Clinical performance of the ASAS health index in chinese patients with ankylosing spondylitis and its influencing factors.

OBJECTIVE: The aim of this study was to investigate the status of health-related quality of life in Chinese patients with ankylosing spondylitis (AS) and to analyze factors associated with the Assessment of SpondyloArthritis international Society Health Index (ASAS-HI) in AS and its relationship with disease activity and psychological status. METHODS: A cross-sectional study of 484 patients with AS attending 10 hospitals in China from March 2021 to September 2023 was recruited. The ASAS-HI assessed general health and functional status; the Depression Anxiety Stress Scales (DASS-21) assessed psychological disorders such as anxiety, depression, and stress; and the Functional Assessment of Chronic illness Therapy-Fatigue Scale (FACIT-F) assessed patients' fatigue symptoms; the Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein (ASDAS-CRP), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), and Bath Ankylosing Spondylitis Measurement Index (BASMI) were used to assess patients' disease activity and functional impairment. The correlation between ASAS-HI and the ASDAS, poor psychological status, and fatigue symptoms was observed. Univariate and multivariate logistic regression analyses were used to explore the relevant influencing factors of ASAS-HI. RESULTS: A total of 484 patients were included in this study of whom 162 were in poor health, 139 in moderate health, and 183 in good health. On univariate analysis, disease activity is an important factor affecting ASAS-HI. People with extremely high disease activity (ASDAS ≥ 3.5) had a 12 times elevated risk of having poor health status (OR = 12.53; P < 0.001). Other significant covariates included age ≥ 36 (OR = 1.58; P = 0.015), BMI ≥ 24 kg/m2 (OR = 2.93; P = 0.013), smoke (OR = 1.96; P = 0.002), BASFI (OR = 1.49; P < 0.001), BASMI (OR = 1.22; P < 0.001), fatigue (OR = 6.28; P < 0.001), and bad psychological conditions such as depression (OR = 10.86; P < 0.001), anxiety (OR = 3.88; P < 0.001), and stress (OR = 4.65; P < 0.001). The use of bMARDs is inversely associated with the appearance of adverse health status (OR = 0.54; P = 0.012). There was no significant relationship between HLA-B27 and sex. Multivariable logistic regression showed that higher disease activity (ASDAS ≥ 3.5) (OR = 5.14; P = 0.005), higher scores of BASMI (OR = 1.10; P = 0.009), self-reported depression (OR = 3.68; P = 0.007), and fatigue (OR = 2.76; P < 0.001) were factors associated with adverse health status. CONCLUSION: The health status of AS patients is related to age, BMI, smoking, disease activity, poor psychological status, and fatigue and is influenced by a combination of multiple factors such as emotional state, economic level, pain, and dysfunction. Therefore, clinicians should pay attention to the early assessment of ASAS-HI in order to improve the prognosis of the disease. Key Points •Ankylosing spondylitis (AS) is a chronic inflammatory autoimmune disease with a long course and heavy disease burden, which greatly affects patients' quality of life. Therefore, this study aims to evaluate the health status of ankylosing spondylitis in the Chinese population and its influencing factors. •This is a multi-center cross-sectional study in China, which can better reflect the overall situation of the Chinese population.

Prevalence of spondyloarthritis in inflammatory bowel disease according ASAS and ultrassonography and its correlation with plasma calprotectin.

BACKGROUND: Enteropathic spondyloarthritis is underdiagnosed and inflammatory biomarkers and ultrasonography (US) could be useful for screening inflammatory bowel disease (IBD) patients. The objective of this study was to evaluate the prevalence of spondyloarthritis (SpA) in IBD patients, according to the Assessment of SpondyloArthritis International Society (ASAS) criteria and the correlation of results of US of entheses and joints with plasma calprotectin levels. METHODS: This was an observational cross-sectional study. Patients from the IBD outpatient clinic of a reference center were evaluated according to ASAS criteria classification, results of US of entheses and joints, and inflammatory biomarker measurements (erythrocyte sedimentation rates, C-reactive protein levels, fecal and plasma calprotectin levels). A p value lower than 0.05 was considered significant. RESULTS: A total of 30.5% of the studied sample (n = 118) of patients with IBD presented at least one inflammatory musculoskeletal manifestation. The overall prevalence of enteropathic SpA was 13.55%, with 10.16% axial SpA and 4.23% peripheral SpA according to the ASAS criteria. A total of 42.1% of patients had an MASEI score greater than 18, 35.2% had synovitis, and 14.7% had tenosynovitis on US, increasing the frequency of diagnosis of enteropathic SpA to 22.8%. Plasma calprotectin levels were similar to those in healthy controls, and correlated only with the fecal calprotectin level (p 0.041). CONCLUSIONS: A total of 13.5% of patients met the criteria in accordance with the ASAS criteria for enteropathic SpA, which increased to 22.8% with the addition of US. The prevalence of enthesitis, synovitis and tenosynovitis by US of symptomatic joints and entheses were 42%, 35% and 14.7% respectively. Plasma calprotectin was correlated with fecal calprotectin but not with inflammatory biomarkers or US or ASAS criteria.

