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1.
Int J Rheum Dis ; 2021 Apr 09.
Artigo em Inglês | MEDLINE | ID: mdl-33835718

RESUMO

AIM: The aim of the study was to explore in patients with rheumatoid arthritis (RA) ≥55 years: (1) whether the occurrence of frailty as measured by the Groningen Frailty Indicator (GFI) increases with age (survey 1); and (2) to gain insight into which frailty characteristics (eg, loneliness) contribute to frailty (survey 2). METHODS: The GFI was assessed in 3 age groups (55-64/65-74/≥75-years), ensuring equal representation. GFI-subdomains that discriminated most between those classified as frail were further studied in a subset of patients using validated domain-specific questionnaires (eg Hospital Anxiety and Depression Scale [HADS]) and semi-structured interviews. Questionnaires were filled out twice: for current age and the recalled situation at age 40, to see whether psychiatric symptomatology might be misinterpreted for frailty. RESULTS: Of 90 patients included, frailty prevalence on the GFI across age groups was 43.3%-40.0%-43.4%, respectively. Frail patients often reported depressive (73.7% vs. 11.5%) and anxious (57.9% vs. 15.4%) feelings. There were 32/90 patients who filled out the psycho-social questionnaires twice. More frail patients had signs of an anxiety disorder on the HADS (missing data 4 patients), both at current age (5/11 frail patients vs. 0/17 non-frail patients, P = .01) and age 40 (7/11 frail patients vs. 0/0 non-frail patients, P < .01). During the interviews, especially frail patients reported gloomy feelings, although none confirmed depression or anxiety. CONCLUSIONS: Frailty is highly prevalent in RA patients ≥55 years. As frail patients were characterized by symptoms of anxiety both at current age but (recalled) also at age 40, this finding suggests that pre-existing psychiatric symptomatology may confound assessment of frailty.

2.
Neurorehabil Neural Repair ; : 15459683211005028, 2021 Apr 13.
Artigo em Inglês | MEDLINE | ID: mdl-33847188

RESUMO

BACKGROUND: Persons with multiple sclerosis (pwMS) experience walking impairments, characterized by decreased walking speeds. In healthy subjects, the self-selected walking speed is the energetically most optimal. In pwMS, the energetically most optimal walking speed remains underexposed. Therefore, this review aimed to determine the relationship between walking speed and energetic cost of walking (Cw) in pwMS, compared with healthy subjects, thereby assessing the walking speed with the lowest energetic cost. As it is unclear whether the Cw in pwMS differs between overground and treadmill walking, as reported in healthy subjects, a second review aim was to compare both conditions. METHOD: PubMed and Web of Science were systematically searched. Studies assessing pwMS, reporting walking speed (converted to meters per second), and reporting oxygen consumption were included. Study quality was assessed with a modified National Heart, Lung and Blood Institute checklist. The relationship between Cw and walking speed was calculated with a second-order polynomial function and compared between groups and conditions. RESULTS: Twenty-nine studies were included (n = 1535 pwMS) of which 8 included healthy subjects (n = 179 healthy subjects). PwMS showed a similar energetically most optimal walking speed of 1.44 m/s with a Cw of 0.16, compared with 0.14 mL O2/kg/m in healthy subjects. The most optimal walking speed in treadmill was 1.48 m/s, compared with 1.28 m/s in overground walking with a similar Cw. CONCLUSION: Overall, the Cw is elevated in pwMS but with a similar energetically most optimal walking speed, compared with healthy subjects. Treadmill walking showed a similar most optimal Cw but a higher speed, compared with overground walking.

3.
Ann Rheum Dis ; 2021 Apr 08.
Artigo em Inglês | MEDLINE | ID: mdl-33832966

RESUMO

BACKGROUND: Clinical studies with work participation (WP) as an outcome domain pose particular methodological challenges that hamper interpretation, comparison between studies and meta-analyses. OBJECTIVES: To develop Points to Consider (PtC) for design, analysis and reporting of studies of patients with inflammatory arthritis that include WP as a primary or secondary outcome domain. METHODS: The EULAR Standardised Operating Procedures were followed. A multidisciplinary taskforce with 22 experts including patients with rheumatic diseases, from 10 EULAR countries and Canada, identified methodologic areas of concern. Two systematic literature reviews (SLR) appraised the methodology across these areas. In parallel, two surveys among professional societies and experts outside the taskforce sought for additional methodological areas or existing conducting/reporting recommendations. The taskforce formulated the PtC after presentation of the SLRs and survey results, and discussion. Consensus was obtained through informal voting, with levels of agreement obtained anonymously. RESULTS: Two overarching principles and nine PtC were formulated. The taskforce recommends to align the work-related study objective to the design, duration, and outcome domains/measurement instruments of the study (PtC: 1-3); to identify contextual factors upfront and account for them in analyses (PtC: 4); to account for interdependence of different work outcome domains and for changes in work status over time (PtC: 5-7); to present results as means as well as proportions of patients reaching predefined meaningful categories (PtC: 8) and to explicitly report volumes of productivity loss when costs are an outcome (PtC:9). CONCLUSION: Adherence to these EULAR PtC will improve the methodological quality of studies evaluating WP.

