Dataset Information

The Prevalence of Non-radiographic Axial Spondyloarthritis Among Patients with Inflammatory Back Pain from Northwest and South Africa: Data from a Noninterventional, Cross-Sectional Study.

ABSTRACT: INTRODUCTION:Information is limited on the prevalence and clinical characteristics of nonradiographic axial spondyloarthritis (nr-axSpA) among patients with inflammatory back pain (IBP) in African countries. A global study estimated the prevalence of nr-axSpA among patients with IBP from 19 countries in Latin America, Europe, Asia, and Africa. This post hoc subset analysis focused on estimating prevalence of nr-axSpA and clinical characteristics among patients with IBP from Northwest Africa (Morocco and Algeria) and South Africa. METHODS:Patients from Northwest Africa and South Africa diagnosed with nr-axSpA according to protocol completed patient-reported outcome measures to assess disease activity and functional limitations, including Ankylosing Spondylitis Disease Activity Score (ASDAS). RESULTS:Of the 206 patients with IBP from Africa (n?=?168, Northwest Africa and n?=?38, South Africa), 33 (16.0%) were diagnosed with nr-axSpA (n?=?26, Northwest Africa and n?=?7, South Africa), corresponding to prevalence rates of 15.5% and 18.4%, respectively. Disease activity per region, measured as mean ASDAS, was 2.4?±?1.4 and 2.4?±?0.9, respectively, based on erythrocyte sedimentation rate and 2.4?±?1.3 and 2.7?±?0.7 based on C-reactive protein. CONCLUSIONS:Although the number of patients available for the analysis was low, it appears that the prevalence of nr-axSpA among patients with IBP is similar between Northwest and South Africa, and the disease burden is substantial. Limited access to magnetic resonance imaging may hinder early detection in these areas, thereby affecting the assessment of prevalence. FUNDING:Pfizer.

SUBMITTER: Shirazy K

PROVIDER: S-EPMC6251850 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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The Prevalence of Non-radiographic Axial Spondyloarthritis Among Patients with Inflammatory Back Pain from Northwest and South Africa: Data from a Noninterventional, Cross-Sectional Study.

Shirazy Khalid K Hajjaj-Hassouni Najia N Hammond Constance C Jones Heather H Ladjouze Rezig Aicha A Pedersen Ron R Vlahos Bonnie B

Rheumatology and therapy 20180802 2

<h4>Introduction</h4>Information is limited on the prevalence and clinical characteristics of nonradiographic axial spondyloarthritis (nr-axSpA) among patients with inflammatory back pain (IBP) in African countries. A global study estimated the prevalence of nr-axSpA among patients with IBP from 19 countries in Latin America, Europe, Asia, and Africa. This post hoc subset analysis focused on estimating prevalence of nr-axSpA and clinical characteristics among patients with IBP from Northwest Afr ...[more]

