Test–retest reliability of outcome measures: data from three trials in radiographic and non-radiographic axial spondyloarthritis

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.

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Female patients with ankylosing spondylitis: analysis of the impact of gender across treatment studies

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2012-202431 ◽

2012 ◽

Vol 72 (7) ◽

pp. 1221-1224 ◽

Cited By ~ 59

Author(s):

Irene E van der Horst-Bruinsma ◽

Debra Jeske Zack ◽

Annette Szumski ◽

Andrew S Koenig

Keyword(s):

Back Pain ◽

Ankylosing Spondylitis ◽

Disease Activity ◽

Outcome Measures ◽

Burden Of Disease ◽

Disease Onset ◽

Female Patients ◽

Patient Reported ◽

Male Patients ◽

The Impact

ObjectivesTo examine the impact (if any) of gender on the clinical, functional and patient-reported outcomes of treatment using data pooled from four controlled clinical trials.MethodsStudy data were pooled from four clinical control trials in which 1283 adult patients with active ankylosing spondylitis (AS) were treated with etanercept, sulfasalazine or placebo. Patients were stratified by gender and analysed for differences/similarities in baseline demographics, disease characteristics, and efficacy in AS outcome measures and safety and discontinuation rates after 12 weeks of therapy.ResultsSignificant baseline differences were observed between 326 female patients compared with 957 male patients. Female patients had an older mean age of disease onset (35.0 vs 31.2 years; p<0.001), shorter mean time of disease duration (7.4 vs 9.5 years; p<0.001) and lower mean baseline C-reactive protein (13.1 vs 20.9 mg/l; p<0.001); a lower proportion was HLA-B27 positive (76.3% vs 85.2%; p<0.001) compared with male patients. Women had significantly (p<0.001) smaller differences in all week 12 efficacy assessments including AS disease activity score (0.87 vs −1.08), Bath AS disease activity index (−19.22 vs −23.41) and Bath AS functional index (−13.89 vs −16.88) relative to men. A similar relationship was observed between women and men in the adjusted mean difference of nocturnal back pain (4.04, 95% CI 0.77 to 7.32; p<0.05), total back pain (3.80, 95% CI 0.77 to 7.32; p<0.05) and patient global assessment (4.79, 95% CI 1.51 to 8.08; p<0.01).ConclusionsWomen had a higher burden of disease and less improvement in AS outcome measures compared with men. This was observed despite women having a later disease onset of shorter duration; the mechanism behind this observation is unclear. Additional research is necessary to better understand female patients with AS and the burden of disease in this population.

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P088 Multidisciplinary working in the management of axial and peripheral spondyloarthritis

Rheumatology ◽

10.1093/rheumatology/keab247.086 ◽

2021 ◽

Vol 60 (Supplement_1) ◽

Author(s):

Tania Gudu ◽

Deepak R Jadon

Keyword(s):

