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1.
Curr Opin Rheumatol ; 36(4): 267-273, 2024 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-38533807

RESUMO

PURPOSE OF REVIEW: To evaluate the current applications and prospects of artificial intelligence and machine learning in diagnosing and managing axial spondyloarthritis (axSpA), focusing on their role in medical imaging, predictive modelling, and patient monitoring. RECENT FINDINGS: Artificial intelligence, particularly deep learning, is showing promise in diagnosing axSpA assisting with X-ray, computed tomography (CT) and MRI analyses, with some models matching or outperforming radiologists in detecting sacroiliitis and markers. Moreover, it is increasingly being used in predictive modelling of disease progression and personalized treatment, and could aid risk assessment, treatment response and clinical subtype identification. Variable study designs, sample sizes and the predominance of retrospective, single-centre studies still limit the generalizability of results. SUMMARY: Artificial intelligence technologies have significant potential to advance the diagnosis and treatment of axSpA, providing more accurate, efficient and personalized healthcare solutions. However, their integration into clinical practice requires rigorous validation, ethical and legal considerations, and comprehensive training for healthcare professionals. Future advances in artificial intelligence could complement clinical expertise and improve patient care through improved diagnostic accuracy and tailored therapeutic strategies, but the challenge remains to ensure that these technologies are validated in prospective multicentre trials and ethically integrated into patient care.


Assuntos
Inteligência Artificial , Espondiloartrite Axial , Aprendizado de Máquina , Humanos , Espondiloartrite Axial/diagnóstico , Aprendizado Profundo , Tomografia Computadorizada por Raios X/métodos , Imageamento por Ressonância Magnética/métodos
2.
Radiology ; 311(3): e231786, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38860891

RESUMO

Whereas previous projects attempted to standardize imaging in patients with axial spondyloarthritis (axSpA), few studies have been published about the need for specific details regarding the image acquisition and lesions that may be less familiar to general radiologists. This work reports consensus recommendations developed by the Assessment of SpondyloArthritis International Society (ASAS) that aim to standardize the imaging reports in patients suspected of having or with known axSpA. A task force consisting of radiologists and rheumatologists from ASAS and one patient representative formulated two surveys that were completed by ASAS members. The results of these surveys led to the development of 10 recommendations that were endorsed by 73% (43 of 59) of ASAS members. The recommendations are targeted to the radiologist and include best practices for the inclusion of clinical information, technical details, image quality, and imaging findings in radiology reports. These recommendations also emphasize that imaging findings that indicate differential diagnoses and referral suggestions should be included in the concluding section of the radiology report. With these recommendations, ASAS aims to improve the diagnostic process and care for patients suspected of having or with known axSpA.


Assuntos
Articulação Sacroilíaca , Humanos , Articulação Sacroilíaca/diagnóstico por imagem , Espondiloartrite Axial/diagnóstico por imagem , Sociedades Médicas , Espondilartrite/diagnóstico por imagem , Diagnóstico Diferencial , Imageamento por Ressonância Magnética/métodos
3.
Ann Rheum Dis ; 83(2): 184-193, 2024 Jan 11.
Artigo em Inglês | MEDLINE | ID: mdl-37890976

RESUMO

OBJECTIVES: Early diagnosis of inflammatory arthritis is critical to prevent joint damage and functional incapacities. However, the discrepancy between recommendations of early diagnosis and reality is remarkable. The Rheuma-VOR study aimed to improve the time to diagnosis of patients with early arthritis by coordinating cooperation between primary care physicians, specialists and patients in Germany. METHODS: This prospective non-randomised multicentre study involved 2340 primary care physicians, 72 rheumatologists, 4 university hospitals and 4 rheumatology centres in 4 German Federal States. The two coprimary endpoints (time to diagnosis and screening performance of primary care physicians) were evaluated for early versus late implementation phase. Additionally, time to diagnosis and secondary endpoints (decrease of disease activity, increase in quality of life and overall well-being, improvement of fatigue, depression, functional ability, and work ability, reduction in drug and medical costs and hospitalisation) were compared with a reference cohort of the German Rheumatism Research Centre (DRFZ) reflecting standard care. RESULTS: A total of 7049 patients were enrolled in the coordination centres and 1537 patients were diagnosed with a rheumatic disease and consented to further participation. A follow-up consultation after 1 year was realised in 592 patients. The time to diagnosis endpoint and the secondary endpoints were met. In addition, the calculation of cost-effectiveness shows that Rheuma-VOR has a dominant cost-benefit ratio compared with standard care. DISCUSSION: Rheuma-VOR has shown an improvement in rheumatological care, patient-reported outcome parameters and cost savings by coordinating the cooperation of primary care physicians, rheumatologists and patients, in a nationwide approach.


