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Objectives: To determine the frequency of sustained remission (R) or low diseas activity (LDA) in patients with axial spondyloarthritis (axSpA) undergoing long-term biological therapy and to analyse predictive factors for achieving these outcomes., Design: Prospective, observational cohort study., Setting: Spanish hospital., Participants: Patients with axSpA who initiated biological treatment between 2003 and 2017., Intervention: Assessment of demographic and clinical characteristics at the beginning of treatment and disease activity every 6 months up to a maximum of 2 years., Main Outcome Measures: Disease activity was measured by Ankylosing Spondylitis Disease Activity Score (ASDAS) and Bath Ankylosing Spondylitis Disease Activity Index and C reactive protein (BASDAI&CRP). Sustained R was defined as ASDAS<1.3 and/or BASDAI <2 and normal CRP while sustained LDA was defined as ASDAS <2.1 and/or BASDAI <4 and normal CRP on at least three consecutive visits., Results: In total 186 patients (66.1% men and 75.3% with radiographic sacroiliitis) were included. Overall, 76.8% of patients achieved ASDAS R/LDA (R53.2%/LDA23.6%) in at least one visit. Forty per cent (R17.6%/LDA22.4%) of the patients fulfilled the sustained ASDAS R/LDA state, whereas only 30.8% maintained this status (R14.8%/LDA15.9%) according to BASDAI&CRP. In the multivariate analysis, male sex (OR=4.01), younger age at the beginning of biological therapy (OR=0.96) and an HLA*B27 positive status (OR=4.30) were associated with achieving sustained ASDAS R/LDA., Conclusions: In clinical practice, around one-third of patients on biological disease-modifying antirheumatic drugs achieve a sustained R/LDA status, but these rates drop to less than one in five when targeting remission, preventing the use of the latter as a feasible target. Male sex, HLA*B27 positivity and younger age at the beginning of biological therapy are the main predictors for achieving sustained R/LDA., Competing Interests: Competing interests: DB received grants/speaker/research supports from Roche and Abbvie. CP-R received grants/speaker/research supports from Pfizer, Sanofi, Novartis, Roche and Lilly. RN received grants/speaker/research supports from Novartis, Sanofi Genzyme, Pfizer and Montpellier. IM received grants/research supports from Novartis and speaker’s fees from AbbVie, UCB, Roche and Novartis. DP received grants/research supports from Abbvie, Lilly, MSD and Roche, and had participation in company sponsored speaker’s bureau from Abbvie, Novartis, Lilly, Roche, and MSD. AB received Grant/research support, fees for consultancies or as a speaker for Abbvie, Pfizer, Novartis, BMS, Nordic, Sanofi, Sandoz, Lilly, UCB, Roche. VN-C: consultancy/speaker/research grants from: Abbvie, BMS, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Aim: To compare the burden of disease in Spanish patients with axial spondyloarthritis (axSpA) vs other European countries (OEC)., Methods: Data from 2846 unselected patients from the European Map of Axial Spondyloarthritis (EMAS) and the Atlas of Axial Spondyloarthritis in Spain (Atlas) were collected through online surveys. Comparative analysis was carried out between Spanish patients (2016) and patients from 12 OEC ( 2017-2018). Socio-demographic characteristics, life habits, and patient-reported outcomes (Bath Ankylosing Spondylitis Disease Activity Index 0-10, spinal stiffness 3-12, functional limitation 0-54, the 12-Item General Health Questionnaire [GHQ-12] for psychological distress 0-12) were compared. Chi-square and Mann-Whitney tests were used for qualitative and quantitative variables respectively., Results: 680 (23.9%) Spanish axSpA patients were compared to 2166 axSpA patients (76.1%) from OEC. Compared to Spain, the OEC group had a higher percentage of females (64.1% vs 52.5%; P < .001) and university-educated participants (51.7% vs 36.9%; P < .001). Spanish patients showed a greater diagnostic delay (8.5 ± 7.7 vs 7.2 ± 8.6 years; P < .001), visits to orthopedic specialists before diagnosis (56.9% vs 25.3%; P < .001), human leukocyte antigen-B27 carriership (77.1% vs 70.1%; P = .003), disease activity (5.7 ± 2.0 vs 5.4 ± 2.0; P = .024), and higher unemployment rates (21.7% vs 9.2%; P < .001). Despite lower rates of diagnosed anxiety and depression, Spanish patients were at higher risk of psychological distress according to the GHQ-12 (5.7 ± 4.5 vs 4.8 ± 4.0; P < .001)., Conclusion: Compared to European axSpA patients, Spanish patients experience a longer diagnostic delay and greater psychological distress. Being wrongly referred to orthopedic specialists and facing a more precarious labor scenario appear as possible causal factors, highlighting the need to increase the number of rheumatologists, the training of healthcare professionals, and improving axSpA patients' working conditions., (© 2021 The Authors. International Journal of Rheumatic Diseases published by Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.)