Acanthamoeba Sequence Types and Allelic Variations in Isolates from Clinical and Different Environmental Sources in Italy.

The genus Acanthamoeba comprises free-living amoebae distributed in a wide variety of environments. These amoebae are clinically significant, causing opportunistic infections in humans and other animals. Despite this, limited data on Acanthamoeba sequence types and alleles are available in Italy. In the present study, we analyzed all Acanthamoeba sequences deposited from Italy with new positive Acanthamoeba clinical samples from symptomatic AK cases, to provide an overview of the genetic variants' spatial patterns from different sources within the Italian context. A total of 137 Acanthamoeba sequences were obtained. Six sequence types were identified: T2/6, T3, T4, T11, T13, and T15. Only T4 and T15 were found in both sources. The Acanthamoeba T4 sequence type was found to be the most prevalent in all regions, accounting for 73% (100/137) of the Italian samples analyzed. The T4 sequence type demonstrated significant allelic diversity, with 30 distinct alleles from clinical and/or environmental samples. These outcomes enabled a better understanding of the distribution of Acanthamoeba isolates throughout Italy, reaffirming its well-recognized ubiquity. Acanthamoeba isolates analysis from keratitis, together with the environmental strains monitoring, might provide important information on different genotypes spreading. This might be useful to define the transmission pathways of human keratitis across different epidemiological scales.

Prevalence of spondyloarthritis in inflammatory bowel disease according ASAS and ultrassonography and its correlation with plasma calprotectin

Abstract Background Enteropathic spondyloarthritis is underdiagnosed and inflammatory biomarkers and ultrasonography (US) could be useful for screening inflammatory bowel disease (IBD) patients. The objective of this study was to evaluate the prevalence of spondyloarthritis (SpA) in IBD patients, according to the Assessment of SpondyloArthritis International Society (ASAS) criteria and the correlation of results of US of entheses and joints with plasma calprotectin levels. Methods This was an observational cross-sectional study. Patients from the IBD outpatient clinic of a reference center were evaluated according to ASAS criteria classification, results of US of entheses and joints, and inflammatory biomarker measurements (erythrocyte sedimentation rates, C-reactive protein levels, fecal and plasma calprotectin levels). A p value lower than 0.05 was considered significant. Results A total of 30.5% of the studied sample (n = 118) of patients with IBD presented at least one inflammatory musculoskeletal manifestation. The overall prevalence of enteropathic SpA was 13.55%, with 10.16% axial SpA and 4.23% peripheral SpA according to the ASAS criteria. A total of 42.1% of patients had an MASEI score greater than 18, 35.2% had synovitis, and 14.7% had tenosynovitis on US, increasing the frequency of diagnosis of entero- pathic SpA to 22.8%. Plasma calprotectin levels were similar to those in healthy controls, and correlated only with the fecal calprotectin level (p 0.041). Conclusions A total of 13.5% of patients met the criteria in accordance with the ASAS criteria for enteropathic SpA, which increased to 22.8% with the addition of US. The prevalence of enthesitis, synovitis and tenosynovitis by US of symptomatic joints and entheses were 42%, 35% and 14.7% respectively. Plasma calprotectin was correlated with fecal calprotectin but not with inflammatory biomarkers or US or ASAS criteria.

Human Leukocyte Antigen B*27-Negative Spondyloarthritis: Clinical, Serological, and Radiological Features of a Single-Center Cohort.

The strong genetic association between HLA-B*27 and spondyloarthritis (SpA) accounts for about 90% of the susceptibility to axial SpA (axSpA), and the presence of HLA-B*27 is helpful in classifying patients according to the Assessment of SpondyloArthritis International Society (ASAS) classification criteria. However, over the years, other HLA-B alleles have been associated with an increased risk of developing SpA; on this basis, the aim of our study was to describe the demographic, clinical, and radiological characteristics of a cohort of SpA patients who were negative for HLA-B*27. We identified 85 patients with a clinical diagnosis of SpA displaying HLA-B alleles other than HLA-B*27; HLA-B*51 emerged as the most prevalent allele (N = 33, 39%), regardless of the fulfilment of either the axial or the peripheral ASAS criteria. The second most prevalent allele in the full cohort (N = 16, 19%) and in the patients fulfilling either the axial or the peripheral criteria was HLA-B*35. The third most prevalent allele in the full cohort was HLA-B*18 (N = 12, 15%), which was also the second most prevalent allele in the patients fulfilling neither of the two sets of criteria. Overall, the clinical picture was similar across the subgroups fulfilling the different sets of ASAS criteria; however, the patients not fulfilling any ASAS criteria had a higher likelihood of having arthritis compared to the patients fulfilling the axial criteria, whereas the Bath Ankylosing Spondylitis Functional Index was significantly higher in those patients fulfilling the axial criteria compared to those who did not fulfill any criteria. Our results indicate that other HLA alleles, beyond HLA-B*27, could be useful in facilitating SpA diagnosis, particularly in patients with a clinical picture which is consistent with SpA but does not fulfill the ASAS classification criteria.

