Self-reported Disease Activity Research Articles

Cognitive behavioural therapy for the management of inflammatory bowel disease-fatigue with a nested qualitative element: study protocol for a randomised controlled trial

BackgroundFatigue is one of the most prevalent and burdensome symptoms for patients with inflammatory bowel disease (IBD). Although fatigue increases during periods of inflammation, for some patients it persists when disease is in remission. Compared to other long-term conditions where fatigue has been extensively researched, optimal management of fatigue in patients with IBD is unknown and fatigue has rarely been the primary outcome in intervention studies. To date, interventions for the management of IBD-fatigue are sparse, have short-term effects and have not been implemented within the existing health system. There is a need to integrate current best evidence across different conditions, patient experience and clinical expertise in order to develop interventions for IBD-fatigue management that are feasible and effective. Modifying an existing intervention for patients with multiple sclerosis, this study aims to assess the feasibility and initial estimates of efficacy of a cognitive behavioural therapy (CBT) intervention for the management of fatigue in patients with IBD.MethodsThe study will be a two-arm pilot randomised controlled trial. Patients will be recruited from one outpatient IBD clinic and randomised individually to either: Group 1 (CBT manual for the management of fatigue, one 60-min session and seven 30-min telephone/Skype sessions with a therapist over an eight-week period); or Group 2 (fatigue information sheet to use without therapist help). Self-reported IBD-fatigue (Inflammatory Bowel Disease-Fatigue Scale) and IBD-quality of life (United Kingdom Inflammatory Bowel Disease Questionnaire) and self-reported disease activity will be collected at baseline, three, six and 12 months post randomisation. Illness perceptions, daytime sleepiness, anxiety and depression explanatory variables will be collected only at three months post randomisation. Clinical and sociodemographic data will be retrieved from the patients’ medical notes. A nested qualitative study will evaluate patient and therapist experience, and healthcare professionals’ perceptions of the intervention.DiscussionThe study will provide evidence of the feasibility and initial estimates of efficacy of a CBT intervention for the management of fatigue in patients with IBD. Quantitative and qualitative findings from the study will contribute to the development and implementation of a large-scale randomised controlled trial assessing the efficacy of CBT interventions for IBD-fatigue.Trial registrationISRCTN Registry, ISRCTN17917944. Registered on 2 September 2016.

Is frailty a relevant concept in SLE?

ObjectiveIn geriatric populations, frailty is associated with poor health outcomes, including mortality. Frailty has not been examined in lupus, although components of the phenotype seem relevant.MethodsWomen with lupus (n=152) participated...

Fluctuations in patient reported disease activity, pain and global being in patients with ankylosing spondylitis.

To evaluate in patients with AS (i) the fluctuation in self-reported disease activity (BASDAI), patient global well-being [visual analogue scale (VAS)-global] and spinal pain (VAS-pain) during 2 years of follow-up on a group level and (ii) the clinical relevance of these fluctuations on a patient level. Dutch patients from the Outcome in AS International Study cohort completed patient-reported outcome measures every 2 months over 2 years. On the group level, mixed linear models were used to analyse whether the outcome measures were constant over time. On a patient level, relevant changes in scores were assessed by the frequency in which changes would exceed predefined cut-off values (>1.0 or >2.0 on a 0-10 scale) during the 2 years of follow-up using 2-, 4-, 6-, 12- or 24-month assessments. Ninety patients [median age 47.3 years (sd 11.4), 67.8% male, symptom duration 25.2 years (sd 11.3)] were included. On the group level, the outcome measures remained constant over time. However, large fluctuations were found on the patient level. For example, using 2 month intervals, 92% and 69% of the patients had at least one change of > 1.0 or > 2.0, respectively, in the BASDAI during the 2 year follow-up. When prolonging the interval, the proportion of changes exceeding the cut-off decreased, indicating that information is lost. Similar results were found for the VAS-global and VAS-pain. Substantial fluctuations in BASDAI, VAS-global and VAS-pain were found in individuals over time. With longer intervals, fewer fluctuations were observed, indicating that relevant changes might be missed.

