Artificial intelligence improves the diagnosis of human leukocyte antigen (HLA)-B27-negative axial spondyloarthritis based on multi-sequence magnetic resonance imaging and clinical features.

Background: Axial spondyloarthritis (axSpA) is frequently diagnosed late, particularly in human leukocyte antigen (HLA)-B27-negative patients, resulting in a missed opportunity for optimal treatment. This study aimed to develop an artificial intelligence (AI) tool, termed NegSpA-AI, using sacroiliac joint (SIJ) magnetic resonance imaging (MRI) and clinical SpA features to improve the diagnosis of axSpA in HLA-B27-negative patients. Methods: We retrospectively included 454 HLA-B27-negative patients with rheumatologist-diagnosed axSpA or other diseases (non-axSpA) from the Third Affiliated Hospital of Southern Medical University and Nanhai Hospital between January 2010 and August 2021. They were divided into a training set (n=328) for 5-fold cross-validation, an internal test set (n=72), and an independent external test set (n=54). To construct a prospective test set, we further enrolled 87 patients between September 2021 and August 2023 from the Third Affiliated Hospital of Southern Medical University. MRI techniques employed included T1-weighted (T1W), T2-weighted (T2W), and fat-suppressed (FS) sequences. We developed NegSpA-AI using a deep learning (DL) network to differentiate between axSpA and non-axSpA at admission. Furthermore, we conducted a reader study involving 4 radiologists and 2 rheumatologists to evaluate and compare the performance of independent and AI-assisted clinicians. Results: NegSpA-AI demonstrated superior performance compared to the independent junior rheumatologist (≤5 years of experience), achieving areas under the curve (AUCs) of 0.878 [95% confidence interval (CI): 0.786-0.971], 0.870 (95% CI: 0.771-0.970), and 0.815 (95% CI: 0.714-0.915) on the internal, external, and prospective test sets, respectively. The assistance of NegSpA-AI promoted discriminating accuracy, sensitivity, and specificity of independent junior radiologists by 7.4-11.5%, 1.0-13.3%, and 7.4-20.6% across the 3 test sets (all P<0.05). On the prospective test set, AI assistance also improved the diagnostic accuracy, sensitivity, and specificity of independent junior rheumatologists by 7.7%, 7.7%, and 6.9%, respectively (all P<0.01). Conclusions: The proposed NegSpA-AI effectively improves radiologists' interpretations of SIJ MRI and rheumatologists' diagnoses of HLA-B27-negative axSpA.

Four-year real-world experience of secukinumab in a large Italian cohort of axial spondyloarthritis.

Objectives: This study aims to evaluate in a real-life Italian multicenter cohort of axial spondyloarthritis (axSpA) (1) the 4-year effectiveness and safety of secukinumab, (2) the drug retention rate (DRR), and (3) the impact of the line of bDMARDs treatment, subtype of axSpA, and sex on achieving low disease activity (LDA) and very low disease activity (VLDA). Methods: Consecutive axSpA patients receiving secukinumab between 2016 and 2023 were prospectively evaluated. Data on disease characteristics, previous/ongoing treatments, comorbidities, and follow-up duration were collected. Treatment response was evaluated at 6 and 12 months after initiation and yearly up to 48 months (T48). DRR and effectiveness outcomes were evaluated according to bDMARDs treatment, axSpA subtype, and sex. Infections and adverse events (AEs) were recorded. Results: We enrolled 272 patients (48.2% male; median age, 51; 39.7% HLA-B27+; 40.4% nr-axSpA), of whom 30.9% were naïve to secukinumab. Overall, secukinumab yielded improvement in effectiveness outcomes; the naïve patients maintained lower disease activity vs. the non-naïve ones. At T48, the LDA and VLDA rates were higher in naïve patients and in male individuals. Treatment was discontinued in 104 patients due to primary/secondary loss of effectiveness and in 34 patients due to AEs. The DRR at T48 was 67.4% in the whole population, regardless of treatment line, axSpA subtype, and sex. Conclusions: Secukinumab was safe and effective in all axSpA patients irrespective of treatment line, disease subtype, and sex. The patients achieved sustained 4-year remission and DRR.

Elevated type-17 cytokines are present in axial spondyloarthritis stool.

