Sustained low functional impairment in axial spondyloarthritis (axSpA): which are the primary outcomes that should be targeted to achieve this?

OBJECTIVES: To (i) determine whether sustained disease activity states, as measured by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS), impact function, and (ii) evaluate characteristics predicting sustained low functional impairment in a prospective axial spondyloarthritis (axSpA) cohort. METHODS: Biologic Treatment Registry Across Canada (BioTRAC) was a multi-center, prospective registry that collected real-world data on axSpA patients receiving infliximab or golimumab between 2006 and 2017. Generalized estimating equations (GEE) were used to test baseline characteristics, treatment, and duration (at 6 and 12 months vs. only at 6 or 12 months vs. neither) of low BASDAI (< 3), ASDAS-inactive disease (ID)(< 1.3), and ASDAS-low disease activity (LDA) in predicting sustained low Bath Ankylosing Spondylitis Functional Index (BASFI)(< 3) between 12 and 18 months. The adjusted impact of achieving low disease state at 6 and/or 12 months on BASFI at 18 months was analyzed by generalized linear models. RESULTS: Eight hundred ten patients were enrolled. 33.7%, 13.4%, and 24.7% achieved sustained low BASDAI, ASDAS-ID, and ASDAS-LDA, respectively. In univariable GEE of baseline variables, age and baseline BASDAI, BASFI, and ASDAS significantly predicted sustained low BASFI. In multivariable GEE, sustained low BASDAI (p < 0.001), low BASDAI only at 6 or 12 months (p = 0.001), and baseline BASFI (p < 0.001) were the only predictors of sustained low BASFI. Sustained ASDAS-ID (p = 0.040) and ASDAS-LDA (p < 0.001) were also predictors when forced into the model. Similar results were obtained when evaluating the BASFI score at 18 months. CONCLUSION: Sustained BASDAI < 3 may be a valid and feasible target for a treat-to-target strategy in axSpA having function as treatment goal.

Translation and French Linguistic Validation of the Bath Ankylosing Spondylitis Functional Index and the Bath Ankylosing Spondylitis Global Score in Patients with Axial Spondyloarthritis.

BACKGROUND: Axial spondyloarthritis (axSpA) may lead to functional and physical disturbances. Self-administered questionnaires can measure functional limitations associated to axSpA. If these questionnaires are currently used in clinical practice and research, the French version of these questionnaires has not been validated. The aim of this study was to translate and perform a linguistic validation of the Bath Ankylosing Spondylitis Functional Index (BASFI) and the Bath Ankylosing Spondylitis Global score (BAS-G) in French. METHODS: The study has been approved by local ethic committee and is registered in Clinical Trial (NCT04212806). The translation process was performed through a forward/backward validation process, followed by clinician experts validation and patient cognitive interviews. RESULTS: The two questionnaires were translated into a French version by two independent translators. Translators then agreed on sentences being different between the two translations. The backward translation was equivalent to the initial English version except for two questions. Five French clinician experts on rheumatology made essential changes in sentences constructions of the translated questionnaire. The last version of the questionnaires was presented to 5 patients with axSpA which all found them clear and understandable. CONCLUSION: BASFI and BAS-G would be a generally reliable instrument for patients with axSpA. These questionnaires can be widely used in clinical practice and research in French-speaking population. The use of these questionnaires is expected to have a positive impact on patient care to better understand physical consequences of axSpA.

Generating EQ-5D-5L health utility scores from BASDAI and BASFI: a mapping study in patients with axial spondyloarthritis using longitudinal UK registry data.

BACKGROUND: Preference-based health-state utility values (HSUVs), such as the EuroQol five-dimensional questionnaire (EQ-5D-5L), are needed to calculate quality-adjusted life-years (QALYs) for cost-effectiveness analyses. However, these are rarely used in clinical trials of interventions in axial spondyloarthritis (axSpA). In these cases, mapping can be used to predict HSUVs. OBJECTIVE: To develop mapping algorithms to estimate EQ-5D-5L HSUVs from the Bath Ankylosing Disease Activity Index (BASDAI) and the Bath Ankylosing Spondylitis Functional Index (BASFI). METHODS: Data from the British Society for Rheumatology Biologics Register in Ankylosing Spondylitis (BSRBR-AS) provided 5122 observations with complete BASDAI, BASFI, and EQ-5D-5L responses covering the full range of disease severity. We compared direct mapping using adjusted limited dependent variable mixture models (ALDVMMs) and optional inclusion of the gap between full health and the next feasible value with indirect response mapping using ordered probit (OPROBIT) and generalised ordered probit (GOPROBIT) models. Explanatory variables included BASDAI, BASFI, and age. Metrics to assess model goodness-of-fit and performance/accuracy included Akaike and Bayesian information criteria (AIC/BIC), mean absolute error (MAE) and root mean square error (RMSE), plotting predictive vs. observed estimates across the range of BASDAI/BASFI and comparing simulated data with the original data set for the preferred/best model. RESULTS: Overall, the ALDVMM models that did not formally include the gap between full health and the next feasible value outperformed those that did. The four-component mixture models (with squared terms included) performed better than the three-component models. Response mapping using GOPROBIT (no squared terms included) or OPROBIT (with squared terms included) offered the next best performing models after the three-component ALDVMM (with squared terms). Simulated data of the preferred model (ALDVMM with four-components) did not significantly underestimate uncertainty across most of the range of EQ-5D-5L values, however the proportion of data at full health was underrepresented, likely due in part to model fitting on a small number of observations at this point in the actual data (4%). CONCLUSIONS: The mapping algorithms developed in this study enabled the generation of EQ-5D-5L utilities from BASDAI/BASFI. The indirect mapping equations reported for the EQ-5D-5L facilitate the calculation of the EQ-5D-5L utility scores using other UK and country-specific value sets.