Patient-Reported Outcomes Measurement Information System in Children with Crohn's Disease

To assess the criterion validity and responsiveness of Patient-Reported Outcomes Measurement Information System (PROMIS) in a web-based cohort of children with Crohn's disease. We recruited children with Crohn's disease (ages 9-17 years) and their parents from the web-based Crohn's and Colitis Foundation of America Kids and Teens Study cohort. Upon entry into the cohort and 6months later, children self-reported Crohn's disease activity, health-related quality of life, and PROMIS domains of pain interference, anxiety, depression, fatigue, and peer relationships. Mean PROMIS scores for the 276 participating patients were worse among those with worse self-reported Crohn's disease activity (per Short Crohn's Disease Activity Index, P<.005 for all), Crohn's disease activity in the prior 6months (per Manitoba Index, P<.01 for all), and health-related quality of life (per IMPACT-35, P<.001 for all). One hundred forty-three patients and their parents completed follow-up questionnaires, 75% of whom reported stable disease activity. Those with improved Crohn's disease activity reported improved PROMIS scores, and those with worsened Crohn's disease activity reported worse PROMIS scores for all domains except anxiety. All participants reported improved anxiety from baseline, but those with stable or worsened Crohn's disease activity reported less improvement (P=.07). PROMIS scores were significantly associated with Crohn's disease activity in a linear and clinically meaningful manner, and responded to change in Crohn's disease activity over a 6-month period. This supports the criterion validity and responsiveness of pediatric PROMIS.

Work Outcome in Patients With Ankylosing Spondylitis: Results From a 12-Year Followup of an International Study.

To understand the impact of ankylosing spondylitis (AS) on work disability (WD) over 12 years compared with the general population, and explore factors predicting adverse work outcome, defined as new partial WD or reduction in working hours. Source of data was the Outcome Assessments in Ankylosing Spondylitis International Study, which includes patients from The Netherlands, France, and Belgium. Standardized WD rates over time compared to the general population were calculated using indirect standardization (Dutch patients only). Cox survival analyses identified baseline predictors as well as time-varying factors influencing adverse work outcome over 12 years. Of 215 patients, 55 (26%) were full WD at baseline and 139 (65%) were at risk for adverse work outcome during followup. When compared to the general population, WD over 12 years continued to be increased in Dutch men (incidence rate [IR] 2.9 [95% confidence interval (95% CI) 1.2, 4.6]), but less clearly for women (IR 1.2 [95% CI -0.4, 2.9]). Within the entire sample, baseline predictors of adverse work outcome over 12 years were residence in The Netherlands (versus France or Belgium) (hazard ratio [HR] 3.4 [95% CI 1.4, 8.4]) and worse Bath Ankylosing Spondylitis Functional Index (BASFI) (HR 1.2 [95% CI 1.0, 1.4]). Time-varying predictors over 12 years were residence in The Netherlands, uveitis, and either BASFI or Bath Ankylosing Spondylitis Disease Activity Index with age and inflammatory bowel disease. Although WD was already prevalent at inclusion in the cohort, a substantial proportion of patients incurred further adverse work outcome over 12 years. In addition to country of residence, uveitis, age, and self-reported physical function or disease activity predicted long-term adverse work outcome.

Upswings in Cheerful Mood and Disease Activity in Patients with Rheumatoid Arthritis.

The influence of a cheerful mood on disease activity levels in rheumatoid arthritis is investigated in this cross-sectional study. State cheerfulness (i.e., how individuals feel at the time of the assessment) and trait cheerfulness (i.e., how individuals usually feel) were assessed at the same time as the clinical indicators of disease activity and just before measuring patient-reported disease activity with the Disease Activity Score-28 (DAS-28). State cheerfulness contributed significantly to the variance in the DAS-28 scores that was not accounted for by trait cheerfulness or demographic or clinical variables. Higher state cheerfulness was associated with lower values of self-reported disease activity and C-reactive protein. The patient-reported disease activity was not uniquely caused by the clinical indicators of disease, but it also depended on patients' cheerful mood at the moment of assessment. The findings suggest interesting possibilities for the diagnosis and monitoring of disease activity in rheumatoid arthritis.

