Search

Objective To investigate the effect of pharmacological treatment of SpA on depressive symptoms and explore whether this effect differs between drug classes. Methods Data from the observational Assessment of SpondyloArthritis international Society Health Index Validation Study were used. Patients were assessed at baseline and after initiation of NSAIDs/conventional synthetic DMARDs (csDMARDs)/TNF inhibitors (TNFis). Depressive symptoms were assessed with the Hospital Anxiety and Depression Scale depression subscale [HADS-D; 0–21 (best–worst)]. Covariables included demographics and disease characteristics, including disease activity [Ankylosing Spondylitis Disease Activity Score (ASDAS)/BASDAI]. The change in HADS-D from baseline was compared between treatments (NSAIDs/csDMARDs/TNFis) with analysis of variance and multivariable regression analysis. Results A total of 304 patients were included; 102/45/157 initiated NSAIDs/csDMARDs/TNFis and 260 (85%) / 44 (15%) had axial/peripheral SpA. At baseline, the mean HADS-D was 6.9 (s.d. 4.2); 126 (42%) were possibly depressed (HADS-D ≥8) and 66 (22%) were probably depressed (HADS-D ≥11). At follow-up, depressive symptoms significantly improved in all treatment groups. In multivariable regression without disease activity measures, initiating TNFis compared with NSAIDs was associated with greater improvement in depressive symptoms [β = −1.27 (95% CI −2.23, −0.32)] and lower odds of possible depression at follow-up [odds ratio 0.47 (95% CI 0.23, 0.94)]. This association was attenuated after additional adjustment for disease activity (ASDAS/BASDAI) but not CRP. csDMARDs did not differ from NSAIDs regarding their effect on HADS-D. Between-drug class results were confirmed in axial SpA (axSpA), although less clear in peripheral SpA. Conclusion Treatment of active SpA also improves depressive symptoms. Especially in axSpA, TNFis have a greater effect than NSAIDs, which is mainly explained by a stronger effect on disease activity. We found no evidence for a direct link between CRP-mediated inflammation and depressive symptoms in SpA.

Objectives This study aimed to (i) investigate actual work participation in Belgian spondyloarthritis (SpA) patients compared with the general population, and (ii) identify determinants of work-related outcomes. Material and methods Adult SpA patients from the Ghent University Hospital based Be-GIANT cohort (fulfilling ASAS classification criteria) were cross-sectionally questioned on their socio-economic status and completed a Work Productivity and Activity Impairment questionnaire (May 2018 to May 2019). Results were compared with national and regional data on the general population using indirect standardization. Associations between clinical and job characteristics and work-related outcomes were analysed with logistic regression (having a paid job) and negative binomial hurdle models (sick leave and presenteeism, i.e. restrictions while at work). Results A total of 215/262 (82%) patients of working age ( Conclusions Evidence from this academic cohort study does not support a work participation gap between SpA patients and the general population, but confirms the role of physical function, overall HRQoL, and education or job type as risk factors for adverse work outcomes.

Objective To describe the development of an Environmental contextual factors (EF) Item Set (EFIS) accompanying the disease specific Assessment of SpondyloArthritis international Society Health Index (ASAS HI). Method First, a candidate item pool was developed by linking items from existing questionnaires to 13 EF previously selected for the International Classification of Functioning, Disability and Health (ICF) /ASAS Core Set. Second, using data from two international surveys, which contained the EF item pool as well as the items from the ASAS HI, the number of EF items was reduced based on the correlation between the item and the ASAS HI sum score combined with expert opinion. Third, the final English EFIS was translated into 15 languages and cross-culturally validated. Results The initial item pool contained 53 EF addressing four ICF EF chapters: products and technology (e1), support and relationship (e3), attitudes (e4) and health services (e5). Based on 1754 responses of axial spondyloarthritis patients in an international survey, 44 of 53 initial items were removed based on low correlations to the ASAS HI or redundancy combined with expert opinion. Nine items of the initial item pool (range correlation 0.21–0.49) form the final EFIS. The EFIS was translated into 15 languages and field tested in 24 countries. Conclusions An EFIS is available complementing the ASAS HI and helps to interpret the ASAS HI results by gaining an understanding of the interaction between a health condition and contextual factors. The EFIS emphasizes the importance of support and relationships, as well as attitudes of the patient and health services in relation to self-reported health.

Objectives To evaluate the extent to which internationally agreed treat-to-target recommendations were applied in clinical practice in patients with axial spondyloarthritis. Methods Data were used from a web-based patient registry for monitoring SpA in daily practice in the Netherlands. The extent to which treat-to-target was applied was evaluated through four indicators: the proportion of patients (i) with ≥1 Ankylosing Spondylitis Disease Activity Score (ASDAS) assessed during a 1-year period, (ii) having inactive disease/low disease activity (i.e. ASDAS Results In 185 out of 219 patients (84%), disease activity was monitored with ≥1 ASDAS during a 1-year period, of whom 71 (38%) patients had a score below the target (ASDAS Conclusions Treat-to-target was applied to a limited extent in clinical practice in patients with axial spondyloarthritis. Available disease activity scores seemed not to be used for determining the frequency of re-evaluation nor treatment adaptation.

