Complementary App-Based Yoga Home Exercise Therapy for Patients With Axial Spondyloarthritis: Usability Study.

BACKGROUND: Axial spondyloarthritis (AS) is a chronic inflammatory rheumatic disease characterized by potentially disabling inflammation of the spine and adjacent joints. Regular exercise is a cornerstone of treatment. However, patients with AS currently have little support. YogiTherapy (MaD Lab) is an app developed to support patients with AS by providing instructions for yoga-based home exercise therapy. OBJECTIVE: This study aimed to evaluate the usability and acceptance of the newly designed YogiTherapy app for patients with AS. METHODS: Patients completed the User Version of the Mobile Application Rating Scale (uMARS) and net promoter score (NPS) questionnaires after the app introduction. Wilcoxon Mann-Whitney rank sum test, chi-square test for count data, and correlation analysis were conducted to examine the usability of the app, acceptance, and patient characteristics. RESULTS: A total of 65 patients with AS (33, 51% female; age: mean 43.3, SD 13.6 years) were included in the study from May 2022 to June 2023. Subsequently, the data were analyzed. Usability was rated moderate, with a mean uMARS of 3.35 (SD 0.47) points on a scale from 0 to 5. The highest-rated uMARS dimension was information (mean 3.88, SD 0.63), followed by functionality (mean 3.84, SD 0.87). Females reported a significantly higher uMARS total score than males (mean 3.47, SD 0.48 vs mean 3.23, SD 0.45; P=.03, Vargha and Delaney A [VDA] 0.66, 95% CI 0.53-0.77). The mean average of the NPS was 6.23 (SD 2.64) points (on a scale from 0 to 10), based on 43% (26/65 nonpromoters, 42% (25/65) indifferent, and 15% (9/65) promoters. A total of 7% (5/65) of those surveyed did not answer the question. When applying the NPS formula, the result is -26%. The NPS showed a positive correlation with the usage of mobile apps (r=0.39; P=.02). uMARS functionality was significantly higher rated by patients younger than 41 years (mean 4.17, SD 0.55 vs mean 3.54, SD 1; P<.001; VDA 0.69, 95% CI 0.56-0.80). Patients considering mobile apps as useful reported higher uMARS (r=0.38, P=.02). The uMARS app quality mean score was correlated with the frequency of using apps (r=-0.21, P<.001). CONCLUSIONS: The results revealed moderate acceptance and usability ratings, prompting further app improvement. Significant differences were observed between age and gender. Our results emphasize the need for further improvements in YogiTherapy.

Major Determinants of Well-Being in Patients With Axial Spondyloarthritis: 2 Year Follow-Up.

OBJECTIVES: Bath Ankylosing Spondylitis Patient Global Score (BAS-G) is a uni-dimensional scale that enables patients to evaluate the effects of their illness on their health. The aim of this study was to determine the impact of disease related outcomes on the BAS-G scores in patients with axSpA. METHODS: A total of 309 patients (56.6% of whom were male, mean age 44 ± 11) were included in the study. Socio-demographic characteristics (age, sex and education level) and clinical characteristics such as disease activity (BASDAI and CRP), spinal mobility (BASMI), functional status (BASFI), radiographic structural damage (mSASS, mNY, and BASRI-hip), and health related quality of life (SF-36 and ASQoL) of the patients were recorded at baseline. In addition, BASDAI total and each item score, BASFI, BAS-G, and CRP levels were collected at 6, 12, and 24 months. RESULTS: Female patients had significantly higher BAS-G scores (p = 0.037). Baseline BASDAI total score (p < 0.001) and all BASDAI item scores (p < 0.001 for each item), BASFI total score (p < 0.001), ASQoL total score (p < 0.001), and SF-36 PCS sum-score (p < 0.001) were moderately/highly correlated with BAS-G. Multivariate analysis revealed that back pain (BASDAI Q2) (p < 0.001) and the severity of morning stiffness (BASDAI Q5) (p < 0.001) were the main determinants of BAS-G in patients with axSpA. In 2-year follow-up, BASDAI Q1, BASDAI Q5, and BASFI scores were independent determinants of BAS-G in patients with axSpA. CONCLUSION: According to the results of the present study, patients with axSpA mainly rely on morning stiffness and back pain to determine their global health status. Moreover, fatigue, severity of morning stiffness and function are the determinants of BAS-G during follow-up.