Altered sleep in axial spondyloarthritis and psoriatic arthritis: Post hoc comparative study based on a sleep-specific question from the ASAS health index.

BACKGROUND AND AIMS: Sleep problems are common in spondyloarthritis (SpA), but the factors associated with them are only partially known. In this study, responses to item #16 from the Assessment of SpondyloArthritis international Society-Health Index (ASAS HI) that explores the sleep category according to the International Classification of Functioning, Disability and Health (ICF) were compared between psoriatic arthritis (PsA) and axial SpA (axSpA). METHODS: Post hoc analysis of a multicentre cross-sectional study included a total of 201 consecutive patients. The prevalence, correlations, and disease factors associated with a positive response to item #16 were analyzed in both SpA populations. RESULTS: Forty-eight/111 (43.2%) patients with axSpA and 42/90 (46.7%) with PsA reported sleep problems. There was a moderate-high correlation between item #16 and the ASAS HI sum score in both populations (r≥.59). In axSpA, poor sleep was associated with disease activity (OR 8.45, p<.001), biological therapy use (OR .24, p<.05) and CRP levels (OR .16, p<.05). In PsA, disturbed sleep was independently associated with disease activity showing a dose-response effect (OR 1.16, p<.001). Taking both populations together, disease severity (OR 6.33, p<.001) and axSpA (OR .50, p<.05) were independently associated with a positive response to item #16. Correlations between the different components of the ASAS HI and item #16 were markedly different in both populations. CONCLUSIONS: A positive response to item #16 was common in both SpA phenotypes. However, the link between inflammatory burden and disturbed sleep was higher in axSpA than in PsA.

Altered sleep in axial spondyloarthritis and psoriatic arthritis: Post hoc comparative study based on a sleep-specific question from the ASAS health index / Alteración del sueño en la espondiloartritis axial y la artritis psoriásica: análisis basado en el índice de salud ASAS

Background and aims: Sleep problems are common in spondyloarthritis (SpA), but the factors associated with them are only partially known. In this study, responses to item #16 from the Assessment of SpondyloArthritis international Society-Health Index (ASAS HI) that explores the sleep category according to the International Classification of Functioning, Disability and Health (ICF) were compared between psoriatic arthritis (PsA) and axial SpA (axSpA). Methods: Post hoc analysis of a multicentre cross-sectional study included a total of 201 consecutive patients. The prevalence, correlations, and disease factors associated with a positive response to item #16 were analyzed in both SpA populations. Results: Forty-eight/111 (43.2%) patients with axSpA and 42/90 (46.7%) with PsA reported sleep problems. There was a moderate–high correlation between item #16 and the ASAS HI sum score in both populations (r≥.59). In axSpA, poor sleep was associated with disease activity (OR 8.45, p<.001), biological therapy use (OR .24, p<.05) and CRP levels (OR .16, p<.05). In PsA, disturbed sleep was independently associated with disease activity showing a dose-response effect (OR 1.16, p<.001). Taking both populations together, disease severity (OR 6.33, p<.001) and axSpA (OR .50, p<.05) were independently associated with a positive response to item #16. Correlations between the different components of the ASAS HI and item #16 were markedly different in both populations. Conclusions: A positive response to item #16 was common in both SpA phenotypes. However, the link between inflammatory burden and disturbed sleep was higher in axSpA than in PsA. (AU)

Antecedente y objetivos: Los problemas del sueño son comunes en la espondiloartritis (SpA), pero los factores asociados a ellos solo se conocen parcialmente. En este estudio, se compararon las respuestas al ítem 16 de ASAS HI (Assessment of SpondyloArthritis International Society-Health Index) que explora la categoría del sueño, de acuerdo a ICF (International Classification of Functioning, Disability and Health) entre artritis psoriásica (PsA) y Spa axial (axSpA). Métodos: El análisis post hoc de un estudio transversal multicéntrico incluyó un total de 201 pacientes consecutivos. Se analizaron en ambas poblaciones de SpA la prevalencia, las correlaciones y los factores de la enfermedad asociados a la respuesta positiva al ítem 16. Resultados: Un total de 48/111 (43,2%) pacientes con axSpA y 42/90 (46,7%) con PsA reportaron problemas del sueño. Existió una correlación de modera a alta entre el ítem 16 y la puntuación acumulada de ASAS HI en ambas poblaciones (r≥0,59). En axSpA, el sueño escaso se asoció a la actividad de la enfermedad (OR 8,45, p<0,001), el uso de terapia biológica (OR 0,24, p<0,05) y los niveles de PCR (OR 0,16, p<0,05). En la PsA, la perturbación del sueño estuvo independientemente asociada a la actividad de la enfermedad, lo cual refleja un efecto dosis-respuesta (OR 1,16, p<0,001). Considerando ambas poblaciones conjuntamente, la severidad de la enfermedad (OR 6,33, p<0,001) y axSpA (OR 0,50, p<0,05) estuvieron asociadas de manera independiente a la respuesta positiva al ítem 16. Las correlaciones entre los diferentes componentes de ASAS HI y del ítem 16 fueron marcadamente diferentes en ambas poblaciones. Conclusiones: La respuesta positiva al ítem 16 fue común en ambos fenotipos de SpA. Sin embargo, el vínculo entre carga inflamatoria y perturbación del sueño fue mayor en axSpA en comparación con PsA. (AU)

