed by Cronbach's alpha and test-retest reliability by intra-class correlation coefficient (ICC) 7days after (n=20). Feasibility was assessed by % of missing data. Eighty-two patients were analyzed: median age 53years (Q1:Q3 44.7; 60.7), disease duration 4.2years (1.4; 8.8), 66 (81%) women and 54 (66%) Chinese. Although RA was moderately active (median DAS28, 3.2 (2.5; 4.3)), RAID score was very low (median, 1.9 (0.6; 3.7)) with 44 (53.7%) patients having RAID score between 0 and 2. RAID was strongly correlated with PGA (r=0.75), and moderately with other outcomes (DAS28 r=0.46, SF12 physical r=-0.45 and SF12 mental r=-0.52, p<0.0001 for all). Consistency was high (Cronbach's alpha=0.91). Test-retest reliability was excellent; ICC=0.84 (95% confidence interval 0.74-0.90). Feasibility was good with only 2 patients with missing data. Despite considerable floor effects, the RAID appeared to be a valid and practical PRO to assess the impact of RA in Asia. Multiethnic Asian patients may underestimate the impact of their disease compared to European patients.

Patient- and clinician-reported outcomes for patients with new presentation of inflammatory arthritis: observations from the National Clinical Audit for Rheumatoid and Early Inflammatory Arthritis.

Our aim was to conduct a national audit assessing the impact and experience of early management of inflammatory arthritis by English and Welsh rheumatology units. The audit enables rheumatology services to measure for the first time their performance, patient outcomes and experience, benchmarked to regional and national comparators. All individuals >16 years of age presenting to English and Welsh rheumatology services with suspected new-onset inflammatory arthritis were included in the audit. Clinician- and patient-derived outcome and patient-reported experience measures were collected. Data are presented for the 6354 patients recruited from 1 February 2014 to 31 January 2015. Ninety-seven per cent of English and Welsh trusts participated. At the first specialist assessment, the 28-joint DAS (DAS28) was calculated for 2659 (91%) RA patients [mean DAS28 was 5.0 and mean Rheumatoid Arthritis Impact of Disease (RAID) score was 5.6]. After 3 months of specialist care, the mean DAS28 was 3.5 and slightly >60% achieved a meaningful DAS28 reduction. The average RAID score and reduction in RAID score were 3.6 and 2.4, respectively. Of the working patients ages 16-65 years providing data, 7, 5, 16 and 37% reported that they were unable to work, needed frequent time off work, occasionally and rarely needed time off work due to their arthritis, respectively; only 42% reported being asked about their work. Seventy-eight per cent of RA patients providing data agreed with the statement 'Overall in the last 3 months I have had a good experience of care for my arthritis'; <2% disagreed. This audit demonstrates that most RA patients have severe disease at the time of presentation to rheumatology services and that a significant number continue to have high disease activity after 3 months of specialist care. There is a clear need for the National Health Service to develop better systems for capturing, coding and integrating information from outpatient clinics, including measures of patient experience and outcome and measures of ability to work.

Sleep disturbance in patients with rheumatoid arthritis is related to fatigue, disease activity, and other patient-reported outcomes