Posture, balance and gait in axial spondyloarthritis: a case-control study.

Axial spondyloarthritis (axSpA) is a chronic inflammatory disease that primarily involves the axial skeleton but may also present with peripheral joint involvement and extra-articular involvement. The present study aims to quantitatively analyze posture, balance, and gait parameters in patients with axSpA and and assess associated factors. This cross-sectional case-control study included 51 axSpA patients (30 males, 21 females; mean age 40.94 ± 10.48 years) and 51 age- and sex-matched healthy controls. In patients with axSpA, the Ankylosing Spondylitis Disease Activity Score CRP, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Bath Ankylosing Spondylitis Functional Index (BASFI), the Bath Ankylosing Spondylitis Metrology Index (BASMI), the Maastrich Ankylosing Spondylitis Enthesitis Score (MASES), and the Ankylosing Spondylitis Quality of Life (ASQoL) scale were used. For postural analysis, DIERS formetric (Diers GmbH, Schlangenbad, Germany) videoraster- stereography device was utilized. HUR SmartBalance BTG4 (HUR-labs Oy, Kokkola, Finland) balance platform was used for postural balance and limit of stability (LOS) measurement. Participants were evaluated using Berg Balance Scale (BBS), Functional Reach Test (FRT) and Timed Up and Go Test (TUG). The Zebris FDM type 3 (Zebris Medical GmbH, Germany) walking platform was used to measure the spatiotemporal parameters of the participants. Comparison of postural parameters showed that sagittal imbalance and cervical depth distance were increased in the axSpA group than in the healthy participants (p < 0.004). Comparison of functional balance parameters showed that BBS and FRT scores were significantly lower (p < 0.001) in the axSpA group than in the control group, while TUG scores were significantly higher (p < 0.001). The LOS values, which evaluate dynamic balance were significantly lower, indicating impairment, in the axSpA group. In the measurement of postural sway, which indicates static balance, all 23 subparameters were found to be similar. When analyzing the spatiotemporal gait parameters, in the axSpA group compared with those in the control group; Foot angles (p= 0.028) and stride width (p = 0.004) were increased, whereas step lengths (p = 0.004) and stride lengths (P = 0.004) were decreased. In the axSpA group the gait speed was decreased (p = 0.004). When axSpA was analyzed separately as radiographic and nonradiographic axSpA, similar findings were observed in posture, balance, and gait parameters. No significant difference was observed. We found that the clinical assessments most closely associated with posture, balance, and gait analyses were BBS, FRT, TUG, and BASFI.

Distinct clinical outcomes linked to peripheral arthritis and dactylitis in axial spondyloarthritis: findings from a retrospective Irish cohort.

INTRODUCTION: Axial spondyloarthritis (AxSpA) is a chronic inflammatory condition primarily affecting the axial skeleton. Peripheral features such as peripheral arthritis (PA) and dactylitis are common in AxSpA disease. This study aimed to investigate the independent impact of these manifestations on patient presentation and disease outcomes within an Irish AxSpA cohort. METHODS: 912 Irish AxSpA patients were analyzed in this study. Disease outcomes in patients with and without peripheral arthritis or dactylitis were compared using univariate and multivariate methods. The prevalence of extra-spinal manifestations was further assessed in relation to AxSpA disease duration. RESULTS: 30.2% of patients reported PA, while 6.6% had dactylitis. PA and dactylitis were strongly linked, with 70% of patients presenting with dactylitis also showing features of PA. Psoriasis was more common in both patients with PA (OR 2.2, P < 0.001) and dactylitis (OR 3.38, P < 0.001). Dactylitis, but not PA was strongly linked to uveitis (OR 2.91, P < 0.001) and inflammatory bowel disease (OR 3.15, P < 0.001), while PA was associated with worse patient functioning and reduced quality of life. PA, but not dactylitis was linked with increased AxSpA disease duration. DISCUSSION: Despite high concurrence of PA and dactylitis in AxSpA patients, each manifestation is independently associated with worse outcomes. While some of these overlapped, several outcomes are specific to either PA or dactylitis. Due to its strong association with uveitis and inflammatory bowel disease, an early presentation of dactylitis may represent a unique subset of patients and serve as a valuable predictive marker for the later onset of these conditions.

Diabetes in axial spondyloarthritis: a systematic review and meta-analysis of observational studies.

