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Clinical characteristics of importance to outcome in patients with axial spondyloarthritis: protocol for a prospective descriptive and exploratory cohort study.

ABSTRACT: INTRODUCTION:Spondyloarthritis (SpA) is a heterogeneous spectrum of rheumatic diseases with either predominantly axial inflammatory symptoms of the spine and sacroiliac joints or predominantly peripheral arthritis. The two main entities of axial SpA (axSpA) are ankylosing spondylitis or non-radiographic axSpA (nr-axSpA). Tumour necrosis factor-? inhibitors have revolutionised the treatment of patients with axSpA who failed to respond to non-steroidal anti-inflammatory drugs and physical therapy. Chronic pain is common in patients with SpA and may still persist despite the lack of signs of inflammation. This has led researchers to hypothesise that central pain sensitisation may play a role in the generation of chronic pain in SpA. The painDETECT Questionnaire (PDQ) is a screening tool developed to detect neuropathic pain components. The primary objective is to explore the prognostic value of the PDQ regarding treatment response in patients with axSpA 3 months after initiating a biological agent. Secondary aim is to evaluate the impact of extra-articular manifestations, comorbidities and patient-reported outcomes and elucidate if these factors influence treatment response. METHOD AND ANALYSIS:We will include 60 participants (?18 years of age) diagnosed with axSpA independent of main entity, who initiate or switch treatment of a biologic. Data will be collected at baseline and at endpoint following Danish clinical practice (?3 months) of treatment with biologics. We will explore whether the PDQ and other phenotypical patient characteristics are prognostically important for response to biological therapy according to established response criteria like 50% improvement in the Bath Ankylosing Spondylitis Disease Activity Index (50%) and Ankylosing Spondylitis Disease Activity Score. ETHICS AND DISSEMINATION:The study is approved by the Region of Southern Denmark's Ethics committee (S-20160094) and has been designed in cooperation with patient representatives. The study is registered at clinicaltrials.gov (NCT02948608, pre-results). Dissemination will occur through publication(s) in international peer-reviewed journal(s).

SUBMITTER: Andreasen RA

PROVIDER: S-EPMC5734256 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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Clinical characteristics of importance to outcome in patients with axial spondyloarthritis: protocol for a prospective descriptive and exploratory cohort study.

Andreasen Rikke Asmussen RA Kristensen Lars Erik LE Ellingsen Torkell T Christensen Robin R Baraliakos Xenofon X Wied Jimmi J Aalykke Claus C Ulstrup Thomas T Schiøttz-Christensen Berit B Horn Hans Christian HC Emamifar Amir A Duerlund Bent B Fischer Lars L Hansen Inger Marie Jensen IMJ

BMJ open 20170710 7

<h4>Introduction</h4>Spondyloarthritis (SpA) is a heterogeneous spectrum of rheumatic diseases with either predominantly axial inflammatory symptoms of the spine and sacroiliac joints or predominantly peripheral arthritis. The two main entities of axial SpA (axSpA) are ankylosing spondylitis or non-radiographic axSpA (nr-axSpA). Tumour necrosis factor-α inhibitors have revolutionised the treatment of patients with axSpA who failed to respond to non-steroidal anti-inflammatory drugs and physical ...[more]