Assuntos
Artrite Reumatoide , Doenças Reumáticas , Humanos , Artrite Reumatoide/diagnóstico , Qualidade de Vida , Estudos Prospectivos , Doenças Reumáticas/diagnóstico , Doenças Reumáticas/terapia , Atenção à Saúde
4.
Ann Rheum Dis ; 83(5): 599-607, 2024 Apr 11.
Artigo em Inglês | MEDLINE | ID: mdl-38228361

RESUMO

OBJECTIVES: The study aimed to evaluate the effect of adding a non-steroidal anti-inflammatory drug (NSAID), celecoxib (CEL), to a tumour necrosis factor inhibitor (TNFi), golimumab (GOL), compared with TNFi monotherapy on radiographic spinal progression in patients with radiographic axial spondyloarthritis (r-axSpA) over 2 years. METHODS: R-axSpA patients, having risk factors for radiographic progression (high disease activity plus C reactive protein >5 mg/L and/or ≥1 syndesmophyte(s)), underwent a 12-week run-in phase with GOL 50 mg every 4 weeks. In the core phase (96 weeks), only patients with a good clinical response at week 12 were randomised (1:1) to GOL+CEL 200 mg two times per day (combination therapy) or GOL monotherapy. The primary endpoint was radiographic progression assessed by modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) change at week 108 in the intent-to-treat population. RESULTS: A total of 128 patients were enrolled in the run-in phase; and 109 patients were randomised at week 12 to monotherapy (n=55) or combination therapy (n=54). At week 108, 97 (52 vs 45) patients completed the study. The change in mSASSS at week 108 was 1.7 (95% CI 0.8 to 2.6) in the monotherapy vs 1.1 (95% CI 0.4 to 1.8) in the combination therapy groups (p=0.79). New syndesmophytes occurred in 25% of patients in the monotherapy vs 11% of patients in the combination therapy groups (p=0.12). During the study, no significant differences in adverse events and serious adverse events were observed between the groups. CONCLUSIONS: Combination therapy with GOL+CEL did not demonstrate statistically significant superiority over GOL monotherapy in retarding radiographic spinal progression over 2 years in r-axSpA.


Assuntos
Espondiloartropatias , Espondilite Anquilosante , Humanos , Anti-Inflamatórios não Esteroides/uso terapêutico , Inibidores do Fator de Necrose Tumoral/uso terapêutico , Radiografia , Coluna Vertebral/diagnóstico por imagem , Coluna Vertebral/patologia , Espondilite Anquilosante/tratamento farmacológico , Celecoxib/uso terapêutico , Espondiloartropatias/tratamento farmacológico , Progressão da Doença
5.
Ann Rheum Dis ; 83(5): 547-549, 2024 Apr 11.
Artigo em Inglês | MEDLINE | ID: mdl-38071514

RESUMO

Ankylosing spondylitis (AS) is the historic term used for decades for the HLA-B27-associated inflammatory disease affecting mainly the sacroiliac joints (SIJ) and spine. Classification criteria for AS have radiographic sacroiliitis as a dominant characteristic. However, with the availability of MRI of SIJ, it could be demonstrated that the disease starts long before definite SIJ changes become visible on radiographs. The Assessment of SpondyloArthritis international Society, representing a worldwide group of experts reached consensus on changes in the nomenclature pertaining to axial spondyloarthritis (axSpA), such as the terminology of diagnosis and of assessment of disease activity tools. These are important changes in the field, as experts in axSpA are now in agreement that the term axSpA is the overall term for the disease. A further differentiation, of which radiographic versus non-radiographic is only one aspect, may be relevant for research purposes. Another important decision was that the terms AS and radiographic axSpA (r-axSpA) can be used interchangeably, but that the preferred term is r-axSpA. Based on the decision that axSpA is the correct terminology, a proposal was made to officially change the meaning of the ASDAS acronym to 'Axial Spondyloarthritis Disease Activity Score'. In addition, for simplification it was proposed that the term ASDAS (instead of ASDAS-CRP) should be preferred and applied to the ASDAS calculated with C reactive protein (CRP). It is hoped that these changes will be used consequently for education, in textbooks, manuscripts and presentations.


Assuntos
Sacroileíte , Espondilartrite , Espondilite Anquilosante , Humanos , Espondilite Anquilosante/diagnóstico , Índice de Gravidade de Doença , Espondilartrite/diagnóstico , Articulação Sacroilíaca/diagnóstico por imagem , Sacroileíte/diagnóstico por imagem , Proteína C-Reativa
6.
Artigo em Inglês | MEDLINE | ID: mdl-38507706

RESUMO

OBJECTIVE: To assess the association of body composition, evaluated by bioimpedance analysis (BIA), with disease activity, physical function, and mobility in patients with axSpA undergoing bDMARD treatment for one year. METHODS: Patients with AS (radiographic axSpA) were enrolled in an extension of the German Spondyloarthritis Inception Cohort (GESPIC). Patients were required to be candidates for bDMARD therapy at baseline presenting high disease activity despite previous treatment with nonsteroidal anti-inflammatory drugs. Outcomes (disease activity, function, and mobility) and body composition parameters were assessed at baseline and every 6 months thereafter. Body composition was assessed by BIA. The association between body composition parameters and outcomes over 1 year was analyzed using longitudinal generalized estimating equations. RESULTS: Seventy-four patients with radiographic axSpA were included in current analysis with a mean age of 36.5 years, disease duration of 6.2 years and ASDAS-CRP score of 3.4 at baseline. Fat mass value and fat mass index were positively associated with disease activity (ASDAS: ß = 0.01, 95% CI [-0.01, 0.03] and ß = 0.04, 95% CI [-0.01, 0.08], respectively) and functional disability (BASFI). Visceral adipose tissue (VAT) was associated with reduced spine mobility (BASMI: ß = 0.20, 95% CI [0.07, 0.33]). Additionally, increase in VAT and fat mass parameters was linked to worse disease activity and functional disability in women, while they were strongly associated with reduced spinal mobility in men. CONCLUSIONS: Higher levels of body fat and VAT were positively associated with increased disease activity, functional disability, and reduced spinal mobility in patients with radiographic axSpA treated with bDMARDs.

