33 results on '"Navarro-Compán, V."'
Search Results
2. POS0508 WHAT FACTORS ARE ASSOCIATED WITH PAIN INTENSITY IN AXIAL SPONDYLOARTHRITIS? RESULTS FROM THE INTERNATIONAL MAP OF AXIAL SPONDYLOARTHRITIS (IMAS)
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Garrido-Cumbrera, M., primary, Navarro-Compán, V., additional, Sommerfleck, F., additional, Bundy, C., additional, Makri, S., additional, Correa-Fernández, J., additional, Akerkar, S. M., additional, Lowe, J., additional, Karam, E., additional, and Poddubnyy, D., additional
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- 2024
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3. AB0897 PREDICTIVE MODELS TO FORECAST DIFFICULT-TO-MANAGE AXIAL SPONDYLOARTHRITIS
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Juárez, M., primary, Benavent, D., additional, Navarro-Compán, V., additional, Díaz-Almirón, M., additional, Novella-Navarro, M., additional, Peiteado, D., additional, Villalba, A., additional, Monjo-Henry, I., additional, Nuño, L., additional, Balsa, A., additional, and Plasencia-Rodríguez, C., additional
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- 2024
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4. AB0958 HOW ARE PATIENT REPORTED OUTCOME MEASUREMENTS USED IN AXIAL SPONDYLOARTHRITIS? A QUALITATIVE STUDY WITH HEALTH CARE PROFESSIONALS AND PATIENTS
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Juanola-Roura, X., primary, Navarro-Compán, V., additional, Moltó, A., additional, Oton, T., additional, and Carmona, L., additional
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- 2024
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5. POS0194 FACTORS ASSOCIATED WITH RADIOGRAPHIC SPINAL PROGRESSION IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS RECEIVING IL-17A INHIBITOR OR TNF INHIBITOR THERAPY: A POST-HOC ANALYSIS OF THE SURPASS STUDY
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Poddubnyy, D., primary, Braun, J., additional, Machado, P., additional, Navarro-Compán, V., additional, Gensler, L. S., additional, Hermann, K. G., additional, Quebe-Fehling, E., additional, Pieterse, C. C., additional, Readie, A., additional, Gaillez, C., additional, and Baraliakos, X., additional
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- 2024
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6. POS0215 LONG-TERM SAFETY AND EFFICACY OF BIMEKIZUMAB IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS: 5-YEAR RESULTS FROM A PHASE 2B STUDY AND ITS OPEN-LABEL EXTENSION
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Deodhar, A., primary, Navarro-Compán, V., additional, Poddubnyy, D., additional, Gensler, L. S., additional, Ramiro, S., additional, Tomita, T., additional, Marzo-Ortega, H., additional, Fleurinck, C., additional, Vaux, T., additional, Massow, U., additional, Van der Heijde, D., additional, and Baraliakos, X., additional
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- 2024
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7. AB0945 THE IMPACT OF AXIAL SPONDYLOARTHRITIS ON PATIENTS’ SEXUAL LIFE. RESULTS FROM THE INTERNATIONAL MAP OF AXIAL SPONDYLOARTHRITIS (IMAS)
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Garrido-Cumbrera, M., primary, Poddubnyy, D., additional, Sommerfleck, F., additional, Bundy, C., additional, Makri, S., additional, Correa-Fernández, J., additional, Akerkar, S. M., additional, Lowe, J., additional, Karam, E., additional, and Navarro-Compán, V., additional
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- 2024
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8. POS0799 EFFICACY OF BDMARDS IN EARLY VERSUS ESTABLISHED DISEASE IN AXIAL SPONDYLOARTHRITIS: A META-ANALYSIS OF RANDOMIZED TRIALS
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Benavent, D., primary, Navarro-Compán, V., additional, Capelusnik, D., additional, and Ramiro, S., additional
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- 2024
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9. POS0507 FACTORS ASSOCIATED WITH POOR MENTAL HEALTH IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS. RESULTS FROM THE INTERNATIONAL MAP OF AXIAL SPONDYLOARTHRITIS (IMAS)
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Garrido-Cumbrera, M., primary, Navarro-Compán, V., additional, Poddubnyy, D., additional, Sommerfleck, F., additional, Makri, S., additional, Correa-Fernández, J., additional, Akerkar, S. M., additional, Lowe, J., additional, Karam, E., additional, and Bundy, C., additional
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- 2024
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10. Clinical information on imaging referrals for suspected or known axial spondyloarthritis: recommendations from the Assessment of Spondyloarthritis International Society (ASAS).
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Diekhoff T, Giraudo C, Machado PM, Mallinson M, Eshed I, Haibel H, Hermann KG, de Hooge M, Jans L, Jurik AG, Lambert RG, Maksymowych W, Marzo-Ortega H, Navarro-Compán V, Østergaard M, Pedersen SJ, Reijnierse M, Rudwaleit M, Sommerfleck FA, Weber U, Baraliakos X, and Poddubnyy D
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- Humans, Consensus, Magnetic Resonance Imaging methods, Rheumatology standards, Tomography, X-Ray Computed, Rheumatologists, Diagnosis, Differential, Societies, Medical, Referral and Consultation, Delphi Technique, Axial Spondyloarthritis diagnostic imaging, Axial Spondyloarthritis diagnosis
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Objectives: This study aims to establish expert consensus recommendations for clinical information on imaging requests in suspected/known axial spondyloarthritis (axSpA), focusing on enhancing diagnostic clarity and patient care through guidelines., Materials and Methods: A specialised task force was formed, comprising 7 radiologists, 11 rheumatologists from the Assessment of Spondyloarthritis International Society (ASAS) and a patient representative. Using the Delphi method, two rounds of surveys were conducted among ASAS members. These surveys aimed to identify critical elements for imaging referrals and to refine these elements for practical application. The task force deliberated on the survey outcomes and proposed a set of recommendations, which were then presented to the ASAS community for a decisive vote., Results: The collaborative effort resulted in a set of six detailed recommendations for clinicians involved in requesting imaging for patients with suspected or known axSpA. These recommendations cover crucial areas, including clinical features indicative of axSpA, clinical features, mechanical factors, past imaging data, potential contraindications for specific imaging modalities or contrast media and detailed reasons for the examination, including differential diagnoses. Garnering support from 73% of voting ASAS members, these recommendations represent a consensus on optimising imaging request protocols in axSpA., Conclusion: The ASAS recommendations offer comprehensive guidance for rheumatologists in requesting imaging for axSpA, aiming to standardise requesting practices. By improving the precision and relevance of imaging requests, these guidelines should enhance the clinical impact of radiology reports, facilitate accurate diagnosis and consequently improve the management of patients with axSpA., Competing Interests: Competing interests: TD: speakers bureau: Canon MS, Lilly, MSD, Novartis, Pfizer and UCB; consultant: Lilly; grant/research support: Canon MS. CG: speakers bureau: Boehringer Ingelheim. VN-C: has received speakers fees from AbbVie, Eli Lilly, Fresenius Kabi, Janssen, MSD, Novartis, Pfizer, UCB Pharma; consultant of AbbVie, Eli Lilly, MSD, Novartis, Pfizer, UCB Pharma; grant/research support from AbbVie and Novartis. IE: speakers bureau: AbbVie, Novartis. HH: speakers bureau: AbbVie, MSD, Janssen, Roche, Sobi and Pfizer, consultant of Roche, Boehringer Ingelheim, Janssen, MSD, AbbVie, Novartis and Sobi. PMM: honoraria from AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB, all unrelated to this manuscript, and is supported by the National Institute for Health Research (NIHR), University College London Hospitals (UCLH), Biomedical Research Centre (BRC). WM: speaking: AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, UCB consultant: AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Novartis, Pfizer, UCB grants: AbbVie, Eli Lilly, Novartis, Pfizer, UCB. HM-O: research grants from Janssen, Novartis, Pfizer and UCB, honoraria/speaker fees from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Moonlake, Novartis, Pfizer, Takeda and UCB. MØ: speaker fees: AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MEDAC, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi and UCB. XB: consultant: AbbVie, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Galapagos, Gilead, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi and UCB; grant/research support: AbbVie, Amgen, BMS, Celgene, Eli Lilly, Merck, Novartis and UCB. MRu: speaker fees from and/or advisor for AbbVie, Boehringer Ingelheim, Eli Lilly, Janssen, Novartis, UCB. KGH: speaker fees from Novartis, MSD and Pfizer. Consulting for AbbVie and Calyx. Co-founder of BerlinFlame. SJP: speaking fees from MSD, Pfizer, AbbVie, UCB, Novartis; consulting fees and/or honoraria from AbbVie, UCB, Novartis and research support from AbbVie, MSD and Novartis. MRe: ISS grant; ASAS consultant. RGWL: consultant: Calyx, CARE Arthritis, Image Analysis Group. UW: speaker fees: Novartis, Eli Lilly. AGJ: none for this article. MdH: speaker fees from UBC. FAS: speaker fees: Novartis, Pfizer, AbbVie, Janssen., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ on behalf of EULAR.)