A study protocol for a randomised controlled trial on the efficacy of yoga as an adjuvant therapy for patients with Ankylosing spondylitis amidst COVID-19 pandemic.

Background: Amidst the adversities of the COVID-19 pandemic, the health care system has seen a new paradigm shift towards e-health or telehealth services. In the advent of catering to the geometrically increasing health care needs of the patients suffering from various chronic health conditions when in social isolation, the need for such shifts is paramount. Patients with Ankylosing spondylitis using immunosuppressants with variable degrees of disabilities are at higher risk from this isolated status. This study aims to assess the efficacy of e-Yoga as a treatment option for these patients. Methods: The proposed study is a single-center, parallel-group prospective randomized, open-blinded end-point trial. Patients aged between 30 and 50 years will be recruited from the members of Antardhwani: A society of ankylosing spondylitis based in Ahmedabad, Gujarat. Yoga experts will administer a scientifically developed and validated Yoga module via e-Yoga modalities. A total of 135 patients will be recruited and randomly allocated to Yoga and control groups. Data will be recorded at baseline and three months on disease activity, degree of functional limitations in patients, quality of life, inflammatory biomarkers, depression, and anxiety using Bath AS Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), AS Quality of Life index (ASQOL), C reactive protein (CRP), Erythrocyte sedimentation rate (ESR), Physical health questionnaire-4 (PHQ-4), respectively. Discussion: The study will report the efficacy of e-Yoga in catering to the physical and mental insufficiencies of inpatients with Ankylosing spondylitis amidst COVID-19 pandemic. The study is prospectively registered in the Clinical Trial Registry of India (CTRI/2020/08/027215).

Human motion capture for movement limitation analysis using an RGB-D camera in spondyloarthritis: a validation study.

A human motion capture system using an RGB-D camera could be a good option to understand the trunk limitations in spondyloarthritis. The aim of this study is to validate a human motion capture system using an RGB-D camera to analyse trunk movement limitations in spondyloarthritis patients. Cross-sectional study was performed where spondyloarthritis patients were diagnosed with a rheumatologist. The RGB-D camera analysed the kinematics of each participant during seven functional tasks based on rheumatologic assessment. The OpenNI2 library collected the depth data, the NiTE2 middleware detected a virtual skeleton and the MRPT library recorded the trunk positions. The gold standard was registered using an inertial measurement unit. The outcome variables were angular displacement, angular velocity and lineal acceleration of the trunk. Criterion validity and the reliability were calculated. Seventeen subjects (54.35 (11.75) years) were measured. The Bending task obtained moderate results in validity (r = 0.55-0.62) and successful results in reliability (ICC = 0.80-0.88) and validity and reliability of angular kinematic results in Chair task were moderate and (r = 0.60-0.74, ICC = 0.61-0.72). The kinematic results in Timed Up and Go test were less consistent. The RGB-D camera was documented to be a reliable tool to assess the movement limitations in spondyloarthritis depending on the functional tasks: Bending task. Chair task needs further research and the TUG analysis was not validated. Comparation of both systems, required software for camera analysis, outcomes and final results of validity and reliability of each test.

Factores asociados con el uso de inhibidores del factor de necrosis tumoral alfa en una población de pacientes colombianos con espondiloartritis / Factors associated with the use of tumor necrosis factor alpha inhibitors in a population of Colombian patients with spondyloarthritis