7.
Skeletal Radiol ; 53(7): 1295-1302, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38224381

RESUMO

OBJECTIVE: Conventional magnetic resonance imaging (MRI) uses T1-weighted and short-tau inversion recovery (STIR) sequences to characterize bone marrow in axial spondyloarthritis. However, quantification is restricted to estimating the extent of lesions because signal intensities are highly variable both within individuals and across patients and MRI scanners. This study evaluates the performance of quantitative T1 mapping for distinguishing different types of bone marrow lesions of the sacroiliac joints. MATERIALS AND METHODS: In this prospective study, 62 patients underwent computed tomography (CT) and MRI of the sacroiliac joints including T1, STIR, and T1 mapping. Bone marrow lesions were characterized by three readers and assigned to one of four groups: sclerosis, osteitis, fat lesions, and mixed marrow lesions. Relaxation times on T1 maps were compared using generalized estimating equations and receiver operating characteristics (ROC) analysis. RESULTS: A total of 119 lesions were selected (sclerosis: 38, osteitis: 27, fat lesions: 40; mixed lesions: 14). T1 maps showed highly significant differences between the lesions with the lowest values for sclerosis (1516±220 ms), followed by osteitis (1909±75 ms), and fat lesions (2391±200 ms); p<0.001. T1 mapping differentiated lesions with areas under the ROC curve of 99% (sclerosis vs. osteitis) and 100% (other comparisons). CONCLUSION: T1 mapping allows accurate characterization of sclerosis, osteitis, and fat lesions at the sacroiliac joint but only for homogeneous, non-mixed lesions. Thus, further sequence development is needed before implementation in clinical routine.


Assuntos
Espondiloartrite Axial , Imageamento por Ressonância Magnética , Articulação Sacroilíaca , Tomografia Computadorizada por Raios X , Humanos , Imageamento por Ressonância Magnética/métodos , Masculino , Feminino , Adulto , Estudos Prospectivos , Articulação Sacroilíaca/diagnóstico por imagem , Articulação Sacroilíaca/patologia , Tomografia Computadorizada por Raios X/métodos , Espondiloartrite Axial/diagnóstico por imagem , Medula Óssea/diagnóstico por imagem , Medula Óssea/patologia , Pessoa de Meia-Idade , Doenças da Medula Óssea/diagnóstico por imagem , Osteíte/diagnóstico por imagem
8.
Z Rheumatol ; 83(Suppl 1): 20-30, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36749363

RESUMO

OBJECTIVE: This study aimed to update the prevalence estimates of inflammatory rheumatic diseases (IRD) in Germany. METHODS: A systematic literature search in PubMed and Web of Science (last search 08 November 2022) identified original articles (regional and nationwide surveys and claims data analyses for arthritides, connective tissue diseases, and vasculitides) on prevalences for the period 2014-2022. Data sources, collection period, case definition, and risk of bias are reported. Prevalences were estimated from available national data, with consideration of international data. RESULTS: Screening by two authors yielded 263 hits, of which 18 claims data analyses and 2 surveys met the inclusion criteria. Prevalences ranged from 0.42 to 1.85% (rheumatoid arthritis), 0.32-0.5% (ankylosing spondylitis), 0.11-0.32% (psoriatic arthritis), 0.037-0.14% (systemic lupus erythematosus), 0.07-0.77% (Sjögren's disease/sicca syndrome), 0.14-0.15% (polymyalgia rheumatica, ≥ 40 years), 0.04-0.05% (giant cell arteritis, ≥ 50 years), and 0.015-0.026% (ANCA-associated vasculitis). The risk of bias was moderate in 13 and high in 7 studies. Based on the results, we estimate the prevalence of IRD in Germany to be 2.2-3.0%, which corresponds to approximately 1.5-2.1 million affected individuals. The prevalence of juvenile idiopathic arthritis was reported to be around 0.10% (0.07-0.10%) of 0-18-year-olds, corresponding to about 14,000 children and adolescents in Germany. CONCLUSION: This systematic review shows an increase in the prevalence of IRD in Germany, which is almost exclusively based on claims data analyses. In the absence of multistage population studies, the available data are, overall, uncertain sources for prevalence estimates, with a moderate to high risk of bias.


Assuntos
Artrite Reumatoide , Arterite de Células Gigantes , Lúpus Eritematoso Sistêmico , Polimialgia Reumática , Doenças Reumáticas , Febre Reumática , Síndrome de Sjogren , Espondilite Anquilosante , Criança , Adolescente , Humanos , Prevalência , Artrite Reumatoide/epidemiologia , Espondilite Anquilosante/diagnóstico , Espondilite Anquilosante/epidemiologia , Síndrome de Sjogren/epidemiologia , Lúpus Eritematoso Sistêmico/epidemiologia , Arterite de Células Gigantes/epidemiologia , Doenças Reumáticas/diagnóstico , Doenças Reumáticas/epidemiologia
9.
Lancet ; 400(10349): 369-379, 2022 07 30.
Artigo em Inglês | MEDLINE | ID: mdl-35908570