Determinants of health-related quality of life and global functioning and health in axSpA, pSpA, and PsA: results from the ASAS-PerSpA study.

OBJECTIVES: We aim to identify determinants of health-related quality of life (HRQoL) and global functioning and health (GH) in axial spondyloarthritis (axSpA), peripheral spondyloarthritis (pSpA), and psoriatic arthritis (PsA). METHODS: ASAS-perSpA study data were analyzed. Models for the three patient groups were performed separately to explore factors associated with HRQoL and GH, assessed by EQ-5D and ASAS-HI, respectively. RESULTS: The analyses included 4185 patients: 2719 with axSpA, 433 with pSpA, and 1033 with PsA.In axSpA, disease activity (DA) (ß=-0.061), physical function (ß=-0.041), female sex (ß=-0.019), and fibromyalgia (ß=-0.068) were associated with worse HRQoL; age (ß = 0.001) and university education (ß = 0.014) with better HRQoL. In pSpA, DA (ß=-0.04) and physical function (ß=-0.054) were associated with worse HRQoL. In PsA, DA (ß=-0.045), physical function (ß=-0.053), axial disease (ß=-0.041), and female sex (ß=-0.028) were associated with worse HRQoL.In axSpA, DA (ß = 0.889), physical function (ß = 0.887), peripheral disease (ß = 0.564), female sex (ß = 0.812) and fibromyalgia (ß = 1.639) were associated with worse GH; age (ß=-0.013) and university education (ß=-0.274) with better GH. In pSpA, physical function (ß = 1.142), and female sex (ß = 1.060) were associated with worse GH; university education (ß=-0.611) with better GH. In PsA, DA (ß = 0.703), physical function (ß = 1.025), axial involvement (ß = 0.659), female sex (ß = 0.924), and fibromyalgia (ß = 1.387) were associated with worse GH; age (ß=-0.024) and university education (ß=-0.856) with better GH. CONCLUSIONS: DA and physical function are major HRQoL and GH determinants across spondyloarthritis types, and clinical characteristics and sociodemographic factors play an important role, highlighting the importance of a holistic approach for individual patients.

Axial Spondyloarthritis: Evolving concepts regarding the disease's diagnosis and treatment.

Spondyloarthritis (SpA) is a chronic inflammatory disease that affects the axial skeleton (axSpA) and/or the peripheral joints (p-SpA) and entheses. The natural history of SpA in the decades of the 80 and 90 s involved a progressive disease with pain, spinal stiffness, ankylosis of the axial skeleton, structural damage of peripheral joints, and a poor prognosis. In the last 20 years, enormous advances in understanding and managing SpA have occurred. With the introduction of the ASAS classification criteria and MRI, early disease recognition is now possible. The ASAS criteria widened the spectrum of SpA to include all the disease phenotypes, such as radiographic (r-axSpA), non-radiographic (nr-axSpA), and p-SpA and extraskeletal manifestations. Nowadays, the treatment of SpA is based on a shared decision between patients and rheumatologists and includes non-pharmacological and pharmacological therapies. Moreover, the discovery of TNFα, IL-17, which play a pivotal role in disease pathophysiology, has revolutionized disease management. Thus, new targeted therapies and many biological agents are now available and used in SpA patients. TNFα inhibitors (TNFi), IL-17, and JAK inhibitors were proven to be efficacious, with an acceptable toxicity profile. Overall, their efficacy and safety are comparable with some differences. Sustained clinical disease remission, low disease activity, improvement of patient's quality of life, and prevention of progression of structural damage, are the results of the above interventions. The concept of SpA has changed in the last 20 years. The disease burden can be ameliorated by early and accurate diagnosis and targeting therapies.

The identification of association between ultrasonographic enthesitis and the ASAS Health Index in patients with axial spondyloarthritis.