PMID: 28698330

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Project description:BackgroundThe aim of this study was to explore the impact of sex and disease classification on outcomes in axial spondyloarthritis (axSpA) patients, including both radiographic (r-) axSpA and non-radiographic (nr-) axSpA, in males and females, respectively.MethodsAxSpA patients were consecutively recruited from two rheumatology outpatient university clinics. We explored how sex and axSpA disease classification affected patient-reported outcome measures (PROMs). General linear models were used to investigate if there was an association between the continuous variables and each of the main effects of interest (sex and axSpA classification), as well as the possible interaction between them. Categorical outcome measures were analyzed with the use of logistic regression with the same fixed effects. We analyzed the relationship between tender point count (TPC) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The prevalence of extra-articular manifestations (EAMs) and the Charlson Comorbidity Index (CCI) were determined.ResultsAccording to the protocol, a total of 100 outpatients with axSpA were enrolled (r-axSpA males 30, r-axSpA females 10, nr-axSpA males 25, nr-axSpA females 35). The BASDAI scores appeared higher among nr-axSpA females (median [Q1; Q3], 47 [21; 60]) compared with the combined median for the 3 other subgroups 25 [12; 25]. Female sex was associated with a higher number of tender point count (TPC, P?<?0.001). TPC and BASDAI were correlated for female nr-axSpA patients (r?=?0.44, P?=?0.008) and male nr-axSpA patients (r?=?0.56, P?=?0.003). Being classified as nr-axSpA was associated with a lower SF-36 Mental Component Summary (median for the 4 subgroups: nr-axSpa females 46.7, nr-axSpA males 52.3 vs. r-axSpA males 56.9 and r-axSpA females 50.4). EAMs were frequent (up to 50%). The CCI was low in all 4 subgroups, and no difference in the CCI between the subgroups was observed (P?=?0.14). However, male sex had a significant impact on the CCI (P?=?0.03).ConclusionsIn summary, patients with r-axSpA, regardless of sex, appeared less affected on most PROMs compared with nr-axSpA patients. However, female sex was associated with a higher number of TPC. TPC could possibly confound disease activity outcomes such as BASDAI, and one can consider different thresholds for defining high disease activity depending on the patient's sex.Trial registrationThe trial is registered and approved by the Region of Southern Denmark's Ethics Committee ( S-20150219 ). Registered 19 February 2015.

Project description:BACKGROUND:There is a remarkable lack of detailed knowledge on pain areas in axial spondyloarthritis (axSpA), and their clinical relevance is largely unknown. Pain area may reflect local disease processes, but amplification of nervous system signalling may alter this relationship. Also, gender differences in pain area may exist in axSpA, possibly confounding disease activity outcomes. Therefore, we firstly detailed pain locations in axSpA and evaluated gender differences. Secondly, we explored the relationship of regional pain definitions with clinical outcomes. Finally, we explored the role of pain area in the assessment of disease activity. METHODS:Body charts informed on the presence of axial, peripheral articular and non-articular pain in 170 patients (108 men, 62 women) with axSpA. Multivariate Odds Ratios (ORs) were used to compare genders. General linear models were used to explore clinical differences in disease activity (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]), activity limitations (Bath Ankylosing Spondylitis Functional Index [BASFI]), fear of movement (Tampa Scale for Kinesiophobia 11-item version [TSK-11]), anxiety (Hospital Anxiety and Depression Scale subscale anxiety [HADS-A]) and depression (HADS subscale depression [HADS-D]) between four subgroups classified by widespread non-articular pain (WNAP+/-) and physician global assessment of disease activity (PGDA+/-) (p?<?.05). Principal Component Analysis (PCA) was performed to explore gender differences in the structure of disease activity. RESULTS:Axial thoracic pain was least prevalent (lumbar, 74.4%; cervical, 47.6%; cervicothoracic, 47.6%; thoracic, 32.4%), but it was about three times more likely in women (OR, 2.92; p?=?.009). Axial cervicothoracic junction pain spread more diffusely in women (OR, 2.48; p?=?.018). Women exhibited a two- to threefold increased likelihood of widespread axial (OR, 3.33; p?=?.007) and peripheral articular (OR, 2.34; p?=?.023) pain. A subgroup of WNAP+/PGDA- combined with low PGDA (27% of all patients) was associated with worse BASFI, BASDAI, HADS-A and HADS-D in men and worse TSK-11 and HADS-A in women (p?<?.05). Disease activity outcomes showed a two-factor structure in women but not in men. CONCLUSIONS:In patients with axSpA, the location and spread of pain was different between genders and was related to worse clinical status. On the basis of pain area and PGDA, clinical subgroups exhibiting a remarkably distinct health status were identified. Outcome instruments such as BASDAI should acknowledge gender differences to ensure structural validity.