Objective: To develop a consensus to standardize the use of Spanish terms, abbreviations and acronyms in the field of spondyloarthritis (SpA)., Methods: An international task force comprising all native Spanish-speaking Assessment of SpondyloArthritis International Society (ASAS) members, the executive committee of Grupo para el estudio de la Espondiloartritis de la Sociedad Española de Reumatología (GRESSER), two methodologists, two linguists from the Real Academia Nacional de Medicina de España (RANM) and two patients from the Spanish Coordinator of Spondylitis Associations (CEADE) was established. A literature review was performed to identify the conflicting terms/abbreviations/acronyms in SpA. This review examined written sources in Spanish including manuscripts, ICF and ICD, guidelines, recommendations and consensuses. This was followed by a nominal group meeting and a three-round Delphi. The recommendations from the RANM based on the Panhispanic dictionary were followed throughout the process., Results: Consensus was reached for 46 terms, abbreviations or acronyms related to the field of SpA. A Spanish translation was accepted for 6 terms and 6 abbreviations to name or classify the disease, and for 6 terms and 4 abbreviations related to SpA. It was agreed not to translate 15 acronyms into Spanish. However, when mentioning them, it was recommended to follow this structure: type of acronym in Spanish and acronym and expanded form in English. With regard to 7 terms or abbreviations attached to acronyms, it was agreed to translate only the expanded form and a translation was also selected for each of them., Conclusions: Through this standardization, it is expected to establish a common use of the Spanish nomenclature for SpA. The implementation of this consensus across the community will be of substantial benefit, avoiding misunderstandings and time-consuming processes., (Copyright © 2018 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.)

Background: TNF inhibitors (TNFis) are widely used for the treatment of rheumatoid arthritis (RA), although the response rates to this therapy in patients with RA remains heterogeneous and < 50% achieve remission (REM). Objective: To analyze baseline peripheral blood leukocytes profiles in order to search for biomarkers identifying patients who will most likely not achieve REM under TNFi treatment. Methods: A prospective bi-center pilot study including 98 RA patients treated with TNFis and followed-up during 6 months. Patients were classified according to DAS28 as follows: those who achieved REM (DAS28 ≤ 2.6) and those who did not (DAS28 > 2.6) at 6 months after starting TNFis. These rates were also assessed by simplified disease activity index (SDAI ≤ 3.3 and SDAI > 3.3, respectively). Peripheral blood immune cells were studied by flow cytometry before treatment initiation. Results: At 6 months, 61 or 80% of patients did not achieve REM by DAS28 or SDAI, respectively. Basal leukocyte profiles differed between REM vs. non-REM patients. Non-REM patients showed lower percentages of total and naïve B cells at baseline than REM subjects. A B lymphocyte/CD4+ lymphocyte ratio (BL/CD4 ratio) <0.2 clearly associated with a higher probability of non-REM status based on DAS28 at 6 months (OR = 9.2, p = 0.006). These data were confirmed when patient response was evaluated by SDAI index. Conclusion: Our results strongly suggest that BL/CD4 ratio could be considered as a useful biomarker for the early identification of non-remitters to TNFi in clinical practice., (Copyright © 2020 Rodríguez-Martín, Nieto-Gañán, Hernández-Breijo, Sobrino, García-Hoz, Bachiller, Martínez-Feito, Navarro-Compán, Lapuente-Suanzes, Bonilla, Pascual-Salcedo, Roy, Jurado, Nozal, Vázquez-Díaz, Balsa, Villar and Plasencia-Rodríguez.)