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- 2024
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11. Improved Pain, Morning Stiffness, and Fatigue With Bimekizumab in Axial Spondyloarthritis: Results From the Phase III BE MOBILE Studies.
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Navarro-Compán V, Rudwaleit M, Dubreuil M, Magrey M, Marzo-Ortega H, Mease PJ, Walsh JA, Dougados M, de la Loge C, Fleurinck C, Massow U, Vaux T, Taieb V, and Deodhar A
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Objective: To assess the effect of bimekizumab on pain, morning stiffness, and fatigue in patients with nonradiographic and radiographic axial spondyloarthritis (axSpA) in the phase III BE MOBILE studies (ClinicalTrials.gov: NCT03928704 and NCT03928743)., Methods: Patients were randomized to bimekizumab 160 mg or placebo every 4 weeks; and all patients received bimekizumab from week 16. Patients reported spinal pain, peripheral pain, morning stiffness, and fatigue to week 52. Total and nocturnal spinal pain were each assessed on a 0-10 numerical rating scale (NRS). Individual Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) items (0-10-point NRS) assessed peripheral arthritis pain (question [Q] 3), enthesitis pain/discomfort (Q4), morning stiffness (mean of Q5 and Q6), and fatigue (Q1). Functional Assessment of Chronic Illness Therapy Fatigue subscale score (FACIT-Fatigue) is also reported., Results: At week 16, bimekizumab-treated patients reported lower mean nocturnal spinal pain, total spinal pain, and BASDAI scores (nominal except for nocturnal spinal pain; all P ≤ 0.001), as well as higher FACIT-Fatigue scores (nominal P < 0.05) vs placebo, indicating improved symptom levels. Improvements continued to week 52 in continuous bimekizumab-treated patients and in placebo-bimekizumab switchers. A higher proportion of bimekizumab- vs placebo-randomized patients achieved increasingly stringent thresholds for low spinal and peripheral pain at week 16; this was sustained or improved at week 52. Results were similar for morning stiffness and fatigue. At week 52, over half of patients were considered FACIT-Fatigue responders (≥ 8-point increase in score)., Conclusion: Bimekizumab treatment led to rapid improvements in levels of pain and morning stiffness. Substantial improvements were seen in all domains across the full disease spectrum of axSpA and continued to week 52.
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- 2024
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12. Comparing Treatment Guidelines for Axial Spondyloarthritis: Insights From PANLAR and ASAS-EULAR.
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Soriano ER, Navarro-Compán V, Bautista-Molano W, and Baraliakos X
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Competing Interests: The authors declare no conflict of interest.
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- 2024
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13. Prevalence of chondrocalcinosis and calcium pyrophosphate deposition disease in a cohort of adult patients with low alkaline phosphatase levels and a positive versus negative genetic ALPL study.
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Tornero C, de Miguel E, Navarro-Compán V, Balsa A, and Aguado P
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Objectives: To estimate the prevalence of chondrocalcinosis and calcium pyrophosphate dihydrate deposition disease (CPPD) in patients with low alkaline phosphatase (ALP) levels and a positive ALPL genetic study (+GT) for hypophosphatasia (HPP) compared to those with the same biochemical abnormality and a negative genetic test (-GT). As a secondary objective, to analyze the biochemical factors associated with its presence in subjects with ALPL variants., Methods: Seventy-eight subjects with persistently low ALP levels and ALPL genetic test were included. Baseline and 24-mo knee ultrasounds were performed in 42 + GT and 36 -GT subjects, in whom the fibrocartilage, hyaline cartilage of menisci, tendons, and synovial fluid were scanned to detect calcium pyrophosphate deposits. A MyLabTwice ultrasound machine (Esaote) with a multifrequency linear array transducer (4-13 MHz) was used., Results: A higher percentage of chondrocalcinosis was observed in the +GT group [9/42 (21.4%)] compared to the -GT group [2/36 (5.6%), p =.045)]. Two patients (4.76%), both in the +GT group, had arthritis secondary to CPPD. No new cases were identified at the 24-mo control. When comparing +GT patients with and without chondrocalcinosis, ALP levels were lower, and pyridoxal-5'-phosphate (PLP) and phosphate levels were higher in the former group ( p <.05). Logistic regression analysis revealed that higher PLP levels are associated with the presence of chondrocalcinosis (OR: 1.1; 95% confidence interval, CI, 1.001-1.012)., Conclusions: Chondrocalcinosis was a frequent ultrasonographic finding in HPP. Arthritis secondary to calcium pyrophosphate deposits, however, proved less prevalent. Genetic causes, such as HPP, should be considered when evaluating patients with chondrocalcinosis in clinical practice., Competing Interests: P.A. and C.T. have received fees for advisory board participation from Alexion Pharmaceuticals and have been recipients of a research grant from this biopharmaceutical company, but not for this original manuscript. The rest of authors declare that they do not have any other conflict of interest regarding the publication of this article., (© The Author(s) 2024. Published by Oxford University Press on behalf of the American Society for Bone and Mineral Research.)
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- 2024
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14. Diagnostic delay in patients from the international map of axial spondyloarthritis: geographic, socio-demographic and disease-related factors.
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Poddubnyy D, Garrido-Cumbrera M, Sommerfleck F, Navarro-Compán V, Bundy C, Makri S, Correa-Fernández J, Akerkar S, Davies J, and Karam E
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Objectives: To assess diagnostic delay and its associated factors globally, in a large sample of patients included in the International Map of Axial Spondyloarthritis (IMAS)., Methods: IMAS is a cross-sectional online survey (2017-2022) of 5,557 axSpA patients from 27 countries. Diagnostic delay was calculated as the difference between age at diagnosis and age at first symptom onset reported by patients. Associations between diagnostic delay and regions, sociodemographic characteristics, as well as disease-related factors were explored through univariable and multivariable linear regression analysis., Results: Data from 5,327 patients who reported data on diagnostic delay in IMAS survey were analysed: 3,294 were from Europe, 752 from North America, 590 from Asia, 545 from Latin America, and 146 from Africa. Overall, patients reported a mean diagnostic delay of 7.4 years (median: 4.0) since symptom onset, with substantial variation across regions; being the highest delay in South Africa and the lowest in Asia. The variables associated with longer diagnostic delay in the final multivariable regression model were: younger age at symptom onset (b=-0.100), female gender (b = 2.274), being diagnosed by rheumatologist (b = 1.163), greater number of HCPs seen before diagnosis (b = 1.033), and history of uveitis (b = 1.286)., Conclusion: In this global sample of axSpA patients, the mean diagnostic delay was 7.4 years, and showed significant differences across regions. Younger age at symptom onset, female gender, diagnosis made by a rheumatologist, greater number of HCPs seen before diagnosis, and the history of uveitis were the parameters associated with a longer diagnostic delay in axSpA patients., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
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- 2024
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15. Regional differences in clinical phenotype of axial spondyloarthritis: results from the International Map of Axial Spondyloarthritis (IMAS).
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Poddubnyy D, Sommerfleck F, Navarro-Compán V, Bundy C, Makri S, Akerkar S, Wermskog L, Karam E, Correa-Fernández J, Siddiqui A, and Garrido-Cumbrera M
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- Humans, Male, Female, Adult, Cross-Sectional Studies, Latin America epidemiology, South Africa epidemiology, Europe, Asia epidemiology, HLA-B27 Antigen genetics, Middle Aged, Age of Onset, North America, Severity of Illness Index, Antirheumatic Agents therapeutic use, Phenotype, Axial Spondyloarthritis diagnosis, Delayed Diagnosis
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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 5557 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 5557 IMAS participants, 3493 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 and 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 conventional synthetic DMARDS; both were more frequent in Latin America and South Africa. Almost half of the patients had ever taken biologic DMARDs, more frequent use being in the Americas., Conclusion: 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., (© The Author(s) 2023. Published by Oxford University Press on behalf of the British Society for Rheumatology.)
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- 2024
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16. Exploratory analysis of the potential disconnect between objective inflammatory response and clinical response following certolizumab pegol treatment in patients with active axial spondyloarthritis.
