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BACKGROUND: Preference-based measures of health-related quality of life (HRQoL), such as the EQ-5D or the SF-6D, are essential for health economic evaluation. However, they are rarely included in clinical trials of ankylosing spondylitis (AS). This study aims to develop mapping algorithms to predict EQ-5D-3L and EQ-5D-5L health utility scores from the Bath Ankylosing Disease Activity Index (BASDAI) and the Bath Ankylosing Spondylitis Functional Index (BASFI). METHODS: Patients with AS were recruited from the largest tertiary hospital in Shandong province, China, between December 2019 and October 2020. Patients were selected by convenience sampling method according to the following criteria: (1) diagnosed with AS according to the New York criteria; (2) aged 18 years and above; and (3) without mental disorders; (4) able to understand the questionnaires; (5) without serious complications. There were 243 patients who completed the face-to-face questionnaire survey, and 5 cases with missing values in key variables were excluded. Ordinary least squares, censored least absolute deviations, Tobit, adjusted limited dependent variable mixture model and beta-mixture model (BM) in the direct approach and ordered logit and multinomial logit (Mlogit) model in the response approach were used to develop mapping algorithms. Mean absolute error, root mean square error, Spearman's correlation coefficient and concordance correlation coefficient were used to access predictive performance. RESULTS: The 238 patients with AS had a mean age of 35.19 (SD = 9.59) years, and the majority (74.47%) were male. The observed EQ-5D-3L and EQ-5D-5L health utility values were 0.88 (SD = 0.12) and 0.74 (SD = 0.27), respectively. The EQ-5D-5L had higher conceptual overlap with the BASDAI and BASFI than the EQ-5D-3L did. The Mlogit was the best-performing model for the EQ-5D-3L, and the BM showed better performance in predicting EQ-5D-5L than other direct and indirect mapping models did. CONCLUSION: This study demonstrates that the EQ-5D-5L, rather than EQ-5D-3L, should be selected as the target outcome measure of HRQoL in patients with AS in China, and the BM mapping algorithm could be used to predict EQ-5D-5L values from BASDAI and BASFI for health economic evaluation.

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BACKGROUND: Psoriasis vulgaris (PsV) and psoriatic arthritis (PsA) are complex, multifactorial diseases significantly impacting health and quality of life. Predicting treatment response and disease progression is crucial for optimizing therapeutic interventions, yet challenging. Automated machine learning (AutoML) technology shows promise for rapidly creating accurate predictive models based on patient features and treatment data. OBJECTIVE: This study aims to develop highly accurate machine learning (ML) models using AutoML to address key clinical questions for PsV and PsA patients, including predicting therapy changes, identifying reasons for therapy changes, and factors influencing skin lesion progression or an abnormal Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score. METHODS: Clinical study data from 309 PsV and PsA patients were extensively prepared and analyzed using AutoML to build and select the most accurate predictive models for each variable of interest. RESULTS: Therapy change at 24 weeks follow-up was modeled using the extreme gradient boosted trees classifier with early stopping (area under the receiver operating characteristic curve [AUC] of 0.9078 and logarithmic loss [LogLoss] of 0.3955 for the holdout partition). Key influencing factors included the initial systemic therapeutic agent, the Classification Criteria for Psoriatic Arthritis score at baseline, and changes in quality of life. An average blender incorporating three models (gradient boosted trees classifier, ExtraTrees classifier, and Eureqa generalized additive model classifier) with an AUC of 0.8750 and LogLoss of 0.4603 was used to predict therapy changes for 2 hypothetical patients, highlighting the significance of these factors. Treatments such as methotrexate or specific biologicals showed a lower propensity for change. An average blender of a random forest classifier, an extreme gradient boosted trees classifier, and a Eureqa classifier (AUC of 0.9241 and LogLoss of 0.4498) was used to estimate PASI (Psoriasis Area and Severity Index) change after 24 weeks. Primary predictors included the initial PASI score, change in pruritus levels, and change in therapy. A lower initial PASI score and consistently low pruritus were associated with better outcomes. BASDAI classification at onset was analyzed using an average blender of a Eureqa generalized additive model classifier, an extreme gradient boosted trees classifier with early stopping, and a dropout additive regression trees classifier with an AUC of 0.8274 and LogLoss of 0.5037. Influential factors included initial pain, disease activity, and Hospital Anxiety and Depression Scale scores for depression and anxiety. Increased pain, disease activity, and psychological distress generally led to higher BASDAI scores. CONCLUSIONS: The practical implications of these models for clinical decision-making in PsV and PsA can guide early investigation and treatment, contributing to improved patient outcomes.