RESUMO

BACKGROUND: Upadacitinib, a Janus kinase inhibitor, has been shown to be effective in patients with ankylosing spondylitis. We aimed to assess the efficacy and safety of upadacitinib in non-radiographic axial spondyloarthritis. METHODS: The SELECT-AXIS 2 non-radiographic axial spondyloarthritis study was a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial at 113 sites across 23 countries (Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, France, Germany, Hungary, Israel, Japan, Mexico, Poland, Russia, Slovakia, South Korea, Spain, Taiwan, Turkey, Ukraine, and the USA). Eligible adults had active non-radiographic axial spondyloarthritis, with objective signs of inflammation based on MRI or elevated C-reactive protein and an inadequate response to non-steroidal anti-inflammatory drugs. Patients were randomly assigned (1:1) to receive oral upadacitinib 15 mg once daily or placebo using interactive response technology. Random treatment assignment was stratified by MRI inflammation in the sacroiliac joints and screening high-sensitivity C-reactive protein status (MRI-positive and C-reactive protein-positive, MRI-positive and C-reactive protein-negative, and MRI-negative and C-reactive protein-positive) and previous exposure to biologic disease-modifying antirheumatic drugs (yes vs no). Treatment assignment was masked from patients, investigators, study site personnel, and the study sponsor. The primary endpoint was the proportion of patients with an Assessment of SpondyloArthritis international Society 40 (ASAS40) response at week 14. Analyses were performed on the full analysis set of patients, who underwent random allocation and received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, NCT04169373. FINDINGS: Between Nov 26, 2019, and May 20, 2021, 314 patients with active non-radiographic axial spondyloarthritis were enrolled into the study, and 313 received study drug (156 in the upadacitinib group and 157 in the placebo group); 295 (94%) patients (145 in the upadacitinib group and 150 in the placebo group) received treatment for the full 14 weeks. A significantly higher ASAS40 response rate was achieved with upadacitinib compared with placebo at week 14 (70 [45%] of 156 patients vs 35 [23%] of 157 patients; p<0·0001; treatment difference 22%, 95% CI 12-32). The rate of adverse events up to week 14 was similar in the upadacitinib group (75 [48%] of 156 patients) and placebo group (72 [46%] of 157 patients). Serious adverse events and adverse events leading to discontinuation of study drug occurred in four (3%) of 156 patients in the upadacitinib group and two (1%) of 157 patients in the placebo group. Few patients had serious infections or herpes zoster in either treatment group (each event occurred in two [1%] of 156 patients in the upadacitinib group and one [1%] of 157 patients in the placebo group). Five (3%) of 156 patients in the upadacitinib group had neutropenia; no events of neutropenia occurred in the placebo group. No opportunistic infections, malignancies, major adverse cardiovascular events, venous thromboembolic events, or deaths were reported with upadacitinib treatment. INTERPRETATION: Upadacitinib significantly improved the signs and symptoms of non-radiographic axial spondyloarthritis compared with placebo at week 14. These findings support the potential of upadacitinib as a new therapeutic option in patients with active non-radiographic axial spondyloarthritis. FUNDING: AbbVie.


Assuntos
Espondiloartrite Axial , Neutropenia , Espondiloartrite Axial não Radiográfica , Adulto , Proteína C-Reativa , Método Duplo-Cego , Compostos Heterocíclicos com 3 Anéis , Humanos , Inflamação , Resultado do Tratamento
10.
Ann Rheum Dis ; 82(2): 212-216, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36100350

RESUMO

OBJECTIVES: To evaluate the recapture of response with open-label (OL) ixekizumab (IXE) retreatment at week 104 in patients with axial spondyloarthritis who flared after withdrawal of IXE therapy. METHODS: COAST-Y (NCT03129100) is a phase III extension study that included a double-blind, placebo-controlled, randomised withdrawal-retreatment period (RWRP). Patients who achieved remission (Ankylosing Spondylitis Disease Activity Score (ASDAS) <1.3 (inactive disease, ID) at least once at week 16 or 20 and <2.1 (low disease activity, LDA) at both visits) were randomised 2:1 at week 24 to continue IXE or withdraw to placebo. Patients who subsequently flared were switched to OL IXE every 2 or 4 weeks (Q2W or Q4W) at the next visit. The proportions of patients who recaptured ASDAS LDA and ID were summarised for those who experienced flare. RESULTS: Of the 155 patients who entered the RWRP (placebo, n=53; IXE Q4W, n=48; IXE Q2W, n=54), 138 (89%) completed week 104. Of the placebo-treated patients (n=53), 28 (53%) experienced a flare during weeks 24-104; of these, 4 (14%) recaptured ASDAS LDA before retreatment with OL IXE, and 23 (82%) recaptured ASDAS LDA and 19 (68%) met ASDAS ID after retreatment. Of the continuously treated IXE patients (n=102), 13 experienced flare; 7 of 13 (54%) recaptured ASDAS LDA before switching to OL IXE retreatment, while 5 of 13 (38%) recaptured ASDAS LDA and 4 of 13 (31%) met ID after switching. CONCLUSIONS: Ninety-six per cent of patients withdrawn to placebo recaptured at least ASDAS LDA and 71% recaptured ASDAS ID with IXE retreatment at week 104. This may provide support to patients who may require a brief interruption in therapy.