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Rudwaleit M, Marzo-Ortega H, Navarro-Compán V, Tham R, Kumke T, Bauer L, de Peyrecave N, Kim M, and Van den Bosch F
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- Adult, Female, Humans, Male, Middle Aged, Antirheumatic Agents administration & dosage, C-Reactive Protein analysis, C-Reactive Protein metabolism, Sacroiliac Joint diagnostic imaging, Sacroiliac Joint pathology, Severity of Illness Index, Treatment Outcome, Axial Spondyloarthritis blood, Axial Spondyloarthritis diagnosis, Axial Spondyloarthritis drug therapy, Axial Spondyloarthritis immunology, Certolizumab Pegol administration & dosage, Magnetic Resonance Imaging
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Introduction: This post hoc analysis evaluated the relationship between objective measures of inflammation and clinical outcomes following 12 weeks of certolizumab pegol (CZP) treatment in patients with active axial spondyloarthritis (axSpA)., Methods: We report the proportion of patients achieving ≥50% and ≥75% improvements in clinical composite outcome measures of disease activity (Axial Spondyloarthritis Disease Activity Score [ASDAS], Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]) and objective measures of inflammation (C reactive protein [CRP], Ankylosing Spondylitis spine MRI score [ASspiMRI-a] Berlin score and Spondyloarthritis Research Consortium of Canada [SPARCC] MRI Sacroiliac Joints [SIJ] score) following 12 weeks of CZP treatment. Data from two independent readers over four MRI reading campaigns were pooled using a mixed model with repeated measures for each variable., Results: 136 patients (radiographic axSpA [r-axSpA]: 76; non-radiographic axSpA [nr-axSpA]: 60) were included. Following CZP treatment, CRP, ASspiMRI-a Berlin score and SPARCC SIJ score were reduced by ≥50% in most patients (CRP: 136/136 [100.0%]; Berlin: 73/136 [53.7%]; SPARCC SIJ: 71/136 [52.2%]), and often by ≥75%. Less than half of patients with r-axSpA and nr-axSpA showed ≥50% reduction in clinical responses (BASDAI: 64/136 [47.1%]; ASDAS: 66/136 [48.5%]). These results were also observed at the individual patient level; ≥50% improvements in MRI/CRP inflammatory measures did not translate into similar improvements in clinical responses for most patients., Conclusion: There is a potential disconnect between objective measures of inflammation and clinical outcome responses in patients with axSpA. The use of only clinical response measures as trial endpoints may underestimate anti-inflammatory treatment effects., Trial Registration Number: NCT01087762., Competing Interests: Competing interests: MR: Speakers bureau from AbbVie, Boehringer Ingelheim, Chugai, Eli Lilly, Janssen, Novartis, Pfizer, UCB Pharma; consultant of AbbVie, Eli Lilly, Novartis, UCB Pharma. HM-O: Research grants from Janssen, Novartis, Pfizer and UCB Pharma. Speaking honoraria and/or consultancy fees from AbbVie, Amgen, Biogen, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer, Takeda and UCB Pharma. HM-O is supported by the National Institute for Health Research (NIHR) Leeds Biomedical Research Centre (LBRC). The views expressed are those of the authors and not necessarily those of the (UK) National Health Service (NHS), the NIHR, or the (UK) Department of Health. VN-C: Speakers bureau for AbbVie, Eli Lilly, Fresenius Kabi, Janssen, MSD, Novartis, Pfizer and UCB Pharma; consultant for AbbVie, Eli Lilly, Galapagos, MoonLake, MSD, Novartis, Pfizer and UCB Pharma; grant/research support from AbbVie and Novartis. RT: Veramed statistical consultant for UCB Pharma. TK, LB, NdP and MK: Employee and stockholder of UCB Pharma. FvdB: Consultancy fees from AbbVie, Amgen, Eli Lilly, Galapagos, Janssen, Merck, Novartis, Pfizer and UCB Pharma; speakers bureau for AbbVie, Amgen, Bristol Myers-Squibb, Celgene, Janssen, Merck, Novartis, Pfizer and UCB Pharma., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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17. Systematic literature review to inform the EULAR recommendations for the use of imaging in crystal-induced arthropathies in clinical practice.
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Gessl I, Sakellariou G, Wildner B, Filippou G, Mandl P, D'Agostino MA, and Navarro-Compán V
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- Humans, Calcium Phosphates analysis, Calcium Pyrophosphate analysis, Practice Guidelines as Topic, Radiography, Sensitivity and Specificity, Chondrocalcinosis diagnostic imaging, Chondrocalcinosis diagnosis, Crystal Arthropathies diagnostic imaging, Gout diagnostic imaging, Tomography, X-Ray Computed standards, Ultrasonography methods, Ultrasonography standards
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Objective: To summarise current data regarding the use of imaging in crystal-induced arthropathies (CiAs) informing a European Alliance of Associations for Rheumatology task force., Methods: We performed four systematic searches in Embase, Medline and Central on imaging for diagnosis, monitoring, prediction of disease severity/treatment response, guiding procedures and patient education in gout, calcium pyrophosphate dihydrate deposition (CPPD) and basic calcium phosphate deposition (BCPD). Records were screened, manuscripts reviewed and data of the included studies extracted. The risk of bias was assessed by validated instruments., Results: For gout, 88 studies were included. Diagnostic studies reported good to excellent sensitivity and specificity of dual-energy CT (DECT) and ultrasound (US), high specificity and lower sensitivity for conventional radiographs (CR) and CT. Longitudinal studies demonstrated sensitivity to change with regard to crystal deposition by US and DECT and inflammation by US and structural progression by CR and CT. For CPPD, 50 studies were included. Diagnostic studies on CR and US showed high specificity and variable sensitivity. There was a single study on monitoring, while nine assessed the prediction in CPPD. For BCPD, 56 studies were included. There were two diagnostic studies, while monitoring by CR and US was assessed in 43 studies, showing a reduction in crystal deposition. A total of 12 studies with inconsistent results assessed the prediction of treatment response. The search on patient education retrieved two studies, suggesting a potential role of DECT., Conclusion: This SLR confirmed a relevant and increasing role of imaging in the field of CiAs., Competing Interests: Competing interests: VN-C: consulting fees: ABBvie, Galapagos, Lilly, Novartis, Lilly, Pfizer, UCB; honoraria: Abbvie, Fresenius, Lilly, Novartis, Pfizer, UCB; ASAS. MAD’A: consulting fees: Novartis, BMS, Janssen, Amgen, Boehringer Ingelheim, AbbVie, Astra-Zeneca, Pfizer, UCB, Eli Lilly; honoraria: Novartis, BMS, Janssen, Amgen, Boehringer Ingelheim, AbbVie, Astra-Zeneca, Pfizer, UCB, Eli Lilly. The other authors have no competing interests to declare., (© European Alliance of Associations for Rheumatology, EULAR 2024. Re-use permitted under CC BY-NC-ND. No commercial re-use. No derivatives. See rights and permissions. Published by BMJ on behalf of EULAR.)
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- 2024
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18. ASAS consensus definition of early axial spondyloarthritis.
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Navarro-Compán V, Benavent D, Capelusnik D, van der Heijde D, Landewé RB, Poddubnyy D, van Tubergen A, Baraliakos X, Van den Bosch FE, van Gaalen FA, Gensler L, López-Medina C, Marzo-Ortega H, Molto A, Pérez-Alamino R, Rudwaleit M, van de Sande M, Sengupta R, Weber U, and Ramiro S
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- Humans, Spondylarthritis diagnosis, Spondylarthritis classification, Terminology as Topic, Early Diagnosis, Societies, Medical, Rheumatology standards, Delphi Technique, Consensus, Axial Spondyloarthritis diagnosis
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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., Competing Interests: Competing interests: VN-C: Speaker fees—AbbVie, Eli Lilly, Janssen, MSD, Novartis, Pfizer, UCB Pharma; Consultancy fees- AbbVie, Eli Lilly, Galapagos, MoonLake, MSD, Novartis, Pfizer, UCB Pharma; Grants: AbbVie, Novartis. DB: Grant/research support from Novartis, and speaker fees from Janssen, Abbvie, and Galapagos. DvdH: Consulting AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Novartis, Pfizer, UCB Pharma. Director of Imaging Rheumatology bv. RBML: Consulting AbbVie, Eli-Lilly, Janssen, Galapagos, Gilead, Novartis, Pfizer, UCB. Director of Rheumatology Consultancy BVD. DP: Research grant from AbbVie, Eli Lilly, MSD, Novartis, Pfizer, Consultation AbbVie, Biocad, BMS, Eli Lilly, Gilead, MSD, Novartis, Pfizer, Samsung Bioepis, UCB, Speaker AbbVie, BMS, Lilly, MSD, Novartis, Pfizer, UCB. AvT: Speaker fees: Pfizer; Consulting fees: Novartis, Galapagos, UCB; Grants: Pfizer, UCB, Novartis XB: Abbvie, Amgen, Chugai, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, Roche, Sandoz, UCB. FEVdB: received speaker and/or consultancy fees from AbbVie, Amgen, Eli Lilly, Galapagos, Janssen, Moonlake, Novartis, Pfizer and UCB FAvG: Research Grants—Novartis; consultancy -MSD, AbbVie, Novartis and BMS LG: Research grants UCB, Novartis, Consulting fees AbbVie, Acelyrin, Eli Lilly, Fresenius Kabi, Janssen, Novartis, Pfizer, UCB Pharma CL-M: Speaker fees AbbVie, Eli Lilly, Novartis, Janssen, UCB Pharma. Consulting fees Eli Lilly, Novartis, UCB Pharma. HM-O: Speaker fees/consultancy: ABvie, Eli-Lilly, Janssen, Moonlake, Novartis, Pfizer and UCB. Research grants from Janssen, Novartis and UCB. AM: Consulting fees AbbVie, Biogen, BMS, Cyxone, Eisai, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, UCB Pharma. Grants: UCB RP-A: Speaker fees Abbvie, Eli Lilly, Novartis, Janssen, Pfizer. Consulting fees Abbvie, Eli Lilly, Janssen, Novartis. MR: Speaker- AbbVie, Boehringer Ingelheim, Eli Lilly, Janssen, Novartis, UCB Pharma; Consultancy AbbVie, Eli Lilly, Novartis, Pfizer, UCB Pharma MvdS: Speaker -Janssen, Novartis, UCB; Consultancy Abbvie, Eli Lilly, Novartis, UCB; Research Grants: Eli Lily, Novartis, UCB RS: Speaker - AbbVie, Biogen, Eli Lilly, MSD, Novartis, UCB; Consultancy—AbbVie, Eli Lilly, Novartis, Pfizer, UCB. Grants: AbbVie, Novartis, UCB UW: Speaker fees NovartisS. SR: Research Grants—AbbVie, Galapagos, MSD, Novartis, Pfizer, UCB; consultancy—AbbVie, Eli Lilly, MSD, Novartis, Pfizer, Sanofi, UCB., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
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19. The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale in patients with axial spondyloarthritis: psychometric properties and clinically meaningful thresholds for interpretation.