Axial spondyloarthritis (axSpA) is characterized by type-17 immune-driven joint inflammation, and intestinal inflammation is present in around 70% of patients. In this study, we asked whether axSpA stool contained Th17-associated cytokines and whether this related to systemic Th17 activation. We measured stool cytokine and calprotectin levels by ELISA and found that patients with axSpA have increased stool IL-17A, IL-23, GM-CSF, and calprotectin. We further identified increased levels of circulating IL-17A+ and IL-17F+ T-helper cell lymphocytes in patients with axSpA compared to healthy donors. We finally assessed stool metabolites by unbiased nuclear magnetic resonance spectroscopy and found that multiple stool amino acids were negatively correlated with stool IL-23 concentrations. These data provide evidence of type-17 immunity in the intestinal lumen, and suggest its association with microbial metabolism in the intestine.

Assessment of the sacroiliac joint in patients with axial spondyloarthritis via three-dimensional ultrashort echo time magnetic resonance imaging.

Background: Bone erosion in the sacroiliac joint (SIJ) is highly specific for the diagnosis of axial spondyloarthritis (axSpA) and may indicate early disease progression. The 3D ultrashort echo time (3D-UTE) technique excels in providing clear contrast between the articular cartilage and the bone cortex interface. Additionally, it is emerging as a promising quantitative tool for detecting early cartilage changes. Therefore, this study aimed to evaluate the diagnostic performance of 3D-UTE sequences in identifying bone erosion in the SIJ of patients with axSpA and to clarify the potential of cartilage T2* values as a quantitative biomarker for axSpA. Methods: This prospective study employed convenience and consecutive sampling methods to recruit patients diagnosed with axSpA in Peking University Third Hospital who met the Assessment of Spondyloarthritis International Society (ASAS) criteria and also an equal number of healthy volunteers. After providing informed consent, all participants underwent 3D-UTE sequences and conventional T2* mapping of the SIJs. Two radiologists separately interpreted the bone erosion of each SIJ on 3D-UTE sequences. Erosion detection of SIJs via computed tomography (CT) served as the standard of reference. The T2* values of the cartilage were measured and compared, and the diagnostic efficacy of the T2* value for axSpA diagnosis was evaluated. Results: A total of 32 patients and 32 healthy volunteers were included. The 3D-UTE sequence, as separately assessed by two reviewers in terms of its ability to detect erosions, exhibited a notable level of accuracy. For the two reviewers, the respective diagnostic sensitivities were 94.7% and 92.9%, the specificities were 97.4% and 96.5%, positive predictive values were 96.7% and 95.4%, the negative predictive values were 95.9% and 94.5%, the accuracies were 96.2% and 94.9%, and the areas under the curve (AUCs) were 96.1% and 94.7%. For the detection of erosions, the interreader κ value was 0.949. The T2* values of the SIJ cartilage were significantly higher in patients with axSpA than in healthy volunteers. The intraobserver intraclass correlation coefficients (ICCs) for T2* measurements ranged between 80.5% and 82.2%. Meanwhile, the interobserver ICCs for UTE-T2* and gradient echo T2* measurements were 81.5% and 80.8%, respectively. The AUCs of the UTE-T2* values for discriminating patients with axSpA from the healthy volunteers of the two readers were 73.3% and 71.6%, respectively. Conclusions: 3D-UTE sequences can be used as a reliable morphological imaging technique for detecting bone erosion in the SIJ. Additionally, UTE-T2* values of the cartilage may offer a quantitative method for identifying patients with axSpA.

Efficacy and NSAID-sparing effect of secukinumab 150 mg in ankylosing spondylitis: results from phase IV ASTRUM study.

Background: Radiographic axial spondyloarthritis (r-axSpA), formerly known as ankylosing spondylitis (AS), is a chronic, inflammatory rheumatic disease associated with symptoms such as inflammatory back pain, morning stiffness, and arthritis. First-line recommendations for patients with AS include treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for reducing pain and stiffness. Objectives: The objective of our study is to evaluate the efficacy and short-term NSAID-sparing effect of secukinumab in patients with AS currently treated with NSAIDs. Design: We assessed the clinical Assessment of SpondyloArthritis International Society (ASAS20) response to secukinumab and evaluated the extent to which the use of concomitant NSAID can be reduced between weeks 4 and 12 in r-axSpA patients treated with secukinumab 150 mg compared with placebo. Methods: ASTRUM was a prospective 24-week randomized controlled trial of adult patients with active r-axSpA [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ⩾4] who had a documented inadequate response to ⩾2 NSAIDs. Patients were randomized (1:1:1) to initiate treatment with subcutaneous secukinumab 150 mg from either week 0 (group 1), week 4 (group 2), or week 16 (group 3). From week 4 onward, tapering of NSAIDs was allowed in all groups. Results: This study included 211 patients (n = 71, 70, and 70 in groups 1, 2, and 3, respectively). ASAS20 response at week 12 for pooled groups 1 and 2 versus group 3 was 51.1% versus 44.3% (p = 0.35). A higher proportion of patients in groups 1 and 2 achieved ASAS40 and BASDAI50 and showed improvements in other secondary clinical outcomes as compared to group 3 at week 16. More patients in groups 1 and 2 versus group 3 stopped their NSAID intake from baseline through week 16. Conclusion: Treatment with secukinumab improved clinical outcomes and showed a short-term NSAID-sparing effect in patients with r-axSpA, even though the primary endpoint was not met. Trial registration: ClinicalTrials.gov; NCT02763046, EudraCT 2015-004575-74.

