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An Italian Disease-Based Registry of Axial and Peripheral Spondyloarthritis: The SIRENA Study.

ABSTRACT: Introduction: Data about the clinical presentation and management of early and mild spondyloarthritis (SpA) are limited. Objectives: The objective of this study was to describe the baseline characteristics of disease-modifying antirheumatic drug (DMARD)-naïve patients with axial or peripheral SpA. Methods: The Spondyloarthritis Italian Registry: Evidence from a National Pathway (SIRENA) study is an ongoing, Italian, multicenter, prospective registry of patients with a first or newly confirmed diagnosis of SpA according to the Assessment of SpondyloArthritis International Society (ASAS) criteria. To be included, patients had to be naïve to conventional, targeted, and biological DMARDs for SpA. Patients were enrolled between June 2017 and June 2019 and classified into groups according to disease presentation: predominantly axial or peripheral manifestations. The study is ongoing, and patients are being followed for 2 years, with an evaluation every 6 months according to clinical practice. Differences in baseline demographics, lifestyle, and clinical characteristics between axial and peripheral SpA were evaluated. Results: In this study, 350 patients were enrolled, of which 123 (35.1%) were axial and 227 (64.9%) were peripheral patients. Patients with axial SpA were significantly younger at enrollment (median age: 44 vs. 53 years), had significantly more anxiety/depression (13 vs. 2.6%), and expressed higher disease activity compared to patients with peripheral SpA. Patients with peripheral SpA had significantly more cardiometabolic disorders (33 vs. 18.7%), skin psoriasis (65.2 vs. 21.1%), and nail psoriasis (35.5 vs. 17.1%) than patients with axial SpA. Dactylitis, enthesitis, and fibromyalgia were observed, respectively, in 17.6, 51.2, and 5.7% of patients with axial SpA and 24.3, 40, and 3.1% of patients with peripheral SpA. In both disease groups, women tended to report depression, joint tenderness, and higher disease activity more frequently than their male counterparts. At inclusion, a new diagnosis of SpA was performed in 58% of axial and 77% of peripheral patients, with a median time from symptom onset to diagnosis of 36 and 24 months, respectively. At baseline, most patients with axial SpA (77%) started a biological DMARD, while over half of the peripheral patients started a conventional DMARD. Conclusions: Based on a well-characterized clinical registry of SpA, we provided real-world insights on the clinical features of DMARD-naïve SpA patients, pointing out major differences between axial and peripheral disease in terms of clinical characteristics and treatment pattern. Future prospective evaluations within the SIRENA study will improve knowledge on SpA and contribute to defining the best therapeutic approach.

SUBMITTER: Zabotti A

PROVIDER: S-EPMC8492964 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundLittle evidence is available about the impact of diet on disease activity of axial spondyloarthritis (axSpA). This study evaluated the impact of a 6-month nutritional advice based on the Mediterranean diet on the disease activity of axSpA.MethodsWe prospectively collected the information of a group of axSpA patients who were offered nutritional advice for a 6-month period, who were compared to axSpA patients followed at the same center who were not on a specific diet. A nutritionist gave suggestions for dietary modification at baseline and thereafter every 2 months until month 6. Adherence to the Mediterranean diet was evaluated with the PREDIMED questionnaire ranging from 0 (no adherence) to 10 (optimal adherence); disease activity was evaluated with ASDAS-CRP. A multivariable regression analysis was conducted to identify independent predictors of PREDIMED and of ASDAS-CRP improvement (improvement ≥ 20% of each score).ResultsA total of 161 patients were included: 81 receiving nutritional advice and 80 controls; 47 in the nutritional group and 63 controls had complete information until month 6. Overall, 40 (36.4%) were females, the mean age was 51.7 ± 1.3 years, and 58 (52.7%) were affected with psoriasis. No relevant change of anthropometric or laboratory measures was observed in either group. Adherence to the Mediterranean diet was moderate (PREDIMED score 6.7 ± 1.8 at baseline; 7.6 ± 2.1 at month 6) and improved more in the nutritional group compared to controls (p = 0.020). Predictors of a PREDIMED improvement ≥ 20% were receiving nutritional advice (OR 4.53, 1.36-15.1, p = 0.014), age (per 10-year increase OR 1.05, 1.02-1.68, p = 0.007), and BMI (OR 0.77, 0.63-0.9, p = 0.006). An ASDAS-CRP improvement ≥ 20% was more frequent in the nutritional group compared to controls (p = 0.020). A PREDIMED improvement ≥ 20% was associated with a ASDAS-CRP improvement ≥ 20% (OR 6.75,1.8-25.3, p = 0.005). Psoriasis and disease duration were negatively but not significantly associated to the ASDAS-CRP improvement.ConclusionsImproving adherence to the Mediterranean diet may have a beneficial impact on the activity of axSpA. Patients with a lower BMI and older patients are less prone to modify their diet towards the Mediterranean diet following nutritional advice. Patients with psoriasis may have a limited benefit from dietary improvement.Study registrationProtocol No. 52723, Padova Hospital Medical Ethical Committee (October 11, 2010).