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Objective: In the absence of axial psoriatic arthritis (axPsA)-specific tools, the BASDAI and Ankylosing Spondylitis Disease Activity Score (ASDAS) are used to assess axial symptoms in patients with PsA. Here, we assessed the performance of BASDAI and ASDAS in patients with PsA. Methods: Patients with active PsA in DISCOVER-1 and DISCOVER-2 (ClinicalTrials.gov: NCT03162796 and NCT03158285, respectively) with or without axPsA but with available baseline BASDAI information were analysed; those with investigator-identified axial symptoms and imaging-confirmed sacroiliitis comprised the axPsA cohort. Correlations between BASDAI/ASDAS and clinical variables were assessed with Pearson's coefficient (r). Longitudinal effects of enthesitis (Leeds Enthesitis Index [LEI]), swollen joint count and presence versus absence of axPsA on BASDAI/ASDAS (normalized 0-10 scale) were analysed with mixed models for repeated measures. Results: At baseline in the axPsA (n = 312) and non-axPsA (n = 124) cohorts, BASDAI scores showed no or weak correlation with swollen joint count (0.18-0.20), tender joint count (0.12-0.29), LEI (-0.04 to 0.24) and physician global assessment (0.35-0.43); moderate correlation with fatigue (both -0.56); and strong correlation with patient global assessment of disease activity (0.62-0.69) and patient-reported pain (0.66-0.70). Similar correlations were observed for ASDAS. Axial involvement versus non-involvement was associated with higher BASDAI scores and ASDAS (all ß ≥ 0.5), without differences between instruments; longitudinal associations between swollen joint count (ß ≤ 0.06)/LEI (ß ≤ 0.19) and BASDAI/ASDAS were clinically unimportant. Conclusion: BASDAI and ASDAS performed similarly in patients with active PsA and axial involvement, independent of peripheral disease involvement, supporting their performance in assessing axial disease activity. Trial registration: ClinicalTrials.gov, http://clinicaltrials.gov, NCT03162796 and NCT03158285.

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Objectives: The study aimed to evaluate the correlation between the clinical disease activity of axial spondyloarthropathy (axSpA) and magnetic resonance imaging findings of the sacroiliac joint. Patients and methods: Thirty-two patients (21 males, 11 females; mean age: 39.3±9.2 years; range, 18 to 55 years) who were diagnosed with axSpA according to the Assessment in Spondyloarthritis International Society classification criteria between November 2015 and August 2017 were included in this cross-sectional study. Visual Analog Scale (VAS), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Ankylosing Spondylitis Disease Activity Score (ASDAS)-erythrocyte sedimentation rate (ESR), and ASDAS-C-reactive protein (CRP) were used as the indicators of clinical activity. Magnetic resonance imaging of the sacroiliac joint was performed and the Spondyloarthritis Research Consortium of Canada (SPARCC) score was evaluated by a radiologist who was blinded to the clinical and laboratory parameters of the patients. Results: The mean duration of symptom onset was 9.3±7.7 years, and the mean duration of diagnosis was 3.6±2.8 years. Human leukocyte antigen (HLA)-B27 was positive in 16 (50%) patients. There was no correlation between the SPARCC score and VAS, BASDAI, MASES, BASFI, ASDAS-CRP, ASDAS-ESR, ESR, and CRP values (p>0.05). In the HLA-B27 subgroup analyses, a statistically significant correlation was found between HLA-B27-negative patients and SPARCC score (r=0.639, p=0.008). Conclusion: No relationship was found between other clinical disease parameters and sacroiliac joint imaging findings, except for the relationship between the SPARCC and BASDAI in HLA-B27- negative patients with axSpA.

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Axial spondyloarthritis (axSpA) is an inflammatory joint disease, in which the dominant symptom is inflammatory back pain. It affects approximately 1% of the population, with a higher incidence in males. Spinal pain associated with spondyloarthritis is referred to as inflammatory back pain. In clinical practice, it is extremely important to be able to assess the activity of inflammatory back diseases and to select appropriate treatment and monitor the therapy. Currently, two main tools are used for assessment of the activity of axial spondyloarthritis: BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) and ASDAS (Ankylosing Spondylitis Disease Activity Score). The BASDAI is a tool used for years for assessment of disease activity, determining eligibility for treatment, and making decisions about continuation of therapy. Since BASDAI depends entirely on patient self-assessment, it is considered less objective than the ASDAS index. In turn, the latter includes not only answers to questions provided by the patient but also a parameter of inflammation such as erythrocyte sedimentation rate or C-reactive protein (CRP). Additionally, increasing numbers of studies report advantages of the ASDAS index over BASDAI. Moreover, as indicated by ASAS/EULAR (Assessment in Spondyloarthritis International Society/European Alliance of Associations for Rheumatology) 2022, ASDAS, especially ASDAS-CRP is the preferred tool for assessment of the activity of axSpA, whereas BASDAI is used only when the evaluation of the ASDAS is not possible. This paper presents the definition and symptoms of axSpA and reviews the latest research on ASDAS and BASDAI, with emphasis on the objectivity of the ASDAS assessment also presenting the doubts and limitations concerning this tool.