5.
Int J Rheum Dis ; 24(3): 293-296, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33523595
6.
J Rheumatol ; 2021 Feb 15.
Artigo em Inglês | MEDLINE | ID: mdl-33589554

RESUMO

OBJECTIVE: To evaluate the efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with active ankylosing spondylitis (AS). METHODS: This phase III, multicenter, double-blind, placebo-controlled study (NCT01583374) randomized patients with active AS (1:1:1) to placebo, apremilast 20 mg twice daily, or apremilast 30 mg twice daily for 24 weeks, followed by a long-term extension phase (up to 5 years). The primary endpoint was assessment of the SpondyloArthritis International Society 20 (ASAS 20) response at Week 16. The impact of treatment on radiographic outcomes after 104 weeks was assessed using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). RESULTS: In total, 490 patients with active AS were randomized in the study (placebo: n=164; apremilast 20 mg twice daily: n=163; apremilast 30 mg twice daily: n=163). The primary endpoint of ASAS 20 response at Week 16 was not met (placebo: 37%; apremilast 20 mg twice daily: 35%; apremilast 30 mg twice daily: 33%; p=0.44 vs placebo). At Week 104, mean (SD) changes from baseline in mSASSS were 0.83 (3.6), 0.98 (2.2), and 0.57 (1.9) in patients initially randomized to placebo, apremilast 20 mg twice daily, and apremilast 30 mg twice daily, respectively. The most frequently reported adverse events through Week 104 were diarrhea, nasopharyngitis, upper respiratory infection, and nausea. CONCLUSION: No clinical benefit was observed with apremilast treatment in patients with active AS. The safety and tolerability of apremilast were consistent with its known profile.

7.
RMD Open ; 7(1)2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33542048

RESUMO

OBJECTIVE: To summarise the methodological aspects in studies with work participation (WP) as outcome domain in inflammatory arthritis (IA) and other chronic diseases. METHODS: Two systematic literature reviews (SLRs) were conducted in key electronic databases (2014-2019): search 1 focused on longitudinal prospective studies in IA and search 2 on SLRs in other chronic diseases. Two reviewers independently identified eligible studies and extracted data covering pre-defined methodological areas. RESULTS: In total, 58 studies in IA (22 randomised controlled trials, 36 longitudinal observational studies) and 24 SLRs in other chronic diseases were included. WP was the primary outcome in 26/58 (45%) studies. The methodological aspects least accounted for in IA studies were as follows (proportions of studies positively adhering to the topic are shown): aligning the studied population (16/58 (28%)) and sample size calculation (8/58 (14%)) with the work-related study objective; attribution of WP to overall health (28/58 (48%)); accounting for skewness of presenteeism/sick leave (10/52 (19%)); accounting for work-related contextual factors (25/58 (43%)); reporting attrition and its reasons (1/58 (2%)); reporting both aggregated results and proportions of individuals reaching predefined meaningful change or state (11/58 (16%)). SLRs in other chronic diseases confirmed heterogeneity and methodological flaws identified in IA studies without identifying new issues. CONCLUSION: High methodological heterogeneity was observed in studies with WP as outcome domain. Consensus around various methodological aspects specific to WP studies is needed to improve quality of future studies. This review informs the EULAR Points to Consider for conducting and reporting studies with WP as an outcome in IA.