Introduction: During the last years, regulatory agencies raised some relevant concerns with regard to the possibility of administrating biological therapy (BT) to non-SpA patients. Especially, the possibility of treating women with fibromyalgia as non-radiographic axSpA (nr-axSpA) was mentioned., Objectives: To evaluate if the gender distribution and clinical pattern of patients with axSpA initiating biological therapy (BT) was modified in clinical practice after its approval for non radiographic-axSpA (nr-axSpA)., Methods: Baseline dataset from a prospective ongoing cohort including all patients with axSpA treated with BT at the Rheumatology Department of University Hospital La Paz, Madrid, Spain, was analysed. Patient's characteristics and disease activity parameters were collected. Based on the approval indication date of BT for nr-axSpA, patients were classified in two periods according to the starting date for the first BT: period 1 (before 2013) and period 2 (during or after 2013). Gender distribution and disease' characteristics were compared between both groups using Chi-square and Student-t tests., Results: In total, 385 patients initiated BT: 266 (69%) in period 1 and 119 (31%) in period 2. No significant differences between both periods were observed regarding gender distribution (38% and 39% of women; p = 0.8). Out of those patients with nr-axSpA initiating BT in period 2, the majority (60%) were men. Women starting BT in period 2 had significantly higher systemic inflammation and mobility restriction compared with women in period 1 [median (interquartile range) CRP 10.2 mg/l (3.0-24.9) vs 3.2 mg/l (2.0-9.4); p = 0.02 and BASMI 2.7 (1.8-3.5) vs. 2.0 (1.2-2.6); p = 0.01, respectively]. In addition, they also presented significantly higher disease activity [BASDAI 6.5 (5.4-8.0) vs. 5.8 (4.6-6.8); p = 0.02; ASDAS, mean (SD) 3.6 ± 3.4 vs. 3.2 ± 1.0; p = 0.02, respectively] and more functional limitation [BASFI 5.7 (3.8-6.7) vs. 4.3 (2.0-6.1); p = 0.01, respectively] than men treated in period 2., Conclusions: In our clinical practice, the frequency of women who started BT did not increase since their approval for nr-axSpA. Women treated with BT after 2012 had more objective disease activity parameters than before their approval for nr-axSpA treatment., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objective: To assess the risk of mental disorders in patients with axial spondyloarthritis (axSpA) and to examine the factors associated with this., Methods: In 2016, a sample of 680 patients with axSpA were interviewed as part of the development process for the Atlas of Axial Spondyloarthritis in Spain. The risk of mental disorders in these patients was assessed using the 12-item General Health Questionnaire scale. Additionally, the variables associated with the risk of mental disorders were investigated, including sociodemographic characteristics (age, sex, relationship, patient association membership, job status, and educational level), disease status (Bath Ankylosing Spondylitis Disease Activity Index, spinal stiffness, and functional limitation), and previous diagnosis of mental disorders (depression and anxiety). Bivariate correlation analyses were performed, followed by multiple hierarchical and stepwise regression analysis., Results: A total of 45.6% patients were at risk of mental disorders. All variables except educational level and thoracic stiffness significantly correlated with risk of mental disorders. Nevertheless, disease activity, functional limitation, and age showed the highest coefficient (r = 0.543, p ≤ 0.001; r = 0.378, p ≤ 0.001; r = -0.174, p ≤ 0.001, respectively). In the stepwise regression analysis, 4 variables (disease activity, functional limitation, patient association membership, and cervical stiffness) explained the majority of the variance for the risk of mental disorders. Disease activity displayed the highest explanatory degree (R 2 = 0.875, p < 0.001)., Conclusion: In patients with axSpA, the prevalence of risk of mental disorders is high. Combined with a certain sociodemographic profile, high disease activity is a good indicator of the risk for mental disorders.

Objective: Atlas of Axial Spondyloarthritis in Spain 2017 aims to better understand the reality of the patients suffering from this disease from an integrated approach., Methods: The Atlas 2017 based its results on an extensive cross-sectional patient survey conducted in Spain (2016), validated by a multidisciplinary group of experts on spondyloarthritis., Results: Data from 680 patients with axSpA were obtained, most of them suffered from AS, were HLA-B27 positive, older than 45 years, and live as part of a couple. A large percentage had university studies, were disabled and members of a patient association. Patients reported a diagnostic delay of 8.5 years, high disease activity (BASDAI 5.5±2.2), moderate-important stiffness (61.0%), medium-high functional limitation (74.9%), and psychological distress (GHQ 5.7±4.5). A total of 54.7% reported taking NSAIDs, 28.4% DMARDs, 36.3% biological therapy and 32.2% were not receiving pharmacological treatment., Conclusions: The Atlas survey data reveals still a long diagnostic delay, high disease activity, psychological distress, while an important proportion could be undertreated., (Copyright © 2018 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.)