Role of Sleep Disturbance, Depression, Obesity, and Physical Inactivity in Fatigue in Rheumatoid Arthritis

Fatigue is a major concern for individuals with rheumatoid arthritis (RA). However, in order to treat fatigue adequately, its sources need to be identified. Data were collected during a single home visit (number of participants = 158). All participants had physician-diagnosed RA. Assessments of self-reported sleep quality, depression, physical activity, RA disease activity, muscle strength, functional limitations, and body composition were made. Information on demographics, medications, and smoking was collected. The Fatigue Severity Inventory (FSI; measuring average fatigue over the past 7 days) was used as the primary outcome. Analyses were first conducted to evaluate bivariate relationships with fatigue. Correlations among risk factors were examined. Multivariate analyses identified independent predictors of fatigue. The mean ± SD age was 59 ± 11 years, the mean ± SD disease duration was 21 ± 13 years, and 85% of subjects were female. The mean ± SD FSI rating was 3.8 ± 2.0 (range 0-10). In multivariate analyses, self-reported disease activity, poor sleep, depression, and obesity were independently associated with fatigue. Physical inactivity was correlated with poor sleep, depression, and obesity. Mediation analyses indicated that physical inactivity had an indirect association with fatigue, mediated by poor sleep, depression, and obesity. This cross-sectional study suggests that fatigue may not be solely a result of RA disease activity, but may result from a constellation of factors that includes RA disease activity or pain, but also includes inactivity, depression, obesity, and poor sleep. The results suggest new avenues for interventions to improve fatigue in individuals with RA, such as increasing physical activity or addressing depression or obesity.

Job Accommodations Availability and Utilization Among People With Lupus: An Examination of Workplace Activity Limitations and Work Context Factors.

The aim of this study was to examine the availability of diverse job accommodations (or flexible working arrangements) and to describe their use among people with systemic lupus erythematosus (lupus), as well as to examine factors associated with the use of job accommodations. A mail survey was sent to adult lupus patients receiving care from a lupus clinic based in Toronto, Canada. The survey assessed demographic information, self-reported disease activity, work history, workplace activity limitations, job strain, and the availability and use of job accommodations. Standard multivariable linear regression analysis was used to examine factors associated with the use of job accommodations. We received 362 responses of 604 mailed surveys (60% response rate). Participants who were employed within the last 5 years, but who were not currently working, were less likely than currently employed participants to report having had job accommodations available to them at their last place of employment. The use of job accommodations was reported by 70% of currently employed respondents and by 72% of those not currently employed. The most common job accommodation used was sick leave days. Factors positively associated with the use of job accommodations among those who were employed included higher levels of education, being diagnosed with fibromyalgia, at least 1 episode of short-term work disability, not belonging to a union, greater workplace activity limitations, and greater job strain. The use of job accommodations among people with lupus is common. Work context factors, such as workplace activity limitations and job strain, are the main factors associated with the use of job accommodations.

Gender-attributable differences in outcome of ankylosing spondylitis: long-term results from the Outcome in Ankylosing Spondylitis International Study.

To investigate gender-attributable differences regarding clinical outcome [disease activity, physical function and quality of life (QoL)] and radiographic damage in patients with AS over time. Data from the Outcome in AS International Study were used. Disease activity was assessed by the BASDAI, ASDAS and CRP; physical function by BASFI; QoL by the Short Form-36, Ankylosing Spondylitis Quality of Life (ASQoL) score and European Quality Of Life scale; and radiographic damage by the modified Stoke AS Spine Score (mSASSS). Cross-sectional comparative analyses were done at baseline. Next, separate models were created to assess gender-attributable differences on each outcome measure over time using time-adjusted generalized estimating equations. A total of 216 patients [154 (72.3%) males, mean age 43.6 years (s.d. 12.7), symptom duration 20.5 years (s.d. 11.8), mean follow-up duration 8.3 years (s.d. 4.1)] were included. At baseline, male compared with female patients had lower self-reported disease activity (BASDAI 3.2 vs 3.9, P = 0.03) but more radiographic damage (mSASSS 13.8 vs 6.5, P = 0.02). No significant gender-attributable differences in other clinical parameters were found. In multivariable analysis, male gender was significantly associated with a better ASQoL (B = -1.18, 95% CI: -2.17, -0.20, P = 0.02), and in a separate model with a higher mSASSS over time (B = 8.24, 95% CI: 4.38, 12.09, P < 0.01). In this prospective cohort study, no gender-attributable differences in disease activity or physical function over time were found. However, radiographic damage was more severe in males. Furthermore, males had a better QoL over time.