Objective To investigate the association between clinical joint tenderness and intra- and periarticular inflammation as assessed by ultrasound and MRI in patients with active PsA and to explore if the associations differ according to patient-reported outcomes (PROs) and structural damage. Methods Forty-one patients with active PsA and hand involvement had 76/78 joints examined for swelling/tenderness and ultrasound and MRI of 24 and 12 finger joints, respectively. Synovitis, tenosynovitis, periarticular inflammation and erosions were assessed using OMERACT definitions and scoring systems. Correlation between imaging inflammation sum-scores (intra-and periarticular) and tender/swollen joint counts were calculated using Spearman’s rho, agreement at joint level was examined using prevalence and bias adjusted kappa (PABAK). Subgroup analyses explored the influence of PROs and radiographic erosive disease on these associations. Results No significant correlations were found between tender or swollen joint counts and imaging inflammation sum-scores (rho = −0.31–0.38). In patients with higher level of overall pain, disability and lower self-reported mental health, a tendency towards negative correlations were found. At joint level, intra- and periarticular imaging inflammatory lesions had slight agreement with joint tenderness (PABAK = 0.02–0.19) and slight to moderate with swelling (PABAK = 0.16–0.54). For tender joints, agreement with imaging inflammation was even weaker in patients with either high overall pain scores, high disability scores, and/or non-erosive disease. Conclusion Joint tenderness had low association with imaging signs of inflammation in PsA patients, particularly in patients with high self-reported pain, disability and low mental health, indicating that tenderness is influenced by other parameters than local inflammation.

ObjectiveThe aim of this study was to explore the longitudinal associations between health literacy profiles and disease activity and medication prescription in patients with RA.MethodsPatients with RA who previously completed the Health Literacy Questionnaire (HLQ) and were assigned 1 of 10 distinct health literacy profiles based on cluster analysis were further aggregated into three groups: ‘several health literacy limitations’, ‘some health literacy limitations’ and ‘good health literacy’. Linear mixed modelling (LMM) was used to analyse the association between health literacy groups and disease activity over the course of 1 year. Chi-squared tests and logistic regression analyses were used to compare medication prescriptions between the groups.ResultsA total of 108 patients with RA were included. LMM showed a significant effect of health literacy group on disease activity over time (P = 0.010). Patients with ‘good health literacy’ had significantly lower disease activity over time [28-joint DAS with ESR (DAS28-ESR) = 2.4] than patients with ‘several health literacy limitations’ (DAS28-ESR = 3.1), independent of age, gender and education level. Patients with ‘good health literacy’ were most often prescribed a biologic DMARD (50%), whereas patients with ‘some health literacy limitations’ more commonly received a conventional synthetic DMARD only [72.7%; odds ratio (OR) 4.24], and patients with ‘several health literacy limitations’ were more often prescribed prednisolone (52.4%; OR 3.56).ConclusionSignificant differences in longitudinal disease activity and medication prescription were observed between groups with different health literacy levels. These results stress the importance of insights into the role of health literacy in treatment and outcomes in patients with RA.

Objectives The aim of this study was to investigate the association between individual-level and country-level socio-economic (SE) factors and health outcomes across SpA phenotypes. Methods Patients with axial SpA (axSpA), peripheral SpA (pSpA) or PsA from the ASAS-perSpA study (in 23 countries) were included. The effect of individual-level (age, gender, education and marital status) and country-level [e.g. Gross Domestic Product (GDP)] SE factors on health outcomes [Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥ 2.1, ASDAS, BASFI, fatigue and the Assessment of SpondyloArthritis international Society Health Index (ASAS-HI)] was assessed in mixed-effects models adjusted for potential confounders. Interactions between SE factors and disease phenotype were tested. A mediation analysis was conducted to explore whether the impact of country-level SE factors on ASDAS was mediated through biologic/targeted synthetic (b/ts) DMARD uptake. Results In total, 4185 patients (61% males, mean age 45) were included (65% axSpA, 25% PsA, 10% pSpA). Female gender [β= 0.14 (95% CI: 0.06, 0.23)], lower educational level [β = 0.35 (0.25, 0.45)) and single marital status [β = 0.09 (0.01, 0.17)] were associated with higher ASDAS. Living in lower GDP countries was also associated with higher ASDAS [β = 0.39 (0.16, 0.63)], and 7% of this association was mediated by b/tsDMARD uptake. Higher BASFI was similarly associated with female gender, lower education and living alone, without the effect of country-level SE factors. Female gender and lower educational level were associated with worse ASAS-HI, while more fatigue was associated with female gender and higher country-level SE factors [lower GDP, β = −0.46 (−0.89 to −0.04)]. No differences across disease phenotypes were found. Conclusions Our study shows country-driven variations in health outcomes in SpA, independently influenced by individual-level and country-level SE factors and without differences across disease phenotypes.