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Objetivo: Determinar el impacto de la enfermedad en pacientes con artritis psoriásica (APs) en la práctica clínica diaria, y evaluar su relación con la actividad axial.Métodos: Se realizó un estudio transversal multicéntrico en pacientes consecutivos vistos desde enero 2021 hasta diciembre 2021 que cumplieron con los criterios CASPAR, con clínica dolor lumbar inflamatorio y prueba de imagen positiva, con o sin afectación periférica. También se recogieron datos demográficos, clínicos, analíticos, índice Health Assessment Questionnaire, PsAID12 e índices de actividad axial (BASDAI y ASDAS-PCR). Se dividió a los pacientes en 2 grupos según el alto o bajo impacto del cuestionario PsAID. Las variables continuas se mostraron como mediana (Q1-Q3) y las categóricas como porcentajes y frecuencias. Resultados: Se incluyeron 72 pacientes con afectación axial de los 269 evaluados con APs, 40 varones (55,6%), con una mediana de edad de 54,1 años y duración de la enfermedad de 7 años. El 28,3% de los pacientes eran obesos y el nivel sérico de PCR fue de 0,45mg/dl (0,08-1,10). El BASDAI fue de 4,2 (2,0-6,2) y el ASDAS-PCR de 2,4 (1,5-3,2), estando en baja actividad o remisión el 39,6%. La mediana de la puntuación total de PsAID fue de 3,9 (1,6-5,4), evaluado en 61 pacientes. Los pacientes que alcanzaron un PsAID12≤4 fueron el 63%, predominantemente varones, presentaron valores de PCR menores y se asoció a una menor puntuación de BASDAI y ASDAS-PCR. Conclusiones: Los pacientes con afectación axial reflejaban un bajo impacto de la enfermedad medido por PsAID12 y este se correlacionaba con baja actividad medido por BASDAI y el ASDAS-PCR.(AU)

Objective: To determine the impact of the disease in patients with PsA in daily clinical practice and to evaluate its relationship with its axial activity. Methods: A cross-sectional study was conducted in consecutive patients attended from January 2021 to December 2021 who met the CASPAR criteria, with clinical of inflammatory back pain and positive axial imaging, with or without peripheral involvement. Demographic, clinical, analytical data, HAQ index, PsAID12 and activity index (BASDAI and ASDAS-PCR) were also collected. Patients were divided into two groups, those with high impact and those with low impact according to PsAID results. Continuous variables are shown as median (Q1-Q3) and categorical variables as percentages and frequencies. Results: Of the 269 patients evaluated with PsA, 72 patients with axial involvement were included, 40 men (55.6%), with a median age of 54.1 years and disease duration of 7 years. 28.3% of the patients were obese and serum CRP level was 0.45mg/dl (0.08-1.10). BASDAI was 4.2 (2.0-6.2) and ASDAS-PCR was 2.4 (1.5-3.2), which translates into 39.6% of patients in low activity or remission. The median PsAID total score was 3.9 (1.6–5.4), evaluated in 61 patients. The patients who achieved a PsAID12≤4 were 63%, mostly men and with lower CRP levels than PsAID≥4 patients. In addition, low impact measured by the PsAID12 was associated with low results in BASDAI and ASDAS-PCR. Conclusions: Axial involvement reflected lower impact of the disease measured by PsAID12 and it is correlated with low activity measured by BASDAI and ASDAS-PCR.(AU)