This study aimed to evaluate association between the entheseal abnormalities in ultrasound and the Assessment of Spondyloarthritis International Society Health Index (ASAS HI) in patients with axial spondyloarthritis (axSpA). Seventy-four patients with axSpA were enrolled in this study. Ultrasonographic evaluation of entheses was performed by a blinded rheumatologist with the Madrid Sonographic Enthesitis Index (MASEI). The MASEI total score and the MASEI sub-scores (e.g., structural damage and activity scores) were calculated. The ASAS HI and the other SpA tools (e.g., Bath Ankylosing Spondylitis Disease Index, the Ankylosing Spondylitis Disease Activity Score) were used to evaluate patients' health and disease activity. Correlation and multivariate linear regression analyses were performed to assess the relationship between the MASEI and the ASAS HI. The mean score of the ASAS HI was 7.7 ± 4.6. The MASEI total score was calculated as 8.4 ± 6.8, while the mean MASEI-activity was 4.7 ± 3.6 and the mean MASEI-structural damage was 3.8 ± 4.5. There was no correlation between ASAS HI and MASEI total scores (r = 0.11, p = 0.34). However, the ASAS HI had a positive correlation with the MASEI-activity (r = 0.49, p < 0.001) and had a low negative correlation with the MASEI-structural damage (r = - 0.29, p < 0.05). In the linear regression model, the MASEI-activity and MASEI-structural damage were significantly related to the ASAS HI (ß = 0.72 and - 0.58, respectively; R2 = 0.53 p < 0.001). This study reported that the ASAS HI score was more negatively affected by active entheseal lesions rather than structural lesions. We suggest adding the entheses evaluation with ultrasonography to other tools for monitoring the health status of patients with axSpA.

Non-Physical Disease Facets in Spondyloarthritis: An ASAS Health Index-Based Analysis between Psoriatic Arthritis and Axial Spondyloarthritis.

Background: Psychosocial health is a key driver of quality of life (QoL) in axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA), but it is often overlooked in clinical practice. We aimed to analyze this aspect of QoL by using the Assessment of SpA International Society−Health Index (ASAS HI) in both SpA phenotypes. Patients and methods: One hundred and eleven patients with axSpA and 90 with PsA were consecutively recruited from two rheumatology centers. In both populations, the categories of stress handling (ASAS HI items #11 and 17) and emotional functions (ASAS HI item #13) were analyzed based on the International Classification of Functioning, Disability, and Health (ICF). A multivariate regression model was used to analyze the explanatory factors associated with positive responses to these items. Results: Thirty-four of the 90 PsA patients (37.8%) and 37/111 of the patients (33.3%) with axSpA reported a positive response to at least one of the stress-handling items. Compared to the patients with PsA, patients with axSpA were less likely to report stress-handling issues (OR 0.48, p < 0.05). Thirty-one of the 90 PsA patients (34.4%) and 44/111 of the patients (39.6%) with axSpA reported positive responses to item #13. In both groups of SpA patients, disease activity and severity (OR 6.6, p < 0.001) were independently associated with alterations in psychosocial health. Compared with those in the axSpA group, the psychosocial health items were better correlated with each other and with the ASAS HI sum score in the PsA group. Conclusions: Psychosocial health is frequently altered in SpA. Both disease activity and severity are associated with this issue. However, psychosocial factors seem to have a greater impact on QoL in PsA than in axSpA.

Physical activity is associated with physical and global function in patients with axial spondyloarthritis, independent of disease activity.

OBJECTIVES: To investigate whether physical activity is independently associated with physical and global function in patients with axial spondyloarthritis (axSpA), and to analyse the relationship between subtypes of physical activity (work, transport, and recreation) and functional impairment. METHODS: One-hundred-and-eighty-five patients were included. Physical function was assessed using BASFI, and global function was assessed using the ASAS health index (HI). Physical activity was measured using the Global Physical Activity Questionnaire. Levels of physical activity were categorised as low, moderate or high. The associations between levels of physical activity and the BASFI and ASAS HI scores were analysed using multivariate regression analysis. RESULTS: Of the 185 patients, 46, 63 and 76 reported low, moderate and high levels of physical activity, respectively. There was a negative correlation between the BASFI and total physical activity. Multivariate linear regression analysis revealed that a high level of physical activity was independently associated with BASFI after adjusting for age, ASDAS. sacroiliitis and syndesmophyte number (ß (95% CI) =-0.88 (-1.49--0.26); p=0.006). One-hundred-and-forty-six had good global functioning (ASAS HI≤5). Multivariate logistic regression analysis revealed that moderate physical activity was independently associated with good global functioning (OR (95% CI) = 2.82 (1.02-7.86); p = 0.047). Recreational activity, but not work- and transport-related activity, showed a significant relationship with ASAS HI scores (ß (95% CI) =-0.55 (-1.02-0.08); p = 0.023). CONCLUSIONS: Physical activity in those with axSpA is associated independently with physical and global functioning. Among the subtypes of physical activity, recreational activity is related to global functioning.