An update in the pharmacological management of axial spondyloarthritis.

INTRODUCTION: Significant progress has been made in the diagnosis and management of axial spondyloarthritis (AxSpA) over recent decades. A greater understanding of the immunopathogenesis of the disease has paved the way for the development of targeted treatments. Their efficacy has been demonstrated in randomized controlled trials, meta-analyses and one head-to-head study of biologic DMARDs. Treatment decisions in AxSpA are currently influenced by patient choice, co-morbidity, clinician familiarity and cost. AREAS COVERED: We review the clinical trials that underpin the evidence base for treatments in AxSpA. We also cover the meta-analyses and head-to-head data that seek to support clinicians in personalizing treatment decisions. Further, we discuss the recent international guidelines that provide clinicians with treatment pathways and guidance. EXPERT OPINION: We conclude that treatment decisions in managing both radiographic and non-radiographic AxSpA should be based on shared decision-making with patients, the clinical effectiveness of drug class, co-morbidity and cost. At present, we have limited head-to-head data to prioritize one drug class over another for first-line treatment but can recommend tumor necrosis factor (TNF), interleukin 17 (IL17) and JAK inhibition as being comparable in terms of clinical, structural and patient-reported outcome measures. Further real-world data may guide treatment decision-making in individual patients.

Selective JAK-Inhibitors in Spondyloarthritis.

As our research interest and knowledge increases in the field of Spondyloarthritis, new aspects also emerge as regards to their therapeutic approach. JAK inhibitors (JAKi) are a relatively new treatment option, aiming molecules in the JAK-STAT pathway, which has a leading role in the pathophysiology of both Psoriatic Arthritis and Axial Spondyloarthritis. JAKi exhibit different selectivity towards the four different members of the JAK family (namely JAK1, JAK2, JAK3, and TYK2), possibly reflecting different efficacy and safety profile. Although knowledge is more consolidated for rheumatoid arthritis in which JAKi are being used for more than 10 years, data are still accumulating for PsA/SpA. In this review we aim to present and assess current knowledge about the efficacy of JAKi (with a focus on selective JAKi) in the treatment of patients with SpA and evaluate their safety profile as some concerns may arise around this therapeutic option.

Evaluation of a hybrid telehealth care pathway for patients with axial spondyloarthritis including self-sampling at home: results of a longitudinal proof-of-concept mixed-methods study (TeleSpactive).

Patients with axial spondyloarthritis (axSpA) require close monitoring to achieve the goal of sustained disease remission. Telehealth can facilitate continuous care while relieving scarce healthcare resources. In a mixed-methods proof-of-concept study, we investigated a hybrid telehealth care axSpA pathway in patients with stable disease over 6 months. Patients used a medical app to document disease activity (BASDAI and PtGA bi-weekly, flare questionnaire weekly). To enable a remote ASDAS-CRP (TELE-ASDAS-CRP), patients used a capillary self-sampling device at home. Monitoring results were discussed and a decision was reached via shared decision-making whether a pre-planned 3-month on-site appointment (T3) was necessary. Ten patients completed the study, and eight patients also completed additional telephone interviews. Questionnaire adherence was high; BASDAI (82.3%), flares (74.8%) and all patients successfully completed the TELE-ASDAS-CRP for the T3 evaluation. At T3, 9/10 patients were in remission or low disease activity and all patients declined the offer of an optional T3 on-site appointment. Patient acceptance of all study components was high with a net promoter score (NPS) of +50% (mean NPS 8.8 ± 1.5) for self-sampling, +70% (mean NPS 9.0 ± 1.6) for the electronic questionnaires and +90% for the T3 teleconsultation (mean NPS 9.7 ± 0.6). In interviews, patients reported benefits such as a better overview of their condition, ease of use of telehealth tools, greater autonomy, and, most importantly, travel time savings. To our knowledge, this is the first study to investigate a hybrid approach to follow-up axSpA patients including self-sampling. The positive results observed in this scalable proof-of-concept study warrant a larger confirmatory study.