PWE-054 Independent validation of the ibd-control questionnaire: results from a large-scale electronic patient experience survey (ibd2020)

Introduction The IBD-Control Questionnaire is a self-completed patient reported outcome measure developed to rapidly capture disease control from the patient perspective.1Eight of the question items generate a summary score (IBD-Control-8) ranging from 0 (worst control) to 16 (best control). We aimed to evaluate the feasibility of capturing the items electronically (rather than on paper) and to validate their measurement properties independently within the setting of a large-scale UK patient experience survey. Method The IBD2020 survey was an electronic (online) questionnaire of patient experiences of healthcare across Europe, promoted in the UK by the national charity, Crohn’s and Colitis UK. The survey included items about sociodemographics, disease type, treatments, self-reported disease activity (last 3 months), relapse status (last 12 months), disease impact and a wide range of questions about care experiences. The IBD-Control-8 questions were incorporated into the UK survey, allowing an opportunity to validate its performance. Results 818 UK patients completed the survey (Female n = 611; Under 30 years, n = 259; 30–44 yrs n = 352; 45–59 yrs 1n=42, 60 yrs plus n = 45; CD n = 483; Previous surgery n = 275; Current stoma n = 69). Self-reported disease activity in last 3 months: Remission 10.8%, Minimal 21.1%, Mildly 28.0%, Moderately 22.1%, Severely 8.7%, Missing 9.3%. 701/818 (85.7%) completed all IBD-Control-8 questions, (mean score [sd]: 7.3 [4.9]; range: 0–16). Internal consistency was strong (Cronbach’s alpha: 0.82). Construct validity of IBD-Control-8 was confirmed by: (a) moderately strong negative correlation (Spearman’s rho values) with ‘Disease Activity In Last 3 months’ (Overall -0.68; CD -0.67; UC -0.66; Post-surgery -0.65) and ‘Number of Relapses in Last 12 months’ (Overall -0.61; CD -0.59; UC -0.60; Post-surgery -0.58) and (b) Significantly higher mean [sd] scores for remission versus any level of disease activity (13.1 [3.1] versus 6.4 [4.5]; p < 0.001). Utility of IBD-Control-8 as a screening test to identify ‘quiescent’ patients (score of 13+) was confirmed (specificity: 88.2% versus self-reported ‘remission’ status; 95% versus remission or minimal activity). Conclusion The IBD-Control-8 items from the IBD-Control Questionnaire are well suited to large-scale electronic surveys, with excellent completion rates within a lengthy patient experience survey. This study provides independent confirmation of its previously reported psychometric properties in a large cohort of UK patients. Disclosure of interest None Declared. Reference 1. Bodger, et al . Gut. 2014;63(7):1092–102

인공신경망 분석과 결정트리 융합에 의한 금연 프로그램 참여 결정 요인

The purpose of this study was to analyze the factors that affects the participating in a smoking cessation program. Data were from the A Study on the Seoul Welfare Panel Study 2010. Subjects were 1,326 smokers aged 19 and older living in the community. Dependent variable was defined as experience of smoking cessation. Explanatory variables were included as age, gender, level of education, employment status, household income, marital status, drinking, self-reported health status, depression, disease, and physical activity. A prediction model was developed by the use of a Decision Tree and Neural Network Algorithm. In the Prediction model, self reported health status, disease, income, household income were significantly associated with participating in a smoking cessation program. Based this study, systematic education and development of programs are required.