MALT1 positively relates to Th17 cells, inflammation/activity degree, and its decrement along with treatment reflects TNF inhibitor response in ankylosing spondylitis patients.

BACKGROUND: Mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT1) facilitates CD4+ T-cell differentiation, immune response, inflammation, and osteoclastogenesis. This study aimed to explore the relation between MALT1 and treatment efficacy to tumor necrosis factor inhibitor (TNFi) in ankylosing spondylitis (AS) patients. METHODS: This study recruited 73 AS patients underwent adalimumab treatment. Peripheral blood mononuclear cell (PBMC) was obtained at Week (W) 0, W4, W8, and W12 after treatment initiation; then, MALT1 was measured using RT-qPCR. Furthermore, PBMC and serum at W0 were proposed to flow cytometry and ELISA for Th1 cells, Th17 cells, IFN-γ, and IL-17A levels measurement. Besides, 20 osteoarthritis patients and 20 healthy controls (HCs) were enrolled to detect MALT1. RESULTS: Mucosa-associated lymphoid tissue lymphoma translocation protein 1 expression was higher in AS patients compared with HCs (p < 0.001) and osteoarthritis patients (p < 0.001). Besides, MALT1 expression was positively linked with CRP (p = 0.002), BASDAI (p = 0.026), PGADA (p = 0.040), ASDASCRP (p = 0.028), Th17 cells (p = 0.020), and IL-17A (p = 0.017) in AS patients, but did not relate to other clinical features, Th1 cells or IFN-γ (all p>0.050). MALT1 was decreased along with treatment only in AS patients with ASAS40 response (p < 0.001), but not in those without ASAS40 response (p = 0.064). Notably, MALT1 expression was of no difference at W0 (p = 0.328), W4 (p = 0.280), and W8 (p = 0.080), but lower at W12 (p = 0.028) in AS patients with ASAS40 response compared with those without ASAS40 response. CONCLUSION: Mucosa-associated lymphoid tissue lymphoma translocation protein 1 positively correlates with Th17 cells, inflammatory, and activity degree; meanwhile, its decrement along with treatment reflects the response to TNF inhibitor in AS patients.

When disease extent is not always a key parameter: Management of refractory ulcerative proctitis.

BACKGROUND: Patients with ulcerative proctitis represent a sub-group of ulcerative colitis patients with specific characteristics. Disease-related symptoms, endoscopic findings and patient's personality perspectives create a difficult-to-assess condition in certain cases. OBJECTIVES: To summarize available evidence on the management of refractory ulcerative proctitis and provide insights in treatment options. RESULTS: /Conclusion: Topical therapy plays a central role due to the location of the disease. However, well-established treatment options may become exhausted in a considerable proportion of ulcerative proctitis patients, indicating the need to advance to more potent therapies in order to induce and maintain clinical response and remission in these refractory cases. Systemic corticosteroids, thiopurines, calcineurin inhibitors, biologic agents and small molecules have all been tested with variable success rates. Investigational interventions as well as surgical procedures are kept as the ultimate resort in multi-treatment resistant cases. Identifying early prognostic factors that herald a disabling disease progression will help in optimizing treatment and avoiding surgery.

Poor health and functioning in patients with axial spondyloarthritis during the COVID-19 pandemic and lockdown: REUMAVID study (phase 1).

AIM: To evaluate the overall health and functioning in patients with axial spondyloarthritis (axSpA) and related factors affecting these during the COVID-19 pandemic and lockdown measures. METHODS: Data from 587 axSpA patients participating in the first phase (April-July 2020) of the REUMAVID study who completed the ASAS Health Index (ASAS-HI) were analysed. REUMAVID is a cross-sectional study that collects data through an online survey to assess the impact of the COVID-19 pandemic on patients with rheumatic and musculoskeletal diseases across seven European countries. Poor health was defined as ASAS-HI ⩾ 12. The World Health Organization Five well-being index, self-perceived health status and change in health status during COVID-19 pandemic were evaluated as secondary outcomes. Logistic regression models were used to identify the factors associated with poor health. RESULTS: According to the ASAS-HI, 147 (25.0%) patients reported poor health. Pain and moving around were the main affected categories. In addition, 14.0% reported their self-perceived health status as 'bad' or 'very bad' and 46.8% as worse than before the pandemic. In the multivariate analysis, smoking (OR = 1.98), diabetes (OR = 4.89) and taking painkillers (OR = 2.82) or corticosteroids use (OR = 2.20) were significantly associated with poor health, while engaging in physical activity (OR = 0.54) and being actively employed (OR = 0.48) were inversely associated with this. CONCLUSIONS: During the first wave of the COVID-19 pandemic, one in four axSpA patients reported poor health and functioning, while the self-perceived health status of almost half of these patients worsened. Nonsmoking, physical activity and being employed were associated with better outcomes.