Assuntos
Anticorpos Monoclonais Humanizados , Espondilite Anquilosante , Humanos , Anticorpos Monoclonais Humanizados/uso terapêutico , Espondilite Anquilosante/tratamento farmacológico , Retratamento , Método Duplo-Cego , Resultado do Tratamento
11.
Ann Rheum Dis ; 2023 Jun 15.
Artigo em Inglês | MEDLINE | ID: mdl-37321799

RESUMO

OBJECTIVES: To develop a consensual definition for the term 'early axial spondyloarthritis-axSpA'-and 'early peripheral spondyloarthritis-pSpA'. METHODS: The ASAS (Assessment of SpondyloArthritis international Society-Spondyloarthritis EARly definition) steering committee convened an international working group (WG). Five consecutive steps were followed: (1) systematic literature review (SLR); (2) discussion of SLR results within the WG and ASAS community; (3) a three-round Delphi survey inviting all ASAS members to select the items that should be considered for the definition; (4) presentation of Delphi results to the WG and ASAS community and (5) ASAS voting and endorsement (2023 annual meeting). RESULTS: Following the SLR, consensus was to proceed with an expert-based definition for early axSpA (81% in favour) but not for pSpA (54% against). Importantly, early axSpA should be based on symptom duration taking solely axial symptoms into account. 151-164 ASAS members participated in the Delphi surveys. Consensus was achieved for considering the following items within early axSpA definition: duration of symptoms ≤2 years; axial symptoms defined as cervical/thoracic/back/buttock pain or morning stiffness; regardless of the presence/absence of radiographic damage. The WG agreed that in patients with a diagnosis of axSpA 'early axSpA' should be defined as a duration of ≤2 years of axial symptoms. Axial symptoms should include spinal/buttock pain or morning stiffness and should be considered by a rheumatologist as related to axSpA. The ASAS community endorsed this proposal (88% in favour). CONCLUSIONS: Early axSpA has newly been defined, based on expert consensus. This ASAS definition should be adopted in research studies addressing early axSpA.

12.
Ann Rheum Dis ; 82(6): 763-772, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-35680390

RESUMO

OBJECTIVES: To define the instruments for the Assessment of SpondyloArthritis international Society-Outcomes Measures in Rheumatology (ASAS-OMERACT) core domain set for axial spondyloarthritis (axSpA). METHODS: An international working group representing key stakeholders selected the core outcome instruments following a predefined process: (1) identifying candidate instruments using a systematic literature review; (2) reducing the list of candidate instruments by the working group, (3) assessing the instruments' psychometric properties following OMERACT filter 2.2, (4) selection of the core instruments by the working group and (5) voting and endorsement by ASAS. RESULTS: The updated core set for axSpA includes seven instruments for the domains that are mandatory for all trials: Ankylosing Spondylitis Disease Activity Score and Numerical Rate Scale (NRS) patient global assessment of disease activity, NRS total back pain, average NRS of duration and severity of morning stiffness, NRS fatigue, Bath Ankylosing Spondylitis Function Index and ASAS Health Index. There are 9 additional instruments considered mandatory for disease-modifying antirheumatic drugs (DMARDs) trials: MRI activity Spondyloarthritis Research Consortium of Canada (SPARCC) sacroiliac joints and SPARCC spine, uveitis, inflammatory bowel disease and psoriasis assessed as recommended by ASAS, 44 swollen joint count, Maastricht Ankylosing Spondylitis Enthesitis Score, dactylitis count and modified Stoke Ankylosing Spondylitis Spinal Score. The imaging outcomes are considered mandatory to be included in at least one trial for a drug tested for properties of DMARD. Furthermore, 11 additional instruments were also endorsed by ASAS, which can be used in axSpA trials on top of the core instruments. CONCLUSIONS: The selection of the instruments for the ASAS-OMERACT core domain set completes the update of the core outcome set for axSpA, which should be used in all trials.


Assuntos
Antirreumáticos , Espondilartrite , Espondilite Anquilosante , Humanos , Espondilite Anquilosante/diagnóstico , Espondilite Anquilosante/tratamento farmacológico , Espondilartrite/diagnóstico , Espondilartrite/tratamento farmacológico , Coluna Vertebral , Antirreumáticos/uso terapêutico , Avaliação de Resultados em Cuidados de Saúde
13.
Ann Rheum Dis ; 82(4): 515-526, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-36649967

RESUMO

OBJECTIVES: Axial spondyloarthritis (axSpA) is a complex disease with diverse manifestations, for which new treatment options are warranted. BE MOBILE 1 (non-radiographic (nr)-axSpA) and BE MOBILE 2 (radiographic axSpA (r-axSpA)) are double-blind, phase 3 trials designed to evaluate efficacy and safety of bimekizumab, a novel dual interleukin (IL)-17A and IL-17F inhibitor, across the axSpA spectrum. METHODS: In parallel 52-week trials, patients with active disease were randomised 1:1 (nr-axSpA) or 2:1 (r-axSpA) to bimekizumab 160 mg every 4 weeks:placebo. From week 16, all patients received bimekizumab 160 mg every 4 weeks. Primary (Assessment of SpondyloArthritis international Society ≥40% improvement (ASAS40)) and secondary endpoints were assessed at week 16. Here, efficacy and treatment-emergent adverse events (TEAEs) are reported up to week 24. RESULTS: 254 patients with nr-axSpA and 332 with r-axSpA were randomised. At week 16, primary (ASAS40, nr-axSpA: 47.7% bimekizumab vs 21.4% placebo; r-axSpA: 44.8% vs 22.5%; p<0.001) and all ranked secondary endpoints were met in both trials. ASAS40 responses were similar across TNFi-naïve and TNFi-inadequate responder patients. Improvements were observed in Ankylosing Spondylitis Disease Activity Score (ASDAS) states and objective measures of inflammation, including high-sensitivity C-reactive protein (hs-CRP) and MRI of the sacroiliac joints and spine. Most frequent TEAEs with bimekizumab (>3%) included nasopharyngitis, upper respiratory tract infection, pharyngitis, diarrhoea, headache and oral candidiasis. More fungal infections (all localised) were observed with bimekizumab vs placebo; no major adverse cardiovascular events (MACE) or active tuberculosis were reported. Incidence of uveitis and adjudicated inflammatory bowel disease was low. CONCLUSIONS: Dual inhibition of IL-17A and IL-17F with bimekizumab resulted in significant and rapid improvements in efficacy outcomes vs placebo and was well tolerated in patients with nr-axSpA and r-axSpA.