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Cella D, de la Loge C, Fofana F, Guo S, Ellis A, Fleurinck C, Massow U, Dougados M, Navarro-Compán V, and Walsh JA
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- Humans, Male, Female, Adult, Middle Aged, Cross-Sectional Studies, Reproducibility of Results, Psychometrics methods, Fatigue etiology, Fatigue diagnosis, Patient Reported Outcome Measures, Severity of Illness Index, Axial Spondyloarthritis
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Background: Fatigue is an important symptom for most patients with axial spondyloarthritis (axSpA). The FACIT-Fatigue is a 13-item patient-reported outcome (PRO) instrument that has been used in axSpA clinical trials to measure fatigue severity and impact on daily activities. However, the psychometric properties of the FACIT-Fatigue are not fully evaluated across the entire spectrum of axSpA including non-radiographic axSpA (nr-axSpA) and radiographic axSpA (r-axSpA). This study determined: (1) the psychometric properties of the FACIT-Fatigue in nr-axSpA, r-axSpA, and the broad axSpA population and (2) FACIT-Fatigue scores representing meaningful within-patient change (MWPC), meaningful between-group differences, and cross-sectional severity bands., Methods: Data from two Phase 3 trials in adults with nr-axSpA (BE MOBILE 1; N = 254) and r-axSpA (BE MOBILE 2; N = 332) were analyzed pooled and separately to assess the psychometric properties of the FACIT-Fatigue. MWPC and meaningful between-group difference estimates were derived using anchor-based and distribution-based methods. Cross-sectional fatigue severity bands were estimated using logistic regression analysis., Results: The FACIT-Fatigue presented good internal consistency, adequate convergent and known-groups validity, and was sensitive to change over time across the full axSpA spectrum. A 5-11-point increase in FACIT-Fatigue score was estimated to represent a MWPC, with an 8-point increase selected as the responder definition. A 2.14-5.34-point difference in FACIT-Fatigue score change over a 16-week period was estimated to represent a small-to-medium meaningful between-group difference. FACIT-Fatigue score severity bands were defined as: none or minimal (>40), mild (>30 to ≤40), moderate (>21 to ≤30), and severe (≤21)., Conclusions: These findings support the use of the FACIT-Fatigue as a fit-for-purpose measure to assess fatigue-related treatment benefit in axSpA clinical trials. The proposed score estimates and thresholds can guide FACIT-Fatigue score interpretation across the full axSpA spectrum., Trial Registration: ClinicalTrials.Gov, NCT03928704. Registered 26 April 2019-Retrospectively registered, https://classic., Clinicaltrials: gov/ct2/show/NCT03928704 ., Clinicaltrials: Gov, NCT03928743. Registered 26 April 2019-Retrospectively registered, https://classic., Clinicaltrials: gov/ct2/show/NCT03928743 ., (© 2024. The Author(s).)
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20. Regional Differences in Diagnosis Journey and Healthcare Utilization: Results from the International Map of Axial Spondyloarthritis (IMAS).
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Garrido-Cumbrera M, Poddubnyy D, Sommerfleck F, Bundy C, Makri S, Correa-Fernández J, Akerkar S, Lowe J, Karam E, and Navarro-Compán V
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Introduction: To assess differences in the diagnosis journey and access to care in a large sample of patients with axial spondyloarthritis (axSpA) from around the world, included in the International Map of Axial Spondyloarthritis (IMAS)., Methods: IMAS was a cross-sectional online survey (2017-2022) of 5557 unselected patients with axSpA from 27 countries. Across five worldwide geographic regions, the patient journey until diagnosis and healthcare utilization in the last 12 months prior to survey were evaluated. Univariable and multivariable linear regression was used to analyze factors associated with higher healthcare utilization., Results: Of 5557 participants in IMAS, the diagnosis took an average of 7.4 years, requiring more than two visits to HCPs (77.7% general practitioner and 51.3% rheumatologist), and more than two diagnostic tests [67.5% performed human leukocyte antigen B27 (HLA-B27), 64.2% x-ray, and 59.1% magnetic resonance imaging (MRI) scans]. North America and Europe were the regions with the highest number of healthcare professional (HCP) visits for diagnosis, while the lowest number of visits was in the Asian region. In the previous 12 months, 94.9% (n = 5272) used at least one healthcare resource, with an average of 29 uses per year. The regions with the highest healthcare utilization were Latin America, Europe, and North America. In the multiple linear regression, factors associated with higher number of healthcare utilization were younger age (b = - 0.311), female gender (b = 7.736), higher disease activity (b = 1.461), poorer mental health (b = 0.624), greater functional limitation (b = 0.300), greater spinal stiffness (b = 1.527), and longer diagnostic delay (b = 0.104)., Conclusion: The diagnosis of axSpA usually takes more than two visits to HCPs and at least 7 years. After diagnosis, axSpA is associated with frequent healthcare resource use. Younger age, female gender, higher disease activity, poorer mental health, greater functional limitation, greater spinal stiffness, and longer diagnostic delay are associated with higher healthcare utilization. Europe and North America use more HCP visits and diagnostic tests before and after diagnosis than the other regions., (© 2024. The Author(s).)
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21. Effect of Secukinumab Versus Adalimumab Biosimilar on Radiographic Progression in Patients With Radiographic Axial Spondyloarthritis: Results From a Head-to-Head Randomized Phase IIIb Study.
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Baraliakos X, Østergaard M, Poddubnyy D, van der Heijde D, Deodhar A, Machado PM, Navarro-Compán V, Hermann KGA, Kishimoto M, Lee EY, Gensler LS, Kiltz U, Eigenmann MF, Pertel P, Readie A, Richards HB, Porter B, and Braun J
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- Humans, Male, Female, Adult, Middle Aged, Treatment Outcome, Spine diagnostic imaging, Double-Blind Method, Antibodies, Monoclonal, Humanized therapeutic use, Disease Progression, Adalimumab therapeutic use, Antirheumatic Agents therapeutic use, Radiography, Biosimilar Pharmaceuticals therapeutic use, Axial Spondyloarthritis drug therapy, Axial Spondyloarthritis diagnostic imaging
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Objective: Spinal radiographic progression is an important outcome in radiographic axial spondyloarthritis (SpA). The objective of the phase IIIb SURPASS study was to compare spinal radiographic progression in patients with radiographic axial SpA treated with secukinumab (interleukin-17A inhibitor) versus adalimumab biosimilar (Sandoz adalimumab [SDZ-ADL]; tumor necrosis factor inhibitor)., Methods: Biologic-naive patients with active radiographic axial SpA, at high risk of radiographic progression (high-sensitivity C-reactive protein [hsCRP] ≥5 mg/L and/or ≥1 syndesmophyte[s] on spinal radiographs), were randomized (1:1:1) to secukinumab (150/300 mg) or SDZ-ADL (40 mg). The proportion of patients with no radiographic progression (change from baseline [CFB] in modified Stoke Ankylosing Spondylitis Spinal Score [mSASSS] ≤0.5) on secukinumab versus SDZ-ADL at week 104 (primary endpoint), mean CFB-mSASSS, proportion of patients with ≥1 syndesmophyte(s) at baseline with no new syndesmophyte(s), and safety were evaluated., Results: Overall, 859 patients (78.5% male, mSASSS 16.6, Bath Ankylosing Spondylitis Disease Activity Index 7.1, hsCRP 20.4 mg/L, and 73.0% with ≥1 syndesmophyte[s]) received secukinumab 150 mg (n = 287), secukinumab 300 mg (n = 286), or SDZ-ADL (n = 286). At week 104, the proportion of patients with no radiographic progression was 66.1%, 66.9%, and 65.6% (P = not significant, both secukinumab doses) and mean CFB-mSASSS was 0.54, 0.55, and 0.72 in secukinumab 150 mg, secukinumab 300 mg, and SDZ-ADL arms, respectively. Overall, 56.9%, 53.8%, and 53.3% of patients on secukinumab 150 mg, secukinumab 300 mg, and SDZ-ADL, respectively, with ≥1 syndesmophyte(s) at baseline did not develop new syndesmophyte(s) by week 104. There were no unexpected safety findings., Conclusion: Spinal radiographic progression over two years was low with no significant difference between secukinumab and SDZ-ADL arms. The safety of both treatments was consistent with previous reports., (© 2024 The Authors. Arthritis & Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)
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22. Factors Associated with Poor Mental Health in Patients with Axial Spondyloarthritis: Results from the International Map of Axial Spondyloarthritis (IMAS).