RESUMEN Introducción: El uso de TNFi es cada vez más frecuente en los pacientes con espondiloartritis. Identificar tempranamente aquellos que los requerirán o poder predecir su uso puede ayudar a hacer un tratamiento más efectivo y oportuno racionalizando su uso. Objetivo: Determinar los factores qué mejor explican la indicación de TNFi en la población en estudio. Material y métodos: La asociación entre el uso de medicamentos anti-TNFα y las variables categóricas demográficas, clínicas, de laboratorio, radiológicas y de tratamiento se exploró por prueba exacta de Fisher. La asociación con las variables cuantitativas fue evaluada con t de Student o U de Mann Withney, de acuerdo con su distribución. Aquellas variables con p < 0,25 fueron ingresadas a modelos univariante de regresión logística explicativa para construir los OR crudos; aquellas con p < 0,25 se incluyeron en el modelo multivariante para construir OR ajustados. Resultados y discusión: La población está constituida por 181 pacientes. Modelo univariante: la artritis reactiva, uretritis y compromiso periférico fueron factores protectores para el uso de TNFi. Espondiloartritis axial, lumbalgia inflamatoria, dolor glúteo alternante, rigidez matinal sacroilitis demostrada por cualquier método, tratamiento con inhibidores COX-2, tiempo de evolución de tres arios o más y los puntajes de BASDAI y BASFI se asociaron con el uso de TNFi. Modelo multivariante: artritis reactiva (OR 0,1, IC 95% 0,012-0,86, p = 0,036), lumbalgia inflamatoria (OR 13,63, IC 95% 1,36-136, p = 0,026), sacroilitis (OR 7,71, IC 95% 1,04-57, p = 0,045, uso de coxib (OR 10,1, IC 95% 2,71-37,62, p = 0,001) y el puntaje máximo de BASDAI (4-6: OR 6,1, IC 95% 1,3-28,7, p = 0,022, mayor de 6: OR 15,8, IC 95% 2,2-113, p = 0,006) se asociaron independientemente con el uso de TNFi. El uso de coxib se asoció con la indicación de usar TNFi tanto en los pacientes con espondiloartritis axial (OR 4,2, IC 95% 1,74-10,11, p = 0,001) como periférica (OR 4, IC 95% 1,85-8,62, p < 0,001). Conclusiones: El inicio de la enfermedad en la forma de artritis reactiva se comportó como un factor protector para la necesidad posterior de usar TNFi, mientras que presentar lumbalgia inflamatoria, sacroilitis demostrada por cualquier método, el tratamiento con coxib y el puntaje máximo de BASDAI mayor de 4 se asociaron con el uso de estos medicamentos.

ABSTRACT Introduction: The use of tumor necrosis factor (TNF) alpha inhibitors is increasing in patients with spondyloarthritis. Early identification of those that would require them, or the ability to predict their use, could lead to a more effective and timely treatment by rationalizing their use. Objective: To determine factors that better explain the indication of TNFi in the study population. Material and methods: The association between anti-TNFα use and categorical demographic, clinical, laboratory, radiological and treatment variables was explored using Pearson's Chi2 or Fisher's exact test. The association with the quantitative variables was evaluated using Student's t test or Mann Whitney U test, depending on their distribution. Those variables with P < 0.25 were entered into univariate models of explanatory logistic regression to cons truct crude ORs, and those with P < 0.25 were included in the multivariate model to construct adjusted ORs. Results and discussion: The study population includes 181 patients. In the univariate model: reactive arthritis, urethritis, and peripheral involvement were protective factors for the use of TNFi. Axial spondyloarthritis, inflammatory lumbalgia, alternating gluteal pain, morning stiffness, sacroiliitis demonstrated by any method, treatment with COX-2 inhibitors, evolu tion time of three years or more, and BASDAI and BASFI scores were associated with the use of TNFi. Multivariate model: reactive arthritis (P = 0.036), inflammatory back pain (P = 0.026), sacroiliitis (P = 0.045), use of coxibs (P = 0.001) and the maximum score of BASDAI (P = 0.022, P = 0.006) were independently associated with the use of TNFi. The use of coxibs was associa ted with the indication of using TNFi in both patients with axial spondyloarthritis (P = 0.001) and peripheral (P < 0.001). Conclusions: The onset of the disease in the form of reactive arthritis behaved as a protective factor for the subsequent need to use TNFi, while presenting with inflammatory back pain, sacroiliitis, demonstrated by any method, treatment with coxibs, and the maximum score of BASDAI greater than 4 associated with the use of these medications.

Association between facet joint ankylosis and functional impairment in patients with radiographic axial spondyloarthritis.

OBJECTIVES: To investigate the occurrence of facet joint ankylosis in the spine of patients with radiographic axial spondyloarthritis (r-axSpA) using low dose computed tomography (ldCT), and to examine the association between facet joint ankylosis and functional impairment. METHODS: A group of 126 patients with r-axSpA was selected from Incheon Saint Mary's axSpA observational cohort and whole spine ldCT data were examined. Facet joint (right and left, C2-S1) ankylosis was scored from 0-46 (total). The presence of facet joint ankylosis was assessed by two readers, each blinded to the patient data. The inter-reader reliability of facet joint ankylosis scoring was assessed using intraclass correlation coefficients (ICCs). The CT Syndesmophyte Score (CTSS) was assessed. Lumbar spinal mobility was evaluated using the modified Schober test. Functional impairment was measured using the Bath AS functional index (BASFI). RESULTS: The ICCs of ankylosed facet joint scores at the cervical, thoracic, lumbar and whole spine were 0.84, 0.88, 0.92 and 0.90, respectively. Facet joint ankylosis was most common in the thoracic spine. Scores for the whole spine correlated positively with the ASDAS, mSASSS and the syndesmophyte score. Multivariate analysis revealed that facet joint ankylosis was significantly associated with decreased lumbar motion. For both readers, the scores for the whole spine were independently associated with BASFI after adjusting for syndesmophyte score and disease activity. CONCLUSIONS: Facet joint ankylosis in patients with r-axSpA was associated with functional impairment and spinal mobility. Facet joints should be incorporated into a structural damage assessment method.