8.
Ann Rheum Dis ; 2020 Dec 11.
Artigo em Inglês | MEDLINE | ID: mdl-33310727

RESUMO

BACKGROUND: Patients with rheumatoid arthritis (RA) commonly use oral glucocorticoids (GCs) and proton pump inhibitors (PPIs), both associated with osteoporotic fractures. We investigated the association between concomitant use of oral GCs and PPIs and the risk of osteoporotic fractures among patients with RA. METHODS: This was a cohort study including patients with RA aged 50+ years from the Clinical Practice Research Datalink between 1997 and 2017. Exposure to oral GCs and PPIs was stratified by the most recent prescription as current use (<6 months), recent use (7-12 months) and past use (>1 year); average daily and cumulative dose; and duration of use. The risk of incident osteoporotic fractures (including hip, vertebrae, humerus, forearm, pelvis and ribs) was estimated by time-dependent Cox proportional-hazards models, statistically adjusted for lifestyle parameters, comorbidities and comedications. RESULTS: Among 12 351 patients with RA (mean age of 68 years, 69% women), 1411 osteoporotic fractures occurred. Concomitant current use of oral GCs and PPIs was associated with a 1.6-fold increased risk of osteoporotic fractures compared with non-use (adjusted HR: 1.60, 95% CI: 1.35 to 1.89). This was statistically different from a 1.2-fold increased osteoporotic fracture risk associated with oral GC or PPI use alone. Most individual fracture sites were significantly associated with concomitant use of oral GCs and PPIs. Among concomitant users, fracture risk did not increase with higher daily dose or duration of PPI use. CONCLUSIONS: There was an interaction in the risk of osteoporotic fractures with concomitant use of oral GCs and PPIs. Fracture risk assessment could be considered when a patient with RA is co-prescribed oral GCs and PPIs.

9.
ACR Open Rheumatol ; 2020 Dec 31.
Artigo em Inglês | MEDLINE | ID: mdl-33381919

RESUMO

OBJECTIVE: Integrating patient's and physician's goals, especially in elderly patients with multimorbidity, might ultimately improve care. Efforts to develop such care innovations in patients with rheumatoid arthritis (RA) are lacking. The objective of our study was to develop and to pilot test a clinic for elderly patients with RA and multimorbidity. METHODS: First, a referral strategy for and the content of an Elderly Multimorbidity Clinic (EMC) was developed. Next, the EMC was implemented, and it primarily focused on the personal goals of patients and medication review. The EMC was evaluated in a quantitative-qualitative approach. RESULTS: Referral considered useful by the rheumatologist was chosen as the referral criterion. A rheumatologist and internist-geriatrician provided care to referred patients (≥ 55 years) at the EMC during three visits over 1 year. Twenty patients with RA participated in the pilot study (mean age 76.8±7.7 years; 30% male). Only 12 (60%) patients attended the first follow-up consultation, and three (15%) attended the second follow-up consultation. During any follow-up visit, 9/12 (75%) patients achieved one or more goals. Examples of accomplished goals were reduction of medication and improvement of mobility. In 19/20 (95%) patients, medication was remediated (stop medication for 13 patients; start medication for five patients) during the first visit. After 1 year, medication was changed back in 10 patients. Rheumatologists revealed uncertainty about meaningful referral, and patients and rheumatologists mentioned high (caregiver) burden because of extra visits as reasons for not attending follow-up. Patients were satisfied with the care provided. CONCLUSION: This goal-directed EMC led to the accomplishment of at least one goal in 75% of patients. Sustained benefits could not be demonstrated because of low follow-up.

10.
J Rheumatol ; 2020 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-33191282

RESUMO

OBJECTIVE: To explore the possibility of integrating patient-important outcomes like pain, fatigue and physical function into the evaluation of disease status in early rheumatoid arthritis (ERA), without compromising correct disease activity measurement. METHODS: Patients from the 2-year Care-in-early-Rheumatoid-Arthritis (CareRA) trial were included. Pain and fatigue (visual analogue scales), Health Assessment Questionnaire (HAQ), standard components of disease activity (swollen/tender joint counts (SJC/TJC), C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR), Physician (Ph) and Patient's (Pa) global health (GH)) were recorded at every visit (n=10). Pearson correlation and exploratory factor analyses (EFAs), using multiple imputation (15 times) and outputation (1000 times), were performed per timepoint and overall, on standard components of disease activity scores with and without pain, fatigue and HAQ. Each of the 15 000 datasets was analyzed with principal component extraction and oblimin rotation to determine which variables belong together. RESULTS: We included 379 patients. EFAs on standard composite score components extracted 2 factors with no substantial cross-loadings. Still, pain (0.83), fatigue (0.65) and HAQ (0.59) were strongly correlated with PaGH. When rerunning the EFAs with the inclusion of pain, fatigue and HAQ, the 2-factor model had substantial cross-loadings between factors. However, a 3-factor model was optimal, with Factor 1: Patient's assessment, Factor 2: Clinical assessment (PhGH, SJC and TJC), and Factor 3: Laboratory (ESR/CRP). CONCLUSION: PaGH, pain, fatigue, and physical function represent a separate aspect of the disease burden of ERA patients, that could be further explored as a target for care apart from disease activity.