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OBJECTIVE: To determine the impact of the disease in patients with PsA in daily clinical practice and to evaluate its relationship with its axial activity. METHODS: A cross-sectional study was conducted in consecutive patients attended from January 2021 to December 2021 who met the CASPAR criteria, with clinical of inflammatory back pain and positive axial imaging, with or without peripheral involvement. Demographic, clinical, analytical data, HAQ index, PsAID12 and activity index (BASDAI and ASDAS-PCR) were also collected. Patients were divided into two groups, those with high impact and those with low impact according to PsAID results. Continuous variables are shown as median (Q1-Q3) and categorical variables as percentages and frequencies. RESULTS: Of the 269 patients evaluated with PsA, 72 patients with axial involvement were included, 40 men (55.6%), with a median age of 54.1 years and disease duration of 7 years. 28.3% of the patients were obese and serum CRP level was 0.45 mg/dl (0.08-1.10). BASDAI was 4.2 (2.0-6.2) and ASDAS-PCR was 2.4 (1.5-3.2), which translates into 39.6% of patients in low activity or remission. The median PsAID total score was 3.9 (1.6-5.4), evaluated in 61 patients. The patients who achieved a PsAID12 ≤ 4 were 63%, mostly men and with lower CRP levels than PsAID ≥ 4 patients. In addition, low impact measured by the PsAID12 was associated with low results in BASDAI and ASDAS-PCR. CONCLUSIONS: Axial involvement reflected lower impact of the disease measured by PsAID12 and it is correlated with low activity measured by BASDAI and ASDAS-PCR.

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Introduction and objectives: This study aimed to evaluate the efficacy of secukinumab (SEC) in axial spondyloarthropathy (axSpA) in anti-TNFα naïve and anti-TNFα experienced patients. It also focused on the duration of SEC treatment and its side effects. Patients and methods: The patients with axSpA treated with SEC and followed up in our outpatient clinic from May 2018 through October 2021 were included in this study. All patients in the study also fulfilled the ASAS classification criteria for axSpA. Patients were separated into two groups according to whether they received prior anti-TNFα therapy. While anti-TNFα naïve patients comprised group 1, anti-TNFα experienced patients were included in group 2. Pre- and post-treatment BASDAI scores were reported and compared. Results: Eighty-four axSpA patients (42 men; duration of the disease: 86.86±65.35 months in group 1 and 160.65±97.4 months in group 2) were treated with SEC. 45.5% of anti-TNFα naïve patients and 56.5% of anti-TNFα experienced patients were still on SEC therapy in October 2021. Duration of SEC treatment was 12.5±7.9 months in group 1 and 17.19±12 months in group 2 (p=0.098). The differences between pre-and post-treatment BASDAI scores were statistically significant in both groups (p<0.001). While patients in group 1 did not develop any adverse effects, three patients in group 2 experienced alopecia, uveitis, and recurrent pneumonia after SEC treatment. Conclusion: Our study's efficacy and safety data on the use of SEC were reassuring in both anti-TNFα naïve and anti-TNFα experienced patients. However, further studies are still needed to determine the appropriate timing to begin SEC treatment.(AU)

Antecedentes y objetivo: Este estudio tuvo como objetivo evaluar la eficacia de secukinumab (SEC) en la espondiloartropatía axial (axSpA) en pacientes sin experiencia previa con anti-TNFα y con experiencia con anti-TNFα. También se centró en la duración del tratamiento SEC y sus efectos secundarios. Materiales y métodos: Se incluyeron en este estudio los pacientes con axSpA tratados con SEC y seguidos en nuestra consulta externa desde mayo de 2018 hasta octubre de 2021. Todos los pacientes en el estudio también cumplían con los criterios de clasificación de ASAS para axSpA. Los pacientes se separaron en dos grupos según si habían recibido terapia anti-TNFα previa. Mientras que los pacientes sin tratamiento previo con anti-TNFα comprendían el grupo 1, los pacientes con experiencia con anti-TNFα se incluyeron en el grupo 2. Se informaron y compararon las puntuaciones BASDAI antes y después del tratamiento. Resultados: Ochenta y cuatro pacientes con axSpA (42 hombres; duración de la enfermedad: 86,86 ±65,35 meses en el grupo 1 y 160,65±97,4 meses en el grupo 2) fueron tratados con SEC. El 45,5% de los pacientes sin experiencia previa con anti-TNFα y el 56,5% de los pacientes experimentados con anti-TNFα seguían en tratamiento con SEC en octubre de 2021. La duración del tratamiento con SEC fue de 12,5±7,9 meses en el grupo 1 y de 17,19±12 meses en el grupo 2 (p=0,098). Las diferencias entre las puntuaciones BASDAI antes y después del tratamiento fueron estadísticamente significativas en ambos grupos (p<0,001). Mientras que los pacientes del grupo 1 no desarrollaron ningún efecto adverso, tres pacientes del grupo 2 experimentaron alopecia, uveítis y neumonía recurrente después del tratamiento con SEC. Conclusiones: Los datos de eficacia y seguridad de nuestro estudio sobre el uso de secukinumab fueron alentadores tanto en pacientes sin tratamiento previo con anti-TNFα como en pacientes experimentados con anti-TNFα. Sin embargo, aún se...(AU)

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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.