Concomitant Diagnosis of Fibromyalgia and Ankylosing Spondylitis: Relation to Clinical Features and Plasma Pentraxin -3 Level.

BACKGROUND: Ankylosing spondylitis (AS) is a chronic systemic inflammatory rheumatic disease that specifically affects the spine and sacroiliac joint. AS diagnosis is often delayed in the clinical practice and this delay may cause the patients to miss the chance of early treatment. Fibromyalgia (FM) is a frequently encountered clinical syndrome, fibromyalgianess is a term used when patients who are diagnosed with inflammatory arthropathies meet the criteria for FM syndrome as shown in rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), Sjogren syndrome, and AS. OBJECTIVES: We aimed primarily to assess the frequency of concomitant diagnosis of FM syndrome in AS patients and study its impact on clinical disease aspects. Secondary, our aim extended as a preliminary pilot study to assess the Plasma Pentraxin-3(PTX-3) as a potential marker for the diagnosis of FM syndrome in AS patients. METHODS: Plasma PTX-3 in 61 AS patients was compared to 60 matched controls. FM was diagnosed by FM Rapid Screening Tool. Bath AS disease activity index (BASDAI) and AS disease assessment score using C- reactive protein (ASDAS-CRP), Bath AS functional impairment index (BASFI), Bath AS metrology index (BASMI), AS quality of life (ASQoL) scale, Beck Depression Inventory, and Bath AS Radiology Index (BASRI) were assessed. RESULTS: The patients were categorized into two groups according to the concomitant diagnosis of FM syndrome. Group I included 14 (22.9%) AS patients who fulfilled the clinical diagnosis of FM syndrome. Group II included 47 (77.1%) AS patients without FM syndrome. AS patients with FM (Group I) had significantly(p<0.001) increased an average of ages, disease duration, diagnostic delay of AS, switching of bDMARDs, morning stiffness duration, ASDAS-CRP, BASFI, ASQoL score, BASDAI (p=0.008), and BDI score (p=0.005) compared to AS patients without FM (Group II). PTX-3 levels were significantly (p<0.001) higher in Group I (p<0.001) (median, 0.23; IQR, 0.15-0.41 ng/ml) than Group II (median, 0.13; IQR, 0.035-0.21ng/ml) which showed no significant differences (p>0.05) compared to the controls. PTX-3 levels had significant positive correlations (p<0.05) with disease duration, BASFI, and ASQOl. Age, female sex, switch of biologic, ASDAS - CRP, and PTX-3 were significant predictors of FM in AS patients. CONCLUSION: These results indicate that concomitant FM is a significant problem in patients with AS and its presence is associated with higher disease activity, impaired function as well as an overall negative impact on QoL. Easy scanning of suspicious cases of FM with FiRST questionnaire can be done in daily practice. PTX-3 is more or less accurate as the clinical features to improve the diagnostic certainty of FM in the presence of AS with a proven sensitivity of 62.3%, a specificity of 90%, a positive predictive value of 82.75%, and a negative predictive value of 73.9%.

Development of a Bangla version of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Bath Ankylosing Spondylitis Functional Index (BASFI).

AIM: Development of a Bangla version of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Bath Ankylosing Spondylitis Functional Index (BASFI). METHODS: This biphasic observational study performed the translation and adaptation of the questionnaires carried out in 5 steps with pre-testing in 30 AS patients followed by the psychometric validation of the pre-final Bangla version utilizing content and construct validity in 115 AS patients. The reliability was examined through internal consistency and test-retest reliability involving 23 AS patients. RESULTS: After pre-testing of the pre-final Bangla version of both indices, the psychometric validation found that the convergent validity of Bangla version of BASDAI showed strong correlation with C-reactive protein (r = .75) and the Maastricht Ankylosing Spondylitis Enthesitis (r = .64), and moderate correlation with erythrocyte sedimentation rate (r = .49). Again, the Bangla BASFI showed significant correlation with occiput-to-wall distance (OWD) (r = .50), mentum-to-sternum distance (MSD) (r = .50), chest expansion (CE) (r = -.40), finger-to-floor (FFD) (r = .55), number of swollen joints (r = .69), and number of enthesitis (r = .68). The divergent validity demonstrated weak correlations between BASDAI and OWD (r = .43), MSD (r = .34), CE (r = -.44), FFD (r = .47). The divergent validity of BASFI could not be assessed due to lack of a suitable comparing parameter. The instruments revealed acceptable internal consistency as Cronbach's alpha was 0.86 for BASDAI and 0.93 for BASFI. A 7-day test-retest reliability measured by the intraclass correlation coefficient were 0.80 (CI at 95% = 0.58-0.90) for BASDAI and 0.83 (CI at 95% = 95% 0.64-0.92) for BASFI respectively. CONCLUSIONS: Bangla version of BASDAI and BASFI may be useful in disease activity and functional ability assessment in AS patients.

Health-Related Quality of Life in Patients with Ankylosing Spondylitis: Relationship with Disease-Related Variables.