Objectives To investigate the impact of clinical and socioeconomic factors on work disability (WD) in early axial spondyloarthritis (axSpA). Methods Patients from the DESIR cohort with a clinical diagnosis of axSpA were studied over 5 years. Time to WD and potential baseline and time-varying predictors were explored, with a focus on socioeconomic (including ethnicity, education, job-type, marital/parental status) and clinical (including disease activity, function, mobility) factors. Univariable analyses, collinearity and interaction tests guided subsequent multivariable time-varying Cox survival analyses. Results From 704 patients eligible for this study, the estimated incidence of WD among those identified as at risk (n = 663, 94%), and across the five years of DESIR, was 0.05 (95% CI 0.03, 0.06) per 1000 person-days. Significant differences in baseline socioeconomic factors, including lower educational status and clinical measures, including worse disease activity, were seen in patients developing WD over follow-up, compared with those who never did. In the main multivariable model, educational status was no longer predictive of WD, whereas the AS disease activity score (ASDAS) and the BASFI were significantly and independently associated with a higher hazard of WD [HR (95%CI) 1.79 (1.27, 2.54) and 1.42 (1.22, 1.65), respectively]. Conclusion WD was an infrequent event in this early axSpA cohort. Nevertheless, clinical factors were among the strongest predictors of WD, over socioeconomic factors, with worse disease activity and function independently associated with a higher hazard of WD. Disease severity remains a strong predictor of adverse work outcome even in early disease, despite substantial advances in therapeutic strategies in axSpA.

Objective. Patients' experience of overall health is often assessed through a single-item global question. Here, we evaluated among patients with AS and population controls whether single-item questions on the constructs health, wellbeing and quality of life (QoL) are interchangeable. Methods. In a mixed quantitative and qualitative approach, all subjects scored the three single-item globals on a numeric rating scale (0-10, best). Next, they indicated for each of the questions which aspects they had been considering when scoring. After forced reflection, globals were scored again. Dissimilarities in scores among constructs, between patients and controls, and before or after reflection were tested using mixed linear models. Themes identified per construct in the qualitative part were linked to the International Classification of Functioning, Disability and Health. The type of themes per construct was compared between patients and controls. Results. Sixty-eight AS patients and 84 controls completed the questionnaire. Patients scored significantly worse on each global than controls (mean 6.1-6.3 vs 7.2-7.6, all P< 0.01). Within groups, however, no significant differences in scores on each construct, or in scores before or after forced reflection were found. Health-related themes were relevant to each construct for patients, but were less relevant for controls when considering well-being and QoL. Emotional functions were relevant to well-being in all participants. Social roles and financial situation were more frequently related to well-being and QoL in controls. Conclusion. While patients and controls identified content-related dissimilarities between the three constructs studied, this was not reflected in different scores of the globals.

Objectives The aim was to determine changes over time in work outcomes and investigate the predictive value of baseline personal and work-related factors on the evolution of work outcomes among employed patients with AS initiating etanercept. Methods Employment status, absenteeism and presenteeism were assessed using the Work Productivity and Activity Impairment for AS questionnaire in a 24-month open-label, observational study (NCT01421303). The potential effect of baseline factors on work outcomes was analysed using predictive modelling (Cox regression and linear mixed models). Results After 24 months, 11/75 (14.7%) patients had permanently withdrawn from employment (seven because of AS). Absenteeism and presenteeism decreased significantly within 6 months of etanercept treatment and remained stable thereafter. Predictive modelling indicated that male sex (hazard ratio = 0.18; 95% CI: 0.04, 0.85), (log) number of working hours per week (hazard ratio = 0.13; 95% CI: 0.03, 0.51) and the possibility of developing skills (hazard ratio = 0.42; 95% CI: 0.19, 0.91) positively influenced time in employment. Over time, lower absenteeism was significantly associated with the quality of contact with colleagues [coefficient (s.e.): -0.35 (0.10)] and importance of the job for quality of life [-0.49 (0.17)], and higher absenteeism with current smoking [1.66 (0.44)] and change in job because of illness [1.51 (0.66)]. Over time, lower presenteeism was associated with male sex [-14.5 (2.64)], the possibility of postponing work [-6.60 (2.73)], quality of contact with colleagues [-2.04 (0.96)] and >50 workers in the company [-7.65 (2.76)], and higher presenteeism with manual profession [8.41 (2.72)]. Conclusion Contextual factors influence work outcomes over time and should not be ignored when aiming to improve work outcomes in patients with AS. Trial registration ClinicalTrials.gov, http://clinicaltrials.gov, NCT01421303.