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INTRODUCTION AND OBJECTIVES: This study aimed to evaluate the efficacy of secukinumab (SEC) in axial spondyloarthropathy (axSpA) in anti-TNFα naïve and anti-TNFα experienced patients. It also focused on the duration of SEC treatment and its side effects. PATIENTS AND METHODS: The patients with axSpA treated with SEC and followed up in our outpatient clinic from May 2018 through October 2021 were included in this study. All patients in the study also fulfilled the ASAS classification criteria for axSpA. Patients were separated into two groups according to whether they received prior anti-TNFα therapy. While anti-TNFα naïve patients comprised group 1, anti-TNFα experienced patients were included in group 2. Pre- and post-treatment BASDAI scores were reported and compared. RESULTS: Eighty-four axSpA patients (42 men; duration of the disease: 86.86±65.35 months in group 1 and 160.65±97.4 months in group 2) were treated with SEC. 45.5% of anti-TNFα naïve patients and 56.5% of anti-TNFα experienced patients were still on SEC therapy in October 2021. Duration of SEC treatment was 12.5±7.9 months in group 1 and 17.19±12 months in group 2 (p=0.098). The differences between pre-and post-treatment BASDAI scores were statistically significant in both groups (p<0.001). While patients in group 1 did not develop any adverse effects, three patients in group 2 experienced alopecia, uveitis, and recurrent pneumonia after SEC treatment. CONCLUSION: Our study's efficacy and safety data on the use of SEC were reassuring in both anti-TNFα naïve and anti-TNFα experienced patients. However, further studies are still needed to determine the appropriate timing to begin SEC treatment.

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BACKGROUND: The objective of this post-hoc analysis was to assess the efficacy and safety of upadacitinib in psoriatic arthritis (PsA) patients with axial involvement. METHODS: Post-hoc analysis of SELECT-PsA 1 and SELECT-PsA 2 in patients randomized to upadacitinib 15 mg (UPA15), placebo (switched to UPA15 at week 24), or adalimumab 40 mg (ADA; SELECT-PsA 1 only). Axial involvement was determined by investigator judgement (yes or no; based on the totality of available clinical information, such as duration and characteristics of back pain, age of onset, and previous lab investigations and imaging, if available) alone, or investigator judgement and patient-reported outcome (PRO)-based criteria (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] ≥ 4 and BASDAI Q2 ≥ 4). Efficacy outcomes that describe axial disease activity, including BASDAI endpoints, such as change from baseline in the overall BASDAI score or proportion of patients achieving BASDAI50 (≥ 50% improvement from baseline), as well as Ankylosing Spondylitis Disease Activity Score (ASDAS) endpoints, such as mean change from baseline in overall ASDAS or proportion of patients achieving ASDAS inactive disease or low disease activity, were evaluated at weeks 12, 24, and 56, with nominal P-values shown. Treatment-emergent adverse events (TEAEs) are summarized through week 56. RESULTS: 30.9% of patients in SELECT-PsA 1 and 35.7% in SELECT-PsA 2 had axial involvement by investigator judgement alone; 22.6% (SELECT-PsA 1) and 28.6% (SELECT-PsA 2) had axial involvement by investigator judgement and PRO-based criteria. Greater proportions of patients achieved BASDAI50 with UPA15 versus placebo using either criterion, and versus ADA using investigator judgement alone, at week 24 in SELECT-PsA 1 (investigator alone: UPA15, 59.0%, placebo, 26.9%, P < 0.0001, ADA, 44.1%, P = 0.015; investigator and PRO-based: UPA15, 60.4%, placebo, 29.3%, P < 0.0001, ADA, 47.1%, P = 0.074), with comparable findings in SELECT-PsA 2. Similar results were observed with UPA15 for additional BASDAI and ASDAS endpoints at weeks 12 and 24, with improvements maintained at week 56. Rates of TEAEs were generally similar across sub-groups irrespective of axial involvement status. CONCLUSIONS: PsA patients with axial involvement determined by predefined criteria showed greater BASDAI and ASDAS responses with UPA15 versus placebo, and numerically similar/greater responses versus ADA. Safety results were generally comparable between patients with or without axial involvement. TRIAL REGISTRATION: ClinicalTrials.gov: SELECT-PsA 1, NCT03104400; SELECT-PsA 2, NCT0310437.