Increased carotid intima-media thickness in patients with radiographic axial spondyloarthritis compared to controls and associations with markers of inflammation.

OBJECTIVE: There is an increased risk for cardiovascular disease (CVD) in patients with radiographic axial spondyloarthritis (r-axSpA). In this cross-sectional study, we aimed to, overall and stratified by sex, (i) compare ultrasound derived carotid intima media thickness (cIMT), between patients and controls, and (ii) investigate associations between cIMT, clinical disease activity and inflammation-related laboratory markers in patients with r-axSpA. METHOD: In total, 155 patients diagnosed with r-axSpA using the modified New York criteria and 400 controls were included. Bilateral carotid ultrasound, laboratory testing, and questionaries were acquired. Disease-specific assessments were carried out for patients. Linear regression analysis was used to assess associations. RESULTS: Linear regression analyses showed that patients with r-axSpA had increased mean cIMT compared to controls (mean ± SD, 0.8 ± 0.1 mm vs 0.7± 0.1 mm, respectively, unstandardized ß (95% CI) -0.076 (-0.10, -0.052), P < 0.001) adjusted for smoking status and age. Linear regression analyses for patients with r-axSpA showed that only males presented significant associations between cIMT and inflammation-related laboratory markers, white blood cell (WBC) count (mean ± SD, 6.8 ± 1.6 109/L) and monocytes (0.6 ± 0.2 109/L); WBC count (unstandardized ß (95% CI) 0.019 (0.0065, 0.031), P = 0.003, R2 = 0.57) and monocytes (0.13 (0.0047, 0.26), P = 0.041, R2 = 0.55), adjusted for age, smoking status, body mass index, hypertension, dyslipidemia, diabetes mellitus, ASDAS-CRP, and treatment with DMARDs and glucocorticoids. No significant association was found between cIMT and clinical disease activity assessed by ASDAS-CRP. CONCLUSION: Patients with r-axSpA had significantly increased cIMT compared to controls. In male patients, higher WBC and monocyte count were associated with an increase in cIMT suggesting the role of inflammation in the development of atherosclerosis. Key Points •Carotid intima-media thickness was increased in patients with radiographic axial spondyloarthritis compared to controls. •White blood cell and monocyte counts were associated with carotid intima-media thickness in male patients with radiographic axial spondyloarthritis.

How to Monitor Disease Activity of Axial Spondyloarthritis in Clinical Practice.

PURPOSE OF REVIEW: Treatment guided by periodic and quantitative data assessment results in better outcomes compared to using clinical gestalt. While validated generic as well as specific disease activity measures for axial spondyloarthritis (axSpA) are available, there is vast scope to improve their actual utilization in routine clinical practice. In this review, we discuss available disease activity measures for axSpA, describe results from the survey conducted among general rheumatologists as well as Spondyloarthritis Research and Treatment Network (SPARTAN) members about disease activity measurement in daily practice, and discuss ways to improve axSpA disease activity using technological advances. We also discuss the definitions of active disease and target for the treatment of axSpA. RECENT FINDINGS: The 2019 American College of Rheumatology (ACR)/Spondylitis Association of America (SAA)/Spondyloarthritis Research and Treatment Network (SPARTAN) axSpA treatment guidelines conditionally recommend the regular monitoring of disease activity using a validated measure such as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) or Ankylosing Spondylitis Disease Severity Index (ASDAS). Assessment of Spondyloarthritis International Society (ASAS)-European Alliance of Associations for Rheumatology (EULAR) guidelines recommend ASDAS as the most appropriate instrument for the assessment of disease activity, preferably calculated using C-reactive protein (CRP). ASAS has selected a core set of variables which were updated recently and have been endorsed by the Outcome Measures in Rheumatology Clinical Trials (OMERACT) group in order to bring homogeneity in assessment of axSpA. In a recent study, Patient-Reported Outcomes Measurement Information System (PROMIS®) measures were able to discriminate inactive, moderate, and high-very high ASDAS activity groups. A newly developed semi-objective index P4 (pain, physical function, patient global, and physician global) correlates well with BASDAI and ASDAS in axSpA and can also be used for other rheumatic diseases in busy clinical practices. Regular disease activity monitoring is critical for long-term management of axSpA and shared decision-making. The integration of electronic health records and smart devices provides a great opportunity to capture patient-reported data. Automated capture of electronic patient-reported outcome measures (ePROMs) is a highly efficient way and results in consistent regular monitoring and may improve the long-term outcomes. While currently used measures focus only on musculoskeletal symptoms of axSpA, a composite disease activity measure that can also incorporate extra-articular manifestations may provide a better assessment of disease activity.