11.
Ann Rheum Dis ; 2020 Nov 06.
Artigo em Inglês | MEDLINE | ID: mdl-33158877

RESUMO

OBJECTIVES: To investigate how the first wave of COVID-19 pandemic influenced decisions of rheumatologists and health professionals in rheumatology regarding the management of patients with inflammatory rheumatic and musculoskeletal diseases (RMDs). METHODS: An English-language questionnaire was developed by a EULAR working group and distributed via national rheumatology societies of EULAR countries, EMEUNET and individual working group members. Responses were collected using an online survey tool. Descriptive statistics were calculated. RESULTS: We analysed 1286 responses from 35/45 EULAR countries. Due to containment measures, 82% of respondents indicated cancellation/postponement of face-to-face visits of new patients (84% of them offering remote consultation) and 91% of follow-up visits (96% with remote consultation). The majority of respondents (58%) perceived that the interval between symptom onset and first rheumatological consultations was longer during containment restrictions than before. Treatment decisions were frequently postponed (34%), and the majority (74%) of respondents stated that it was less likely to start a biological disease modifying anti-rheumatic drug (DMARD)/targeted synthetic DMARD during the pandemic, mainly because of patients' fear, limited availability of screening procedures and decreased availability of rheumatological services. Use of (hydroxy)chloroquine (HCQ) and tocilizumab (TCZ) for the COVID-19 indication was reported by 47% and 42% of respondents, respectively, leading to a shortage of these drugs for RMDs indications according to 49% and 14% of respondents, respectively. CONCLUSION: Measures related to containment of COVID-19 pandemic led to a perceived delay between symptom onset and a first rheumatological visit, postponement of treatment decisions, and shortage of HCQ and TCZ, thereby negatively impacting early treatment and treat-to-target strategies.

13.
RMD Open ; 6(3)2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33148784

RESUMO

Health resource use and identification of related costs are two essential steps in health economics assessment. The elicited costs will be balanced with health outcome improvement and enable the comparison of different diagnostic procedures or therapeutic strategies from a health economic point of view. The cost typology can be disentangled in three main components, that is, direct cost related to health resource use, indirect costs related to productivity loss and sometimes intangible costs (costs related to pain and suffering). These costs can be elicited from different perspectives depending on the general aim of the assessment: payer, societal perspective or patient perspective. Practically, the first step corresponds to the quantification of health resource use, that is, number of consultations, biological or imaging workups, hospitalisation, dispensed medication units or days on sick leave. It can be done by specific self-questionnaires or by access to insurance health databases. The second step is then to value each health resource use item, based on available public databases-either produced by insurance entities or statistics institute-providing the unit costs for each item. Importantly, substantial variability does exist in the costing exercise, requiring accepting a certain uncertainty around cost estimates. This can be taken into account by sensitivity analyses, which capture in what extent measurement error can impact cost assessment, depending on different hypotheses or assumptions. One essential element of health economic assessment is the identification of costs incurred by or associated with a specific health condition for a study on the economic burden of a disease-cost-of-illness study-or with a given diagnostic or therapeutic intervention in the context of health technology assessment in which these costs are compared with the alternative reference strategy-cost-effectiveness study.