Psoriatic Arthritis ◽

Ankylosing Spondylitis ◽

Disease Activity ◽

Outcome Measures ◽

Activity Index ◽

Diagnostic Delay ◽

Disease Activity Index ◽

Performance Measure ◽

Time Interval ◽

Multidisciplinary Working

Abstract Background/Aims Multidisciplinary (MD) care is essential in the management of patients with spondyloarthritis (SpA), but evidence supporting its effectiveness and benefits in SpA is scarce.The objectives of this review were to describe the characteristics, effectiveness and feasibility of MD working compared to uni-disciplinary approach in studies of patients with SpA. Methods A literature review was conducted according to the PICO framework. We included studies on patients with axial and/or peripheral SpA, and we assessed several outcomes such as diagnosis, treatment, feasibility, disease and patient-related outcomes (Table 1). Results Fifteen articles met the review’s eligibility criteria, including 13 observational studies and two randomised controlled trials. In total 4,312 patients were analysed, including patients with psoriatic arthritis, enteropathic SpA, ankylosing spondylitis, and SpA with anterior uveitis. Most of the studies included a combined clinic encompassing a rheumatologist and another specialist, most commonly a dermatologist or a gastroenterologist, working in tandem according to predefined referral criteria and treatment algorithms. The main outcomes assessed in studies on MD working in SpA, matched with their outcome measures are depicted in Table 1. MD working was reported to lead to better outcomes in all studies, including: better identification and diagnosis of the disease; earlier and more comprehensive treatment approach; and better outcomes for patients in terms of disease activity, physical function, quality of life and patient satisfaction. However, these results are mostly derived from studies with design issues and without a uni-disciplinary care comparator arm. Conclusion Despite the lack of strong and reliable evidence to support its benefits compared to standard care, MD working is an essential part of the care of patients with SpA. Further studies and initiatives should be developed so that the challenges and limits of MD care can be improved upon. P088 Table 1:Outcomes and outcome measures evaluated in studies of multidisciplinary working in spondyloarthritisOutcomesOutcome measuresDiagnosisEarly diagnosisAssessment of SpondyloArthritis Society (ASAS) criteria; New York criteria The Classification Criteria for Psoriatic Arthritis (CASPAR); Moll and Wright criteria Rheumatologist’s / dermatologist’s (clinical) judgment Not defined ("standard diagnostic criteria for inflammatory bowel diseases and rheumatic diseases")Diagnosis delayThe total lag time from joint symptom onset to the first rheumatologic assessment Diagnostic delay: the time interval between the onset of the symptoms and the correct diagnosis being made Physician-related diagnostic delay: the time interval between the initial visit to a physician and the time of diagnosisReclassification of diagnosisNumber of patients, N (%)Disease relatedDisease activityMusculoskeletal: - The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) - The Ankylosing Spondylitis Disease Activity Score- C-reactive protein (ASDAS-CRP) - Disease Activity in PSoriatic Arthritis (DAPSA) Gastroenterology: - Crohn''s disease activity index (CDAI) - the partial Mayo (pMAYO) Psoriasis: - Psoriasis Area Severity Index (PASI)Physical functionBath AS Metrology Index (BASMI) Bath AS Functional Index (BASFI) Bath Ankylosing Spondylitis Patient Global Score (BAS-G) Health Assessment Questionnaire (HAQ)ComorbiditiesPrevalence of diabetes, hypertension, hyperlipidaemia, and current/past smoking statusComplications during FU/ adverse eventsPrevalence of infection and adverse medication effects (i.e., elevated liver function test, headache).TreatmentTherapeutic adjustmentNumber of patients, N (%) having had their treatment changedPatient reported outcomesQuality of lifeInflammatory Bowel Disease Questionnaire (IBDQ) Short Form (SF36) Dermatology Life Quality Index (DLQI) Psoriatic Arthritis Impact of Disease (PsAID-12)Global wellness• HAQ • SF36 • Patient Global Assessment (PGA)Patient global assessmentPGAActivity limitations and participation restrictionsThe Canadian Occupational Performance Measure (COPM)Patient satisfactionSatisfaction questionnaire (developed by the multidisciplinary team)Feasibility/ costsHealth service utilisationquestionnaire developed by the Stanford University School of Medicine with four indicators (outpatient visits, emergency visits, hospitalizations, and hospitalization days) Disclosure T. Gudu: None. D.R. Jadon: None.

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HLA-B27 is associated with reduced disease activity in axial spondyloarthritis

Scientific Reports ◽

10.1038/s41598-021-91829-5 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

James T. Rosenbaum ◽

Michael H. Weisman ◽

Hedley Hamilton ◽

Cassie Shafer ◽

Elin Aslanyan ◽

...