BACKGROUND: Ankylosing spondylitis (AS) is a chronic progressive inflammatory disease leading to functional limitations and subsequently impaired quality of life (QoL). Despite the fact that QoL was recognized as a significant perception, it was excluded from the core domains (defined by the Assessment of Spondyloarthritis International Society), because of ambiguity of measurement choice. AIM: To assess QoL in patients with AS using a generic; Short Form-36 (SF-36) and a diseasespecific; Ankylosing Spondylitis quality of life (ASQoL) instruments and to explore its relationship to the clinical characteristics, disease activity, functional status, and radiographic severity. METHODS: A total of 47 AS patients who fulfilled modified New York criteria were included. Disease activity, functional status, spinal mobility, and radiographic severity were assessed by Bath AS Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), Bath AS Metrology Index (BASMI) and Bath AS Radiology Index (BASRI) respectively. SF-36 and ASQoL instruments evaluated Qol. RESULTS: Physical health was more affected especially in patients with peripheral arthritis by SF-36 (p=0.008) and ASQoL (p=0.022) scores. Both SF-36 total and ASQoL scores correlated significantly with BASDAI (r = -0.329, p = 0.024 and r = 0.420, p = 0.003), BASFI (r = -0.399, p = 0.005 and r = 0.513, p=0.001) and BASMI (r = -0.382, p = 0.008 and r = 0.482, p= 0.001) respectively. CONCLUSION: QoL was impaired in AS patients with highest impact on physical health especially in association with peripheral arthritis. SF-36 and ASQol have a comparable achievement in the evaluation of QoL in AS patients and both physical function and spinal mobility were identified as predictors of poor QoL.

Effects of Biqi Capsules on clinical efficacy and cytokines of patients with ankylosing spondylitis / 中草药

Objective: To observe the effects of Biqi Capsules on clinical efficacy and cytokines of patients with ankylosing spondylitis. Methods: Patients (120 cases) with ankylosing spondylitis were randomly divided into control group and treatment group for 60 cases in each group. Patients in the control group were po administered with Sulfasalazine Tablets, four tablets twice a day. Patients in the treatment group were po administered with Biqi Capsules, 1.2 g for each time, three times daily. Four weeks were a course. Patients in two groups were treated for three courses. After treatment, the clinical efficacy was evaluated, and visual analog scales (VAS), Bath ankylosing spondylitis disease active index (BASDAI), Bath ankylosing spondylitis functional index (BASFI), and Bath ankylosing spondylitis metrological index (BASMI) in two groups before and after treatment were compared. Enzyme linked immunosorbent assay (ELISA) were employed to measure the expression levels of cytokines IL-1β, TNF-α, IL-4, and IL-10. Erythrocyte sedimentation rate (ESR) was detected by instrument method and hs-CRP was detected by automatic biochemical analyzer. Results: After treatment, the compliance rate of ASAS20 (20%) and BASDAI50 (50%) in the treatment group was higher than that in the control group, but the difference was not statistically significant. After treatment, VAS, BASDAI, BASFI, BASMI, ESR, and hs-CRP in two groups were significantly decreased, with significantly difference between two groups before and after treatment (P < 0.01). And BASDAI and hs-CRP were significantly lower than those in the control group (P < 0.05). After treatment, IL-4 and IL-10 were significantly increased, but TNF-α and IL-1β were significantly decreased, with significantly difference between two groups before and after treatment (P < 0.01). And IL-10 was significantly higher than that in the control group (P < 0.05). Conclusion: Biqi Capsules has certain therapeutic effect on ankylosing spondylitis, and it may be associated with increasing anti-inflammatory factors, decreasing inflammatory factors and regulating inflammatory immunity.

Effect of Yaotongning Capsules combined with Imrecoxib Tablets in 60 cases of ankylosing spondylitis with cold-dampness and blood-stasis syndrome / 中草药

Objective: To observe the effect of Yaotongning Capsules combined with Imrecoxib Tablets in the treatment of ankylosing spondylitis with cold-dampness and blood-stasis syndrome. Methods: A total of 120 cases with ankylosing spondylitis were randomly divided into two groups: treatment group and control group, with 60 patients in each group. The control group was given Imrecoxib Tablets, and the treatment group was given Imrecoxib Tablets and Yaotongning Capsules. The levels of ESR, CRP, and the scores of BASDAI, BASFI, TCM syndrome were compared before and after treatment, the treatment effect of two groups were evaluated. Results: There was no significant difference in the levels of ESR, CRP and the scores of BASDAI, BASFI, TCM syndrome between two groups before treatment. After treatment, the levels of ESR, CRP and the scores of BASDAI, BASFI, TCM syndrome of the two groups were decreased (P < 0.05), and all the indexes in treatment group were lower than those in control group (P < 0.05), the total effective rate in treatment group (86.67%) was better than that in control group (65.00%) (P < 0.01). Conclusion: Yaotongning Capsules can effectively improve TCM syndrome and functional activity indexes, reduce inflammatory indexes and disease activity, has definite clinical effect on ankylosing spondylitis.

Nephrolithiasis in ankylosing spondylitis and its relationship with disease assessment scales.