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Autoinflammatory diseases (AIDs) arise from disturbances that alter interactions of immune cells and tissues. They give rise to prominent (auto)inflammation in the absence of aberrant autoantibodies and/or autoreactive T cells. AIDs that are predominantly caused by changes in the inflammasome pathways, such as the NLRP3- or pyrin-associated inflammasome, have gained substantial attention over the last years. However, AIDs resulting primarily from other changes in the defense system of the innate immune system are less well-studied. These noninflammasome-mediated AIDs relate to, for example, disturbance in the TNF or IFN signaling pathways or aberrations in genes affecting the IL-1RA. The spectrum of clinical signs and symptoms of these conditions is vast. Thus, recognizing early cutaneous signs constitutes an important step in differential diagnoses for dermatologists and other physicians. This review provides an overview of the pathogenesis, clinical presentation, and available treatment options highlighting dermatologic aspects of noninflammasome-mediated AIDs.

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Introduction and objectives: Understanding the disease activity is fundamental to improve patient prognosis and patients’ quality of life. MiDAS study described disease activity in ankylosing spondylitis (AS) Spanish patients and the proportion of them with controlled disease. Methods: Observational, cross-sectional, multicenter study carried out under conditions of routine clinical practice. Adult (≥18 years) patients with ≥6 months since AS diagnosis treated ≥3 months prior to inclusion. The primary endpoint was the percentage of patients with low disease activity assessed through BASDAI (primary endpoint) and ASDAS-CRP (secondary endpoint). Results: 313 AS patients included: 75.7% male; 78.5% HLA-B*27 positive; mean (SD) baseline age of 50.4 (12.0) years; mean (SD) disease duration of 15.5 (11.6) years; 73.5% were treated with biological disease-modifying antirheumatic drugs (DMARDs), 22.4% with non-biological DMARDs and 53.7% with non-steroidal anti-inflammatory drugs, alone or in combination. Monotherapy with biologics and non-biologics was used by 29.7% and 26.8% of patients, respectively. According to BASDAI, 38.0% were in remission (BASDAI≤2) and 64.5% showed adequate disease control (BASDAI<4). According to ASDAS-CRP, 29.4% achieved remission (ASDAS-CRP<1.3) and 28.1% low disease activity (1.3≤ASDAS-CRP<2.1). Conclusions: Almost two thirds of the AS patients recruited had low disease activity, with about one third of them being in remission (BASDAI≤2, ASDAS-CRP<1.3). These results highlight the existing room for improvement in treating AS patients in clinical practice.(AU)

Introducción y objetivos: Comprender la actividad de la enfermedad es fundamental para mejorar el pronóstico y la calidad de vida de los pacientes. El estudio MiDAS describió la actividad de la enfermedad en pacientes españoles con espondilitis anquilosante (EA) y la proporción de ellos con enfermedad controlada. Métodos: Estudio observacional, transversal, multicéntrico, realizado en condiciones de práctica clínica habitual. Pacientes adultos (≥18años) con ≥6meses desde el diagnóstico de EA tratados ≥3meses antes de la inclusión. La variable principal fue el porcentaje de pacientes en baja actividad, evaluado mediante BASDAI (variable principal) y ASDAS-CRP (variable secundaria). Resultados: Hubo 313 pacientes con EA incluidos: 75,7% varones; 78,5% HLA-B*27 positivos; edad media (DE) basal de 50,4 (12,0) años; duración media (DE) de la enfermedad de 15,5 (11,6) años; el 73,5% fueron tratados con fármacos antirreumáticos modificadores de la enfermedad (FAME) biológicos, el 22,4% con FAME no biológicos y el 53,7% con antiinflamatorios no esteroideos, solos o en combinación. La monoterapia con biológicos y no biológicos fue utilizada por el 29,7 y el 26,8% de los pacientes, respectivamente. Según BASDAI, el 38,0% estaban en remisión (BASDAI≤2) y el 64,5% mostraron un adecuado control de la enfermedad (BASDAI<4). Según ASDAS-CRP, el 29,4% alcanzaron remisión (ASDAS-CRP<1,3) y el 28,1% baja actividad de la enfermedad (1,3≤ASDAS-CRP<2,1). Conclusiones: Casi dos tercios de los pacientes con EA incluidos presentaban baja actividad de la enfermedad, con aproximadamente un tercio de ellos en remisión (BASDAI≤2, ASDAS-CRP<1,3). Estos resultados destacan el margen de mejora existente para tratar pacientes con EA en la práctica clínica.(AU)