Keyword(s):

Back Pain ◽

Ankylosing Spondylitis ◽

Disease Activity ◽

Axial Spondyloarthritis ◽

Activity Index ◽

Disease Activity Index ◽

Medical Decision ◽

Hla B27 ◽

Chi Square ◽

The Difference

AbstractHLA-B27 is associated with increased susceptibility and disease activity of ankylosing spondylitis, but the effect of HLA-B27 on the activity of the broader category now called axial spondyloarthritis (AxSpA) is apparently the opposite. A modified Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was used to assess disease activity among 3435 patients with spondyloarthritis (SpA) who participated in a survey designed to assess the effect of their disease and its treatment on the susceptibility and severity of Covid-19. Chi square testing was used to compare BASDAI scores between HLA-B27 positive and negative subjects. 2836 survey respondents were HLA B27 positive. The average BASDAI for the HLA-B27 negative cohort was 4.92 compared to 4.34 for the HLA-B27 positive subjects. Based on linear regression, a subject’s sex could not fully account for the differing BASDAI score in HLA-B27 negative subjects compared to those who are HLA-B27 positive. The difference between B27 positive and negative subjects was skewed by those with a BASDAI score of one or two. HLA-B27 positive subjects were more than twice as likely to have a BASDAI score of 1 compared to HLA B27 negative subjects and about 60% more likely to have a BASDAI score of 2 (p < 0.0001). HLA-B27 positive subjects have less active spondyloarthritis compared to HLA-B27 negative subjects as measured by a BASDAI score. Our data indicate that patients with mild back pain and a diagnosis of AxSpA are disproportionately HLA-B27 positive. The HLA-B27 test facilitates the diagnosis of axial spondyloarthritis such that patients from a community survey with mild back pain may be disproportionately diagnosed as having AxSpA if they are HLA-B27 positive. The test result likely introduces a cognitive bias into medical decision making and could explain our observations.

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Relationship between disease activity status or clinical response and patient-reported outcomes in patients with non-radiographic axial spondyloarthritis: 104-week results from the randomized controlled EMBARK study

Health and Quality of Life Outcomes ◽

10.1186/s12955-019-1260-4 ◽

2020 ◽

Vol 18 (1) ◽

Author(s):

Maxime Dougados ◽

Désirée van der Heijde ◽

Wen-Chan Tsai ◽

Diego Saaibi ◽

Lisa Marshall ◽

...

Keyword(s):

Back Pain ◽

Ankylosing Spondylitis ◽

Disease Activity ◽

Patient Reported Outcomes ◽

Axial Spondyloarthritis ◽

Analysis Of Covariance ◽

General Fatigue ◽

Composite Indices ◽

Patient Reported ◽

Very High

Abstract Background We assessed the external validity of composite indices Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Assessment in SpondyloArthritis international Society (ASAS) 40 response (ASAS40) by evaluating the correlations between the changes in some patient reported outcomes (PROs) for patients with non-radiographic axial spondyloarthritis (nr-axSpA) and the changes in the scores of the composite indices. Methods This was a post-hoc analysis of data from the EMBARK study in patients with nr-axSpA treated with etanercept. PROs were grouped according to ASDAS status (inactive [< 1.3], low [≥ 1.3 to < 2.1], high [≥ 2.1 to ≤3.5], and very high [> 3.5]), patient achievement of > 50% improvement in BASDAI (BASDAI50 responders), and > 40% improvement in ASAS (ASAS40 responders) at 104 weeks. Analyses were conducted on observed cases available at Week 104. Changes in PROs from Baseline to Week 104 were assessed using analysis of covariance with adjustment for baseline with linear contrast. Results Higher ASDAS disease activity at 104 weeks was associated with lower long-term improvement from baseline in PROs (e.g., total back pain [visual analog scale, cm (95% confidence interval): − 4.58 (− 4.95, − 4.21), − 3.86 (− 4.28, − 3.43), − 2.15 (− 2.68, − 1.61), and 1.30 (− 0.51, 3.12) for inactive, low, high, and very high ASDAS disease activity, respectively; Multidimensional Fatigue Inventory (MFI) general fatigue: − 4.77 (− 5.70, − 3.84), − 2.96 (− 4.04, − 1.87), − 1.00 (− 2.32, 0.31), and 2.14 (− 2.10, 6.38); all p < 0.001)]. BASDAI50 non-responders had less improvement in PROs from Baseline to Week 104 vs. responders (e.g., total back pain: − 1.61 (− 2.05, − 1.18) vs. –4.43 (− 4.69, − 4.18); MFI general fatigue: − 0.01 (− 1.12, 1.09) vs. –4.30 (− 4.98, − 3.62); all p < 0.001). ASAS40 non-responders also had less improvement in PROs from Baseline to Week 104 vs. responders (e.g., total back pain: − 1.91 (− 2.30, − 1.52) vs. –4.75 (− 5.05, − 4.46); MFI general fatigue: − 0.63 (− 1.56, 0.30) vs. –4.64 (− 5.37, − 3.91); all p < 0.001). Conclusion Composite indices are valid for monitoring treatment response and adequately reflect treatment-related changes experienced by patients with nr-axSpA. Trial registration ClinicalTrials.gov identifier: NCT01258738. Registered 9 December 2010.