Axial spondyloarthritis (axSpA) is a chronic inflammatory condition with an increased risk of cardiovascular disease (CVD). Diabetes is a well-established risk factor for CVD and stroke. The objective of this study was to conduct a systematic review to: (i) identify the prevalence of diabetes in axSpA and (ii) compare the risk of diabetes in patients with axSpA and without. A comprehensive literature search was performed for articles published between 1 January 2000 and 15 November 2023 using Medline, Embase and Scopus (PROSPERO: CRD42023482573). Observational studies reporting prevalence, incidence or risk of diabetes in axSpA were included. Search results were independently screened by at least two reviewers. Quality of included studies were assessed using the JBI critical appraisal tool. Study-specific proportions and odds ratios (OR) were combined in a random-effects meta-analysis. 2257 articles were identified from database searching from which 23 studies were included for analysis amounting to a combined sample size of 65 025 patients. The pooled prevalence of diabetes in people with axSpA was 7.0% (95% CI 5.9-8.0%; predictive interval 2.4-12.9%; p < 0.001). The funnel plot was symmetric suggesting no small-study effects (I2 = 98.1% (95% CI 0.05-0.08), τ2 = 0.02; p < 0.001). Comparing patients with axSpA to those without, the pooled OR was 1.29 (95% CI 1.10-1.52; predictive interval 0.76-2.22; p = 0.001) for diabetes. The study suggests an increased prevalence and probably an increased risk of diabetes in people with axSpA. Routine screening for diabetes and lifestyle modifications should be encouraged in this cohort.

Comparison of established and preliminarily proposed ASAS MRI working group cut-offs for inflammatory MRI lesions in the sacroiliac joints in radiographic and non-radiographic axial spondyloarthritis.

BACKGROUND: A consensus definition for active sacroiliitis by MRI, mentioned in the Assessment of SpondyloArthritis International Society (ASAS) classification criteria for axial spondyloarthritis (axSpA), was published in 2009 and included a qualitative and quantitative MRI cut-off component. In 2021, updates to the quantitative component were preliminarily proposed. This post hoc analysis of part A of the phase 3 open-label C-OPTIMISE study (NCT02505542) explores the differences by applying the 2009 and preliminary 2021 inflammatory cut-offs on clinical outcomes of axSpA patients treated with certolizumab pegol. METHODS: Baseline MRI scans were used to classify 657 patients as MRI+ or MRI- according to the quantitative components of the 2009 and preliminary 2021 MRI cut-offs for inflammatory lesions. Clinical outcomes, including ASAS ≥40% improvement (ASAS40), Ankylosing Spondylitis Disease Activity Score and Bath Ankylosing Spondylitis Disease Activity Index, were reported to week 48. RESULTS: Across all analysed outcomes, 2009 MRI+ and preliminary 2021 MRI+ subgroups showed similar results. Notably, clinical outcomes for the discordant group (2009 MRI+but preliminary 2021 MRI- group; 53/657 [8.1%]) were close to those seen in MRI- patients according to either 2009 or preliminary 2021 inflammatory cut-offs, and notably different from the totality of MRI+ subgroups. CONCLUSION: This analysis suggests that the preliminary 2021 cut-offs for MRI inflammatory lesions may slightly increase the specificity of the quantitative part of the 2009 MRI inflammatory lesion definition. The effects of the updated MRI cut-offs need to be assessed on the basis of efficacy outcomes and with the inclusion of aspects of structural changes. TRIAL REGISTRATION NUMBER: NCT02505542.

Rotation or change of biotherapy after TNF blocker treatment failure for axial spondyloarthritis: the ROC-SpA study, a randomised controlled study protocol.