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Garrido-Cumbrera M, Navarro-Compán V, Poddubnyy D, Sommerfleck F, Makri S, Correa-Fernández J, Akerkar S, Lowe J, Karam E, and Bundy C
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- Humans, Male, Female, Adult, Cross-Sectional Studies, Middle Aged, Prevalence, Depression epidemiology, Depression etiology, Surveys and Questionnaires, Risk Factors, Anxiety epidemiology, Anxiety etiology, Mental Health, Axial Spondyloarthritis epidemiology, Axial Spondyloarthritis etiology
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Background: This study aims to assess the prevalence of poor mental health in axial spondyloarthritis (axSpA) and its associated factors in a large sample of patients from the International Map of Axial Spondyloarthritis (IMAS) study from around the globe., Methods: IMAS is a cross-sectional online survey (2017-2022) that includes 5557 unselected patients with axSpA worldwide. Mental health was evaluated by the 12-item General Health Questionnaire (GHQ-12) and the cut-off point for poor mental health was set at 3. Logistic regression analysis was used to evaluate relationships between the investigated factors and poor mental health (GHQ-12≥3) in patients with axSpA (n=4335)., Results: Of 5351 patients, the mean of GHQ-12 was 4.7 and 59.4% were having poor mental health, being 69.9% in South Africa, 63.7% in Latin America, 60.8% in Europe, 54.3% in North America and 51.8% in Asia. Overall, 40.5% and 37.2% of patients experienced anxiety and depression. The factors associated with poor mental health were younger age (OR=0.99), female gender (OR=1.16), being on sick leave or unemployed (OR=1.63), non-physical activity (OR=1.22), smoking (OR=1.20), higher Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] (OR=1.42), functional limitation (OR=1.02) and shorter symptoms duration (OR=0.98)., Conclusions: Globally, 6 in 10 patients with axSpA had poor mental health, with a higher proportion in South Africa and lower in Asia. The factors associated with poor mental health include domains such as younger age, female gender, employment difficulties, harmful habits, disease burden and symptom duration. A holistic management approach to axSpA should encompass both physical and mental health., Competing Interests: Competing interests: MG-C: Grant/research support from: Novartis. VN-C: Speakers bureau: AbbVie, Eli Lilly, Janssen, MSD, Novartis, Pfizer, UCB Pharma, Consultant of: AbbVie, Eli Lilly, Galapagos, MoonLake, MSD, Novartis, Pfizer, UCB Pharma, Grant/research support from: AbbVie, Novartis. DP: Speakers bureau: AbbVie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Grant/research support from: AbbVie, MSD, Novartis, and Pfizer. FS: Speakers bureau: AbbVie, Eli Lilly, Janssen, Novartis, Consultant of: AbbVie, Novartis, Janssen. SM: Consultant of: Novartis, GSK and Bayer. JC-F: None declared. SA: Speakers bureau: Pfizer, Novartis, Eli Lilly, Jansen. JL: Grant/research support from: No personal funding, but ASIF has received funding from Novartis, UCB, Lilly, AbbVie, Boehringer Ingelheim, Pfizer, Janssen. EK: None declared. Laura Christen: Employee of: Novartis employment and stock ownership. CB: Speakers bureau: AbbVie, Celgene, Janssen, Lilly, Novartis and Pfizer., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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23. Sacroiliac radiographic progression over 10 years in axSpA: data from the DESIR inception cohort.
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Molto A, López-Medina C, Sepriano A, Ramiro S, de Hooge M, van Lunteren M, Navarro-Compán V, Wendling D, and Dougados M
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- Humans, Male, Female, Adult, Follow-Up Studies, Middle Aged, Disease Progression, Sacroiliac Joint diagnostic imaging, Radiography, Axial Spondyloarthritis diagnostic imaging
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Objectives: To evaluate sacroiliac radiographic progression over a 10-year follow-up and determine the baseline factors associated with such progression in patients with recent-onset axial spondyloarthritis (axSpA, <3 years)., Methods: This analysis was performed in the DESIR cohort (NCT01648907). The radiographic status of the patients (radiographic axSpA (r-axSpA) vs non-radiographic axSpA (nr-axSpA)) was based on the modified New York (mNY) criteria. Information on mNY criteria on the pelvic radiographs was obtained in four reading waves over a 10-year period. Images were blinded and centrally read by 3 trained readers. The % of mNY net progressors (ie, number of 'progressors' minus number of 'regressors' divided by the total number of patients) was assessed in completers (ie, pelvic radiographs at baseline and 10 years). The yearly likelihood of mNY+ was estimated using an integrated analysis (ie, including all patients with at least one available mNY score ('intention-to-follow' population) using a generalised estimating equations model and time-varying tumour necrosis factor (TNF) use as a confounder. Baseline predictors of mNY+ during 10 years were evaluated., Results: Completers included 294 patients, while intention-to-follow included 659 participants. In the completers, the net % progression (from nr-axSpA to r-axSpA) was 5.8%. In the intention-to-follow population, the probability of being mNY+ was estimated to increase 0.87% (95% CI 0.56 to 1.19) per year (ie, 8.7% after 10 years) while when introducing TNF inhibitors (TNFi) as a time-varying covariate, the probability was 0.45% (95% CI 0.09 to 0.81) (ie, 4.5% after 10 years). Baseline bone marrow oedema (BME) on MRI of the sacroiliac joints (SIJ) was associated with being mNY+ over time OR 6.2 (95% CI 5.3 to 7.2) and OR 3.1 (95% CI 2.4 to 3.9) in HLA-B27+ and HLA-B27-, respectively). Male sex, symptom duration >1.5 years, Axial Spondyloarthritis Disease Activity Score ≥2.1 and smoking (only in HLA-B27 positives) were also associated with being mNY+ over 10 years. BME was not found to be a mediator of the HLA-B27 effect on mNY+ at 10 years., Conclusions: The yearly likelihood of switching from nr-axSpA to r-axSpA in patients after 10 years of follow-up was low, and even lower when considering TNFi use., Competing Interests: Competing interests: AM has received consulting fees from AbbVie, Amgen, BMS, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, UCB Pharma and Viatris. CL-M has received consulting fees from AbbVie, Janssen, Lilly, Novartis. SR has received research grants and/or consulting fees from AbbVie, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, UCB, Sanofi. AS has received research grants and/or consulting fees from AbbVie, Eli Lilly, Novartis, Medac. MdH has received consultancy/speaker/research grants from UCB. MvL had no competing interests. VN-C has received consultancy/speaker/research grants from AbbVie, BMS, Fresenius Kabi, Galapagos, Janssen, Lilly, Moonlake, MSD, Novartis, Pfizer, Roche, UCB. DW has received consulting fees from AbbVie, BMS, MSD, Pfizer, Nordic Pharma, UCB, Novartis, Lilly, Janssen, Galapagos, Fresenius Kabi. MD has received consulting fees from Pfizer, AbbVie, UCB, Amgen, BMS, Galapagos, Lilly, Novartis, Merck., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ on behalf of EULAR.)
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24. Improved physical functioning, sleep, work productivity and overall health-related quality of life with bimekizumab in patients with axial spondyloarthritis: results from two phase 3 studies.