Malignancy in the Upadacitinib Clinical Trials for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis.

INTRODUCTION: This article aims to describe malignancies in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), or non-radiographic axial spondyloarthritis (nr-axSpA) treated with upadacitinib (UPA) or active comparators. METHODS: This integrated safety analysis includes data from 11 phase 3 UPA trials across RA (6 trials), PsA (2 trials), AS (2 trials; one phase 2b/3), and nr-axSpA (1 trial). Treatment-emergent adverse events (TEAEs) were summarized for RA (pooled UPA 15 mg [UPA15], pooled UPA 30 mg [UPA30], adalimumab 40 mg [ADA], methotrexate monotherapy [MTX]), PsA (pooled UPA15, pooled UPA30, ADA), AS (pooled UPA15), and nr-axSpA (UPA15). TEAEs were reported as exposure-adjusted event rates (events/100 patient-years). RESULTS: Median treatment duration ranged from 1.0 to 4.0 years (with a maximum of 6.6 years in RA). Across treatments and indications, rates of malignancy excluding nonmelanoma skin cancer (NMSC) ranged from 0.2 to 1.1, while NMSC ranged from 0.0 to 1.4. In RA, rates of malignancy excluding NMSC were generally similar between UPA15, UPA30, ADA, and MTX (breast and lung cancer were the most common). In RA and PsA, Kaplan-Meier analyses revealed no differences in event onset of malignancy excluding NMSC with UPA15 versus UPA30 over time. In RA, NMSC rates were higher with UPA30 than UPA15; both UPA15 and UPA30 were higher than ADA and MTX. In PsA, rates of malignancy excluding NMSC and NMSC were generally similar between UPA15, UPA30, and ADA. In AS and nr-axSpA, malignancies were reported infrequently. Few events of lymphoma were reported across the clinical programs. CONCLUSION: Rates of malignancy excluding NMSC were generally similar between UPA15, UPA30, ADA, and MTX and were consistent across RA, PsA, AS, and nr-axSpA. A dose-dependent increased rate of NMSC was observed with UPA in RA. TRIAL REGISTRATION: ClinicaTrials.gov identifier: NCT02706873, NCT02675426, NCT02629159, NCT02706951, NCT02706847, NCT03086343, NCT03104400, NCT03104374, NCT03178487, and NCT04169373.

Pathogenesis, assessment, and management of bone loss in axial spondyloarthritis.

INTRODUCTION: Axial spondyloarthritis (axSpA) presents a complex scenario where both new bone formation in entheseal tissues and significant trabecular bone loss coexist, emphasizing the intricate nature of bone dynamics in this context. METHODS: A search of the literature was conducted to compose a narrative review exploring the pathogenesis, possible assessment methods, and potential management options for axSpA. RESULTS: While chronic systemic and local inflammation contribute to bone loss, the mechanisms behind axSpA-associated bone loss exhibit distinct characteristics influenced by factors like mechanical stress and the gut microbiome. These factors directly or indirectly stimulate osteoclast differentiation and activation through the RANK-RANKL axis, while simultaneously impeding osteoblast differentiation via negative regulation of bone anabolic pathways, including the Wnt signaling pathway. This disruption in the balance between bone-resorbing osteoclasts and bone-forming osteoblasts contributes to overall bone loss in axSpA. Early evaluation at diagnosis is prudent for detecting bone changes. While traditional dual x-ray absorptiometry (DXA) has limitations due to potential overestimation from spinal new bone formation, alternative methods like trabecular bone score (TBS), quantitative CT (QCT), and quantitative ultrasound (QUS) show promise. However, their integration into routine clinical practice remains limited. In addition to approved anti-inflammatory drugs, lifestyle adjustments like regular exercise play a key role in preserving bone health. Tailoring interventions based on individual risk profiles holds potential for mitigating bone loss progression. CONCLUSION: Recognizing the pivotal role of bone loss in axSpA underscores the importance of integrating regular assessments and effective management strategies into clinical practice. Given the multifaceted contributors to bone loss in axSpA, a multidisciplinary approach is essential.

