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Background Secukinumab is an interleukin (IL)-17 inhibitor approved to treat patients with axial spondyloarthritis (axSpA), including radiographic (r)-axSpA and non-radiographic (nr)-axSpA. Treatment recommendations highlight the importance of individualized treatment of patients with axSpA according to symptoms, extra-musculoskeletal manifestations, and comorbidities. The objective of this post hoc analysis was to compare clinical responses to secukinumab treatment through Week 16 between younger and older patients with r-axSpA and nr-axSpA from six placebo-controlled phase 3 clinical studies. Methods This post hoc analysis evaluated data pooled from 1427 patients with axSpA from the MEASURE 1–5 trials (NCT01358175, NCT01649375, NCT02008916, NCT02159053, and NCT02896127) and the PREVENT trial (NCT02696031). All patients were randomized to secukinumab 150 mg, 300 mg, or placebo through Week 16. Patient subgroups were defined based on median age at baseline (18 to < 40 years vs. ≥ 40 years). Treatment effect (secukinumab 150/300 mg vs. placebo) within each age subgroup and the difference in treatment effect between younger vs. older age subgroups were assessed. Results Secukinumab treatment demonstrated clinical efficacy and improvements in patient-reported outcomes vs. placebo at Week 16 in patients with r-axSpA or nr-axSpA irrespective of age. No difference in treatment effect of ASAS20, ASAS40, or ASDAS response was observed between younger vs. older patients with r-axSpA or nr-axSpA (all P >.05). Among patients with r-axSpA, younger patients experienced a larger treatment effect of secukinumab on SF-36 than older patients (difference in least-squares mean [LSM]: 2.2; P  < .05). Among patients with nr-axSpA, younger patients experienced a larger treatment effect of secukinumab on the Berlin SIJ total edema score (difference in LSM: − 1.2; P  < .05) and Total ASspi-MRI-a score (LSM, − 0.4; P <.05). Conclusion Clinical efficacy of secukinumab vs. placebo at Week 16 was generally similar between older and younger patients with either r-axSpA or nr-axSpA.

Background Difficult to manage (D2M) axial spondyloarthritis (axSpA) is an evolving clinical concept. We aimed to assess the prevalence, predictors and long-term outcomes of D2M axSpA. Methods Prospective single center cohort study of axSpA patients starting targeted agents (01/01/2007 until 28/02/2024). The ASAS criteria were applied to classify D2M. Baseline parameters were assessed as predictors of D2M development by multivariate logistic regression models. To identify comorbidity clusters and their contribution to D2M, a K-means cluster analysis on binary indicators of most prevalent chronic illnesses was performed. Long-term functional evolution and adverse events’ rate were compared between D2M and non-D2M. Results Out of 434 patients, 50 (11.5%) developed D2M disease. Compared to non-D2M, they had higher disease activity at baseline ( p  = 0.01) and failed to improve at 6 months ( p  < 0.0001), while dyslipidemia, osteoarthritis and fibromyalgia were more prevalent ( p  < 0.0001). Independent predictors for developing D2M axSpA were the presence of fibromyalgia (OR 3.55), osteoporosis (OR 5.67) and dyslipidemia (OR 2.70), while two clusters of comorbidities (“chronic pain syndromes” and “metabolic”) significantly contributed to D2M (OR 2.52 and OR 3.30; p  = 0.010 and 0.013 respectively). During a total follow-up period of 2312 patient-years, D2M patients developed higher functional impairment and had more serious adverse events and hospitalizations ( p  = 0.016) compared to non-D2M patients. Conclusion 11.5% of axSpA patients developed D2M disease and showed adverse long-term outcome compared to non-D2M. While D2M patients had at baseline higher disease’s burden, comorbidities mostly related to chronic pain syndromes predicted D2M development, supporting their significance for D2M axSpA evolution.

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.