OBJECTIVE: The aim of this study was to investigate the frequency of renal calculi in patients with ankylosing spondylitis (AS) and to determine its relationship with disease assessment variables. METHODS: The study was designed retrospectively, and it included a cohort of 320 patients with AS diagnosed using the Modified New York Criteria. A total of 119 patients who underwent renal ultrasonography (USG), in who the erythrocyte sedimentation rate, C-reactive protein, blood calcium, phosphorus, Vitamin D, parathormone, and urinary calcium excretion were measured, and who also had lateral cervical and lumbar radiography in the same time period were extracted from the cohort. All patients' demographic characteristics and the results of blood and urine tests were recorded. The Ankylosing Spondylitis Disease Activity Index (BASDAI), Ankylosing Spondylitis Functional Index (BASFI), Ankylosing Spondylitis Mobility Index (BASMI), and Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) were evaluated in all patients. RESULTS: Thirteen of the 119 patients had renal calculi confirmed by USG data. The frequency of nephrolithiasis detected by USG was 10.9% in patients with AS. The disease lasted significantly longer in patients with renal calculi ([nephrolithiasis (+): 18.39±8.72 years; nephrolithiasis (-): 12.02±8.43 years, p=0.01]). The BASMI total score was significantly higher in the group of patients with renal calculi. There was not any significant difference in terms of blood samples, HLA-B27, BASDAI, BASFI, and mSASSS between groups. CONCLUSION: The frequency of renal stones is increased in patients with AS compared to healthy population. Especially patients who had AS for a long time and higher BASMI values are more susceptible to renal calculi. It is important to point out that the results of this type of studies would be more reliable if the study is conducted on large patient groups and population-based prevalence.

Does relocation of the apex after osteotomy affect surgical and clinical outcomes in patients with ankylosing spondylitis and thoracolumbar kyphosis?

OBJECTIVE: Relocation of the apex is often found in patients with ankylosing spondylitis (AS)-associated thoracolumbar/lumbar kyphosis after corrective surgery. This study evaluates the influence of different postoperative apex locations on surgical and clinical outcomes of osteotomy for patients with AS and thoracolumbar kyphosis. METHODS: Sixty-two patients with a mean age of 34.6 ± 9.7 years (range 17-59 years) and a minimum of 2 years of follow-up, who underwent 1-level lumbar pedicle subtraction osteotomy for AS-related thoracolumbar kyphosis, were enrolled in the study, as well as 62 age-matched healthy individuals. Patients were divided into 2 groups according to the postoperative location of the apex (group 1, T8 or above; group 2, T9 or below). Demographic data, radiographic measurements (including 3 postoperative apex-related parameters), and clinical outcomes were compared between the 2 groups preoperatively, postoperatively, and at the last follow-up. Furthermore, a subgroup analysis was performed among patients with a postoperative apex located at T6-11 and postoperatively the entire AS cohort was compared with normal controls regarding the apex location of the thoracic spine. RESULTS: In the majority of the enrolled patients, the apex location changed from T12-L2 preoperatively to T6-9 postoperatively. The sagittal vertical axis (SVA) differed significantly both postoperatively (25.7 vs 59.0 mm, p = 0.001) and at the last follow-up (34.6 vs 59.9 mm, p = 0.003) between the 2 groups, and the patients in group 1 had significantly smaller horizontal distance between the C7-vertical line and the apex (DCA) than the patients in group 2 (67.5 vs 103.7 mm, p = 0.001). Subgroup analysis demonstrated similar results, showing that the patients with a postoperative apex located at T8 or above had an average SVA < 47 mm. Notably, a significant correlation was found between postoperative SVA and DCA (r = 0.642, p = 0.001). Patients who underwent an osteotomy at L3 had limited apex relocation but larger SVA correction than those at L1 or L2. However, no significant difference was found in health-related quality of life between the 2 groups. CONCLUSIONS: AS patients with an apex located at T8 or above after surgery tended to have better SVA correction (within 47 mm) than those who had a more caudally located apical vertebra. For ideal postoperative apex relocation, a higher (closer to or at the preoperative apex) level of osteotomy is more likely to obtain the surgical goal.

Validity of a Venezuelan version of the Bath Ankylosing Spondylitis Functional Index and Bath Ankylosing Spondylitis Disease Activity Index. / Validación al idioma español de Venezuela de los índices de actividad de enfermedad y el índice funcional para espondilitis anquilosante.