[Multi-sequence relation attention network for diagnosing HLA-B27-negative axial spondyloarthritis].

OBJECTIVE: To develop a new 3D multi-sequence relation attention network for exploring the complementary and correlation information of different magnetic resonance imaging (MRI) modalities and improving the diagnostic performance of HLA-B27-negative axial spondyloarthropathy (axSpA). METHODS: We retrospectively collected T1-weighted imaging (T1WI) and fat suppuration MRI (FS-MRI) data and clinical data of 375 HLA-B27-negative patients from the Third Affiliated Hospital of Southern Medical University (including 164 axSpA and 211 non-axSpA patients) and 49 patients from Nanhai Hospital (including 27 axSpA and 22 non-axSpA patients) between January, 2010 and August, 2021.A 3D relation attention network MSFANet based on multi-sequence MRI was used for automatic diagnosis of axSpA against non-axSpA in these patients.MSFANet consisted of a shallow shared feature learning module and a class-aware feature learning module, and latter module used a 3D multi-sequence relation attention mechanism to refine and fuse multi-sequence MRI features.A hybrid loss function was used to enhance the recognition ability of MSFANet by learning the loss weight coefficients of different branches to improve the classification performance. RESULTS: The experimental results demonstrated that MSFANet outperformed several state-of-the-art fusion algorithms (P<0.05) with AUC, accuracy, sensitivity, and specificity of 0.840, 77.93%, 83.70%, and 70.29% in the internal validation set, and of 0.783, 74.47%, 82.43% and 70.40% in the independent external validation set, respectively.The ablation studies showed that under the same architecture, the fusion model was superior to single-sequence models, which confirmed the effectiveness and necessity of fusing multi-sequence MRI.The visualization results demonstrated that MSFANet could focus on learning information from abnormal areas on MRI during the classification. CONCLUSION: We successfully constructed a 3D deep neural network based on multi-sequence MRI for differential diagnosis of HLA-B27-negative axSpA against nonaxSpA and verified the effectiveness of the multisequence relation attention mechanism for promoting classification performance of the network.

Comparative efficacy and safety of bimekizumab in axial spondyloarthritis: a systematic literature review and network meta-analysis.

OBJECTIVES: To compare the efficacy and safety of bimekizumab 160 mg every 4 weeks, a selective inhibitor of interleukin­17F and 17A, with biologic/targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) in non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS). METHODS: A systematic literature review identified randomised controlled trials until January 2023 for inclusion in Bayesian network meta-analyses (NMAs), including three b/tsDMARDs exposure networks: predominantly-naïve, naïve, and experienced. Outcomes were Assessment of SpondyloArthritis international Society (ASAS)20, ASAS40, and ASAS partial remission (PR) response rates at 12-16 weeks. A safety NMA investigated discontinuations due to any reason and serious adverse events at 12-16 weeks. RESULTS: The NMA included 36 trials. The predominantly-naïve network provided the most comprehensive results. In the predominantly-naïve nr-axSpA analysis, bimekizumab had significantly higher ASAS20 response rates vs secukinumab 150 mg (with loading dose [LD]/without LD), and comparable response rates vs other active comparators. In the predominantly-naïve AS analysis, bimekizumab had significantly higher ASAS40 response rates vs secukinumab 150 mg (without LD), significantly higher ASAS-PR response rates vs secukinumab 150 mg (with LD), and comparable response rates vs other active comparators. Bimekizumab demonstrated similar safety to other b/tsDMARDs. CONCLUSION: Across ASAS outcomes, bimekizumab was comparable to most b/tsDMARDs, including ixekizumab, TNF inhibitors and upadacitinib, and achieved higher response rates vs secukinumab for some ASAS outcomes in predominantly b/tsDMARD-naïve nr-axSpA and AS patients at 12-16 weeks. In a pooled axSpA network, bimekizumab demonstrated comparable safety vs other b/tsDMARDs.

Translation and cross-cultural adaptation of the mSQUASH into Spanish.