The ASAS Health Index: A New Era for Health Impact Assessment in Spondyloarthritis.

Spondyloarthritis (SpA) encompasses a group of inflammatory rheumatic diseases that share clinical and imaging characteristics as well as a common genetic basis. These diseases can affect 0.20-1.6% of the general population, limiting functioning and affecting the quality of life of patients. Considering the patient perspective in the management of the disease and ensuring patients are sufficiently prepared to participate in decision making is critical to treatment success, as well as for optimal health outcomes. The overall picture of impairments, limitations, and restrictions in activities or social participation for patients with SpA is not adequately assessed in SpA-specific instruments. Therefore, it is important to measure the broader range of impairments that can affect patients with SpA and integrate these into a single measure of overall functioning in daily life. The Assessment of SpondyloArthritis international Society Health Index (ASAS HI) is a recently introduced health instrument for evaluating SpA based on the International Classification of Functioning, Disability and Health (ICF) that could cover a good part of the health metric needs in SpA. This review addresses its origins, measurement properties, and use in routine clinical practice, as well as its prospects for future use.

Efficacy and safety of Fengshi Gutong Capsule in patients with active ankylosing spondylitis: A 4-week randomized controlled, double-blinded, double-dummy trial.

ETHNOPHARMACOLOGICAL RELEVANCE: Fengshi Gutong Capsule (FSGTC) is a traditional Chinese herbal medicine that is composed of seven herbs. It has been widely used for the treatment of joint pain in China. However, the clinical evidence supporting its use in patients with ankylosing spondylitis (AS) is lacking. AIM OF THE STUDY: This study aims to explore the efficacy and safety of FSGTC in the treatment of AS. MATERIALS AND METHODS: This randomized, controlled, double-blinded, double-dummy trial enrolled patients with active AS defined as Bath Ankylosing Spondylitis Disease ActivityIndex (BASDAI) ≥ 4 or Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP) ≥ 2.1. Eligible patients were randomized (1:1:1) into combination group (FSGTC plus imrecoxib), FSGTC group (FSGTC plus imrecoxib placebo) or imrecoxib group (imrecoxib plus FSGTC placebo) over a 4-week treatment. The primary endpoint was the composite outcome measure of the Assessment in Ankylosing Spondylitis 20% (ASAS20) response at week 4. The secondary endpoints included ASDAS-CRP, BASDAI, Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), patient's global assessment of disease activity (PGTA) and safety. RESULTS: Of the 180 randomized patients, 159 patients (88.3%) completed the 4-week treatment. ASAS20 response rate at week 4 was achieved by 27.5% in imrecoxib group, compared with 37.0% in combination group (P > 0.05) and 37.0% in FSGTC group (P > 0.05). In comparison to imrecoxib group, there were significantly greater improvements of ASDAS-CRP and PTGA in combination group and greater improvement of ASDAS-CRP in FSGTC group while the rest of the secondary endpoints shown similar improvement. The incidence of gastrointestinal adverse events in imrecoxib group (15.7%) was significantly higher than that of FSGTC group (1.9%) and without a significant difference to combination group (7.4%). CONCLUSION: FSGTC alone or combined with NSAIDs has therapeutic efficacy in decreasing disease activity of active AS patients and with good gastrointestinal tolerability after 4-week of treatment.

Disease activity indexes might not capture the same disease aspects in males and females with ankylosing spondylitis: A real-world nationwide analysis.

Background: To evaluate gender differences in disease activity and health status (HS) in patients with radiographic axial spondyloarthritis (r-axSpA)/ankylosing spondylitis (AS). Methods: Ancillary analysis of the MIDAS study, an observational, non-interventional, cross-sectional and retrospective multicenter nationwide study to assess disease activity and its relationship with HS in clinical practice. Adult patients with AS diagnosis, fulfilling ASAS and modified New York criteria, treated for ≥3 months upon study inclusion according to clinical practice were included. The primary outcome was "disease control" assessed by the percentage of patients in remission and low disease activity (BASDAI and ASDAS-CRP scores). HS was evaluated using the ASAS health index (ASAS-HI). Patients' responses and characteristics were analyzed by gender. Results: We analyzed 313 patients with AS, 237 (75.7%) males and 76 (24.3%) females. A total of 202 (64.5%) patients had adequate disease control (BASDAI < 4); 69.2% of males [mean (SD) BASDAI 2.9 (2.1)] and 50.0% of females [mean (SD) BASDAI 3.8 (2.4); p = 0.01]. According to ASDAS-CRP, 57.5% of patients were adequately controlled (ASDAS-ID +ASDAS-LDA); 138 (58.2%) males and 42 (55.3%) females. The mean (SD) ASDAS-CRP was 1.9 (1.1); being 1.9 (1.0) in males and 2.0 (1.1) in females. Overall, the impact of AS on HS was low to moderate [mean (SD) ASAS-HI 5.8 (4.4)]; being 5.5 (4.4) for males and 6.8 (4.2) for females (p = 0.02). Conclusion: This study showed a higher proportion of females with AS and active disease using the BASDAI definition. When using the ASDAS-CRP definition these differences by gender were less pronounced. The impact of disease activity on HS appears to be higher in females than males.