Objectives: To study whether disease status at treatment initiation has changed after the issue of the ASAS classification criteria., Methods: REGISPONSERBIO registers patients with axial spondyloarthritis (axSpA) on biological treatment since 2013. It includes patients starting biological treatment (incident) or already on biological therapies (prevalent). Patients in both groups were compared in terms of: age at disease onset and at treatment start, disease duration, gender, HLA-B27, body mass index (BMI), BASDAI, BASFI, C-reactive protein, ESR, metrological data, ASQoL, WAPAI, extra-articular manifestations, comorbidities, radiological study, type of biological treatment and concomitant treatments., Results: 256 patients were included, of whom 174 (65%) were already on biologic therapy. Compared to incident patients, prevalent patients started treatment with longer disease duration (15 vs. 8.6 years; p<0.001), a higher proportion of them were men (83% vs. 67%; p=0.01), a smaller proportion of them showed non-radiographic axial spondylarthritis (nr-axSpA)(17% vs. 32%; p<0.01), and a higher proportion had HLAB27 (85% vs. 73%; p=0.02). There were no statistically significant differences in terms of disease activity, degree of disability, quality of life, or prevalence of extra-articular manifestations., Conclusions: Data suggest that, after the issue of the new classification criteria for SpA, biological therapy is being administered earlier than previously in SpA patients and in a higher proportion of patients with nr-axSpA. However, this change in prescribing profile, apparently, has not caused an over-treatment, as patients do not seem to have a lower disease burden than prior to the issue of the criteria.

Objective: Recent data published on biological therapy in axial spondyloarthritis (axSpA) since the last publication of the recommendations of the Spanish Society of Rheumatology (SER) has led to the generation of a review of these recommendations based on the best possible evidence. These recommendations should be a reference for rheumatologists and those involved in the treatment of patients with axSpA., Methods: Recommendations were drawn up following a nominal group methodology and based on systematic reviews. The level of evidence and grade of recommendation were classified according to the model proposed by the Centre for Evidence Based Medicine at Oxford. The level of agreement was established through the Delphi technique., Results: In this review, we did an update of the evaluation of disease activity and treatment objectives. We included the new drugs with approved therapeutic indication for axSpA. We reviewed both the predictive factors of the therapeutic response and progression of radiographic damage. Finally, we drafted some recommendations for the treatment of patients refractory to anti-tumor necrosis factor, as well as for the possible optimization of biological therapy. The document also includes a table of recommendations and a treatment algorithm., Conclusions: We present an update of the SER recommendations for the use of biological therapy in patients with axSpA., (Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.)

Objectives: Dactylitis is a typical feature of psoriatic arthritis. However, dactylitis was included as a spondyloarthritis (SpA) feature for both (axial and peripheral) of the ASAS classification criteria, but data about its prevalence are scarce, especially in patients with a recent onset of the disease. Our objective was to determine the prevalence and characteristics associated with dactylitis in patients with early SpA., Methods: A baseline dataset from the ESPeranza cohort was used. This programme included patients who were suspected of having SpA (age <45 years, symptoms duration of 3-24 months and with inflammatory back pain, or asymmetrical arthritis, or spinal/joint pain plus ≥1 of the SpA features). For this study, 609 patients who were diagnosed with SpA by their physician were included. Descriptive, univariable and multivariable logistic regression analyses were employed to investigate the association between the presence of dactylitis and the characteristics associated with SpA., Results: Fifty-eight (9.5%) patients currently or previously had dactylitis. In the multivariable analysis, dactylitis was independently associated with peripheral arthritis (OR= 4.83; p<0.001), enthesitis (OR= 2.49; p=0.01), psoriasis (OR= 3.62; p<0.01) and the physician's visual analogue scale (OR= 0.82; p=0.01). However, 67% of the patients who had dactylitis did not have peripheral arthritis or psoriasis and 15% had predominantly axial disease., Conclusions: Dactylitis is a frequent manifestation in patients with SpA, even during the early stages of the disease. Its presence is mainly associated with peripheral manifestations and psoriasis. Nevertheless, dactylitis is not exclusive of patients with PsA or peripheral manifestations.

Objective: To standardize clinical evaluation of patients with axial spondyloarthritis (SpA) and psoriatic arthritis (PsA) using a checklist., Methods: Qualitative study that included: 1) nominal group (18 experts); 2) literature reviews of measures used in the assessment of patients with axial SpA or PsA; and 3) focus groups, one with rheumatologists and another with patients, organized to become familiar with their opinion on medical assistance. Taking this into account, the experts selected the measures to be included in the checklist based on their relevance, feasibility, and the outcome type., Results: The checklist includes measures for the evaluation of personal history, physical examination, activity and function, laboratory tests, imaging studies and treatments. It also defines risk factors of radiographic progression, predictors of the response to biological therapies, and comprises measures of excellence., Conclusions: This checklist for patients with axial SpA and PsA could help standardize daily clinical practice and improve clinical management and patient prognosis., (Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.)