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Gender Differences in Disease Activity and Impact in Axial Spondyloarthritis

The Journal of Rheumatology ◽

10.3899/jrheum.210564 ◽

2021 ◽

pp. jrheum.210564

Author(s):

Ying-Ying Leung

Keyword(s):

Gender Differences ◽

Back Pain ◽

Ankylosing Spondylitis ◽

Disease Activity ◽

International Society ◽

Axial Spondyloarthritis ◽

Classification Criteria ◽

Inflammatory Back Pain

Ankylosing spondylitis (AS), characterized by inflammatory back pain and sacroiliitis on radiography, was traditionally considered a condition predominant in men. Since the introduction of the 2009 Assessment in Spondyloarthritis international Society classification criteria1 aiming to facilitate earlier classification of cases without radiographic sacroiliitis, more women have been classified as having axial spondyloarthritis (axSpA).

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OP0110 IS VERY EARLY TREATMENT EFFECTIVE? SIX MONTHS RESULTS OF THE PREVAS STUDY, A PLACEBO-CONTROLLED TRIAL WITH ETANERCEPT IN PATIENTS SUSPECTED OF NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.3472 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 72-73

Author(s):

T. Rusman ◽

M. A. C. Van der Weijden ◽

M. T. Nurmohamed ◽

R. B. M. Landewé ◽

J. J. De Winter ◽

...

Keyword(s):