Objectives. To identify from a patient's perspective, difficulties and differences in the comprehension of five global presenteeism measures in patients with inflammatory arthritis and OA across seven countries. Methods. Seventy patients with a diagnosis of inflammatory arthritis or OA in paid employment were recruited from seven countries across Europe and Canada. Patients were randomly allocated to be cognitively debriefed on 3/5 global measures [Work Productivity Scale - Rheumatoid Arthritis, Work Productivity and Activity Impairment Questionnaire (WPAI), Work Ability Index, Quality and Quantity questionnaire, and WHO Health and Work Performance Questionnaire (HPQ)], with the WPAI debriefed in all patients as a standard measure of comparison between countries and patients. NVivo was used to code the data into four themes: construct and anchor, time recall, reference frame, and attribution. Results. Discrepancies were found in the interpretation of the word performance (HPQ) between countries, with Romania and Sweden relating performance to sports rather than work. Seventy percent of patients considered that a 7-day recall (WPAI) can accurately represent how their disease affects work productivity. The compared to normal reference (Quality and Quantity questionnaire) was reportedly too ambiguous, and the comparison with colleagues (HPQ), made many feel uncomfortable. Overall, 29% of patients said the WPAI was the most relevant to them, making it the most favoured measure. Conclusion. Overall, patients across countries agree that the construct of work productivity in the last 7 days can accurately reflect the impact of disease while at work. Some current constructs to assess at-work productivity are not interchangeable between languages.

Objective To develop algorithms for calculating the Rheumatic Diseases Comorbidity Index (RDCI), Charlson-Deyo Index (CDI) and Functional Comorbidity Index (FCI) from the Medical Dictionary for Regulatory Activities (MedDRA), and to assess how these MedDRA-derived indices predict clinical outcomes, utility and health resource utilization (HRU). Methods Two independent researchers linked the preferred terms of the MedDRA classification into the conditions included in the RDCI, the CDI and the FCI. Next, using data from the Norwegian Register-DMARD study (a register of patients with inflammatory joint diseases treated with DMARDs), the explanatory value of these indices was studied in models adjusted for age, gender and DAS28. Model fit statistics were compared in generalized estimating equation (prediction of outcome over time) models using as outcomes: modified HAQ, HAQ, physical and mental component summary of SF-36, SF6D and non-RA related HRU. Results Among 4126 patients with RA [72% female, mean (s.d.) age 56 (14) years], median (interquartile range) of RDCI at baseline was 0.0 (1.0) [range 0-6], CDI 0.0 (0.0) [0-7] and FCI 0.0 (1.0) [0-6]. All the comorbidity indices were associated with each outcome, and differences in their performance were moderate. The RDCI and FCI performed better on clinical outcomes: modified HAQ and HAQ, hospitalization, physical and mental component summary, and SF6D. Any non-RA related HRU was best predicted by RDCI followed by CDI. Conclusion An algorithm is now available to compute three commonly used comorbidity indices from MedDRA classification. Indices performed comparably well in predicting a variety of outcomes, with the CDI performing slightly worse when predicting outcomes reflecting functioning and health.

Objectives.To estimate the preferences of osteoporotic patients for medication attributes, and analysedata from seven European countries.Methods.A discrete choice experiment was conducted in Belgium, France, Ireland, the Netherlands,Spain, Switzerland and the UK. Patients were asked to choose repeatedly between two hypotheticalunlabelled drug treatments (and an opt-out option) that varied with respect to four attributes: efficacy inreducing the risk of fracture, type of potential common side effects, and mode and frequency of admin-istration. In those countries in which patients contribute to the cost of their treatment directly, a fifthattribute was added: out-of-pocket cost. A mixed logit panel model was used to estimate patients’preferences.Results.In total, 1124 patients completed the experiment, with a sample of between 98 and 257 patientsper country. In all countries, patients preferred treatment with higher effectiveness, and 6-monthly subcuta-neous injection was always preferred over weekly oral tablets. In five countries, patients also preferred amonthly oral tablet and yearly i.v. injections over weekly oral tablets. In the three countries where the out-of-pocket cost was included as an attribute, lower costs significantly contributed to the treatment preference.Between countries, there were statistically significant differences for 13 out of 42 attribute/level interactions.Conclusion.We found statistically significant differences in patients’ preferences for anti-osteoporosismedications between countries, especially for the mode of administration. Our findings emphasized thatinternational treatment recommendations should allow for local adaptation, and that understanding individ-ual preferences is important if we want to improve the quality of clinical care for patients with osteoporosis.