Project description:The Assessment of Spondyloarthritis International Society (ASAS) health index (HI) is a novel tool for approaching disability, health, and functioning in spondyloarthritis (SpA). In the present study we compared ASAS HI between patients with ankylosing spondylitis (AS) and those with nonradiographic axial SpA (nr-axSpA). In addition, we identified predictors of ASAS HI. We designed this cross-sectional study using data from the Catholic Axial Spondyloarthritis COhort (CASCO), a prospective cohort from a single tertiary hospital. We compared baseline characteristics, including ASAS HI, between AS and nr-axSpA, and determined the frequency of each item constituting the ASAS HI. We used linear regression analysis to identify factors associated with ASAS HI. Total of 357 patients with axSpA-261 with AS and 96 with nr-axSpA-were included in analysis. AS patients were older and had higher ASAS HI than nr-axSpA. Among ASAS HI items, pain (item No. 1) and energy/drive (item No. 5) were the most common areas for which axSpA patients experienced discomfort. ASAS HI correlated with other SpA-related parameters such as BASDAI, ASDAS, and BASFI. Multivariable regression analysis of the axSpA group showed that high NSAID intake and mSASSS were positively associated with ASAS HI, whereas higher economic status and alcohol consumption were negatively associated with ASAS HI. Results were consistent in the AS group on subgroup analysis, whereas alcohol consumption was the only factor significantly associated with ASAS HI in the nr-axSpA group. In the present cohort study, patients with AS had poorer health status (higher ASAS HI) than those with nr-axSpA. Items proposed by AS patients (items No. 1 and 5) were the most frequently checked areas as axSpA patients feel discomfort, and this support that ASAS HI could practically assess actual discomfort of axSpA patient. ASAS HI was well correlated with known disease parameters, including activity, function, and quality of life; therefore, ASAS HI could be used in the future to represent the health status of SpA in a systematic way. Spinal structural damage (higher mSASSS), high NSAID intake, alcohol consumption, and economic status were predictors of ASAS HI in patients with axSpA, especially those with AS.

Project description:BACKGROUND:Although gender differences have been observed in the severity of axial spondyloarthritis (axSpA), gender differences in disease presentation of early axSpA have not been thoroughly investigated. In particular, their impact on the diagnostic process is unknown. METHODS:Baseline data from the SPondyloArthritis Caught Early cohort, which includes patients with chronic back pain (CBP; duration ??3 months and ??2 years, age of onset <?45 years), were analysed. Patients underwent a full diagnostic work-up, including MRI and radiograph of the sacroiliac joints (MRI-SIJ and X-SIJ), to establish a diagnosis of axSpA. Characteristics of male and female patients with a certain diagnosis of axSpA (confidence level by the physician ??7 on a 0-10 rating scale) were compared. Regression models were built for: the whole CBP cohort stratified by gender, to study which SpA features were associated most with diagnosis in each gender; and for axSpA patients, to test whether gender was associated with imaging positivity (MRI-SIJ+ and/or X-SIJ+). RESULTS:Of the 719 CBP patients, 275 were male. With 146/275 males and 155/444 females diagnosed as axSpA, males were more likely to be diagnosed with axSpA (OR 2.1, 95% CI 1.5-2.9). Despite similar symptom duration, male axSpA patients were younger at diagnosis (27.4?±?7.5 vs 29.5?±?7.8 years; p =?0.02). Presence of SpA features was similar in male and female axSpA patients, except for HLA-B27 and imaging positivity that were more common in male axSpA patients (80% vs 60%; p <?0.01 and 78% vs 64%; p =?0.01). Nevertheless, these SpA features were still more prevalent in female axSpA patients than in no-axSpA patients, both females (HLA-B27+ 23%, positive imaging 7%) and males (HLAB27+ 34%, positive imaging 11%) (all p <?0.01). Moreover, in multivariable models with diagnosis of axSpA as outcome, HLA-B27 and imaging positivity were associated with the diagnosis in both sexes. In models with imaging positivity as outcome, male gender and HLA-B27 were both independently associated with MRI+ and/or X-SI+. CONCLUSIONS:While our data show clear gender differences in early axSpA, they highlight that HLA-B27 and imaging are still key elements for diagnosis in both genders. Our study does not suggest that separate diagnostic strategies for men and women are required.