BACKGROUND: There is a lack of outcome measures for the assessment of physical activity in patients with axial spondyloarthritis (axSpA). For this matter, the modified Short QUestionnaire to Assess Health (mSQUASH) was developed and validated, originally in Dutch. OBJECTIVE: To translate and cross-culturally adapt the mSQUASH into Spanish and to evaluate the equivalence of the translated version in patients with axSpA. METHODS: The mSQUASH was translated following forward-backward procedure according to the protocol of Beaton. Two bi-lingual translators produced independent forward translations of the mSQUASH into Spanish, and the versions were harmonized in a consensual version. Another translator back translated the synthesized version into Dutch. A scientific committee reached consensus on discrepancies and developed a pre-final version of the questionnaire. The field test with cognitive debriefing involved 10 patients with axSpA with different gender, age, disease duration, educational level and working status. RESULTS: The translation process of the mSQUASH was completed without major issues. The first translation needed several iterations due to small discrepancies in the wording. Back-translation was performed without difficulties, and the scientific committee agreed upon a final version of the questionnaire. Cognitive debriefing showed the Spanish questionnaire to be clear, relevant, understandable and comprehensive. The preliminary version was accepted with minor modifications. CONCLUSIONS: The resulting Spanish version of the mSQUASH showed good linguistic and face validity according to the field test, revealing potential for use in clinical practice and research. In order to conclude the cross-cultural adaptation of the mSQUASH into Spanish, the next step is the assessment of psychometric properties of the Spanish version.

Drug switching in axial spondyloarthritis patients in Germany - a social listening analysis.

Background: Axial spondyloarthritis (axSpA) is a chronic inflammatory disease which primarily affects the axial skeleton resulting in chronic back pain and stiffness. According to the guideline, the first-line treatment includes non-steroidal anti-inflammatory drugs (NSAIDs), conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and non-pharmacological treatment. Second line treatment involves biological disease-modifying antirheumatic drugs (bDMARDs) such as tumour necrosis factor and interleukin-17 inhibitors. Objectives: The aim of this social media listening research project was to analyse switches of medication and the reasons thereof to gain valuable insights into real-life journeys of patients suffering from axSpA. Methods: Publicly available posts in German-speaking disease-specific forums were scanned for disease-specific keywords and commonly used drugs by axSpA patients on the Permea platform. Posts containing at least two key words were selected and switches between medications were manually labelled. A total of 287 scraped posts between 01 July 2010 and 04 Feb 2022 were analysed. Results: The largest group of described medication switches was initially using bDMARDs. Switches to a different bDMARD, termination of medication and switches to glucocorticoids were most frequently named. Patients on NSAIDs switched to glucocorticoids, a different NSAID or bDMARD, whereas patients on csDMARDs most frequently changed to bDMARDs. In all medication groups the main reason for switching was insufficient efficacy and side effects. Additionally, for the medication groups bDMARDs, csDMARDs and corticosteroids, pregnancy and lactation were given as a reason for switching, whereas patients in the NSAID group never mentioned pregnancy and breastfeeding as a reason for switching treatment. Conclusion: Our analysis shows medication switches based on real-life patient experiences shared with peers in a social listening setting. We also show medication switches differing from advised guidelines. Gathering real-life insights into patients' journey dealing with chronic diseases allows us to understand, and thereby improve patient care and treatment.

Student-led clinics and ePROs to accelerate diagnosis and treatment of patients with axial spondyloarthritis: results from a prospective pilot study.

We aimed to investigate (1) student-led clinics and (2) electronic patient-reported outcomes (ePROs) to accelerate diagnosis and treatment of patients with axial spondyloarthritis (axSpA). Patients with suspected axSpA completed an initial student-led clinic visit (T-1) prior to their planned actual rheumatologist visit (T0). Acceleration of patient appointment and NSAID therapy start, availability of diagnostic findings, and treatment response at T0 were evaluated. Beginning at T-1, patients completed electronic BASDAI questionnaires every 2 weeks. Concordance of paper-based and electronic BASDAI was evaluated. Patient acceptance of ePRO reporting and student-led clinics was measured using the net promoter score (NPS). 17/36 (47.2%) included patients were diagnosed with axSpA. Student-led clinics (T-1) significantly accelerated patient appointments by more than 2 months (T0, T-1, p < 0.0001) and axSpA guideline-conform NSAID treatment (p < 0.0001). At T0, diagnostic workup was completed for all patients and 7/17 (41.2%) axSpA patients presented with a clinically important improvement or were in remission. 34/36 (94.4%) patients completed at least 80% of the ePROs between T-1 and T0. Electronic and paper-administered BASDAI correlated well (r = 0.8 p < 0.0001). Student-led clinics and ePROs were well accepted by patients with NPS scores of + 62.0% (mean ± SD 9.2/10.0 ± 0.9) and + 30.5% (mean ± SD 8.0/10.0 ± 1.7), respectively. In conclusion, student-led clinics and ePRO monitoring were well accepted, accelerated diagnostic workup and treatment in patients with axSpA.