INTRODUCTION: Axial spondyloarthritis (axSpA) is a chronic inflammatory disease characterised by inflammatory low back pain. Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended as a first treatment in axSpA. In case of inadequate response to NSAIDs, biological disease-modifying antirheumatic drugs (bDMARDs) should be introduced according to the recommendations of the European League Against Rheumatism (EULAR) and the American College of Rheumatology. Until 2015, only bDMARD was recommended for axSpA in case of failure to anti-tumour necrosis factor (TNF). The 2022 Assessment of SpondyloArthritis International Society (ASAS)-EULAR recommendation proposed to start an alternative bDMARD but without advocating a switch in mode of action as proposed in rheumatoid arthritis. Since 2015, the inhibition of interleukin (IL)-17 has demonstrated efficacy in axSpA. Then, we designed a randomised multicentre clinical trial to identify the more effective treatment after a first anti-TNF failure in axSpA, comparing an anti-IL-17 to a second anti-TNF. METHODS AND ANALYSIS: The ROC-SpA (Rotation Or Change of biotherapy after first anti-TNF treatment failure in axSpA patients) study is a prospective, randomised, multicentre, superiority open-label phase IV trial comparing an anti-IL-17 strategy (secukinumab or ixekizumab) to a second TNF blocker in a 1:1 ratio. Patients with an active axSpA (Bath Ankylosing Spondylitis Disease Activity Index >4 or ankylosing spondylitis disease activity score (ASDAS) >3.5) with inadequate 3 months response to a first anti-TNF and with a stable dose of conventional synthetic DMARDs, oral corticosteroids and/or NSAIDs for at least 1 month are included in 31 hospital centres in France and Monaco. The primary outcome is the ASAS40 response at week 24. The secondary outcomes are ASAS40 at weeks 12 and 52, other clinical scores (ASAS20, partial remission rate, ASDAS major improvement rate) at weeks 12, 24 and 52 with the drugs and anti-drugs concentrations at baseline, weeks 12, 24 and 52. The primary analysis is performed at the end of the study according to the intent-to-treat principle. ETHICS AND DISSEMINATION: Ethics approval was obtained from the committee for the protection of persons (Comité de protection des personnes Ouest IV #12/18_1, 6 February 2018) and registered in ClinicalTrials.gov and in EudraCT. Results of this study, whether positive or negative, will be presented at national and international congresses, to national axSpA patient associations and published in a peer-reviewed journal. It could also impact the international recommendation to manage patients with axSpA. TRIAL REGISTRATION NUMBER: NCT03445845 and EudraCT2017-004700-22.

Sacroiliac and spine imaging in spondyloarthritis: Does phenotype or sex matter?

BACKGROUND: Spondyloarthritis (SpA) encompasses a spectrum of immune-mediated inflammatory conditions primarily affecting the axial skeleton, including sacroiliitis and spondylitis, each with distinct features. This study aimed to investigate imaging disparities, focusing on sacroiliac magnetic resonance and spine radiography, across phenotypes and between males and females in axial SpA. METHOD: A cross-sectional study was conducted to assess clinical data, laboratory findings, magnetic resonance imaging (MRI) scores of sacroiliac joints using the Spondyloarthritis Research Consortium of Canada (SPARCC) and Sacroiliac Joint Structural Score (SSS), and cervical and lumbar spine radiographs utilizing the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). The study aimed to compare these parameters between two groups: axial spondyloarthritis (axSpA, radiographic and non-radiographic) and axial psoriatic arthritis (axPsA), as well as between males and females. RESULTS: Ninety-four patients were included, with 62 patients in the axSpA group and 32 patients in the axPsA group. There were no differences in disease activity, mobility, radiographic damage in the spine (Modified Stoke Ankylosing Spondylitis Spine Score- mSASSS), or sacroiliac magnetic resonance imaging (MRI) scores (Spondyloarthritis Research Consortium of Canada Magnetic Resonance Imaging Index - SPARCC and Sacroiliac Joint Structural Score - SSS) between the two phenotypes. Regarding sex, in imaging exams, men had higher mSASSS (p = 0.008), SSS (p = 0.001), and fat metaplasia (MG) score based on SSS (p = 0.001), while women had significantly higher SPARCC scores (p = 0.039). In the male group, the presence of HLA-B27 allele had an impact on more structural lesions on MRI (SSS), p = 0.013. CONCLUSION: In this study, imaging of sacroiliac joints and spine in patients with axial SpA did not show differences in phenotypes but did reveal differences based on sex, which may have an impact on future diagnostic recommendations. Further studies are needed to confirm these findings.

Gender differences in clinical features and quality of life of patients with axial spondyloarthritis and psoriatic arthritis.