Assuntos
Espondiloartrite Axial não Radiográfica , Espondilartrite , Espondilite Anquilosante , Humanos , Interleucina-17 , Resultado do Tratamento , Espondilite Anquilosante/tratamento farmacológico , Espondilartrite/tratamento farmacológico , Método Duplo-Cego , Ensaios Clínicos Controlados Aleatórios como Assunto
14.
Ann Rheum Dis ; 82(1): 19-34, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-36270658

RESUMO

OBJECTIVES: To update the Assessment of SpondyloArthritis international Society (ASAS)-EULAR recommendations for the management of axial spondyloarthritis (axSpA). METHODS: Following the EULAR Standardised Operating Procedures, two systematic literature reviews were conducted on non-pharmacological and pharmacological treatment of axSpA. In a task force meeting, the evidence was presented, discussed, and overarching principles and recommendations were updated, followed by voting. RESULTS: Five overarching principles and 15 recommendations with a focus on personalised medicine were agreed: eight remained unchanged from the previous recommendations; three with minor edits on nomenclature; two with relevant updates (#9, 12); two newly formulated (#10, 11). The first five recommendations focus on treatment target and monitoring, non-pharmacological management and non-steroidal anti-inflammatory drugs (NSAIDs) as first-choice pharmacological treatment. Recommendations 6-8 deal with analgesics and discourage long-term glucocorticoids and conventional synthetic disease-modifying antirheumatic drugs (DMARDs) for pure axial involvement. Recommendation 9 describes the indication of biological DMARDs (bDMARDs, that is, tumour necrosis factor inhibitors (TNFi), interleukin-17 inhibitors (IL-17i)) and targeted synthetic DMARDs (tsDMARDs, ie, Janus kinase inhibitors) for patients who have Ankylosing Spondylitis Disease Activity Score ≥2.1 and failed ≥2 NSAIDs and also have either elevated C reactive protein, MRI inflammation of sacroiliac joints or radiographic sacroiliitis. Current practice is to start a TNFi or IL-17i. Recommendation 10 addresses extramusculoskeletal manifestations with TNF monoclonal antibodies preferred for recurrent uveitis or inflammatory bowel disease, and IL-17i for significant psoriasis. Treatment failure should prompt re-evaluation of the diagnosis and consideration of the presence of comorbidities (#11). If active axSpA is confirmed, switching to another b/tsDMARD is recommended (#12). Tapering, rather than immediate discontinuation of a bDMARD, can be considered in patients in sustained remission (#13). The last recommendations (#14, 15) deal with surgery and spinal fractures. CONCLUSIONS: The 2022 ASAS-EULAR recommendations provide up-to-date guidance on the management of patients with axSpA.


Assuntos
Antirreumáticos , Espondilartrite , Espondilite Anquilosante , Humanos , Antirreumáticos/uso terapêutico , Anti-Inflamatórios não Esteroides/uso terapêutico , Espondilartrite/tratamento farmacológico , Espondilite Anquilosante/tratamento farmacológico , Analgésicos/uso terapêutico
15.
Rheumatology (Oxford) ; 62(12): 3893-3898, 2023 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-37018132

RESUMO

OBJECTIVE: MRI findings of the SI joint space in axial SpA (axSpA) include inflammation and fat metaplasia inside an erosion; the latter is also termed 'backfill'. We compared such lesions with CT to better characterize whether they represent new bone formation. METHODS: We identified patients with axSpA who underwent both CT and MRI of the SI joints in two prospective studies. MRI datasets were jointly screened by three readers for joint space-related findings and grouped into three categories: type A-high short tau inversion recovery (STIR) and low T1 signal; type B-high signal in both sequences; type C-low STIR and high T1 signal. Image fusion was used to identify MRI lesions in CT before we measured Hounsfield units (HU) in each lesion and surrounding cartilage and bone. RESULTS: Ninety-seven patients with axSpA were identified and we included 48 type A, 88 type B, and 84 type C lesions (maximum 1 lesion per type and joint). The HU values were 73.6 (s.d. 15.0) for cartilage, 188.0 (s.d. 69.9) for spongious bone, 1086.0 (s.d. 100.3) for cortical bone, 341.2 (s.d. 96.7) for type A, 359.3 (s.d. 153.5) for type B and 446.8 (s.d. 123.0) for type C lesions. Lesion HU values were significantly higher than those for cartilage and spongious bone, but lower than those for cortical bone (P < 0.001). Type A and B lesions showed similar HU values (P = 0.93), whereas type C lesions were denser (P < 0.001). CONCLUSION: All joint space lesions show increased density and might contain calcified matrix, suggesting new bone formation, with a gradual increase in the proportion of calcified matrix towards type C lesions (backfill).