INTRODUCTION: Spondyloarthropathies (SpA) are disabling diseases with a prevalence of 1.9% in the general population. The indices designed for monitoring the disease should be valid, reliable and cross-culturally adapted for decision-making concerning the appropriate treatment. Changing an adjective or pronoun in a self-administered questionnaire could be the big difference in condensing an idea in a few words and transmitting that concept to all those who share the same language. OBJECTIVES: To develop a Venezuelan version of the original English version of the BASDAI/BASFI and to evaluate its reliability and validity in Venezuelan patients with SpA. METHODS: Certified linguists were needed for the translation of a Venezuelan version of the BASDAI/BASFI. The evaluation of reliability and validity was performed by calculating correlation coefficients in addition to Cronbach's alpha correlation between the BASDAI score and the clinical parameters (for example: erythrocyte sedimentation rate, C-reactive protein, modified Schöber test, occiput-to-wall distance and enthesis count). RESULTS: We studied 40 patients including 31 men (77.5%) and 9 women (22.5%). The mean age was 35.9 years ± standard deviation (SD) 12.01 and the disease duration was 11.5 years (± SD 9.5). The most common diagnoses were undifferentiated spondyloarthritis (45%), ankylosing spondylitis (27.5%) and psoriatic arthritis (20%). The incidences of reactive arthritis, ankylosing spondylitis and juvenile Reiter's syndrome were 2.5% each. The test-retest reliability of the BASDAI and BASFI was high (R = 0.99 and 0.99, respectively; P<.0001). The internal consistency for the BASDAI was high (Cronbach's alpha = 0.88; P=.002) and the intraclass correlation coefficient for internal consistency: 0.9867 (P=.001). Internal consistency for the BASFI: Cronbach's alpha = 0.7985 (P=.002), intraclass correlation coefficient for internal consistency: 0.9055 (P=.001). Construct validity of the BASDAI was high for general well-being of the patient (R = 0.84) and for enthesis count (R = 0.84). Low back pain showed moderate correlation with BASDAI (R = 0.69; P<.0001) and the erythrocyte sedimentation rate showed a low correlation (R = 0.39683; P=.0112). CONCLUSION: The Venezuelan version of the BASDAI/BASFI could be used in clinical research to assess and evaluate the course of disease activity in Venezuelan SpA patients.

Relevance of structural damage in the sacroiliac joints for the functional status and spinal mobility in patients with axial spondyloarthritis: results from the German Spondyloarthritis Inception Cohort.

BACKGROUND: Functional status and spinal mobility in patients with axial spondyloarthritis (axSpA) are known to be determined both by disease activity and by structural damage in the spine. The impact of structural damage in the sacroiliac joints (SIJ) on physical function and spinal mobility in axSpA has not been studied so far. The objective of the study was to analyze the impact of radiographic sacroiliitis on functional status and spinal mobility in patients with axSpA. METHODS: In total, 210 patients with axSpA were included in the analysis. Radiographs of SIJ obtained at baseline and after 2 years of follow up were scored by two trained readers according to the modified New York criteria grading system (grade 0-4). The mean of two readers' scores for each joint and a sum score for both SIJ were calculated for each patient giving a sacroiliitis sum score between 0 and 8. The Bath Ankylosing Spondylitis Functional Index (BASFI) and Bath Ankylosing Spondylitis Metrology Index (BASMI) at baseline and after 2 years were used as outcome measures. RESULTS: Longitudinal mixed model analysis adjusted for structural damage in the spine (modified Stoke Ankylosing Spondylitis Spine Score - mSASSS), disease activity (Bath Ankylosing Spondylitis Disease Activity Index - BASDAI and C-reactive protein level) and gender, revealed an independent association of the sacroiliitis sum score with the BASFI: b = 0.10 (95% CI 0.01-0.19) and the BASMI: b = 0.12 (95% CI 0.03-0.21), respectively, indicating that change by one radiographic sacroiliitis grade in one joint is associated with BASFI/BASMI worsening by 0.10/0.12 points, respectively, independently of disease activity and structural damage in the spine. CONCLUSION: Structural damage in the SIJ might have an impact on functional status and spinal mobility in axSpA independently of spinal structural damage and disease activity. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01277419 . Registered on 14 January 2011.

The effect of smoking on clinical and structural damage in patients with axial spondyloarthritis: A systematic literature review.

OBJECTIVES: To evaluate the association between smoking and clinical parameters and structural damage in axial spondyloarthritis (axSpA). METHODS: We systematically searched MEDLINE, EMBASE and Cochrane Library till November 2015. We selected articles that analysed the smoking impact on disease activity, functional status, structural damage, physical mobility and life quality. Independent extraction of articles by 2 authors using predefined data fields was performed. Studies quality was graded according to the Oxford Level of Evidence scale. RESULTS: A total of 17 articles were selected for inclusion: 2 case-control, 11 cross-sectional and 4 prospective cohort studies, which analysed 4694 patients. Weak evidence suggested a smoking effect on pain, overall assessment of health, disease activity, physical mobility and life quality in ankylosing spondylitis (AS). Moderate-good evidence revealed higher HAQ-AS among smokers (0.025units/y; 95% CI: 0.0071-0.0429; p = 0.007). Every additional unit of ASDAS resulted in an increase of 1.9 vs. 0.4 mSASSS units/2y in AS smokers vs. non-smokers. Good evidence revealed that cigarette smoking and smoking intensity was associated with spinal radiographic progression in axSpA [mSASSS ≥2 units/2y: OR = 2.75, 95% CI: 1.25-6.05, p=0.012; mSASSS progression in heavy smokers (>10 cigarettes/d): OR = 3.57, 95% IC: 1.33-9.60, p = 0.012]. CONCLUSIONS: Published data indicate that smoking has a dose-dependent impact on structural damage progression in axSpA. There is worse HAQ among AS smokers compared to non-smokers. Respect to pain, overall assessment of health, disease activity, physical mobility and life quality, although the evidence level is poor, all evidence points in the same direction: smoking AS patients are worse than non-smoking.