Objectives: To explore factors related to sleep disturbance in patients with rheumatoid arthritis (RA).Method: Cross-sectional data from 986 patients in the Oslo RA Register (ORAR) collected in 2009 were included. Sleep problems were assessed by four measures: the Medical Outcomes Study (MOS) sleep disturbance scale, and the sleep components of the Rheumatoid Arthritis Impact of Disease (RAID) score, the Multi-Dimensional Health Assessment Questionnaire (MDHAQ), and the 15-dimensional quality of life questionnaire (15D). Patient-reported outcomes (PROs) were recorded using standard questionnaires for physical and mental function [the HAQ and the MOS 36-item Short-Form Health Survey (SF-36), disease activity (the RA Disease Activity Index, RADAI), utility (SF-6D), and visual analogue scales (VAS) for pain, fatigue, and disease activity]. Demographics including comorbidity were collected. Information on use of medication for RA and sleep disturbance was obtained using checklists. Multivariate analyses were used to identify factors independently associated with sleep problems by four different measures.Results: The mean (standard deviation, SD) age of the patients was 59.4 (12.5) years, 76.9% were females, and the mean (SD) disease duration was 13.7 (10.7) years. The correlation between the various sleep measures was high (r2 = 0.71–0.78). Sleep disturbance was moderately correlated to pain (r2 = 0.41–0.61), fatigue (r2 = 0.44–0.58), physical function (r2 = 0.33–0.48), RADAI (r2 = 0.42–0.55), and utility (r2 = 0.49–0.61). RAID sleep demonstrated the highest correlation with other PROs. RADAI, fatigue, the mental component score of SF-36, physical function, body mass index (BMI), and use of Z-drugs/benzodiazepines were independently associated with two or more measures of sleep problems (all p < 0.001).Conclusions: Sleep disturbance measured by four different measures was independently related to other PROs including fatigue, pain, and disease activity in RA patients.

Content validity of the Dutch Rheumatoid Arthritis Impact of Disease (RAID) score: results of focus group discussions in established rheumatoid arthritis patients and comparison with the International Classification of Functioning, Disability and Health core set for rheumatoid arthritis.

BackgroundThe Rheumatoid Arthritis Impact of Disease (RAID) score was developed as a European League Against Rheumatism initiative to obtain a patient reported outcome score for clinical trials in patients with rheumatoid arthritis (RA), based on patients’ perception of the impact of the disease on several domains of health. The objective of this study was to assess the content validity of this score in Dutch RA patients.MethodsDuring three focus group discussions (n = 23), patients with RA reflected on comprehensiveness of the RAID to measure impact of RA on their life, relevance of the RAID domains and formulation of questions. Also, the domains of the RAID score were compared to the comprehensive International Classification of Functioning, Disability and Health core set for RA.ResultsPatients confirmed that RA had impact on five domains already incorporated in the RAID score: emotional well-being, pain, performing daily activities, fatigue and coping. There was variation in interpretation of some of the items of the RAID score, suggesting problems in comprehension. Patients indicated that the domains work, relationships with others (such as family and friends) and spare time/hobbies were missed in the RAID and could be added to obtain a more ‘complete’ picture of the impact of the disease.ConclusionThe RAID score has fairly good content validity. If confirmed as important in other patient groups, items in the above mentioned areas should be considered in a future upgrade.Electronic supplementary materialThe online version of this article (doi:10.1186/s13075-015-0911-z) contains supplementary material, which is available to authorized users.

Patient Acceptable Symptom State in Self-Report Questionnaires and Composite Clinical Disease Index for Assessing Rheumatoid Arthritis Activity: Identification of Cut-Off Points for Routine Care.

Objective. To provide information on the value of Patient Acceptable Symptom State (PASS) in rheumatoid arthritis (RA) by the identification of PASS thresholds for patient-reported outcomes (PROs) composite scores. Methods. The characteristics of RA patients with affirmative and negative assignment to PASS were compared. Contributors to physician response were estimated by logistic regression models and PASS thresholds by the 75th percentile and receiver-operating characteristic (ROC) curve methods. Results. 303 RA patients completed the study. All PROs were different between the PASS (+) and PASS (−) groups (p < 0.0001). The thresholds with the 75th percentile approach were 2.0 for the RA Impact of Disease (RAID) score, 2.5 for the PRO-CLinical ARthritis Activity (PRO-CLARA) index, and 1.0 for the Recent-Onset Arthritis Disability (ROAD) questionnaire. The cut-off values for Clinical Disease Activity Index (CDAI) were in the moderate range of disease activity. Assessing the size of the logistic regression coefficients, the strongest predictors of PASS were the disease activity (p = 0.0007) and functional state level (0.006). Conclusion. PASS thresholds were relatively high and many patients in PASS had moderate disease activity states according to CDAI. Factors such as disease activity and physical function may influence a negative PASS.