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Dubreuil M, Navarro-Compán V, Boonen A, Gaffney K, Gensler LS, de la Loge C, Vaux T, Fleurinck C, Massow U, Taieb V, Mørup MF, Deodhar A, and Rudwaleit M
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- Humans, Male, Female, Adult, Middle Aged, Treatment Outcome, Axial Spondyloarthritis drug therapy, Axial Spondyloarthritis etiology, Severity of Illness Index, Physical Functional Performance, Double-Blind Method, Efficiency, Antibodies, Monoclonal, Humanized, Quality of Life, Sleep
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Objective: To assess the impact of bimekizumab on physical functioning, sleep, work productivity and overall health-related quality of life (HRQoL) in patients with non-radiographic (nr-) and radiographic (r-) axial spondyloarthritis (axSpA) in the phase 3 studies BE MOBILE 1 and 2., Methods: Patients were randomised to subcutaneous bimekizumab 160 mg or placebo every 4 weeks; from Week 16, all patients received bimekizumab 160 mg every 4 weeks. We report the following outcomes to Week 52: Bath Ankylosing Spondylitis Functional Index (BASFI), Medical Outcomes Study Sleep Scale Revised (MOS-Sleep-R) Index II, Work Productivity and Activity Impairment: axSpA (WPAI:axSpA), Short Form-36 Physical and Mental Component Summary (SF-36 PCS/MCS) and Ankylosing Spondylitis Quality of Life (ASQoL)., Results: At Week 16, bimekizumab-randomised patients demonstrated significantly greater improvement from baseline versus placebo in BASFI, SF-36 PCS and ASQoL (p<0.001), and numerically greater improvements in MOS-Sleep-R Index II and WPAI:axSpA scores. Higher proportions of bimekizumab-randomised versus placebo-randomised patients at Week 16 achieved increasingly stringent thresholds for improvements in BASFI (0 to ≤4), and thresholds for meaningful improvements in SF-36 PCS (≥5-point increase from baseline) and ASQoL (≥4-point decrease from baseline). Responses were sustained or further improved to Week 52, where 60%-70% of bimekizumab-treated patients achieved BASFI ≤4 and meaningful improvements in SF-36 PCS and ASQoL, regardless of whether originally randomised to bimekizumab or placebo., Conclusion: Bimekizumab treatment led to early improvements in physical function, sleep, work productivity and overall HRQoL at Week 16 in patients across the full axSpA disease spectrum. Improvements were sustained to Week 52., Trial Registration Numbers: NCT03928704; NCT03928743., Competing Interests: Competing interests: MD: Educational grant from Pfizer paid to institution; consulting fees (eg, advisory boards) from Amgen and UCB Pharma; VN-C: Speakers bureau for AbbVie, Eli Lilly, Fresenius Kabi, Janssen, MSD, Novartis, Pfizer and UCB Pharma; consultant for AbbVie, Eli Lilly, Galapagos, MoonLake, MSD, Novartis, Pfizer and UCB Pharma; grant/research support from AbbVie and Novartis; AB: Research grants from AbbVie; speakers honoraria and consultation fees from AbbVie, Galapagos, Pfizer, Novartis and UCB Pharma; KG: Speakers bureau for AbbVie, Eli Lilly, Novartis and UCB Pharma; consultant for AbbVie, Eli Lilly, Novartis and UCB Pharma; grant/research support from AbbVie, Gilead, Eli Lilly, Novartis and UCB Pharma; LSG: Grants from Novartis and UCB Pharma paid to institution; consulting fees from AbbVie, Acelyrin, Eli Lilly, Fresenius Kabi, Janssen, Novartis, Pfizer and UCB Pharma; CdlL: Consultant to UCB Pharma; TV, UM and MFM: Employees of UCB Pharma; CF and VT: Employees and shareholders of UCB Pharma; AD: Speakers bureau for Janssen, Novartis, and Pfizer; consultant for AbbVie, BMS, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer and UCB Pharma; grant/research support from AbbVie, BMS, Celgene, Eli Lilly, MoonLake, Novartis, Pfizer and UCB Pharma; MR: Speakers bureau for AbbVie, Boehringer Ingelheim, Chugai, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma; consultant of AbbVie, Eli Lilly, Novartis and UCB Pharma., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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25. Reporting Sacroiliac Joint Imaging Performed for Known or Suspected Axial Spondyloarthritis: Assessment of SpondyloArthritis International Society Recommendations.
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Diekhoff T, Eshed I, Giraudo C, Haibel H, Hermann KGA, de Hooge M, Jans L, Jurik AG, Lambert RG, Machado P, Mallinson M, Maksymowych WP, Marzo-Ortega H, Navarro-Compán V, Østergaard M, Pedersen SJ, Reijnierse M, Rudwaleit M, Sommerfleck F, Weber U, Baraliakos X, and Poddubnyy D
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- Humans, Axial Spondyloarthritis diagnostic imaging, Societies, Medical, Spondylarthritis diagnostic imaging, Diagnosis, Differential, Magnetic Resonance Imaging methods, Sacroiliac Joint diagnostic imaging
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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., (© RSNA, 2024 See also the editorial by Gandikota in this issue.)
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26. Time to improvement of pain, morning stiffness, fatigue, and disease activity in patients with ankylosing spondylitis treated with tofacitinib: a post hoc analysis.
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Navarro-Compán V, Deodhar A, Bahiri R, Bushmakin AG, Cappelleri JC, and Rammaoui J
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- Humans, Female, Male, Adult, Middle Aged, Treatment Outcome, Double-Blind Method, Pain drug therapy, Time Factors, Protein Kinase Inhibitors therapeutic use, Piperidines therapeutic use, Spondylitis, Ankylosing drug therapy, Pyrimidines therapeutic use, Pyrroles therapeutic use, Fatigue drug therapy
- Abstract
Background: Tofacitinib is an oral Janus kinase inhibitor for treatment of ankylosing spondylitis (AS). Time to improvement in core domains of AS was estimated in tofacitinib-treated patients with AS., Methods: This post hoc analysis used phase 3 trial data from patients with AS receiving tofacitinib 5 mg twice daily or placebo to week (W)16; all patients received open-label tofacitinib W16-48., Outcomes: nocturnal pain; total back pain; fatigue, spinal pain, peripheral joint pain/swelling, enthesitis, and morning stiffness (Bath AS Disease Activity Index [BASDAI] questions 1-6); BASDAI total score; AS Disease Activity Score (ASDAS). Median time to improvement events was estimated using non-parametric Kaplan-Meier models. Improvement events were defined as initial (first post-baseline observation) and continued (sustained for 2 consecutive visits) ≥ 30% and ≥ 50% improvement in back/nocturnal pain or BASDAI questions/total scores, or ASDAS improvement ≥ 1.1 and ≥ 2.0 points., Results: 269 patients (tofacitinib: n = 133; placebo-to-tofacitinib: n = 136) were assessed. Median time to improvement was shorter, and more patients experienced improvements with tofacitinib vs. placebo-to-tofacitinib; differences observed from W2 (first post-baseline assessment). Median time to initial (continued) ≥ 30% pain improvement was 4 (4-8) weeks for tofacitinib vs. 24 (24) weeks for placebo-to-tofacitinib (8 [8] weeks post-switch). Median time to initial (continued) ≥ 50% improvement of pain, peripheral joint pain/swelling and enthesitis, morning stiffness, BASDAI total score, and fatigue was 8-24 (12-40) weeks with tofacitinib vs. 24-32 weeks (32 weeks-not estimable [NE]) with placebo-to-tofacitinib. Median time to initial (continued) ASDAS improvement ≥ 1.1 points was 4 (8) weeks for tofacitinib vs. 24 (24) weeks for placebo-to-tofacitinib, and NE for improvement ≥ 2.0 points with either treatment., Conclusions: Improvements in AS core domains occurred more rapidly with tofacitinib vs. placebo-to-tofacitinib. Half of tofacitinib-treated patients with AS will likely experience improvements ≥ 30% in pain and ≥ 1.1 points in ASDAS during month (M)1, ≥ 50% improvement in nocturnal pain and enthesitis by M2, and in morning stiffness by M3. Results show that initiating tofacitinib as soon as possible is associated with quicker improvements in AS core domains vs. delaying treatment., Trial Registration: ClinicalTrials.gov, NCT03502616, 11 April 2018., (© 2024. Pfizer Inc and Navarro-Compán, Deodhar, Bahiri.)
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27. Natural language processing to identify and characterize spondyloarthritis in clinical practice.
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Benavent D, Benavent-Núñez M, Marin-Corral J, Arias-Manjón J, Navarro-Compán V, Taberna M, Salcedo I, Peiteado D, Carmona L, and de Miguel E
- Subjects
- Humans, Male, Female, Middle Aged, Retrospective Studies, Adult, Comorbidity, Arthritis, Psoriatic diagnosis, Arthritis, Psoriatic epidemiology, Antirheumatic Agents therapeutic use, Natural Language Processing, Electronic Health Records, Spondylarthritis diagnosis, Spondylarthritis epidemiology, Spondylarthritis drug therapy
- Abstract
Objective: This study aims to use a novel technology based on natural language processing (NLP) to extract clinical information from electronic health records (EHRs) to characterise the clinical profile of patients diagnosed with spondyloarthritis (SpA) at a large-scale hospital., Methods: An observational, retrospective analysis was conducted on EHR data from all patients with SpA (including psoriatic arthritis (PsA)) at Hospital Universitario La Paz, between 2020 and 2022. Data were collected using Savana Manager, an NLP-based system, enabling the extraction of information from unstructured, free-text EHRs. Variables analysed included demographic data, SpA subtypes, comorbidities and treatments. The performance of the technology in detecting SpA clinical entities was evaluated through precision, recall and F-1 score metrics., Results: From a hospital population of 639 474 patients, 4337 (0.7%) patients had a diagnosis of SpA or their subtypes in their EHR. The population predominantly comprised men (55.3%) with a mean age of 50.9 years. Peripheral SpA (including PsA) was reported in 31.6%, axial SpA in 20.9%, both axial and peripheral SpA in 3.7%, while 43.7% of patients did not have the SpA subtype reported. Common comorbidities included hypertension (25.0%), dyslipidaemia (22.2%) and diabetes mellitus (15.5%). The use of conventional disease-modifying antirheumatic drugs (csDMARDs) and biological DMARDs (bDMARDs) was documented, with methotrexate (25.3% of patients) being the most used csDMARDs and adalimumab (10.6% of patients) the most used bDMARD. The NLP technology demonstrated high precision and recall, with all the assessed F-1 score values over 0.80, indicating reliable data extraction., Conclusion: The application of NLP technology facilitated the characterisation of the SpA patient profile, including demographics, clinical features, comorbidities and treatments. This study supports the utility of NLP in enhancing the understanding of SpA and suggests its potential for improving patient management by extracting meaningful information from unstructured EHR data., Competing Interests: Competing interests: DB: Speakers bureau: AbbVie, BMS, Galapagos, Janssen, Lilly, MSD. Research grants: Novartis. Consultancy: Sandoz, UCB. Part-time work in Savana Research. MBN worked at MedSavana during the development of the study. JMC and MT work at Savana Research SL. JAM and NS work at MedSavana. VNC: Consultancy/Speaker/Research grants from: Abbvie, BMS, Fresenius Kabi, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, UCB. Member of ASAS Executive Committee. EdM: Research funding/consulting and conferences fees from: Abbvie, Novartis, Roche, Pfizer, Janssen, Lilly, MSD, BMS, UCB, Grunental and Sanofi., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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28. 2023 EULAR recommendations on imaging in diagnosis and management of crystal-induced arthropathies in clinical practice.