Assuntos
Espondiloartrite Axial , Espondilartrite , Humanos , Articulação Sacroilíaca/diagnóstico por imagem , Articulação Sacroilíaca/patologia , Estudos Prospectivos , Osteogênese , Imageamento por Ressonância Magnética/métodos , Tomografia Computadorizada por Raios X , Espondilartrite/diagnóstico por imagem , Espondilartrite/patologia
16.
Rheumatology (Oxford) ; 62(3): 1117-1123, 2023 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-35532084

RESUMO

OBJECTIVES: To assess the impact of joint shape variations on inflammatory lesions on SI joint MRIs in patients with axial spondyloarthritis (axSpA). METHODS: A total of 1194 patients from four different prospective cohorts were evaluated, with 684 (57.3%) having sufficient imaging data for inclusion (379 axSpA, 305 controls). All images were evaluated for joint form, erosion, sclerosis, fat metaplasia and bone marrow oedema (BMO) by two independent readers. Logistic regression analyses were used to assess the association of joint form and lesions on imaging for axSpA patients and controls. RESULTS: Atypical joint forms were common in both axSpA (43.5% [154/354]) and control patients (44.2% [134/303]); both intra-articular variants and a crescent joint shape were significantly more common in axSpA patients (18.4% vs 11.6% and 11.0% vs 5.3.%, respectively; P < 0.001). The axSpA patients with intra-articular joint form variants had 2-fold higher odds of exhibiting erosions [odds ratio (OR) 2.09 (95% CI 1.18, 3.69)] and BMO [OR 1.79 (95% CI 1.13, 2.82)]; this association was not observed in controls. Accessory joints increased the odds for sclerosis in axSpA patients [OR 2.54 (95% CI 1.10, 5.84)] and for sclerosis [OR 17.91 (95% CI 6.92, 46.37)] and BMO [OR 2.05 (95% CI 1.03, 4.07)] in controls. CONCLUSIONS: Joint form variations are associated with the presence of inflammatory lesions on SI joint MRIs of axSpA patients. This should be taken into consideration in future research on the interplay of mechanical strain and inflammation in axSpA.


Assuntos
Espondiloartrite Axial , Doenças da Medula Óssea , Espondilartrite , Humanos , Articulação Sacroilíaca/patologia , Espondilartrite/complicações , Estudos Prospectivos , Medula Óssea/patologia , Esclerose/complicações , Esclerose/patologia , Doenças da Medula Óssea/patologia , Imageamento por Ressonância Magnética/métodos , Edema/etiologia
17.
Rheumatology (Oxford) ; 62(4): 1398-1409, 2023 04 03.
Artigo em Inglês | MEDLINE | ID: mdl-36099043

RESUMO

OBJECTIVE: To summarize evidence on the relationship between early treatment (definition based on symptom/disease duration or radiographic damage) and treatment clinical response in patients with SpA. METHODS: A systematic literature review was conducted in studies on SpA patients treated with NSAIDs or biological/targeted synthetic DMARDs addressing the impact of symptom/disease duration or presence of radiographic damage on treatment response assessed by any disease activity outcome. For categorical outcomes, relative risk, relative risk ratio and number needed to treat were calculated, and for continuous outcomes, differences in differences, to compare groups stratified based on symptom/disease duration or the presence of radiographic damage. RESULTS: From the 8769 articles retrieved, 25 were included and 2 added by hand-search, all in axial SpA (axSpA), most of them with low risk of bias. Twenty-one studies compared groups based on symptom duration (n = 6) or disease duration (n = 15) and seven studies based on absence/presence of radiographic damage (two studies used two comparisons). When early axSpA was defined by symptom duration (<5 years) in randomized controlled trials, early treatment was associated with better outcomes in patients with non-radiographic axSpA [n = 2, ASAS40 relative risk ratio 5.24 (95% CI 1.12, 24.41) and 1.52 (0.60, 3.87)] but not in radiographic axSpA (n = 1) [ASAS20 0.96 (0.53-1.73)]. When early axSpA was defined based on disease duration or radiographic damage, no differences were found between groups. CONCLUSION: Evidence towards better outcomes in early axSpA is very limited and restricted to non-radiographic axSpA and <5 years symptom duration. When early axSpA is defined based on disease duration or radiographic damage, no differences in response to treatment are found.