Background Limited information is available on the impact of treatment with a tumor necrosis factor inhibitor (TNFi) on structural lesions in patients with recent-onset axial spondyloarthritis (axSpA). We compared 2-year structural lesion changes on magnetic resonance imaging (MRI) in the sacroiliac joints (SIJ) of patients with recent-onset axSpA receiving etanercept in a clinical trial (EMBARK) to similar patients not receiving biologics in a cohort study (DESIR). We also evaluated the relationship between the Ankylosing Spondylitis Disease Activity Score (ASDAS) and change in MRI structural parameters. Methods The difference between etanercept (EMBARK) and control (DESIR) in the net percentage of patients with structural lesion change was determined using the SpondyloArthritis Research Consortium of Canada SIJ Structural Score, with and without adjustment for baseline covariates. The relationship between sustained ASDAS inactive disease, defined as the presence of ASDAS < 1.3 for at least 2 consecutive time points 6 months apart, and structural lesion change was evaluated. Results This study included 163 patients from the EMBARK trial and 76 from DESIR. The net percentage of patients with erosion decrease was significantly greater for etanercept vs control: unadjusted: 23.9% vs 5.3%; P  = 0.01, adjusted: 23.1% vs 2.9%; P  = 0.01. For the patients attaining sustained ASDAS inactive disease on etanercept, erosion decrease was evident in significantly more than erosion increase: 34/104 (32.7%) vs 5/104 (4.8%); P  < 0.001. A higher proportion had erosion decrease and backfill increase than patients in other ASDAS status categories. However, the trend across ASDAS categories was not significant and decrease in erosion was observed even in patients without a sustained ASDAS response. Conclusions These data show that a greater proportion of patients achieved regression of erosion with versus without etanercept. However, the link between achieving sustained ASDAS inactive disease and structural lesion change on MRI could not be clearly established. Trial registration EMBARK: ClinicalTrials.gov identifier: NCT01258738 , Registered 13 December 2010; DESIR: ClinicalTrials.gov identifier: NCT01648907 , Registered 24 July 2012.

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.

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.

To determine the prevalence of fibromyalgia (FM) in patients with ankylosing spondylitis (AS) or psoriatic arthritis (PsA) characterized by axial involvement (axial-PsA), and to assess the discriminative ability of different versions of the Ankylosing Spondylitis Disease Activity Score (ASDAS) and the Bath Ankylosing Spondylitis Activity Disease Activity Index (BASDAI) in measuring disease activity in three different cohorts of patients with axial spondyloarthritis (axial-SpA), FM, or both (axial-SpA + FM), this study was divided into two phases: (1) 402 patients with definite AS or axial-PsA were examined to diagnose FM and estimate its prevalence; and (2) 419 patients (111 with axial-SpA, 248 with FM, and 60 with aSpA + FM) were evaluated using the different versions of the ASDAS and BASDAI to assess the effect on disease activity. The overall prevalence of FM in the axial-SpA population was 14.9 %, significantly higher among women ( p  < 0.0001); the estimated prevalence in AS was 12.7 % and in axial-PsA was 17.2 %. Although the BASDAI scores correlated with those of ASDAS–C-reactive protein (CRP) and ASDAS–erythrocyte sedimentation rate (ESR) ( p  < 0.0001), only ASDAS had sufficient discriminatory ability to assess disease activity. The addition of only one marker of inflammation led to an adequate level of significance (ASDAS–CRP, p  = 0.0018; ASDAS–ESR, p  = 0.003). FM is common in axial-SpA and more prevalent in female patients. Our findings suggest that ASDAS is better than BASDAI in distinguishing patients with disease activity from those with functional impairment. The use of ASDAS may be very useful in clinical practice as it allows treating patients with the most appropriate therapy.