OBJECTIVE: The aim of the current study was to compare the clinical and treatment characteristics and dimensions of health-related quality of life between female and male patients with axial spondyloarthritis (SpA) and psoriatic arthritis (PsA). METHODS: The present study is cross-sectional and comprises 119 patients with axial SpA and 198 patients with PsA. Clinical data were collected by standardized and self-reported instruments. Disease activity was evaluated by the Ankylosing Spondylitis Disease Activity Score with C-reactive protein and the Disease Activity in PSoriatic Arthritis (for SpA and PsA, respectively). Health-related quality of life was assessed with the Medical Outcomes Study 36-item Short Form Survey. Patients were stratified by gender, and the socio-demographic, clinical, and quality-of-life data were compared. RESULTS: Women with axial SpA and PsA had significantly lower education (p<0.001, p=0.004, respectively) and higher disease activity (p<0.001, p=0.003, respectively). Female patients with axial SpA were more frequently under second-line therapy (p=0.026) and glucocorticoid treatment (p=0.005), while women with PsA had more radiographic progression (p=0.006). Female patients with axial SpA and PsA had worse scores in the dimensions of quality of life regarding physical role, bodily pain, vitality, and mental health. Women with axial SpA had lower scores in general health, while women with PsA had lower scores in physical and social functioning. CONCLUSIONS: Women with axial SpA and PsA had worse scores than men in most clinical and treatment characteristics and health-related quality of life dimensions.

The role of sacro-iliac joint magnetic resonance imaging in the diagnosis of axial spondyloarthritis: focus on differential diagnosis in women.

OBJECTIVE: To review the role of sacro-iliac magnetic resonance imaging (MRI) in the diagnosis of axial spondyloarthritis (AxSpA), with a focus on gender differences. METHODS: The experience of the authors and the results of an informal literature review are reported. RESULTS: Inflammatory changes of the sacro-iliac joint are the hallmark of AxSpA. Early, non-radiographic sacroiliitis may be diagnosed with MRI through the assessment of bone marrow edema (BMO) as well as concomitant structural damage. The MRI protocol should include three necessary sequences, i.e., fat-saturated T2-weighted sequences on two orthogonal planes, T1-weighted semi-coronal sequence, and fat-suppressed T1-weighted semi-coronal sequence. Inflammatory changes comprise required signs (BMO and/or osteitis) and additional signs, including synovitis (better defined as joint space enhancement), enthesitis, and capsulitis. Structural changes consist of erosions, sclerosis, fat metaplasia, and ankylosis. Due to mechanical axial strain, inflammatory changes in the sacro-iliac joint can be found in healthy individuals, runners, and patients with nonspecific low back pain. The prevalence of BMO is higher in women during pregnancy and postpartum, even 12 months after childbirth, but the extent and distribution of MRI findings may help in the differential diagnosis. Other challenges in the MRI diagnosis of sacroiliitis are subchondral T2 hyperintensity during developmental age, periarticular sclerosis in healthy subjects, or osteitis condensans ilii, and several pathological conditions that may mimic AxSpA, some of which are more frequently found in women. CONCLUSIONS: The described diagnostic challenges impose a multidisciplinary approach combining imaging findings with clinical and laboratory data.

The management of axial spondyloarthritis with cutting-edge therapies: advancements and innovations.

INTRODUCTION: Axial involvement in spondyloarthritis has significantly evolved from the original 1984 New York criteria for ankylosing spondylitis, leading to an improved understanding of axial spondyloarthritis (axSpA) as a disease continuum encompassing non- radiographic axSpA (nr-axSpA) and radiographic axSpA (r-axSpA). A clear definition for early axSpA has been established, underscoring the need for early intervention with biological and targeted synthetic drugs to mitigate pain, reduce functional impairment, and prevent radiographic progression. AREAS COVERED: This review explores therapeutic strategies in axSpA management, focusing on biological and targeted synthetic therapies and recent advancements. Biologics targeting TNFα or IL-17 and targeted synthetic disease-modifying antirheumatic drugs (DMARDs) are primary treatment options. These therapies significantly impact clinical outcomes, radiographic progression, and patient-reported functional improvement. EXPERT OPINION: AxSpA treatment has evolved significantly, offering various therapeutic options. Biological DMARDs, particularly TNFα inhibitors, have transformed treatment, significantly enhancing patient outcomes. However, challenges persist for patients unresponsive or intolerant to existing therapies. Emerging therapeutic targets promise to address these challenges. Comprehensive management strategies and personalized approaches, considering extra-articular manifestations and individual patient factors, are crucial for achieving optimal outcomes in axSpA management.

Bone marrow edema detection for diagnostic support of axial spondyloarthritis using MRI.