Assuntos
Antirreumáticos , Espondiloartrite Axial , Espondilartrite , Espondilite Anquilosante , Humanos , Espondilartrite/diagnóstico por imagem , Espondilartrite/tratamento farmacológico , Espondilartrite/induzido quimicamente , Anti-Inflamatórios não Esteroides/uso terapêutico , Antirreumáticos/uso terapêutico , Risco , Espondilite Anquilosante/tratamento farmacológico
18.
Rheumatology (Oxford) ; 62(4): 1631-1635, 2023 04 03.
Artigo em Inglês | MEDLINE | ID: mdl-35951746

RESUMO

OBJECTIVES: To compare MRI and conventional radiography of SI joints for detection of structural lesions typical for axial spondyloarthritis (axSpA). METHODS: Adult patients from the Assessment of SpondyloArthritis international Society (ASAS) cohort with symptoms suggestive of axSpA and both SI joint MRI and radiographs available for central reading were included. Radiographs were evaluated by three readers according to the modified New York (mNY) criteria grading system. The presence of structural damage on radiographs was defined as fulfilment of the radiographic mNY criterion and, additionally, a lower threshold for sacroiliitis of at least grade 2 unilaterally. MRI scans were assessed for the presence of structural changes indicative of axSpA by seven readers. Diagnostic performance [sensitivity, specificity, positive and negative predictive values (PPV and NPV) and positive and negative likelihood ratios (LR+ and LR-)] of MRI and radiographs (vs rheumatologist's diagnosis of axSpA) were calculated. RESULTS: Overall, 183 patients were included and 135 (73.7%) were diagnosed with axSpA. Structural lesions indicative of axSpA on MRI had sensitivity 38.5%, specificity 91.7%, PPV 92.9%, NPV 34.6%, LR+ 4.62 and LR- 0.67. Sacroiliitis according to the mNY criteria had sensitivity 54.8%, specificity 70.8%, PPV 84.1%, NPV 35.8%, LR+ 1.88 and LR- 0.64. Radiographic sacroiliitis of at least grade 2 unilaterally had sensitivity 65.2%, specificity 50.0%, PPV 78.6%, NPV 33.8%, LR+ 1.30 and LR- 0.69. CONCLUSION: Structural lesions of the SI joint detected by MRI demonstrated better diagnostic performance and better interreader reliability compared with conventional radiography.


Assuntos
Espondiloartrite Axial , Sacroileíte , Espondilartrite , Adulto , Humanos , Sacroileíte/diagnóstico , Reprodutibilidade dos Testes , Estudos de Coortes , Espondilartrite/diagnóstico , Radiografia , Imageamento por Ressonância Magnética , Articulação Sacroilíaca/diagnóstico por imagem , Articulação Sacroilíaca/patologia
19.
Artigo em Inglês | MEDLINE | ID: mdl-37882740

RESUMO

OBJECTIVES: Reporting diagnostic confidence (DC) in axial spondyloarthritis (axSpA) imaging is recommended by the ASAS guidelines. Our aim was to investigate whether self-reported DC predicts diagnostic accuracy in axSpA imaging using X-ray (XR), computed tomography (CT) and magnetic resonance imaging (MRI). METHODS: We performed a post hoc analysis including 163 patients with low back pain (89 axSpA and 56 non-axSpA). Nine blinded readers with different experience levels (inexperienced (< 1 year), semi-experienced (3-8 years) and experienced (> 12 years)) scored the sacroiliac joint images for compatibility with axSpA. DC was reported on a scale from 1 (not sure) to 10 (very sure). Mean DC scores and standard deviations were calculated for correct and incorrect responses using XR, CT, MRI, XR+MRI and CT+MRI. Differences in DC were assessed using the Mann-Whitney U test. RESULTS: DC scores were higher for correct axSpA diagnoses and differed significantly between correct and incorrect responses for all modalities (p< 0.001), with a mean DC of 7.1 ± 2.1 and 6.3 ± 2.1 for XR, 8.3 ± 1.8 and 6.7 ± 2.0 for CT, 8.1 ± 1.9 and 6.2 ± 1.9 for MRI, 8.2 ± 1.8 and 6.7 ± 1.8 for XR+MRI and 8.4 ± 1.8 and 6.8 ± 1.8 for CT+MRI, respectively. This was also the case when looking at the results by experience group, except for XR in the inexperienced group. CONCLUSION: Providing self-reported DC in radiological reports is useful information to predict diagnostic reliability in axSpA imaging.

20.
Artigo em Inglês | MEDLINE | ID: mdl-38128022

RESUMO

OBJECTIVES: To explore differences in axial spondyloarthritis (axSpA) clinical phenotype around the world in a large sample of patients included in the International Map of Axial Spondyloarthritis (IMAS). METHOD: IMAS was a cross-sectional online survey (2017-2022) of 5,557 unselected axSpA patients from 27 countries. We analysed across five geographic regions the age at symptom onset, diagnostic delay, gender, HLA-B27, family history, extra-musculoskeletal manifestations, presence of comorbidities, disease activity (BASDAI), level of spinal stiffness, and treatments. RESULTS: Of 5,557 IMAS participants, 3,493 were from Europe, 770 from North America, 600 from Asia, 548 from Latin America, and 146 from South Africa. Age at symptom onset ranged between 25-30 years and was higher in Latin America. Diagnostic delay was longest in South Africa and lowest in Asia. The lowest HLA-B27 positivity was observed in Latin America and the highest in Asia. Extra-musculoskeletal manifestations were the lowest in Europe. Mean disease activity (BASDAI) was 5.4, with highest values in South Africa and lowest in Asia. Most of the patients had used NSAIDs for their condition and less than half had ever taken csDMARDS; both were more frequent in Latin America and South Africa. Almost half of the patients had ever taken bDMARDs, more frequent being in the Americas. CONCLUSIONS: There is great heterogeneity of axSpA clinical phenotype presentation around the world. AxSpA manifests differently in different regions, so further understanding of these differences of phenotypes is needed to achieve early diagnosis and initiation of optimal disease treatment in axSpA in the different regions.

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