Bone marrow edema in the sacroiliac joints is associated with the development of structural lesions at the same anatomical location over time in patients with axial spondyloarthritis.

OBJECTIVE: To assess whether the presence of bone marrow edema (BME) leads to the development of structural lesions at the same anatomical location of the sacroiliac joints (SIJ), and to investigate the association between BME patterns over time and structural lesions in patients with early axial spondyloarthritis (axSpA). METHODS: Patients with axSpA from the DESIR cohort with ≥2 consecutive magnetic resonance imaging (MRI)-SIJ were assessed at baseline, 2 and 5 years. MRI-SIJ images were divided into 8 quadrants. The association between BME and subsequent structural lesions (sclerosis, erosions, fatty lesions, and ankylosis) on MRI in the same quadrant was tested longitudinally. Additionally, patients were grouped according to the pattern of BME evolution across quadrants over time (no BME, sporadic, fluctuating, and persistent). The association between these patterns and 5-year imaging outcomes (eg: ≥5 erosions and/or fatty lesions on MRI-SIJ) was tested. RESULTS: In total, 196 patients were included. BME in each quadrant was associated with sclerosis (OR:1.9 (95%CI: 1.1;3.4)), erosions (1.9 (1.5;2.5)) and fatty lesions (1.9 (1.4;2.6)). Ankylosis was uncommon. There was a gradient between increased level of inflammation and subsequent damage: compared to the 'no BME' pattern, the sporadic (OR (95% CI): 2.1 (1.0;4.5)), fluctuating (OR:5.6(2.2;14.4)) and persistent (OR:7.5(2.8;19.6)) patterns were associated with higher structural damage on MRI-SIJ at 5-years. CONCLUSIONS: In early axSpA, inflammation on MRI-SIJ leads to damage at the quadrant level. The higher the exposure to inflammation across quadrants in the SIJs over time the higher the likelihood of subsequent structural damage, suggesting a cumulative effect.

A mixed methods study to uncover impediments to accurate diagnosis of nonradiographic axial spondyloarthritis in the USA.

INTRODUCTION/OBJECTIVES: Delayed diagnosis of axial spondyloarthritis (axSpA) is well documented; little is known about the diagnostic journey and impediments for US patients with nonradiographic axSpA (nr-axSpA). It is hypothesized that impediments are varied and exist at both the healthcare provider (HCP) and patient levels. This study aims to understand patient experiences and contributors to delayed nr-axSpA diagnosis in the USA. METHOD: Interviews of adults with rheumatologist-diagnosed nr-axSpA, recruited through Spondylitis Association of America outreach and patient panels, and of rheumatologists, explored the diagnostic journey and diagnostic barriers. Emerging themes were further explored in an online patient survey. A multiple logistic regression analysis evaluated the main outcome variable, factors affecting time to nr-axSpA diagnosis. RESULTS: Interviews were conducted with 25 patients and 16 rheumatologists. Survey responses from 186 eligible patients revealed median time from symptom onset to diagnosis of nr-axSpA was 3.25 years. Delayed diagnosis was significantly more likely for women and people in rural areas. Most patients consulted ≥4 different types of HCPs before a rheumatologist and ≥2 rheumatologists before diagnosis. Impediments to timely diagnosis included insidious chronic pain; episodic symptom patterns attributed to activity; symptoms other than chronic lumbosacral back pain requiring medical consultation; and unfamiliarity with and misperceptions about nr-axSpA among HCPs, radiologists, and rheumatologists. CONCLUSIONS: Delayed nr-axSpA diagnosis is common and reflects HCP knowledge gaps and frequent patient presentation with dominant nonaxial symptoms. Targeted HCP education, research into early disease patterns, and interventions sensitive to the broader spectrum of nr-axSpA manifestations are needed to improve timely diagnosis. Key Points • Patients with nr-axSpA often see multiple types of HCPs, and multiple rheumatologists, before receiving a diagnosis. • Both patients and HCPs are unfamiliar with nr-axSpA and its symptoms, lacking understanding that nr-axSpA can occur in young people, females, and those presenting with normal x-rays. • Disease recognition by nonrheumatology HCPs is key for early referral. • Education on cardinal features, epidemiology, burden, and benefits of timely nr-axSpA diagnosis is warranted for HCPs who commonly manage back pain.