16.
Pharmacoeconomics ; 2020 Oct 07.
Artigo em Inglês | MEDLINE | ID: mdl-33026634

RESUMO

BACKGROUND: Considering the heavy economic burden of osteoporotic fractures, the limits of healthcare resources, and the recent availability of new anti-osteoporosis drugs, there is continuing interest in economic evaluation studies of osteoporosis management strategies. OBJECTIVES: This study aims to (1) systematically review recent economic evaluations of drugs for osteoporosis and (2) to apply an osteoporosis-specific guideline to critically appraise them. METHODS: A literature search was undertaken using PubMed, EMBASE, National Health Service Economic Evaluation database, and the Cost-Effectiveness Analysis Registry to identify original articles containing economic evaluations of anti-osteoporosis drugs, published between 1 July, 2013 and 31 December, 2019. A recent European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases-International Osteoporosis Foundation (ESCEO-IOF) guideline for the conduct and reporting of economic evaluations in osteoporosis was used to assess the quality of included articles. RESULTS: The database search retrieved 3860 records, of which 27 studies fulfilled the inclusion criteria. These studies were conducted in 15 countries; 12 active drugs were assessed, including various traditional pharmacological treatments such as bisphosphonates, raloxifene, strontium ranelate, denosumab, and teriparatide, and new agents such as abaloparatide, romosozumab, and gastro-resistant risedronate. Eight out of 12 studies that compared traditional oral bisphosphonates to other active interventions (denosumab, zoledronic acid, gastro-resistant risedronate, and teriparatide) suggested that the other active agents were generally cost-effective or dominant. Additionally, the cost-effectiveness of sequential therapy has recently been assessed and indications are that it can lead to extra health benefits (larger gains in quality-adjusted life-year). The key drivers of cost effectiveness included baseline fracture risk, drug effect on the risk of fractures, drug cost, and medication adherence/persistence. The current average score for quality assessment was 17 out of 25 (range 2-15); room for improvement was observed for most studies, which could potentially be explained by the fact that most studies were published prior to the osteoporosis-specific guideline. Greater adherence to guideline recommendations was expected for future studies. The quality of reporting was also suboptimal, especially with regard to treatment side effects, treatment effect after discontinuation, and medication adherence. CONCLUSIONS: This updated review provides an overview of recently published cost-effectiveness analyses. In comparison with a previous review, recent economic evaluations of anti-osteoporosis drugs were conducted in more countries and included more active drugs and sequential therapy as interventions/comparators. The updated economic evidence could help decision makers prioritize health interventions and the unmet/unreported quality issues indicated by the osteoporosis-specific guideline could be useful in improving the transparency, quality, and comparability of future economic evaluations in osteoporosis.

17.
Artigo em Inglês | MEDLINE | ID: mdl-33026713

RESUMO

OBJECTIVES: To identify and describe health literacy profiles of patients with rheumatic diseases and explore whether the identified health literacy profiles can be generalized to a broader rheumatology context. METHODS: Patients with rheumatoid arthritis, spondyloarthritis and gout from three hospitals in different regions in the Netherlands completed the Health Literacy Questionnaire (HLQ). Hierarchical cluster analysis was used to identify patients' health literacy profiles based on nine HLQ domains. A multinomial regression model with the identified health literacy profiles as the dependent variable was fitted to assess whether patients with a given disease type or attending a given hospital were more likely to belong to a specific profile. RESULTS: Among 895 participating patients, lowest mean HLQ domain scores (indicating most difficulty) were found for "Critical appraisal", "Navigating the health system" and "Finding good health information". The ten identified profiles revealed substantial diversity in combinations of strengths and weaknesses. While 42% of patients scored moderate to high on all nine domains (profiles 1 and 3), another 42% of patients (profiles 2, 4, 5 and 6) clearly struggled with one or several aspects of health literacy. Notably, 16% (profiles 7 to 10) exhibited difficulty across a majority of health literacy domains. The probability of belonging to one of the profiles was independent of hospital attended or type of rheumatic disease. CONCLUSION: Ten distinct health literacy profiles were identified among patients with rheumatic diseases, independent of disease type and treating hospital. These profiles can be used to facilitate health literacy intervention development in rheumatology.

18.
Artigo em Inglês | MEDLINE | ID: mdl-33044756

RESUMO

OBJECTIVE: To evaluate the effect of ixekizumab on self-reported functioning and health in patients with active non-radiographic axial spondyloarthritis (nr-axSpA). METHODS: COAST-X is a randomized, controlled trial conducted in patients with nr-axSpA of 52-weeks duration. Participants were randomized 1:1:1 to receive subcutaneous 80 mg ixekizumab every 4 weeks (Q4W) or every 2 weeks (Q2W), or placebo for 52 Weeks. Self-reported functioning and health endpoints included the Medical Outcomes Study 36-Item Short Form Health Survey 36-item (SF-36), Assessment of SpondyloArthritis international Society Health Index (ASAS HI), and European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) health-utility. RESULTS: Compared with placebo, ixekizumab treatment improved SF-36 Physical Component Summary scores from baseline (4.7 versus 8.9 IXE Q4W, p<0.05, 9.3 IXE Q2W, p<0.01), with greatest improvements observed in Physical Functioning, Role-physical and Bodily Pain domains at Weeks 16 and 52. Higher proportion of patients receiving ixekizumab reported ASAS HI improvements ≥3 from baseline at Weeks 16 (Q2W, p<0.05) and 52 (p<0.05). Significantly more patients on ixekizumab reported improvements in ASAS HI "good health status" (ASAS HI ≤5) at Weeks 16 (Q4W, p<0.05) and 52 (p<0.05). Patients on ixekizumab reported improvements in EQ-5D-5L versus placebo at Week 16 (0.11 versus 0.17 Q4W, 0.19 Q2W, p<0.05), which remained consistent at Week 52. There were no clinical meaningful differences in responses based on the ixekizumab dosing regimen (Q2W or Q4W). CONCLUSION: Ixekizumab was superior to placebo improving self-reported functioning and health in patients with nr-axSpA at Weeks 16 and 52.