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INTRODUCTION AND OBJECTIVES: Understanding the disease activity is fundamental to improve patient prognosis and patients' quality of life. MiDAS study described disease activity in ankylosing spondylitis (AS) Spanish patients and the proportion of them with controlled disease. METHODS: Observational, cross-sectional, multicenter study carried out under conditions of routine clinical practice. Adult (≥18 years) patients with ≥6 months since AS diagnosis treated ≥3 months prior to inclusion. The primary endpoint was the percentage of patients with low disease activity assessed through BASDAI (primary endpoint) and ASDAS-CRP (secondary endpoint). RESULTS: 313 AS patients included: 75.7% male; 78.5% HLA-B*27 positive; mean (SD) baseline age of 50.4 (12.0) years; mean (SD) disease duration of 15.5 (11.6) years; 73.5% were treated with biological disease-modifying antirheumatic drugs (DMARDs), 22.4% with non-biological DMARDs and 53.7% with non-steroidal anti-inflammatory drugs, alone or in combination. Monotherapy with biologics and non-biologics was used by 29.7% and 26.8% of patients, respectively. According to BASDAI, 38.0% were in remission (BASDAI≤2) and 64.5% showed adequate disease control (BASDAI<4). According to ASDAS-CRP, 29.4% achieved remission (ASDAS-CRP<1.3) and 28.1% low disease activity (1.3≤ASDAS-CRP<2.1). CONCLUSIONS: Almost two thirds of the AS patients recruited had low disease activity, with about one third of them being in remission (BASDAI≤2, ASDAS-CRP<1.3). These results highlight the existing room for improvement in treating AS patients in clinical practice.

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OBJECTIVES: The alternative ASDAS (altASDAS) is an index that can be used when patient global assessment is unavailable. Our aim was to test the truth and discrimination aspects according to OMERACT filter 2.0 of the altASDAS in an external cohort. METHODS: Cohorts from the COAST trials of ixekizumab (COAST-V, -W, -X; 16-week primary endpoint) enrolling radiographic/non-radiographic axial SpA patients were pooled. The ASDAS [original formula with patient global assessment (PGA)] and altASDAS were calculated. Truth was assessed by agreement with the continuous ASDAS [intraclass correlation coefficients (ICCs)] and ASDAS disease activity (DA) states (weighted κ), Bland-Altman plots [mean difference (MD) and 95% limits of agreement (LoA)] and Pearson's correlations between altASDAS/ASDAS and other constructs. Discrimination was tested by the ability of altASDAS to distinguish high/low DA according to nocturnal pain >6/10 as an external anchor and agreement (κ) with ASDAS in major improvement (MI) and clinically important improvement (CII). RESULTS: A total of 958 patients were included. For truth, agreement with ASDAS was very good (ICC = 0.99, κ = 0.91), MD with ASDAS was 0.03 (95% LoA -0.31-0.24) and correlation coefficients of altASDAS with related constructs were within a prespecified 0.3-wide band around those between ASDAS and the same construct. For discrimination, the altASDAS discriminated between DA states and agreed with ASDAS response (κ MI = 0.91, CII = 0.93). CONCLUSIONS: The altASDAS was truthful and discriminative in an external cohort and as such has been fully validated to be used in cases when PGA is unavailable.

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BACKGROUND: Fibromyalgia may be associated to Spondyloarthritis with which it shares some common symptoms such as sleep disorders, fatigue and diffuse pain, leading to diagnostic and treatment dilemmas. OBJECTIVES: We aimed to determine the prevalence of fibromyalgia in axial spondyloarthritis and to determine how fibromyalgia might influence the assessments of disease activity and how it might impact treatment. METHODS: An observational cross-sectional study was conducted. The study included 100 patients with axial spondyloarthritis according to the Assessment of SpondyloArthritis international Society criteria. Fibromyalgia was diagnosed based on the 2010 American College of Rheumatology criteria. Demographics, disease characteristics, activity parameters and treatment were compared between patients with and without fibromyalgia. Patients were recruited from the hospitalization unit and the outpatient clinic of rheumatology. RESULTS: The mean age of patients was 44.65 ± 13.13 years, with a sex ratio equal to 2. The prevalence of fibromyalgia was 20%. Fibromyalgia associated factors were advanced age and a late age at the onset of axial spondyloarthritis. Disease activity parameters such as global pain VAS, BASDAI, ASDAS-ESR, ASDAS-CRP, BASFI and BAS-G as well as MASES and BASMI were significantly higher in the presence of FM. Doses of paracetamol were significantly higher among FM+ patients. Also, treatment duration of the current anti-TNF alpha agent was significantly shorter among FM+ patients. CONCLUSION: Our study showed that fibromyalgia was associated with axial spondyloarthritis in 20% of patients. Its presence was associated with higher disease activity parameters and negative impact on the treatment.