THU0258 The RAID Questionnaire and Other Patient Reported Outcome Variables Are Highly Influenced by the Degree of Pain Catastrophizing, in Contrast to Ultrasound, Clinical and Laboratory Variables; Results from A Follow-Up Study of Patients with Established RA

BackgroundThe Rheumatoid Arthritis (RA) Impact of Disease (RAID) score is a patient developed questionnaire including 7 questions (pain, functional capacity, fatigue, physical and emotional wellbeing, quality of sleep and coping)...

AB1086 Evaluation of the Properties of the Rheumatoid Arthritis Impact of Disease (RAID) Score in Multiethnic Asian Patients with Rheumatoid Arthritis

BackgroundThe RAID is a patient reported outcome (PRO) measure evaluating the impact of rheumatoid arthritis (RA) on patients' quality of life. It comprises 7 domains (pain, function, fatigue, physical and...

AB0288 Rheumatoid Arthritis Impact Disease (RAID) among Moroccan Patients

ObjectivesScore distributions and associations between the RAID score and RA demographic and disease related variables were examined in rheumatoid arthritis (RA) patients.Methods103 patients diagnosed were enrolled in the study. Disease...

AB0222 Comparison of Rheumatoid Arthritis Impact Disease (RAID) and Composite Indexes for the Evaluation of the Activity in the Daily Care in Rheumatoid Arthritis

ObjectivesTo evaluate the correlation between the questionnaire of impact of Rheumatoid Arthritis (RAID: Rheumatoid Arthritis Impact Disease) and questionnaires for assessing disease activity judged by patient (RAPID-3: Routine Assessment of...

THU0237 Transcultural Adaptation and Validation of the Arabic Version of the Self-Assessment Questionnaire Impact of Rheumatoid Arthritis: Rheumatoid Arthritis Impact of Disease

ObjectivesTranslate, adapt and validate self-administered questionnaire: RAID (Rheumatoid Arthritis Impact Disease).MethodsA cross sectional studyin patientswith rheumatoid arthritis according to the2010 ACR/EULAR criteria was conducted. A translation-adaptation ofRAIDin classical Arabic was...

AB0324 Physical Activity in Patients with Rheumatoid Arthritis

ObjectivesThe purpose of this study was to identify physical activity behaviors of Moroccan patients with RA and her associations with RA demographic and disease related variables.MethodsA cross sectional study was...

FRI0078 European Pilot Study on Vitamin D Serum Levels and Disease Activity in Rheumatoid Arthritis Patients

BackgroundSeveral studies have demonstrated low 25(OH)D3 serum levels, which could influence pathogenesis and clinical outcomes of immune-mediated diseases such as rheumatoid arthritis (RA) (1,2).ObjectivesIn order to investigate the necessity to...

SAT0384 Rheumatoid arthritis impact of disease (RAID) score is not associated to synovitis in joints and tendons assessed by ultrasonography; results from cross-sectional and longitudinal analyses

BackgroundUltrasonography (US) detects grey scale synovitis (GS) and vascularization (by use of power Doppler (PD)) in patients with rheumatoid arthritis (RA). Rheumatoid Arthritis Impact of Disease (RAID) score is a...

FRI0161 Raid is highly sensitive to change and is associated to DAS28 in follow-up of patients with ra starting treatment with anti-TNF alpha therapy

BackgroundThe Rheumatoid Arthritis (RA) Impact of Disease (RAID) score includes questions regarding pain, functional capacity, fatigue, physical and emotional wellbeing, quality of sleep and coping, and by use of an...

THU0157 Comprehensive Ultrasound Assessments are Closely Related to Clinical Evaluations of Inflammatory Activity but not with the Patient Developed Raid Questionnaire in RA Patients on Biologic Treatment

BackgroundUltrasound (US) (grey scale (GS) and power Doppler (PD)) is sensitive for scoring of synovitis in patients with rheumatoid arthritis (RA). The RA Impact of Disease (RAID) score is a...