172. Development and Psychometric Testing of a British English Version of the Disabilities Arm Shoulder and Hand Questionnaire

Background: The DASH (developed in Canada) is a widely used outcome measure for upper limb conditions, consisting of 30 items: 21 regarding daily activity and 9 regarding impact of condition. The aim of this study was to develop a British English DASH and psychometrically test it in a UK population of people with rheumatoid arthritis (RA). Methods: The Institute of Work and Health (IWH) cross-cultural adaptation methods were followed: forward translation to British English; synthesis; expert review of equivalence and cognitive debriefing. Psychometric testing included internal consistency (Cronbach’s alpha); test-retest reliability (ICC(2,1), and concurrent validity (Pearson/Spearman Correlations). Adults with RA were recruited from 17 Rheumatology out-patient departments, who completed two test booklets three weeks apart, including the DASH, Health Assessment Questionnaire (HAQ20), SF36v2 and numeric rating scales for disease activity, hand pain, general pain and fatigue. Results: During translation and equivalence review, changes to use plain English and British English terminology were made (eg “do” not “perform”; jumper rather than pullover sweater). 31 people with RA were interviewed (age=63.42 (SD12.04) years, RA duration= 15.71(SD12.61) years). All DASH items were considered understandable and relevant. 340 completed the test 1 booklet: 251 women, 89 men; mean age = 62 (SD12); RA duration=14.44 (SD11.73); average pain score = 5 (IQR 2-7) and 273 completed the re-test. Reliability was good: alpha =0.98; ICC(2,1) = 0.98 (95% CI 0.97, 0.98). Linear weighted kappa coefficients were mostly good (i.e. 0.61 - 0.77) for the activity items (Q1-21), although one (Q17) was marginally lower at 0.58. Coefficients for the symptom/self-image items (Q22-30) were generally lower and mostly moderate, ranging from 0.50 - 0.66. DASH concurrent validity was strong: HAQ20 rs = 0.91; SF36v2 Physical Function r=-0.84; SF36v2 Bodily Pain r = -0.71; hand pain r = 0.75; pain r = 0.70; fatigue r=0.64. The DASH discriminated between good, moderate and poor self-reported disease activity (p=0.001). The MDC95 DASH score = 9.26. There were no floor and ceiling effects. Conclusion: The British English version of the DASH required some modifications, but then was deemed appropriate by people with RA in the UK. It had good reliability and validity. A British English DASH is available for the first time. Results were comparable to DASH studies in RA in other countries.

P-138 Complementary and Alternative Medicine Use in Children with Inflammatory Bowel Diseases

The prevalence of children diagnosed with inflammatory bowel diseases (IBD) has increased over the past few decades. There also is increasing recognition of interest in complementary and alternative medicine (CAM) in patients with chronic diseases, although practitioner and patient definitions of CAM can be variable. Therefore, the aim of our study was to determine how families of pediatric IBD patients use and define CAM. We approached families of IBD patients ages 2–18 years receiving medical care from Nationwide Children's Hospital (NCH) Division of Gastroenterology in July 2014 during a clinic visit and asked them to complete a questionnaire. Questions were organized into the following categories: demographic and disease information; medications and therapies; interest in and attitudes towards CAM; and perceptions of healthcare providers with regards to CAM. CAM was defined as non-pharmaceutical therapy. Enteral therapy, an accepted therapeutic approach in Crohn's disease, was not included in our definition, while multivitamins, probiotics, and prayer were included. Statistical analyses were provided by the Biostatistics core (NCH Research Institute). The research protocol was approved by the NCH Research Institute Institutional Review Board. The questionnaire was completed by 104 patients (mean age 13.86 years ± 3.11 yrs; range 5–18 yrs). The majority of patients had Crohn's disease (75%); 19% had ulcerative colitis and 6% had indeterminate colitis. Patients used an average of 3.09 ± 1.29 medications. All respondents (100%) reported use of 1 or more CAM therapies as defined by our questionnaire, although only 23% considered any of these therapies to be CAM by their own definition. Patients who reported side effects from conventional medications were more likely to implement changes in diet (P = 0.001), seek care from an alternative medicine professional (P = 0.02), and to be interested in learning more about CAM (P = 0.01). Patients with self-reported moderate or severe disease activity were more likely than patients with mild or quiescent disease activity to be interested in CAM (P = 0.002). The most commonly reported CAM therapies were vitamins/supplements (97%), stress management techniques (61%), and dietary changes (57%). There were no significant differences in CAM utilization or interest by disease type. The majority of patients reported that their physicians had a neutral (68%) or positive (29%) impact on their decision to use or not use CAM. Furthermore, 77% of families reported at least some interest in learning more about CAM. Thirty-three percent felt uninformed about CAM versus 15% feeling sufficiently informed. Interest in, and use of, CAM therapies by children at the NCH IBD center is high, particularly by patients with more severe disease and those who report more medication side effects. Our study is unique in that it analyzed CAM use according to different categories, and questioned patients about the impact and knowledge of their GI providers in regards to CAM use. Improved understanding of family and patient interest in CAM could facilitate important discussion between patients and practitioners about ways to treat IBD symptoms. Additional research is necessary to understand what more pediatric specialists can offer patients and families on this topic.