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Mandl P, D'Agostino MA, Navarro-Compán V, Geßl I, Sakellariou G, Abhishek A, Becce F, Dalbeth N, Ea HK, Filippucci E, Hammer HB, Iagnocco A, de Thurah A, Naredo E, Ottaviani S, Pascart T, Pérez-Ruiz F, Pitsillidou IA, Proft F, Rech J, Schmidt WA, Sconfienza LM, Terslev L, Wildner B, Zufferey P, and Filippou G
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- Humans, Chondrocalcinosis diagnostic imaging, Gout diagnostic imaging, Gout drug therapy, Magnetic Resonance Imaging methods, Tomography, X-Ray Computed, Evidence-Based Medicine, Radiography, Crystal Arthropathies diagnostic imaging, Ultrasonography methods
- Abstract
Objective: To formulate evidence-based recommendations and overarching principles on the use of imaging in the clinical management of crystal-induced arthropathies (CiAs)., Methods: An international task force of 25 rheumatologists, radiologists, methodologists, healthcare professionals and patient research partners from 11 countries was formed according to the EULAR standard operating procedures. Fourteen key questions on the role of imaging in the most common forms of CiA were generated. The CiA assessed included gout, calcium pyrophosphate deposition disease and basic calcium phosphate deposition disease. Imaging modalities included conventional radiography, ultrasound, CT and MRI. Experts applied research evidence obtained from four systematic literature reviews using MEDLINE, EMBASE and CENTRAL. Task force members provided level of agreement (LoA) anonymously by using a Numerical Rating Scale from 0 to 10., Results: Five overarching principles and 10 recommendations were developed encompassing the role of imaging in various aspects of patient management: making a diagnosis of CiA, monitoring inflammation and damage, predicting outcome, response to treatment, guided interventions and patient education. Overall, the LoA for the recommendations was high (8.46-9.92)., Conclusions: These are the first recommendations that encompass the major forms of CiA and guide the use of common imaging modalities in this disease group in clinical practice., Competing Interests: Competing interests: AA has received institutional research grants from AstraZeneca and Oxford Immunotech, royalty from UpToDate and Springer, lecture fees from Cadilla Pharmaceuticals, consulting fees from NGM Bio Limbic and Inflazome, all unrelated to the present work. AI has received honoraria, speaker fees and grants from AbbVie, Alfa-sigma, BMS, Celgene, Celltrion, Eli Lilly, Galapagos, Gilead, Janssen, MSD, Novartis, Pfizer, Sanofi Genzyme and Sobi. FB has received consulting fees from Horizon and has a research agreement with Siemens Healthineers. FP has received grants and personal fees from Novartis, Eli Lilly and UCB, and personal fees from AbbVie, Amgen, BMS, Celgene, Janssen, Hexal, Medscape, MSD, Pfizer and Roche outside the presented work. FP-R has received consulting fees from Arthrosi, Horizon, LG Pharma and Protalix; speaker fees from Horizon and Menarini; research grants from Cruces Rheumatology Association; fees in relation to trial committee or DMSB and Selecta-Sobi; and is on the steering committee of LG Pharma. HBH has received honorary for teaching from AbbVie, UCB, Lilly and Novartis and for participating in advisory boards from AbbVie and Novartis. JR has received unrestricted research grant from Sobi and Novartis, and speaker honoraria and consulting fees from BMS, Novartis and Sobi. LMS has received funding from Esaote SPA, Samsung Medison, GE HealthCare, Pfizer, Abiogen, AbbVie, Janssen-Cilag, Novartis, MSD, Merck Serono, Fidia Farmaceutici, RAW and EchoLight. LT has received speaker fees from Janssen, Novartis, GE and Eli Lilly, and is on the advisory board for UCB and Janssen. MAD'A has received speaker or consultant fees from Novartis, BMS, Janssen, Amgen, Boehringer Ingelheim, AbbVie, AstraZeneca, Pfizer, UCB and Eli Lilly. ND has received consulting fees, speaker fees or grants from AstraZeneca, Novartis, Horizon, Selecta, Arthrosi, JW Pharmaceutical Corporation, PK Med, LG Chem, JPI, PTC Therapeutics, Protalix, Unlocked Labs and Hikma. TP has received honorary from Novartis and research grants from Horizon Pharmaceuticals. VN-C has received consulting fees from AbbVie, Galapagos, Lilly, Novartis, Lilly, Pfizer and UCB, and speaker fees from AbbVie, Fresenius, Lilly, Novartis, Pfizer and UCB., (“© European Alliance of Associations for Rheumatology, EULAR 2024. Re-use permitted under CC BY-NC-ND. No commercial re-use. No derivatives. See rights and permissions. Published by BMJ on behalf of EULAR.”.)
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- 2024
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29. Goodbye to the term 'ankylosing spondylitis', hello 'axial spondyloarthritis': time to embrace the ASAS-defined nomenclature.
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van der Heijde D, Molto A, Ramiro S, Braun J, Dougados M, van Gaalen FA, Gensler LS, Inman RD, Landewé RBM, Marzo-Ortega H, Navarro-Compán V, Phoka A, Poddubnyy D, Protopopov M, Reveille J, Rudwaleit M, Sampaio-Barros P, Sepriano A, Sieper J, Van den Bosch FE, van der Horst-Bruinsma I, Machado PM, and Baraliakos X
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- Humans, Severity of Illness Index, Sacroiliac Joint diagnostic imaging, C-Reactive Protein, Spondylitis, Ankylosing diagnosis, Spondylarthritis diagnosis, Sacroiliitis diagnostic imaging
- Abstract
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., Competing Interests: Competing interests: DvdH has received consulting fees from AbbVie, Argenx, Bayer, BMS, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, Novartis, Pfizer, Takeda, UCB Pharma. She is Director of Imaging Rheumatology bv, associate editor of ARD, editorial board member of J Rheumatol and RMD Open, advisor of ASAS. AM has received consulting fees from AbbVie, Amgen, BMS, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, UCB Pharma and Viatris. SR has received research grants and/or consulting fees from AbbVie, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, UCB, Sanofi. MD has received consulting fees from Pfizer, AbbVie, UCB, Amgen, BMS, Galapagos, Lilly, Novartis, Merck. FAvG has received consultation fees from Novartis, BMS, AbbVie, MSD, Janssen, Lily, UCB. LG has received research grants and/or consulting fees from AbbVie, Acelyrin, Eli Lilly, Fresenius Kabi, Janssen, Novartis, Pfizer, UCB. RDI has received consulting fees from Abbvie, Janssen, Novartis, UCB. RBML has received consulting fees from AbbVie, BMS, Galapagos, Eli-Lilly, Novartis, Jansen, Pfizer and UCB, is director of Rheumatology Consultancy BV and past-president and executive member of ASAS. HM-O has received grant support from Janssen, Novartis and UCB. Honoraria and/or speaker fees from AbbVie, Biogen, Eli-Lilly, Janssen, Moonlake, Novartis, Pfizer, Takeda and UCB. VN-C has received consultancy/speaker/research grants from Abbvie, BMS, Fresenius Kabi, Galapagos, Janssen, Lilly, Moonlake, MSD, Novartis, Pfizer, Roche, UCB. AP, Patient with AxSpa, Eupati Fellow, Patient Expert, Advocator, President of Cyprus League of People with Rheumatism, President of AGORA Federation, Secretary of Axial Spondylarthritis International Federation (ASIF), EULAR-Advocacy Committee Member-Pare Committee Member. DP has received research support from AbbVie, Eli Lilly, MSD, Novartis, Pfizer, consulting fees from AbbVie, Biocad, Bristol-Myers Squibb, Eli Lilly, Janssen, Moonlake, Novartis, Pfizer and UCB, and speaker fees from AbbVie, Canon, DKSH, Eli Lilly, Janssen, MSD, Medscape, Novartis, Peervoice, Pfizer and UCB. MP has received consulting fees from Novartis as well as support for attending meetings and/or travel from Abbvie, Jannsen, Novartis and UCB. MR has receieved consulting/speaker fees from Abbvie, Chugai, Boehringer, Eli-Lilly, Janssen, Novartis, UCB. PDS-B has received consulting/ speaker's fees from AbbVie, Celltrion, Eli Lilly, GSK, Janssen, Novartis, Pfizer and UCB. AS has received speaking and/or consulting fees from Abbvie, Novartis, UCB and Lilly. JS has received gees for consultancies and for being a member of speakers’ bureau from Abbvie, Merck, Novartis and UCB. FEVdB has received consulting fees from Abbvie, Amgen, Eli Lilly, Galapagos, Janssen, Moonlake, Novartis and UCB. IvdH-B has received consulting/speaker’s fees from UCB, Lilly, AbbVie, MSD, BMS, Novartis. PMM has received consulting/speaker’s fees from Abbvie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB. XB has received consulting/speaker’s fees Abbvie, Amgen, BMS, Chugai, Galapagos, Gilead, Lilly, MSD, Novartis, Pfizer, Roche, Sandoz, UCB, Zuellig Pharma and is Member of the Editorial Board of ARD, ASAS President and EULAR President Elect., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ on behalf of EULAR.)