Back Pain ◽

Ankylosing Spondylitis ◽

Disease Activity ◽

Axial Spondyloarthritis ◽

Controlled Trial ◽

High Disease Activity ◽

Study Medication ◽

Hla B27 ◽

Research Support ◽

Mean Compliance

Background:Despite the new classification criteria for non-radiographic axial spondyloarthritis (nr-axSpA) patients according to the Assessment of Spondyloarthritis International Society (ASAS), there are limited data on disease progression in nr-axSpA patients.Objectives:First to assess the improvement in disease activity in patients suspected of nr-axSpA after 16 weeks treatment with Etanercept (ETN) or Placebo (PBO). Second, to assess the changes of active inflammation on MRI of the SI-joints (SIJ) between the ETN and PBO group after 16 and 24 weeks without study medication.Methods:The PrevAS study is a randomized, double blind, placebo-controlled trial with ETN performed in the VU University medical center (VUmc) (EudraCT number 2009-015515-40), with a screening period from 2009 until 2014. Patients suspected of nr-axSpA were included if they had chronic back pain for ≥ 3 months, were ≥ 18 years, fulfilled the Calin criteria of inflammatory back pain and had to be either HLA-B27 positive with at least ≥ 1 Spondyloarthritis (SpA)-feature (as defined by the European Spondyloarthropathy Study Group (ESSG), or HLA-B27 negative with at least ≥ 2 SpA-features and had a high disease activity score (Bath Ankylosing Spondylitis Disease Activity Index ≥ 4) plus insufficient response to at least two NSAIDs. Excluded were patients who fulfilled the modified New York criteria for ankylosing spondylitis, or in case of previous biological use. Included patients were randomly assigned (1:1) for 16 weeks treatment with ETN (N=40) or PBO (N=40) and followed after the treatment period for 24 weeks. The primary endpoint was the number of patients achieving the ASAS20 response at week 16. MRI was performed at baseline, 16 and 24 weeks and scored using the Spondyloarthritis Research Consortium of Canada (SPARCC) index for number of active inflammatory lesions.Results:The majority of included patients was female (63.8%). Patient characteristics, like the presence of the HLA-B27 antigen and number of SpA-features at baseline, were comparable between the ETN and PBO group. Mean compliance to the study medication at sixteen weeks was 72.1%. Longitudinal regression analysis over the first 16 weeks showed a trend towards a three times higher chance to achieve the ASAS20 response in the ETN compared to the PBO group (OR = 3.2, 95% CI [0.6;16.7]p=0.18) (Figure 1). No differences were observed in ASAS20 response at 24 weeks. A positive SPARCC score (SPARCC ≥ 2.5) of the SIJ was observed in the ETN and PBO group in 33.3% (13/39 patients) vs. 30.8% (12/39 patients) at baseline, 16.7% (6/36 patients) vs. 17.5% (7/40 patients) at 16 weeks and 21.9% (7/32 patients) vs. 20.0% (7/35 patients) at 24 weeks, respectively. Increased CRP-levels (CRP_UL ≥ 10.0mg/L) nor a positive SPARCC score at baseline, had significant influence on the ASAS20 response at 16 weeks follow-up. The safety profile was consistent with what is known for ETN in AS.Conclusion:Patients suspected of nr-axSpA with high disease activity showed a trend towards a three times higher chance to achieve the ASAS20 response in the ETN group, compared to the PBO group at 16 weeks, regardless of a raised CRP level or positive MRI-SIJ at baseline.Figure:Acknowledgments:We thank Pfizer for financial support of this investigator initiated study. In addition we want to thank H. Hofman and W.A. ter Wee for practical study support.Disclosure of Interests:Tamara Rusman: None declared, Mignon A.C. van der Weijden: None declared, Michael T Nurmohamed Grant/research support from: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Consultant of: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Speakers bureau: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Robert B.M. Landewé Consultant of: AbbVie; AstraZeneca; Bristol-Myers Squibb; Eli Lilly & Co.; Galapagos NV; Novartis; Pfizer; UCB Pharma, Janneke J. de Winter: None declared, B.J.H. Boden: None declared, Pierre M. Bet: None declared, Camile M.A. van der Bijl: None declared, Conny J. van der Laken: None declared, Irene van der Horst-Bruinsma Grant/research support from: AbbVie, Novartis, Eli Lilly, Bristol-Myers Squibb, MSD, Pfizer, UCB Pharma, Consultant of: AbbVie, Novartis, Eli Lilly, Bristol-Myers Squibb, MSD, Pfizer, UCB Pharma

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Translation, Cross-cultural Adaptation and Validation of Ankylosing Spondylitis Disease Activity Score

Faridpur Medical College Journal ◽

10.3329/fmcj.v14i2.48178 ◽

2020 ◽

Vol 14 (2) ◽

pp. 62-66

Author(s):

Abhijit Datta ◽

Minhaj Rahim Choudhury ◽

Md Abu Shahin ◽

Md Nazrul Islam ◽

Shamim Ahmed ◽

...