PURPOSE: This study proposes a process for detecting slices with bone marrow edema (BME), a typical finding of axSpA, using MRI scans as the input. This process does not require manual input of ROIs and provides the results of the judgment of the presence or absence of BME on a slice and the location of edema as the rationale for the judgment. METHODS: First, the signal intensity of the MRI scans of the sacroiliac joint was normalized to reduce the variation in signal values between scans. Next, slices containing synovial joints were extracted using a slice selection network. Finally, the BME slice detection network determines the presence or absence of the BME in each slice and outputs the location of the BME. RESULTS: The proposed method was applied to 86 MRI scans collected from 15 hospitals in Japan. The results showed that the average absolute error of the slice selection process was 1.49 slices for the misalignment between the upper and lower slices of the synovial joint range. The accuracy, sensitivity, and specificity of the BME slice detection network were 0.905, 0.532, and 0.974, respectively. CONCLUSION: This paper proposes a process to detect the slice with BME and its location as the rationale of the judgment from an MRI scan and shows its effectiveness using 86 MRI scans. In the future, we plan to develop a process for detecting other findings such as bone erosion from MR scans, followed by the development of a diagnostic support system.

Analysis of the shorter drug survival times for Janus kinase inhibitors and interleukin-17 inhibitors compared with tumor necrosis factor inhibitors in a real-world cohort of axial spondyloarthritis patients - a retrospective analysis from the RHADAR network.

In recent years Janus kinase inhibitors (JAKi) have joined tumor necrosis factor inhibitors (TNFi) and interleukin (IL)-17 inhibitors (IL-17i) as approved disease modifying anti-rheumatic drugs (DMARD) for moderate to severe forms of axial spondyloarthritis (axSpA). Drug survival in axSpA patients has not been well studied in a real-world outpatient scenario since the approval of JAKi. We aimed to analyze the three drug classes based on modes of actions (MoA) for their persistence rates among German axSpA outpatients. A retrospective analysis of the RHADAR database for axSpA patients with a new initiation of TNFi, IL-17i, or JAKi treatment between January 2015 and October 2023 was conducted. Analyses included Kaplan-Meier curves and adjusted Cox regressions for drug discontinuation. 1222 new biological DMARD (TNFi [n = 954], IL-17i [n = 190]) or JAKi (n = 78) treatments were reported. The median drug survival was 31 months for TNFi, 25 for IL-17i, and 18 for JAKi. The corresponding 2-year drug survival rate was 79.6%, 72.6%, and 62.8% for TNFi, IL-17i, and JAKi, respectively. The probability for discontinuation for JAKi was significantly higher compared with TNFi (HR 1.91 [95% CI 1.22-2.99]) as well as for IL-17i compared with TNFi (HR 1.43 [95% CI 1.02-2.01]), possibly related to more frequent use of TNFis as first-line therapy. IL-17i and JAKi discontinuation probabilities were similar. Primary non-response was the reason for drug discontinuation in most cases across all MoA. TNFi treatment might persist longer than JAKi and IL-17i in German axSpA outpatients, possibly related to more severe or refractory disease in patients with JAKi-treated or IL-17i-treated axSpA.

Patients with axial spondyloarthritis reported willingness to use remote care and showed high adherence to electronic patient-reported outcome measures: an 18-month observational study.

Remote monitoring using electronic patient reported outcomes (ePROs) in axial spondyloarthritis (axSpA) may improve self-management and reduce the need for consultations. However, knowledge regarding patients' willingness to use remote care and adherence to reporting ePROs is scarce. The objective of this study was to assess axSpA patients' willingness to use remote care and adherence to reporting of ePROs. The study was part of a three-armed randomized controlled trial testing digital follow-up strategies (The ReMonit study, NCT: 05031767). AxSpA patients in low disease activity were randomized to usual care, remote monitoring, or patient-initiated care. Demographics, clinical data, and patients' willingness to use remote care were collected at baseline. EPROs were reported either monthly or quarterly by the remote monitoring- and patient-initiated care group over 18 months, respectively. Adherence to reporting was calculated as number of ePROs completed divided by the total number requested. Mixed model logistic regression was utilized to assess factors associated with adherence to reporting of ePROs. In total 242 patients (median age 43 years, 75% males) were included. The majority (96%) reported high willingness to use remote care. Adherence to reporting ePROs remained high over 18 months by remote monitoring and patient-initiated care groups [median (IQR): 88% (77-100) vs. 83% (66-100)]. No patient characteristics were significantly associated with adherence to reporting of ePROs. The high degree of willingness and adherence to reporting ePROs over time indicates that the majority of axSpA patients with low disease activity are motivated to use remote care.