Project description:AimsFirst, to compare clinical features and biological disease modifying anti-rheumatic drugs (bDMARDs) response in patients with axial spondyloarthritis (axSpA) and axial psoriatic arthritis (axPsA). Second, to identify possible predictors of treatment response in both entities.MethodsOne-year follow-up, observational, single-center study including all patients with axSpA or axPsA who started bDMARDs therapy. Clinical features were collected at baseline while disease activity was measured at baseline, 6 and 12 months by the Ankylosing Spondylitis Disease Activity Score and the Physician Global Assessment. The frequency of patients achieving inactive disease (ID), low disease activity (LDA), high or very high disease activity and clinical improvement were compared between axSpA and axPsA. Baseline predictor factors for achieving treatment response were identified through regression models, using odds ratio (OR) as an estimate.ResultsIn total, 352 patients were included: 287 (81.5%) axSpA and 65 (18.5%) axPsA. No significant differences at baseline were observed between the two diseases for most of the characteristics. While HLA-B27 positivity was associated with axSpA (OR = 5.4; p < 0.001), peripheral manifestations were associated with axPsA (OR = 4.7; p < 0.001). The frequency of patients with axSpA and axPsA achieving ID/LDA after 6 and 12 months of bDMARDs was comparable: 53% versus 58%, p = 0.5; and 58% versus 60%, p = 0.9, respectively. Both diseases also presented similar clinical improvement. In axSpA and axPsA, male gender seemed to be associated with achieving LDA [OR at 12 months visit = 2.8 (p < 0.01) and 2.7 (p = 0.09)].ConclusionIn clinical practice, patients with axSpA and axPsA present numerous similarities, including comparable medium-term clinical response to bDMARDs. Male gender could be a predictor of treatment response in both diseases.Keyword: axial spondyloarthritis, psoriatic arthritis, axial involvement, clinical characteristics.

Project description:Clinical assessment of spinal impairment in Axial Spondyloarthritis is currently performed using the Bath Ankylosing Spondylitis Metrological Index (BASMI). Despite being appreciated for its simplicity, the BASMI index lacks sensitivity and specificity of spinal changes, demonstrating poor association with radiographical range of motion (ROM). Inertial measurement units (IMUs) have shown promising results as a cost-effective method to quantitatively examine movement of the human body, however errors due to sensor angular drift have limited their application to a clinical space. Therefore, this article presents a wearable sensor protocol that facilitates unrestrained orientation measurements in space while limiting sensor angular drift through a novel constraint-based approach. Eleven healthy male participants performed five BASMI-inspired functional movements where spinal ROM and continuous kinematics were calculated for five spine segments and four spinal joint levels (lumbar, lower thoracic, upper thoracic and cervical). A Bland-Altman analysis was used to assess the level of agreement on range of motion measurements, whilst intraclass correlation coefficient (ICC), standardised error measurement, and minimum detectable change (MDC) to assess relative and absolute reliability. Continuous kinematics error was investigated through root mean square error (RMSE), maximum absolute error (MAE) and Spearman correlation coefficient (?). The overall error in the measurement of continuous kinematic measures was low in both the sagittal (RMSE = 2.1°), and frontal plane (RMSE = 2.3°). ROM limits of agreement (LoA) and minimum detectable change were excellent for the sagittal plane (maximum value LoA 1.9° and MDC 2.4°) and fair for lateral flexion (overall value LoA 4.8° and MDC 5.7°). The reliability analysis showed excellent level of agreement (ICC > 0.9) for both segment and joint ROM across all movements. The results from this study demonstrated better or equivalent accuracy than previous studies and were considered acceptable for application in a clinical setting. The protocol has shown to be a valuable tool for the assessment of spinal ROM and kinematics, but a clinical validation study on Axial Spondyloarthritis patients is required for the development and testing of a novel mobility index.

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An Italian Disease-Based Registry of Axial and Peripheral Spondyloarthritis: The SIRENA Study.

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