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AIM: To assess the dynamics of activity of ankylosing spondylitis (AS) during the year after childbirth, to identify predictors of high activity. MATERIALS AND METHODS: 75 pregnant with confirmed AS (modified New York criteria, 1984) were included for prospective observation. Of these, 44 women were followed up for 1 year after delivery. The average age of the patients was 32.55.8 years, the duration of the disease was 149.096.3 months. Lactation was established in 40 women and the duration was 10 [4; 12] months. RESULTS: The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) at 1, 6 and 12 months after giving birth was 2.4 [1.4; 4.2], 2.6 [1.4; 4.4] and 2.7 [1.5; 4.1], respectively (p0.05). ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score C-reactive protein) was 2.0 [1.2; 2.7], 1.9 [1.4; 2.5] and 1.7 [1.3; 2.3], respectively (p0.05). There were no differences between the values of BASDAI, ASDAS-CRP between women with and without lactation. Predictors of high AS activity (BASDAI4) 1 month after delivery were: BASDAI4 in the 1st (odds ratio OR 8.1; 95% confidence interval CI 1,837,0) and 2nd trimesters of pregnancy (OR 5.1, 95% CI 1.220.6); NRS back pain 4 in the 2nd trimester (OR 4.3, 95% CI 1.117.2); cancellation of biological disease-modifying antirheumatic drugs therapy in the 1st trimester of pregnancy (OR 21.0, 95% CI 1.0440.9). Predictors of high AS activity in 6 months after delivery were: BASDAI4 in the 1st (OR 6.5, 95% CI 1.528.7), in the 2nd (OR 6.7, 95% CI 1.627.8) and in the 3rd trimesters of pregnancy (OR 8.7, 95% CI 1.938.6); high activity in 1 month after delivery (OR 4.0, 95% CI 1.015.9). CONCLUSION: AS activity remains stable for 1 year after delivery. High AS activity during pregnancy was a risk factor for high activity within 6 months after delivery.

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OBJECTIVE: The aims of this study were to determine thresholds of variations of BASDAI and pain associated with patient-reported outbreak or resolution of flare and to test performance of ASAS preliminary definitions of flare. METHODS: SpA patients registered on the Spondy+platform were invited to fill BASDAI and global pain on numeric rating scales every week during one year and to tell if they experienced flare since last week. Performance of BASDAI and pain variations (ΔBASDAI and Δpain) to detect occurrence and resolution of flare was determined with receiver operator characteristic (ROC) curves. RESULTS: Ninety-one of the 99 axSpA patients included reported at least one episode of flare. Area under the ROC curve was significantly higher for ΔBASDAI than for Δpain to predict outbreak of flare (0.81 vs. 0.77, p<0.05) without statically significant difference to predict flare resolution (0.78 vs. 0.80). Best sensitivity/specificity compromise was obtained for ΔBASDAI of 0.2 and 0.4 points to predict flare outbreak or resolution, respectively. All the ASAS definitions obtained a specificity higher than 95% whereas sensitivity was lower than 40%. CONCLUSION: ΔBASDAI appeared as a suitable variable to monitor occurrence and resolution of patient-reported flare in axSpA.

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In this study, we evaluated the presence of residual disease in patients with axial spondyloarthritis (axSpA) in remission/low disease activity (LDA) status. This cross-sectional post-hoc analysis of the QUASAR study involving 23 rheumatology centres across Italy included adults with axSpA classified according to the Assessment of SpondyloArthritis International Society criteria. Patients with inactive disease (score < 1.3) or at least LDA status (score < 2.1) at baseline visit according to Ankylosing Spondylitis Disease Activity Score were investigated to evaluate how residual disease activity impacts patients' quality of life. They were assessed using the Ankylosing Spondylitis Quality of Life (ASQoL) and EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaires. This study included 480 patients with axSpA (mean age, 47.5 ± 12.9 years, 64% male). In total, 123 patients (25.6%) had inactive disease and 262 (54.6%) had at least LDA. Using the ASQoL, ranges of 10−25% and 20−40% of patients with inactive disease and with LDA status, respectively, experienced tiredness/fatigue. Despite being classified with inactive disease, 48.8% of patients reported light pain/discomfort according to the EQ-5D-5L, with 4.1% reporting moderate pain/discomfort, whereas 55.7% of patients with LDA reported light pain/discomfort and 13% had moderate pain/discomfort. Using the ASQoL questionnaire, in patients with at least LDA, a higher proportion of women compared with males and a higher proportion of patients > 48 years of age (vs. patients ≤ 48 years) experienced tiredness. In this post-hoc analysis, ≥25% of axSpA patients in remission/LDA status were still burdened by residual disease, mainly characterised by pain and fatigue.