Project description:Clinical assessment of spinal impairment in Axial Spondyloarthritis is currently performed using the Bath Ankylosing Spondylitis Metrological Index (BASMI). Despite being appreciated for its simplicity, the BASMI index lacks sensitivity and specificity of spinal changes, demonstrating poor association with radiographical range of motion (ROM). Inertial measurement units (IMUs) have shown promising results as a cost-effective method to quantitatively examine movement of the human body, however errors due to sensor angular drift have limited their application to a clinical space. Therefore, this article presents a wearable sensor protocol that facilitates unrestrained orientation measurements in space while limiting sensor angular drift through a novel constraint-based approach. Eleven healthy male participants performed five BASMI-inspired functional movements where spinal ROM and continuous kinematics were calculated for five spine segments and four spinal joint levels (lumbar, lower thoracic, upper thoracic and cervical). A Bland-Altman analysis was used to assess the level of agreement on range of motion measurements, whilst intraclass correlation coefficient (ICC), standardised error measurement, and minimum detectable change (MDC) to assess relative and absolute reliability. Continuous kinematics error was investigated through root mean square error (RMSE), maximum absolute error (MAE) and Spearman correlation coefficient (?). The overall error in the measurement of continuous kinematic measures was low in both the sagittal (RMSE = 2.1°), and frontal plane (RMSE = 2.3°). ROM limits of agreement (LoA) and minimum detectable change were excellent for the sagittal plane (maximum value LoA 1.9° and MDC 2.4°) and fair for lateral flexion (overall value LoA 4.8° and MDC 5.7°). The reliability analysis showed excellent level of agreement (ICC > 0.9) for both segment and joint ROM across all movements. The results from this study demonstrated better or equivalent accuracy than previous studies and were considered acceptable for application in a clinical setting. The protocol has shown to be a valuable tool for the assessment of spinal ROM and kinematics, but a clinical validation study on Axial Spondyloarthritis patients is required for the development and testing of a novel mobility index.

Project description:BackgroundThe prevalence of axial spondyloarthritis (axSpA) is estimated between 0.15 and 1.2%, with many of those patients experiencing severe fatigue. Current axSpA assessment guidance recommends use of a single-item visual analogue scale for fatigue severity. However, concerns have been raised about the ability of such a limited assessment to identify patients with major fatigue, to detect important change in fatigue or to reflect the multi-dimensional nature of fatigue. The proposed systematic review will identify and evaluate the quality and acceptability of single- and multi-item patient-reported outcome measures (PROMs) used to assess fatigue in axSpA, seeking to make recommendations for the 'best' measures for research and/or clinical practice.Methods/designThe review will seek to include published studies which report evidence of the development and/or measurement and/or practical properties of clearly defined and reproducible measures of fatigue following completion by patients with axSpA. Five major databases will be searched from 1980 to August 2017: MEDLINE (OVID), EMBASE (OVID), PsycINFO (OVID), World of Science and CINAHL. Study methodological quality will be assessed against the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. The measurement and/or practical properties of reviewed measures will be assessed against current international standards. A short list of the 'best'-quality PROMs will be produced. The review will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.DiscussionThis study will provide the first robust and transparent evaluation of patient-reported measures of fatigue used in the axSpA population, synthesising evidence of quality, relevance and acceptability. The review will benefit patients, clinicians, health professionals and researchers wishing to enhance axSpA-fatigue assessment in routine practice, service evaluation and research. The findings will impact future research which seeks to better understand the nature of axSpA fatigue and evaluate the relative benefit of fatigue-management strategies.Systematic review registrationPROSPERO CRD42016042271.

Dataset Information

Clinical characteristics of importance to outcome in patients with axial spondyloarthritis: protocol for a prospective descriptive and exploratory cohort study.

Publications

Clinical characteristics of importance to outcome in patients with axial spondyloarthritis: protocol for a prospective descriptive and exploratory cohort study.

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