Ixekizumab improves spinal pain, function, fatigue, stiffness, and sleep in radiographic axial Spondyloarthritis: COAST-V/W 52-week results.

BACKGROUND: This analysis assessed improvements in patients with radiographic axial spondyloarthritis (r-axSpA) treated with ixekizumab in the Assessment of Spondyloarthritis International Society (ASAS) treatment response domains and additional patient-reported outcomes at 1 year of treatment. METHODS: COAST-V and COAST-W were 52-week, phase 3, randomized controlled trials evaluating the efficacy and safety of ixekizumab in biologic disease-modifying antirheumatic drug (bDMARD)-naïve and tumor necrosis factor inhibitor (TNFi)-experienced patients with radiographic spondyloarthritis, respectively. Patients were treated with 80-mg ixekizumab either every 2 weeks or every 4 weeks. Patient-reported outcomes included Patient Global Disease Activity, Spinal Pain, stiffness as measured by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Questions 5 and 6, function as measured by the Bath Ankylosing Spondylitis Functional Index, fatigue as measured by the Fatigue Numeric Rating Scale and BASDAI question 1, Spinal Pain at Night, and sleep quality as measured by the Jenkins Sleep Evaluation Questionnaire. Mixed-effects models for repeated measures were used to analyze changes from baseline in patient-reported outcomes from weeks 1 to 16, and descriptive statistics were reported from weeks 20 to 52. Analysis of covariance with Scheffé's method was used for the ASAS response association analyses. RESULTS: This study assessed 341 bDMARD-naïve and 316 TNFi-experienced patients in the placebo-controlled blinded treatment dosing period (weeks 1-16) as well as 329 bDMARD-naïve and 281 TNFi-experienced patients in the dose double-blind extended treatment period (weeks 20-52). bDMARD-naïve or TNFi-experienced patients treated with ixekizumab every 2 weeks and every 4 weeks reported improvements in patient global disease activity, spinal pain, function, stiffness, fatigue, spinal pain at night, and sleep quality through week 52. Greater correlations with improvements in all response domains were seen when comparing ASAS40 responders to ASAS20 non-responders (p < 0.001), with up to 10.5-fold greater improvements observed in ASAS40 responses compared with ASAS20 non-responders. Function and fatigue demonstrated the highest values. CONCLUSIONS: Ixekizumab-treated bDMARD-naïve and TNFi-experienced patients with radiographic axial spondyloarthritis achieving ASAS40 reported sustained and consistent improvement in all ASAS response domains and other patient-reported outcomes though week 52, with spinal pain, function, and stiffness as major drivers of the response. TRIAL REGISTRATION: NCT02696785 and NCT02696798 , March 2, 2016.

The ASAS-OMERACT core domain set for axial spondyloarthritis.

BACKGROUND: The current core outcome set for ankylosing spondylitis (AS) has had only minor adaptations since its development 20 years ago. Considering the significant advances in this field during the preceding decades, an update of this core set is necessary. OBJECTIVE: To update the ASAS-OMERACT core outcome set for AS into the ASAS-OMERACT core outcome set for axial spondyloarthritis (axSpA). METHODS: Following OMERACT and COMET guidelines, an international working group representing key stakeholders (patients, rheumatologists, health professionals, pharmaceutical industry and drug regulatory agency representatives) defined the core domain set for axSpA. The development process consisted of: i) Identifying candidate domains using a systematic literature review and qualitative studies; ii) Selection of the most relevant domains for different stakeholders through a 3-round Delphi survey involving axSpA patients and axSpA experts; iii) Consensus and voting by ASAS; iv) Endorsement by OMERACT. Two scenarios are considered based on the type of therapy investigated in the trial: symptom modifying therapies and disease modifying therapies. RESULTS: The updated core outcome set for axSpA includes 7 mandatory domains for all trials (disease activity, pain, morning stiffness, fatigue, physical function, overall functioning and health, and adverse events including death). There are 3 additional domains (extra-musculoskeletal manifestations, peripheral manifestations and structural damage) that are mandatory for disease modifying therapies and important but optional for symptom modifying therapies. Finally, 3 other domains (spinal mobility, sleep, and work and employment) are defined as important but optional domains for all trials. CONCLUSION: The ASAS-OMERACT core domain set for AS has been updated into the ASAS-OMERACT core domain set for axSpA. The next step is the selection of instruments for each domain.