Observations on the Efficacy of Superficial Needling Therapy for Early Ankylosing Spondylitis / 上海针灸杂志

Objective To investigate the clinical efficacy of superficial needling therapy for early ankylosing spondylitis and its effect on tumor necrosis factor-α (TNF-α), interleukin-1 (IL-1) and interleukin-6 (IL-6).Methods Eighty patients with early ankylosing spondylitis meeting the inclusion criteria were randomly allocated to treatment and control groups using random number card method with the ratio of 1:1, 40 cases each. The treatment group received superficial needling therapy alone and the control group, conventional treatment with celecoxib capsules, methotrexate tablets and sulfasalazine enteric-coated tablets. Treatment was given for a total of 24 weeks. Bath AS Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), lumbago, TCM syndrome score, TNF-α, IL-1 and IL-6 were observed in the two groups before and after treatment.Results The BASDAI, BASFI, lumbago, TCM syndrome score, TNF-α, IL-1 and IL-6 improved in the two groups after treatment compared with those before the treatment (P<0.05). The BASDAI, BASFI, lumbago, TCM syndrome score, TNF-α, IL-1 and IL-6 in the treatment group superior to those in the control group after the treatment (P<0.05).Conclusions Superficial needling therapy can relieve the clinical symptoms in patients with early ankylosing spondylitis and improve spinal joint function with good safety. Its mechanism may be related to reducing inflammatory cytokines TNF-α, IL-1 and IL-6.

Observations on the Efficacy of Superficial Needling Therapy for Early Ankylosing Spondylitis / 上海针灸杂志

Objective To investigate the clinical efficacy of superficial needling therapy for early ankylosing spondylitis and its effect on tumor necrosis factor-α (TNF-α), interleukin-1 (IL-1) and interleukin-6 (IL-6).Methods Eighty patients with early ankylosing spondylitis meeting the inclusion criteria were randomly allocated to treatment and control groups using random number card method with the ratio of 1:1, 40 cases each. The treatment group received superficial needling therapy alone and the control group, conventional treatment with celecoxib capsules, methotrexate tablets and sulfasalazine enteric-coated tablets. Treatment was given for a total of 24 weeks. Bath AS Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), lumbago, TCM syndrome score, TNF-α, IL-1 and IL-6 were observed in the two groups before and after treatment.Results The BASDAI, BASFI, lumbago, TCM syndrome score, TNF-α, IL-1 and IL-6 improved in the two groups after treatment compared with those before the treatment (P<0.05). The BASDAI, BASFI, lumbago, TCM syndrome score, TNF-α, IL-1 and IL-6 in the treatment group superior to those in the control group after the treatment (P<0.05).Conclusions Superficial needling therapy can relieve the clinical symptoms in patients with early ankylosing spondylitis and improve spinal joint function with good safety. Its mechanism may be related to reducing inflammatory cytokines TNF-α, IL-1 and IL-6.

The Minimum Clinically Important Improvement and Patient-acceptable Symptom State in the BASDAI and BASFI for Patients with Ankylosing Spondylitis.

OBJECTIVE: To establish cutoffs for the minimum clinically important improvement (MCII) and the patient-acceptable symptom state (PASS) for the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Bath Ankylosing Spondylitis Functional Index (BASFI) in patients with ankylosing spondylitis (AS). METHODS: Patients with AS who started nonsteroidal antiinflammatory drugs were included. After 4 weeks, the PASS and the MCII were defined using external anchor questions (for the PASS, patients considering their condition of AS over the prior 48 h as "acceptable" forever; and for the MCII, those reporting moderate or slightly important improvement). Consistency of the MCII and PASS were tested according to HLA-B27 status, presence/absence of SpA extraarticular manifestations, age, sex, disease duration, and baseline BASDAI/BASFI score. The 75th percentile of the cumulative distribution was used to determine the MCII and PASS. RESULTS: In total, 283 patients from a multinational cohort were included. Overall cutoffs for the PASS were 4.1 in the BASDAI and 3.8 in the BASFI. Cutoffs for the MCII were 0.7 and 0.4 for the BASDAI and BASFI, respectively. Subgroup analyses revealed that disease duration and baseline BASDAI/BASFI were significantly associated with the PASS and MCII. In a subanalysis limited to patients with active disease (baseline BASDAI ≥ 4), the MCII was 1.1 for the BASDAI and 0.6 for the BASFI. CONCLUSION: The conceptual viability of the PASS for the BASDAI is questionable because levels approach those required for the start of biological therapy. Because the MCII is less variable than the PASS, we propose its exclusive use, with cutoffs of 1.1/0.6 for the BASDAI/BASFI in patients with active disease. Because these values are based on a subset of the study population, we recommend confirmation in larger studies focused on patients with baseline BASDAI ≥ 4.