PMID: 30073631

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Project description:BackgroundThis analysis assessed improvements in patients with radiographic axial spondyloarthritis (r-axSpA) treated with ixekizumab in the Assessment of Spondyloarthritis International Society (ASAS) treatment response domains and additional patient-reported outcomes at 1 year of treatment.MethodsCOAST-V and COAST-W were 52-week, phase 3, randomized controlled trials evaluating the efficacy and safety of ixekizumab in biologic disease-modifying antirheumatic drug (bDMARD)-naïve and tumor necrosis factor inhibitor (TNFi)-experienced patients with radiographic spondyloarthritis, respectively. Patients were treated with 80-mg ixekizumab either every 2 weeks or every 4 weeks. Patient-reported outcomes included Patient Global Disease Activity, Spinal Pain, stiffness as measured by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Questions 5 and 6, function as measured by the Bath Ankylosing Spondylitis Functional Index, fatigue as measured by the Fatigue Numeric Rating Scale and BASDAI question 1, Spinal Pain at Night, and sleep quality as measured by the Jenkins Sleep Evaluation Questionnaire. Mixed-effects models for repeated measures were used to analyze changes from baseline in patient-reported outcomes from weeks 1 to 16, and descriptive statistics were reported from weeks 20 to 52. Analysis of covariance with Scheffé's method was used for the ASAS response association analyses.ResultsThis study assessed 341 bDMARD-naïve and 316 TNFi-experienced patients in the placebo-controlled blinded treatment dosing period (weeks 1-16) as well as 329 bDMARD-naïve and 281 TNFi-experienced patients in the dose double-blind extended treatment period (weeks 20-52). bDMARD-naïve or TNFi-experienced patients treated with ixekizumab every 2 weeks and every 4 weeks reported improvements in patient global disease activity, spinal pain, function, stiffness, fatigue, spinal pain at night, and sleep quality through week 52. Greater correlations with improvements in all response domains were seen when comparing ASAS40 responders to ASAS20 non-responders (p < 0.001), with up to 10.5-fold greater improvements observed in ASAS40 responses compared with ASAS20 non-responders. Function and fatigue demonstrated the highest values.ConclusionsIxekizumab-treated bDMARD-naïve and TNFi-experienced patients with radiographic axial spondyloarthritis achieving ASAS40 reported sustained and consistent improvement in all ASAS response domains and other patient-reported outcomes though week 52, with spinal pain, function, and stiffness as major drivers of the response.Trial registrationNCT02696785 and NCT02696798 , March 2, 2016.

Project description:ObjectivesAim of this study was to assess test-retest reliability of candidate instruments for the mandatory domains of the Assessment of Spondyloarthritis international Society (ASAS)-Outcome Measures in Rheumatology core set for axial spondyloarthritis (axSpA).MethodsScreening and baseline data from COAST-V, COAST-X and RAPID-axSpA was used to evaluate test-retest reliability of each candidate instrument for the mandatory domains (disease activity, pain, morning stiffness, fatigue, physical function, overall functioning and health). A maximum time interval of 28 days between both visits was used for inclusion in this study. Test-retest reliability was assessed by intraclass correlation coefficient (ICC). Bland and Altman plots provided mean difference and 95% limits of agreement, which were used to calculate the smallest detectable change (SDC). Data were analysed for radiographic and non-radiographic axSpA separately.ResultsGood reliability was found for Ankylosing Spondylitis Disease Activity Score (ICC 0.79, SDC 0.6), C reactive protein (ICC 0.72-0.79, SDC 12.3-17.0), Bath Ankylosing Spondylitis Functional Index (ICC 0.87, SDC 1.1) and 36-item Short-Form Health Survey (ICC Physical Component Summary 0.81, SDC 4.7, Mental Component Summary 0.80, SDC 7.3). Moderate reliability was found for Bath Ankylosing Spondylitis Disease Activity Index (ICC 0.72, SDC 1.1), patient global assessment (ICC 0.58, SDC 1.5), total back pain (ICC 0.64, SDC 1.3), back pain at night (ICC 0.67, SDC 1.3), morning stiffness (ICC 0.52-0.63, SDC 1.5-2.2), fatigue (ICC 0.65, SDC 1.3) and ASAS-Health Index (ICC 0.74, SDC 2.5). Reliability and SDC for the radiographic and non-radiographic axSpA subgroups were similar.ConclusionOverall reliability was good, and comparable levels of reliability were found for patients with radiographic and non-radiographic axSpA, even though most instruments were developed for radiographic axSpA. Composite measures showed higher reliability than single-item measures in assessing disease activity in patients with axSpA.

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.

Dataset Information

The Prevalence of Non-radiographic Axial Spondyloarthritis Among Patients with Inflammatory Back Pain from Northwest and South Africa: Data from a Noninterventional, Cross-Sectional Study.

Publications

The Prevalence of Non-radiographic Axial Spondyloarthritis Among Patients with Inflammatory Back Pain from Northwest and South Africa: Data from a Noninterventional, Cross-Sectional Study.

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