Keyword(s):

Ankylosing Spondylitis ◽

Disease Activity ◽

Correlation Coefficient ◽

Internal Consistency ◽

Content Validity ◽

Global Assessment ◽

Disease Activity Score ◽

Activity Score ◽

Retest Reliability ◽

Test Retest Reliability

Ankylosing Spondylitis Disease Activity Score (ASDAS) is a very important tool for measuring disease activity in patients with axial spondyloarthritis (axSpA). This study was aimed to develop a culturally adapted, valid and reliable Bengali version of questionnaire for the ASDAS. The original English ASDAS was translated into Bangla and adapted in the local socio-cultural context, following standard international recommendations. Content validity of the adapted Bangla version was assessed by the item-level & scale level content validity indices (I-CVI & S-CVI). A total 120 patients with axSpA were assessed in the study. For construct validity, correlation between ASDAS with BASDAI, ESR, CRP, Maastricht enthesitis score, physician's global assessment and BASMI was assessed by Spearman's rank correlation coefficient. Internal consistency and test-retest reliability were assessed using Cronbach's alpha coefficient and intraclass correlation coefficient respectively. I-CVI for each item was 1 and S-CVI was 1. ASDAS-ESR and ASDAS-CRP showed strong correlation (Spearman's correlation coefficient >0.5) with BASDAI, ESR, MASES and physician global assessment of disease activity. The scale demonstrated excellent internal consistency (Crohnbach's alpha=0.703) and test-retest reliability (ICC=0.98). The adapted Bangla version of the ASDAS demonstrated acceptable psychometric properties (validity & reliability) in Bangladeshi patients with axSpA. Faridpur Med. Coll. J. Jul 2019;14(2): 62-66

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Reliability, Validity and Responsiveness of Physical Activity Monitors in Patients with Inflammatory Myopathy

Rheumatology ◽

10.1093/rheumatology/keab236 ◽

2021 ◽

Author(s):

Bonny Rockette-Wagner ◽

Didem Saygin ◽

Siamak Moghadam-Kia ◽

Chester Oddis ◽

Océane Landon-Cardinal ◽

...

Keyword(s):

Physical Activity ◽

Construct Validity ◽

Disease Activity ◽

Retest Reliability ◽

Activity Monitors ◽

Muscle Testing ◽

Patient Reported ◽

Physical Activity Monitors ◽

Global Disease Activity ◽

Test Retest Reliability

Abstract Objective Idiopathic inflammatory myopathies (IIM) cause proximal muscle weakness, which affect activities of daily living. Wearable physical activity monitors (PAMs) objectively assess continuous activity with potential clinical usefulness in IIM assessment. We examined the psychometric characteristics for PAM outcomes in IIM. Methods Adult IIM patients were prospectively evaluated (baseline, 3 and 6-months) in an observational study. A waist-worn PAM (ActiGraph GT3X-BT) assessed average step counts/min, peak 1-min cadence, and vector magnitude/min. Validated myositis core set measures (CSM) including manual muscle testing (MMT), physician global disease activity (MD global), patient global disease activity (Pt global), extra-muscular disease activity (Ex-muscular global), HAQ-DI, muscle enzymes, and patient-reported physical function were evaluated. Test-retest reliability, construct validity, and responsiveness were determined for PAM measures and CSM using Pearson correlations and other appropriate analyses. Results 50 adult IIM patients enrolled [mean (SD) age, 53.6 (±14.6); 60% female, 94% Caucasian]. PAM measures showed strong test-retest reliability, moderate-to-strong correlations at baseline with MD global (r=-0.37- -0.48), Pt-global (r=-0.43- -0.61), HAQ-DI (r=-0.47- -0.59) and MMT (r = 0.37–0.52), and strong discriminant validity for categorical MMT and HAQ-DI. Longitudinal association with MD global (r=-0.38- -0.44), MMT (r = 0.50–0.57), HAQ-DI (r=-0.45- -0.55), and functional tests (r = 0.30–0.65) were moderate-to-strong. PAM measures were responsive to MMT improvement (≥10%) and moderate-to-major improvement on ACR/EULAR myositis response criteria. Peak 1-min cadence had the largest effect size and Standardized Response Means (SRMs). Conclusion PAM measures showed promising construct validity, reliability, and longitudinal responsiveness; especially peak 1-min cadence. PAMs provide valid outcome measures for future use in IIM clinical trials.