Objectives: The objective of the study was to validate the Ankylosing Spondylitis Disease Activity Score (ASDAS) based on a quick quantitative C-reactive protein (qCRP) assay (ASDAS-Q) in a multicentre, prospective, cross-sectional study in patients with axial spondyloarthritis (axial SpA). Methods: Disease activity assessment was performed in prospectively recruited patients with axial SpA. Routine laboratory CRP was determined in the central laboratory of each study centre, while quick qCRP and erythrocyte sedimentation rate (ESR) were measured locally. Consequently, ASDAS-CRP, ASDAS-Q using the qCRP and ASDAS-ESR were calculated. The absolute agreement on the disease activity category ascertainment was analysed with cross-tabulations and weighted Cohen’s kappa. Bland–Altman plots and intraclass correlation coefficients (ICCs) were used to analyse the criterion validity. Results: Overall, 251 axial SpA patients were included in the analysis. The mean qCRP value (6.34 ± 11.13 mg/l) was higher than that of routine laboratory CRP (5.26 ± 9.35 mg/l). The ICC for routine laboratory CRP versus qCRP was 0.985 [95% confidence interval (CI): 0.972–0.991]. Comparing ASDAS-Q with ASDAS-CRP, 242 of 251 (96.4%) patients were assigned to the same disease activity categories with a weighted Cohen’s kappa of 0.966 (95% CI: 0.943–0.988) and ICC of 0.997 (95% CI: 0.994–0.999). Conclusions: ASDAS-Q showed an almost perfect agreement with ASDAS-CRP in the assignment to specific disease activity categories. Consequently, ASDAS-Q using the qCRP value can be applied as an accurate and quickly available alternative to ASDAS-CRP, thus facilitating the implementation of the treat-to-target concept in clinical trials and clinical routine.

Background: Ankylosing spondylitis (AS) is a chronic inflammatory disease in which accurate assessment of disease activity remains challenging. Although composite indices such as BASDAI and ASDAS are widely used, they may not fully capture systemic inflammatory burden. The C-reactive protein–albumin–lymphocyte (CALLY) index is an emerging composite biomarker integrating inflammatory, nutritional, and immunological components. This study aimed to evaluate the association of the CALLY index with disease activity, functional status, and quality of life in AS. Methods: This medical record-based cross-sectional study included 65 patients with AS. Disease activity was assessed using BASDAI and ASDAS-ESR, functional status using BASFI, and quality of life using the 12-Item Short Form Health Survey (SF-12). The CALLY index was calculated from serum CRP, albumin levels, and lymphocyte counts. Correlation and multivariable linear regression analyses were performed. Results: The mean CALLY index was 58.43 ± 66.20. The index showed moderate negative correlations with ESR and ASDAS-ESR and a positive correlation with lymphocyte count. Its strong inverse correlation with CRP was expected because CRP is part of the formula and was therefore interpreted cautiously. No significant associations were found with BASDAI, BASFI, or SF-12. In multivariable analysis, BMI (β = −0.299, p = 0.012) and NSAID use (β = −0.298, p = 0.011) were independent predictors. Conclusions: The CALLY index was associated mainly with objective inflammatory markers rather than patient-reported outcomes, suggesting a dissociation between biochemical and clinical disease domains in AS. These findings are preliminary and require confirmation in larger longitudinal studies before clinical application.

The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) has been widely utilized to evaluate disease activity in patients with ankylosing spondylitis (AS) by an arbitrary cut-off of ≥4 to indicate high disease activity and initiate biological therapy. The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a new composite index to assess AS disease activity states that have been defined and validated. ASDAS ≥2.1 was selected as a criterion to start biological therapy. The purpose of this study was to estimate the corresponding BASDAI and ASDAS cut-off in a Taiwanese AS cohort. From November 2016 to October 2018, we assessed the ASDAS and the BASDAI regularly and recorded demographic data for 489 AS patients in Taichung Veterans General hospital (TCVGH) using an electronic patient-reported data system linked to electronic medical records. We used receiver operating characteristic curves with Youden's J statistic to determine the BASDAI values that correspond to ASDAS disease activity cut-offs (i.e., 1.3, 2.1, and 3.5). In our population, the best trade-off BASDAI values corresponding to ASDAS -C-reactive protein (CRP) 1.3, 2.1, and 3.5 were 2.1, 3.1, and 3.7, respectively. The optimal BASDAI values corresponding to ASDAS-erythrocyte sedimentation rates 1.3, 2.1, and 3.5 were 2.0, 2.6, and 4.8, respectively. We propose a revised BASDAI cut-off based on our data, as BASDAI scores are commonly used globally. A more reasonable, lower BASDAI cut-off to initiate or change biological therapy will bring us closer to better decisions to treat AS patients.