Positive and negative affective states and disease activity in ankylosing spondylitis.

The aim of the study was to explore the influence of psychological affective states such as cheerfulness and bad mood on self-reported disease activity in patients with ankylosing spondylitis (AS) while controlling for demographic and clinical variables. Patients attending a biological therapy unit were selected for a cross-sectional study if they met the criteria for AS and were already receiving treatment. Their psychological affective state was assessed with the state version of the State-Trait Cheerfulness Inventory. Clinical variables included were patient-reported disease activity using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and acute-phase reactants. We performed univariate and multivariate analyses to verify the robustness of the relationship between psychological affective states and disease activity. We also explored whether disease activity, measured either by self-report or by acute-phase reactants, was influenced by patient's overall affective state. In the recruited 31 patients with AS, overall affective state contributed significantly to the variance in BASDAI scores, adding 21.8% to the overall R-square of the predictive power of clinical and demographic variables (combined R-square = 17%). A higher positive affective state was associated with lower values of C-reactive protein (p < 0.05). Results of a bootstrapping procedure showed that the relationship between C-reactive protein levels and BASDAI scores was mediated by overall affective state. In patients with AS, affective state can induce variability in self-reported disease activity. Patients' overall affective state can explain the relationship between acute-phase reactants and self-reported scores. These findings suggest interesting possibilities for the monitoring of disease activity in AS.

Elevated C-reactive protein and self-reported disease activity in systemic lupus erythematosus.

C-reactive protein (CRP), a biomarker of inflammation, has been associated with increased disease activity in rheumatoid arthritis. However, the association in systemic lupus erythematosus (SLE) remains unclear. We examined the association of CRP with self-reported disease activity in the Carolina Lupus Study and described differences by sociodemographic characteristics. The study included baseline and three-year follow-up data on 107 African-American and 69 Caucasian SLE patients enrolled at a median 13 months since diagnosis. Models estimated prevalence differences in the association of baseline CRP with self-reported flares, adjusting for age, sex, race and education. Active disease or flare was reported by 59% at baseline and 58% at follow-up. Higher CRP (>10 µg/ml vs. <3 µg/ml) was associated with a 17% (95% confidence interval (CI): -20, 53%) higher prevalence of flare at baseline and a 26% (95% CI: -9, 62%) higher prevalence of flare at follow-up. These CRP-flare associations were notably stronger in patients with lower education at baseline and in African-Americans at follow-up. These findings suggest that CRP may be a useful marker in studies of SLE health disparities.

Comparative efficacy of biologics as monotherapy and in combination with methotrexate on patient reported outcomes (PROs) in rheumatoid arthritis patients with an inadequate response to conventional DMARDs--a systematic review and network meta-analysis.