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THU0395 EFFICACY OF IXEKIZUMAB ON DISEASE ACTIVITY AND QUALITY OF LIFE IN PATIENTS WITH ACTIVE NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS AND OBJECTIVE SIGNS OF INFLAMMATION, STRATIFIED BY BASELINE CRP/SACROILIAC JOINT MRI STATUS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.2027 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 432-433

Author(s):

W. P. Maksymowych ◽

H. Marzo-Ortega ◽

M. Ǿstergaard ◽

L. S. Gensler ◽

J. Ermann ◽

...

Keyword(s):

Ankylosing Spondylitis ◽

Treatment Group ◽

Disease Activity ◽

Sacroiliac Joint ◽

Axial Spondyloarthritis ◽

Physical Component Score ◽

Research Support ◽

Advisory Boards ◽

Sf 36 ◽

Active Sacroiliitis

Background:Ixekizumab (IXE), a high-affinity anti-interleukin-17A monoclonal antibody, is effective in patients (pts) with active non-radiographic axial spondyloarthritis (nr-axSpA), who had elevated C-reactive protein (CRP) and/or active sacroiliitis on magnetic resonance imaging (MRI).1Objectives:To determine if disease activity and patient-reported outcomes at Week 16 were similar between groups after stratifying pts by CRP/sacroiliac joint (SIJ) MRI status at baseline.Methods:COAST-X (NCT02757352) included pts with active nr-axSpA and objective signs of inflammation, i.e. presence of sacroiliitis on MRI (Assessment of Spondyloarthritis International Society [ASAS]/ Outcome Measures in Rheumatology criteria) or elevation of serum CRP (>5.0 mg/L). Pts were randomized 1:1:1 to receive subcutaneous 80 mg IXE every 4 weeks (Q4W) or Q2W, or placebo (PBO). Depending on the baseline values of CRP and MRI SIJ (Spondyloarthritis Research Consortium of Canada [SPARCC] score), pts in the intent-to-treat population (N=239) were divided into 3 subgroups (CRP >5 and MRI ≥2; CRP ≤5 and MRI ≥2; CRP >5 and MRI <2). Logistic regression analysis with treatment, subgroup, and treatment-by-subgroup interaction was used to detect treatment group differences in ASAS40, Ankylosing Spondylitis Disease Activity Score (ASDAS) <2.1 (low disease activity), and Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) responses at Week 16. Analysis of covariance model with baseline value, treatment, subgroup, and treatment-by-subgroup interaction was used to detect the treatment group difference in change from baseline in Short Form-36 physical component score (SF-36 PCS).Results:The proportion of pts achieving ASAS40 (primary endpoint), ASDAS <2.1, and BASDAI50 (secondary endpoints) was higher in IXE treatment groups compared to PBO at Week 16 (Figure 1). The response rates in IXE-treated subjects were higher in all subgroups (CRP >5 and MRI ≥2; CRP ≤5 and MRI ≥2; CRP >5 and MRI <2) without consistent differences in efficacy between the subgroups. Similarly, pts in the IXE groups showed improvement in SF-36 PCS scores (secondary endpoint) versus pts on PBO at Week 16 (Figure 2).Conclusion:Pts with active nr-axSpA and objective signs of inflammation at baseline who were treated with IXE showed an overall improvement in the signs and symptoms of the disease. The efficacy was not different between pts with both elevated CRP and active sacroiliitis on MRI and pts with either elevated CRP or active sacroiliitis on MRI.References:[1]Deodhar A, et al.Lancet.2020.Disclosure of Interests:Walter P Maksymowych Grant/research support from: Received research and/or educational grants from Abbvie, Novartis, Pfizer, UCB, Consultant of: WPM is Chief Medical Officer of CARE Arthritis Limited, has received consultant/participated in advisory boards for Abbvie, Boehringer, Celgene, Eli-Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, UCB, Speakers bureau: Received speaker fees from Abbvie, Janssen, Novartis, Pfizer, UCB., Helena Marzo-Ortega Grant/research support from: Janssen, Novartis, Consultant of: Abbvie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, UCB, Speakers bureau: Abbvie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Takeda, UCB, Mikkel Ǿstergaard Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Merck, and Novartis, Consultant of: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Lianne S. Gensler Grant/research support from: Pfizer, Novartis, UCB, Consultant of: AbbVie, Eli Lilly, GSK, Novartis, UCB, Joerg Ermann Grant/research support from: Boehringer-Ingelheim, Pfizer, Consultant of: Abbvie, Eli Lilly, Janssen, Novartis,Pfizer, Takeda, UCB, Atul Deodhar Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, David Sandoval Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Rebecca Bolce Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Andris Kronbergs Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Soyi Liu Leage Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Gabriel Doridot Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Vladimir Geneus Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Ann Leung: None declared, David Adams Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Martin Rudwaleit Consultant of: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma

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Potential relation of cardiovascular risk factors to disease activity in patients with axial spondyloarthritis

Therapeutic Advances in Musculoskeletal Disease ◽

10.1177/1759720x211033755 ◽

2021 ◽

Vol 13 ◽

pp. 1759720X2110337

Author(s):

Iván Ferraz-Amaro ◽

Javier Rueda-Gotor ◽

Fernanda Genre ◽

Alfonso Corrales ◽

Ricardo Blanco ◽

...

Keyword(s):

Risk Factors ◽

Risk Factor ◽

Ankylosing Spondylitis ◽

Disease Activity ◽

Axial Spondyloarthritis ◽

Multivariable Analysis ◽

Activity Score ◽

Increased Risk ◽

Activity Measurements ◽

Beta Coefficient

Background: Axial spondyloarthritis (axSpA) patients are known to have a higher prevalence of several comorbidities, including, among others, an increased risk of atherosclerosis, hypertension, dyslipidemia, and diabetes. The purpose of the present study was to determine whether the sum of traditional cardiovascular (CV) risk factors is related to disease characteristics, such as disease activity, in patients with axSpA. Methods: A cross-sectional study that encompassed 804 patients with axSpA was conducted. Patients were assessed for the presence of five traditional CV risk factors (diabetes mellitus, dyslipidemia, hypertension, obesity, and smoking status), and disease activity measurements. A multivariable regression analysis was performed to evaluate whether the number of classic CV risk factors was independently associated with specific features of the disease, to include disease activity. Results: A multivariable analysis showed that Ankylosing Spondylitis Disease Activity Score–C reactive protein (ASDAS-CRP) activity score was significantly higher in patients with 1 [beta coefficient 0.3 (95% confidence interval (CI) 0.1–0.5), p = 0.001] and ⩾2 [beta coefficient 0.5 (95% CI 0.3–0.7), p = 0.000] CV risk factors compared with those without CV risk factors. Similarly, patients with 1 [OR 2.00 (95%CI 0.99–4.02), p = 0.053] and ⩾2 [OR 3.39 (95%CI 1.82–6.31), p = 0.000] CV risk factors had a higher odds ratio for the presence of high disease activity compared with the zero CV category. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) activity score was significantly associated with the number of CV risk factors, being higher in patients with more CV risk factors. These relationships showed a CV risk factor-dependent effect being beta coefficients and ORs higher for the effect of ⩾2 over 1 CV risk factor. Conclusion: Among patients with axSpA, as the number of traditional CV risk factors increased, disease activity similarly increases in an independent manner.

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