19.
Ann Rheum Dis ; 2020 Oct 14.
Artigo em Inglês | MEDLINE | ID: mdl-33055082

RESUMO

OBJECTIVES: The Outcome Measures in Rheumatology Initiative established the Contextual Factors Working Group to guide the understanding, identification and handling of contextual factors for clinical trials. In clinical research, different uses of the term 'contextual factors' exist. This study explores the perspectives of researchers (including clinicians) and patients in defining 'contextual factor' and its related terminology, identifying such factors and accounting for them in trials across rheumatology. METHODS: We conducted individual semistructured interviews with researchers (including clinicians) who have experience within the field of contextual factors in clinical trials or other potentially relevant areas, and small focus group interviews with patients with rheumatic conditions. We transcribed the interviews and applied qualitative content analysis. RESULTS: We interviewed 12 researchers and 7 patients. Researcher's and patient's descriptions of contextual factors were categorised into two broad themes, each comprising two contextual factors types. The 'treatment effect' theme focused on factors explaining variations in treatment effects (A) among patients and (B) among studies. The 'outcome measurement' theme focused on factors that explain (C) variations in the measurement result itself (apart from actual changes/differences in the outcome) and (D) variations in the outcome itself (beside treatment of interest). Methods for identifying and handling contextual factors differed among these themes and types. CONCLUSIONS: Two main themes for contextual factors with four types of contextual factors were identified based on input from researchers and patients. This will guide operationalisation of contextual factors. Further research should refine our findings and establish consensus among relevant stakeholders.

20.
Arthritis Res Ther ; 22(1): 225, 2020 09 29.
Artigo em Inglês | MEDLINE | ID: mdl-32993799

RESUMO

BACKGROUND: Patients with ankylosing spondylitis (AS) are at increased risk of depression. This increased risk has been hypothesized to be solely secondary due to AS-related symptoms, or additionally due to a common inflammatory pathway. From a clinical perspective, it is important to know whether treatment with tumor necrosis factor alpha inhibitors reduces depressive symptoms, while from a pathophysiological point of view, it would be insightful to understand whether such an effect would be a direct result of reduced inflammation, the result of reduced AS-related symptoms, or both. The objective of this study was to evaluate the effect of infliximab on depressive symptoms in patients with AS in a randomized-controlled trial setting. METHODS: Data were retrieved from a subgroup of patients from the AS Study for the Evaluation of Recombinant Infliximab Therapy (ASSERT). Patients were randomly allocated to infliximab (n = 16) or placebo (n = 7) until week 24, after which all received infliximab until week 54. Associations between treatment group and depressive symptoms, measured with the Center for Epidemiological Studies Depression scale (CES-D, range 0-60 (best-worst)) at baseline and over time, were explored with generalized estimating equations (GEE). RESULTS: Mean CES-D score at baseline was 15.5 (SD 9.3) in the infliximab group and 17.3 (SD 5.7) in the placebo group. Twelve patients (52%) had a CES-D score > 16, suggestive for clinical depression. After 24 weeks, mean CES-D had decreased to 9.5 (SD 11.4) in the infliximab group, but was 18.0 (SD 6.9) in the placebo group. GEE revealed larger improvements in depressive symptoms (B = - 6.63, 95%CI - 13.35 to 0.09) and odds of possible depression (OR = 0.02, 95%CI 0.00 to 0.72) in the infliximab group, compared to the placebo group. Both associations largely disappeared when adjusted for self-reported disease activity and/or physical function. Additional adjustment for C-reactive protein (CRP) did not change results. CONCLUSIONS: Depressive symptoms are common in patients with AS and active disease. Infliximab improves these depressive symptoms in AS when compared to placebo by improving disease symptoms. We did not find an indication for a direct link between CRP-mediated inflammation and depressive symptoms. TRIAL REGISTRATION: Trial registration (ASSERT): NCT00207701 . Registered on September 21, 2005 (retrospectively registered).

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