ObjectiveTo compare biologics as monotherapy or in combination with methotrexate (MTX) in terms of patient reported outcomes (PROs) in RA patients with an inadequate response to conventional DMARDs (DMARD-IR).MethodsWith a systematic literature review 17 RCTs were identified that evaluated adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, abatacept, anakinra or tocilizumab. Treatment effects in terms of pain (0-100 mm), patient’s global assessment of disease activity (PGA; 0-100 mm), Health Assessment-Questionnaire (HAQ) disability index (DI; 0–3), and the physical component summary (PCS) of the SF36 Health Survey (0–100) at 24 weeks were combined by means of Bayesian network meta-analyses.ResultsWith tocilizumab monotherapy, greater improvements in pain (difference = -11.1; (95% Credible Interval -21.3, -0.1)) and PGA (-10.3 (-20.4, 0.8)) were observed than with aTNF monotherapy. Tocilizumab was at least as efficacious as aTNF in HAQ-DI improvements (-0.16; (-0.37, 0.05)). aTNF + MTX (-17.9 (-23.1, -13.0) & -19.1 (-24.2, -14.4)), abatacept + MTX (-23.0 (-47.3, 1. 5) & -13.6 (-28.4, 2.0)) and tocilizumab + MTX (-16.0 (-26.3, -6.3) & -15.1 (-25.1, -5.7)) showed comparable reductions in pain and PGA relative to MTX. Efficacy of anakinra + MTX was much smaller as compared to other biologics. The greatest improvements in HAQ-DI relative to MTX were observed with aTNF + MTX (-0.30 (-0.37, -0.22)) and tocilizumab + MTX (-0.27 (-0.42, -0.12)), followed by abatacept + MTX (-0.21 (-0.37, -0.05)) and anakinra + MTX (-0.11 (-0.26, 0.05)). The improvements in SF36-PCS with abatacept + MTX, aTNF + MTX and tocilizumab + MTX were comparable. There is a >90% probability that aTNF + MTX results in a greater improvement in pain (-12.4), PGA (-16.1) and HAQ-DI (-0.21) than aTNF as monotherapy. Efficacy of tocilizumab + MTX showed comparable improvements in PROs as tocilizumab monotherapy.ConclusionsBased on a network meta-analysis involving indirect comparison of trial findings, the following observations were made for DMARD-IR patients. In monotherapy, tocilizumab was associated with a greater improvement in pain and self-reported disease activity than aTNF, and was at least as efficacious regarding functional ability. The improvements in PROs with aTNF, abatacept and tocilizumab in combination with MTX were comparable. Improvements in PROs with tocilizumab as monotherapy were similar to that of tocilizumab + MTX, whereas aTNF as monotherapy was likely to be less efficacious than aTNF + MTX.

Physical Activity Assessment in Patients with Axial Spondyloarthritis Compared to Healthy Controls: A Technology-Based Approach

IntroductionTraditionally, assessment in axial Spondyloarthritis (aSpA) includes the evaluation of the capacity to execute tasks, conceptualized as physical function. The role of physical activity, defined as movement-related energy expenditure, is largely unknown and almost exclusively studied using patient-reported outcome measures. The aims of this observational cross-sectional study are to compare physical activity between patients with aSpA and healthy controls (HC) and to evaluate the contribution of disease activity to physical activity differences between groups.MethodsForty patients with aSpA were matched by age, gender, period of data acquisition in terms of days and season to 40 HC. Physical activity was measured during five consecutive days (three weekdays and two weekend days) using ambulatory monitoring (SenseWear Armband). Self-reported disease activity was measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Differences in physical activity between patients with aSpA and HC were examined with Wilcoxon signed-rank tests and a mixed linear model. Difference scores between patients and HC were correlated with disease activity.ResultsAverage weekly physical activity level (Med(IQR); HC:1.54(1.41–1.73); aSpA:1.45(1.31–1.67),MET) and energy expenditure (HC:36.40(33.43–41.01); aSpA:34.55(31.08–39.41),MET.hrs/day) were significantly lower in patients with aSpA. Analyses across intensity levels revealed no significant differences between groups for inactivity and time spent at light or moderate physical activities. In contrast, weekly averages of vigorous (HC:4.02(1.20–12.60); aSpA:0.00(0.00–1.20),min/d), very vigorous physical activities (HC0.00(0.00–1.08); aSpA:0.00(0.00–0.00),mind/d) and moderate/(very)vigorous combined (HC2.41(1.62–3.48); aSpA:1.63(1.20–2.82),hrs/d) were significantly lower in patients with aSpA. Disease activity did not interact with differences in physical activity between patients with aSpA and HC, evidenced by non-significant and very low correlations (range: −0.06–0.17) between BASDAI and HC-aSpA patients' difference scores.ConclusionsPatients with aSpA exhibit lower physical activity compared to HC and these differences are independent of self-reported disease activity. Further research on PA in patients with aSpA should be prioritized.