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30. Association of clinical response criteria and disease activity levels with axial spondyloarthritis core domains: results from two phase 3 randomised studies, BE MOBILE 1 and 2.
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Navarro-Compán V, Ramiro S, Deodhar A, Mease PJ, Rudwaleit M, de la Loge C, Fleurinck C, Taieb V, Mørup MF, Massow U, Kay J, and Magrey M
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- Humans, Pain, Quality of Life, Non-Radiographic Axial Spondyloarthritis, Spondylarthritis drug therapy, Spondylitis, Ankylosing diagnosis, Spondylitis, Ankylosing drug therapy
- Abstract
Objective: To assess how achievement of increasingly stringent clinical response criteria and disease activity states at week 52 translate into changes in core domains in patients with non-radiographic (nr-) and radiographic (r-) axial spondyloarthritis (axSpA)., Methods: Patients in BE MOBILE 1 and 2 achieving different levels of response or disease activity (Assessment of SpondyloArthritis International Society (ASAS) and Ankylosing Spondylitis Disease Activity Score (ASDAS) response criteria, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI50)) at week 52 were pooled, regardless of treatment arm. Associations between achievement of these endpoints and change from baseline (CfB) in patient-reported outcomes (PROs) measuring core axSpA domains, including pain, fatigue, physical function, overall functioning and health, and work and employment, were assessed., Results: Achievement of increasingly stringent clinical efficacy endpoints at week 52 was generally associated with sequentially greater improvements from baseline in all PROs. Patients with nr-axSpA achieving ASAS40 demonstrated greater improvements (CfB) than patients who did not achieve ASAS40 but did achieve ASAS20, in total spinal pain (-5.3 vs -2.8, respectively), Functional Assessment of Chronic Illness-Fatigue subscale (12.7 vs 6.7), Bath Ankylosing Spondylitis Function Index (-3.9 vs -1.8), European Quality of Life 5-Dimension 3-Level Version (0.30 vs 0.16), Work Productivity and Activity Impairment-axSpA presenteeism (-35.4 vs -15.9), overall work impairment (-36.5 vs -12.9), activity impairment (-39.0 vs -21.0) and sleep (9.0 vs 3.9). Results were similar for ASDAS and BASDAI50. Similar amplitudes of improvement were observed between patients with nr-axSpA and r-axSpA., Conclusions: Patients treated with bimekizumab across the full axSpA disease spectrum, who achieved increasingly stringent clinical response criteria and lower disease activity at week 52, reported larger improvements in core axSpA domains., Competing Interests: Competing interests: VN-C: Speakers’ bureau for AbbVie, Eli Lilly, Fresenius Kabi, Janssen, MSD, Novartis, Pfizer and UCB Pharma; consultant for AbbVie, Eli Lilly, Galapagos, MoonLake, MSD, Novartis, Pfizer and UCB Pharma; grant/research support from AbbVie and Novartis; SR: Grants from AbbVie, Galapagos, MSD, Novartis, Pfizer and UCB Pharma; consultancy from AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi and UCB Pharma; AD: Speakers’ bureau for Janssen, Novartis and Pfizer; consultant for AbbVie, BMS, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer, and UCB Pharma; grant/research support from AbbVie, BMS, Celgene, Eli Lilly, MoonLake, Novartis, Pfizer, and UCB Pharma; PJM: Research grants from AbbVie, Acelyrin, Amgen, BMS, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Sun Pharma, and UCB Pharma; consultancy fees from AbbVie, Acelyrin, Aclaris, Amgen, BMS, Boehringer Ingelheim, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Moonlake Pharma, Novartis, Pfizer, Sun Pharma, Takeda, UCB Pharma, and Ventyx; speakers’ bureau for AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma; MR: Speakers’ bureau for AbbVie, Boehringer Ingelheim, Chugai, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma; consultant of AbbVie, Eli Lilly, Novartis and UCB Pharma; CdlL: Consultant to UCB Pharma; CF, VT: Employees and shareholders of UCB Pharma; MFM, UM: Employees of UCB Pharma; JK: Consulting fees from Alvotech Swiss AG, Boehringer Ingelheim GmbH, Organon, Ridgeline Discovery, Scipher Medicine, Samsung Bioepis, Sandoz and UCB Pharma; grant/research support paid to institution from Gilead and Novartis; MM: Consultancy fees from AbbVie, BMS, Eli Lilly, Novartis, Pfizer and UCB Pharma; research grants from AbbVie, BMS and UCB Pharma., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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31. Comment on: MRI characteristics in patients with psoriatic arthritis and axial manifestations from the MAXIMISE cohort: Reply.
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Baraliakos X, Pournara E, Coates LC, Navarro-Compán V, Blanco R, O'Brien E, Schulz B, and Landewe R
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- Humans, Sacroiliac Joint, Magnetic Resonance Imaging, Arthritis, Psoriatic diagnostic imaging
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- 2024
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32. Exploring the latest advances in axial spondyloarthritis management.
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Benavent D and Navarro-Compán V
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- Humans, Spondylarthritis diagnosis, Spondylarthritis drug therapy, Spondylitis, Ankylosing, Axial Spondyloarthritis
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- 2024
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33. Magnetic resonance imaging characteristics in patients with psoriatic arthritis and axial manifestations from the MAXIMISE cohort.
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Baraliakos X, Pournara E, Coates LC, Navarro-Compán V, Blanco R, O'Brien E, Schulz B, and Landewe R
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- Humans, Inflammation complications, Spine diagnostic imaging, Spine pathology, Magnetic Resonance Imaging methods, Arthritis, Psoriatic diagnostic imaging, Arthritis, Psoriatic drug therapy, Arthritis, Psoriatic complications, Spondylarthritis diagnostic imaging, Spondylarthritis drug therapy, Spondylarthritis complications
- Abstract
Objective: The current analysis of the MAXIMISE trial was conducted to investigate the presence of post-inflammatory and degenerative spinal changes and inflammatory changes in spinal processes identified in baseline MRIs and their potential for predicting differential treatment effects in a cohort of PsA patients with axial manifestations., Methods: Baseline spinal MRIs from the MAXIMISE trial were re-read to identify additional inflammatory (spinal process), post-inflammatory, and degenerative changes, and investigate the differential treatment effect of these imaging features using logistic regression modelling., Results: In addition to bone marrow oedema assessed at primary analysis, spinal process inflammation and post-inflammatory changes evaluated by FAt Spondyloarthritis Spine Score were documented in 11.1% and 20.2% patients, respectively. At least one type of degenerative change was noted in 64% patients, with Pfirrmann grade ≥3 (51.1%) being the most common. Combining primary and re-read MRI findings, 67.1% of patients presented with inflammatory or post-inflammatory changes while 21.2% had degenerative changes alone. Although not statistically significant, post-inflammatory changes were associated with a trend for better efficacy outcomes in terms of ASAS20, ASAS40 and BASDAI50 responses; a trend for worse outcomes was observed in the presence of degenerative changes., Conclusion: The current analysis revealed the occurrence of additional inflammatory and post-inflammatory changes suggestive of axial PsA (axPsA) and a trend for better clinical outcomes for patients treated with secukinumab. These results elucidate the imaging characteristics and improve our current understanding of axPsA thereby supporting the interpretation of future trials., Trial Registration: ClinicalTrials.gov, NCT02721966., (© The Author(s) 2023. Published by Oxford University Press on behalf of the British Society for Rheumatology.)
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- 2024
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