Is vitamin D associated with disease activity in patients with axial or peripheral spondyloarthritis? A real-life study.

Vitamin D plays important role in inflammatory rheumatic diseases, which in turn rose an interest for investigating association of its deficiency with disease activity. In this research we aimed to evaluate this matter in the context of spondyloarthritis (SpA), together with treatment modalities and bone density in people diagnosed with axial or peripheral SpA in real-life setting. In our study we enrolled 99 patients with diagnosis of SpA treated at the tertiary level rheumatology department. Serum 25(OH)D levels, treatment modality (NSAIR or DMARDs), disease activity, tobacco smoking habits, mineral density of bone, supplementation and seasonal variations were assessed. We used standardized questionnaires such as ASDAS-CRP, BASFI and joint count, among many others, to evaluate some of the mentioned parameters. Sixty-five percent of patients had vitamin D deficiency. We found marginaly higher activity of disease in subjects with low vitamin D. In cases of peripheral SpA, there was a significant association of higher number of swollen joints and lower vitamin D levels. Additionally, the significant correlation was seen between normal serum vitamin D and supplementation. In our real-life study of patients with SpA we found a significant percentage of vitamin D deficit, with a tendency of slightly higher disease activity in those patients.In order to clarify the impact of the vitamin on disease activity in SpA and the supplementation recommendations for patients with these conditions, the conduction of further studies is required.

Exploratory analysis of the potential disconnect between objective inflammatory response and clinical response following certolizumab pegol treatment in patients with active axial spondyloarthritis.

INTRODUCTION: This post hoc analysis evaluated the relationship between objective measures of inflammation and clinical outcomes following 12 weeks of certolizumab pegol (CZP) treatment in patients with active axial spondyloarthritis (axSpA). METHODS: We report the proportion of patients achieving ≥50% and ≥75% improvements in clinical composite outcome measures of disease activity (Axial Spondyloarthritis Disease Activity Score [ASDAS], Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]) and objective measures of inflammation (C reactive protein [CRP], Ankylosing Spondylitis spine MRI score [ASspiMRI-a] Berlin score and Spondyloarthritis Research Consortium of Canada [SPARCC] MRI Sacroiliac Joints [SIJ] score) following 12 weeks of CZP treatment. Data from two independent readers over four MRI reading campaigns were pooled using a mixed model with repeated measures for each variable. RESULTS: 136 patients (radiographic axSpA [r-axSpA]: 76; non-radiographic axSpA [nr-axSpA]: 60) were included. Following CZP treatment, CRP, ASspiMRI-a Berlin score and SPARCC SIJ score were reduced by ≥50% in most patients (CRP: 136/136 [100.0%]; Berlin: 73/136 [53.7%]; SPARCC SIJ: 71/136 [52.2%]), and often by ≥75%. Less than half of patients with r-axSpA and nr-axSpA showed ≥50% reduction in clinical responses (BASDAI: 64/136 [47.1%]; ASDAS: 66/136 [48.5%]). These results were also observed at the individual patient level; ≥50% improvements in MRI/CRP inflammatory measures did not translate into similar improvements in clinical responses for most patients. CONCLUSION: There is a potential disconnect between objective measures of inflammation and clinical outcome responses in patients with axSpA. The use of only clinical response measures as trial endpoints may underestimate anti-inflammatory treatment effects. TRIAL REGISTRATION NUMBER: NCT01087762.

The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale in patients with axial spondyloarthritis: psychometric properties and clinically meaningful thresholds for interpretation.