Elevated C-reactive protein and self-reported disease activity in systemic lupus erythematosus

Elevated C-reactive protein and self-reported disease activity in systemic lupus erythematosus

Tumor Necrosis Factor α Inhibition in Radiographic and Nonradiographic Axial Spondyloarthritis: Results From a Large Observational Cohort

To evaluate the baseline characteristics of patients with radiographic axial spondyloarthritis (SpA; ankylosing spondylitis [AS]) and patients with nonradiographic axial SpA, to investigate determinants of anti-tumor necrosis factor (anti-TNF) agent prescription on the background of a nonrestrictive reimbursement policy, and to assess the response to TNF inhibition. We compared the characteristics of radiographic axial SpA and nonradiographic axial SpA in 1,070 patients from the Swiss Clinical Quality Management (SCQM) Cohort who fulfilled the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial SpA. By taking advantage of the situation that patients who are eligible for anti-TNF treatment are preferentially enrolled in the SCQM Cohort for patients with AS/axial SpA, we explored parameters leading to the initiation of anti-TNF treatment in single and multiple regression models and assessed treatment responses. We confirmed a similar burden of disease (as determined by self-reported disease activity, impaired function, and quality of life) in patients with nonradiographic axial SpA (n = 232) and those with radiographic axial SpA (n = 838). Patients with radiographic axial SpA had higher median levels of acute-phase reactants and higher median AS Disease Activity Scores (ASDAS; 3.2 versus 3.0). Anti-TNF treatment was initiated in 363 patients with radiographic axial SpA and 102 patients with nonradiographic axial SpA, preferentially in those with sacroiliitis on magnetic resonance imaging, peripheral arthritis, a higher C-reactive protein (CRP) level, a higher ASDAS, and a higher Bath Ankylosing Spondylitis Disease Activity Index level. The ASAS criteria for 40% improvement responses at 1 year were higher in patients with radiographic axial SpA compared with those with nonradiographic axial SpA (48.1% versus 29.6%; odds ratio [OR] 2.2, 95% confidence interval [95% CI] 1.12-4.46, P = 0.02). The difference was smaller in the subgroups of patients with elevated baseline CRP levels (51.6% in patients with radiographic axial SpA versus 38.5% in those with nonradiographic axial SpA; OR 1.7, 95% CI 0.68-4.48, P = 0.29). The indications for treatment with anti-TNF agents were comparable for patients with radiographic axial SpA and those with nonradiographic axial SpA. With the exception of patients with elevated CRP levels at baseline, higher rates of response to TNF inhibition were achieved in the group of patients with radiographic axial SpA than in the group with nonradiographic axial SpA.

Alcohol consumption is associated with lower self-reported disease activity and better health-related quality of life in female rheumatoid arthritis patients in Sweden: data from BARFOT, a multicenter study on early RA

BackgroundEarlier studies have found a positive effect of alcohol consumption, with a reduced disease activity in rheumatoid arthritis (RA). The aim of this study was to assess alcohol consumption and its association with disease activity and health related quality of life (HRQL) in Swedish RA patients.MethodsBetween 1992 and 2005, 2,800 adult patients were included in the BARFOT study of early RA in Sweden. In 2010 a self-completion postal questionnaire was sent to all 2,102 prevalent patients in the BARFOT study enquiring about disease severity, HRQL, and lifestyle factors. Alcohol consumption was assessed using the validated AUDIT-C questionnaire.ResultsA total of 1,238 out of 1,460 patients answering the questionnaire had data on alcohol consumption: 11% were non-drinkers, 67% had a non-hazardous drinking, and 21% were classified as hazardous drinkers. Women who drank alcohol reported lower disease activity and better HRQL, but there were no association between alcohol consumption and disease activity in men. For current smokers, alcohol use was only associated with fewer patient-reported swollen joints. The outcome was not affected by kind of alcohol consumed.ConclusionsThere was an association between alcohol consumption and both lower self-reported disease activity and higher HRQL in female, but not in male, RA patients.