BACKGROUND: Fatigue is an important symptom for most patients with axial spondyloarthritis (axSpA). The FACIT-Fatigue is a 13-item patient-reported outcome (PRO) instrument that has been used in axSpA clinical trials to measure fatigue severity and impact on daily activities. However, the psychometric properties of the FACIT-Fatigue are not fully evaluated across the entire spectrum of axSpA including non-radiographic axSpA (nr-axSpA) and radiographic axSpA (r-axSpA). This study determined: (1) the psychometric properties of the FACIT-Fatigue in nr-axSpA, r-axSpA, and the broad axSpA population and (2) FACIT-Fatigue scores representing meaningful within-patient change (MWPC), meaningful between-group differences, and cross-sectional severity bands. METHODS: Data from two Phase 3 trials in adults with nr-axSpA (BE MOBILE 1; N = 254) and r-axSpA (BE MOBILE 2; N = 332) were analyzed pooled and separately to assess the psychometric properties of the FACIT-Fatigue. MWPC and meaningful between-group difference estimates were derived using anchor-based and distribution-based methods. Cross-sectional fatigue severity bands were estimated using logistic regression analysis. RESULTS: The FACIT-Fatigue presented good internal consistency, adequate convergent and known-groups validity, and was sensitive to change over time across the full axSpA spectrum. A 5-11-point increase in FACIT-Fatigue score was estimated to represent a MWPC, with an 8-point increase selected as the responder definition. A 2.14-5.34-point difference in FACIT-Fatigue score change over a 16-week period was estimated to represent a small-to-medium meaningful between-group difference. FACIT-Fatigue score severity bands were defined as: none or minimal (>40), mild (>30 to ≤40), moderate (>21 to ≤30), and severe (≤21). CONCLUSIONS: These findings support the use of the FACIT-Fatigue as a fit-for-purpose measure to assess fatigue-related treatment benefit in axSpA clinical trials. The proposed score estimates and thresholds can guide FACIT-Fatigue score interpretation across the full axSpA spectrum. TRIAL REGISTRATION: ClinicalTrials.Gov, NCT03928704. Registered 26 April 2019-Retrospectively registered, https://classic. CLINICALTRIALS: gov/ct2/show/NCT03928704 . CLINICALTRIALS: Gov, NCT03928743. Registered 26 April 2019-Retrospectively registered, https://classic. CLINICALTRIALS: gov/ct2/show/NCT03928743 .

Significant overlap of inflammatory and degenerative features on imaging among patients with degenerative disc disease, diffuse idiopathic skeletal hyperostosis and axial spondyloarthritis: a real-life cohort study.

BACKGROUND: Differentiating between degenerative disc disease (DDD), diffuse idiopathic skeletal hyperostosis (DISH), and axial spondyloarthritis (axSpA) represents a diagnostic challenge in patients with low back pain (LBP). We aimed to evaluate the distribution of inflammatory and degenerative imaging features in a real-life cohort of LBP patients referred to a tertiary university rheumatology center. METHODS: In a retrospective cross-sectional analysis of patients referred for LBP, demographics, symptom information, and available imaging were collected. SpA-like changes were considered in the spine in the presence of one of the following lesions typically related to SpA: erosions, sclerosis, squaring, and syndesmophytes on conventional radiographs (CR) and bone marrow oedema (BMO), erosions, sclerosis, and fat lesions (FL) on MRI. SIJ CR were graded per New York criteria; on MRIs, SIJs were evaluated by quadrant for BMO, erosions, FL, sclerosis and ankylosis, similar to the approach used by the Berlin SIJ MRI scoring system. The final diagnosis made by the rheumatologist was the gold standard. Data were presented descriptively, by patient and by quadrant, and compared among the three diagnosis groups. RESULTS: Among 136 referred patients, 71 had DDD, 38 DISH, and 27 axSpA; median age 62 years [IQR55-73], 63% males. On CR, SpA-like changes were significantly higher in axSpA in the lumbar (50%, vs. DDD 23%, DISH 22%), in DISH in the thoracic (28%, vs. DDD 8%, axSpA 12%), and in DDD in the cervical spine (67% vs. DISH 0%, axSpA 33%). On MRI, BMO was significantly higher in DISH in the thoracic (37%, vs. DDD 22%, axSpA 5%) and equally distributed in the lumbar spine (35-42%). FL were significantly more frequently identified in DISH and axSpA in the thoracic (56% and 52%) and DDD and axSpA in the lumbar spine (65% and 74%, respectively). Degenerative changes were frequent in the three groups. Sacroiliitis (NY criteria) was identified in 49% (axSpA 76%, DDD 48%, DISH 29%). CONCLUSION: A significant overlap was found among DDD, DISH, and axSpA for inflammatory and degenerative imaging features. Particularly, SpA-like spine CR features were found in one-fourth of patients with DISH, and MRI BMO was found in one-third of those patients.