Objectives: To describe and evaluate clinical and imaging differences between patients with familial and sporadic early spondyloarthritis (SpA)., Methods: This was a cross-sectional study analysing the baseline dataset from ESPERANZA, a national programme developed for the early identification of patients with SpA. Patients fulfilling SpA ASAS classification criteria were included. Familial SpA was defined according to the ASAS/ESSG criteria as the presence in first- or second-degree relatives of any of the following: ankylosing spondylitis, psoriasis, uveitis, reactive arthritis, and inflammatory bowel disease. Socio-demographic and disease characteristics, disease activity, metrology and laboratory and imaging data were compared by descriptive and bivariate statistics., Results: A total of 377 patients were included - 64% men, mean age 32, and mean disease duration 12 months. Out of these, 132 (35%) patients (101 axial and 31 peripheral SpA) were familial forms. In patients with axial SpA, statistically significant differences (p<0.05) were found between familial and sporadic forms regarding age at symptoms onset (29.4±9.2 vs. 31.5±10 years), HLA B27 positivity (83% vs. 71%), BASMI (1.2± 13 vs. 1.6 1.2) and sacroiliitis on magnetic resonance imaging (36% vs. 47%), respectively. In patients with peripheral SpA, there were no significant differences for any of the variables analysed., Conclusions: Familial axial SpA presents symptoms at a younger age, is more frequently HLA-B27 positive and shows better spinal mobility than sporadic axial SpA; this latter presenting sacroiliitis on MRI more frequently than familial axial SpA. Apparently, no differences exist in the expression of familial or sporadic peripheral SpA.

Objectives: The aim of this study is to compare clinical outcomes, incidence of flares and administered drug reduction between rheumatoid arthritis (RA) patients under TNF inhibitors (TNFi) tapering strategy and RA patients on standard regimen., Methods: Two groups of RA patients on TNFi with DAS28<3.2 were compared: the tapering group (TG: 67 pts from Spain) and the control group with standard therapy regimen (CG: 77 pts from the Netherlands). DAS28 was measured at different time points: visit 0 (prior starting TNFi), visit 1 (prior to start tapering in TG and with DAS28<3.2 in TG and CG), visit 2 (6 months after visit 1), visit 3 (1 year after visit 1), visit 4 (the last visit available after visit 1) and visit-flare (visit with the worst flare between visit 1 and visit 4)., Results: Despite the reduction of administered drug at visit 4 in the TG (interval elongation of 32.8% in infliximab, 52.9% in adalimumab and 52.6% in etanercept), the DAS28 remained similar between groups at the end of the study (DAS28: 2.7±0.9 in TG vs. 2.5±1 in CG, p=0.1). No differences were seen in the number of patients with flares [26/67 (38.9%) in the TG vs. 30/77 (39%) in the CG, p=0.324] and only nineteen out of 136 patients (14%) had anti-drug antibodies at the end of the study., Conclusions: The tapering strategy of TNFi in RA patients result in a reduction of the drug administered, while the disease control is not worse than patients on the standard regimen.

Objective: To compare clinical outcomes, incidence of flares, and administered drug reduction between patients with spondyloarthritis (SpA) under TNF inhibitor (TNFi) tapering strategy with patients receiving a standard regimen., Methods: In this retrospective study, 74 patients with SpA from Spain on tapering strategy (tapering group; TG) were compared with 43 patients from the Netherlands receiving a standard regimen (control group; CG). The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was measured at visit 0 (prior to starting the TNFi), visit 1 (prior to starting tapering strategy in TG and at least 6 months with BASDAI < 4 after starting the TNFi in the TG and CG), visit 2 (6 mos after visit 1), visit 3 (1 year after visit 1), and visit 4 (the last visit available after visit 1)., Results: An overall reduction of the administered drug was seen at visit 4 in the TG [dose reduction of 22% for infliximab (IFX) and an interval elongation of 28.7% for IFX, 45.2% for adalimumab, and 51.5% for etanercept] without significant differences in the BASDAI between the groups at visit 4 (2.15 ± 1.55 in TG vs 2.11 ± 1.31 in CG, p = 0.883). The number of patients with flares was similar in both groups [22/74 (30%) in the TG vs 8/43 (19%) in the CG, p = 0.184]., Conclusion: The tapering strategy in SpA results in an important reduction of the drug administered, and the disease control remains similar to that of the patients with SpA receiving the standard regimen.

Introduction: No definitive data are available regarding the value of switching to an alternative TNF antagonist in rheumatoid arthritis patients who fail to respond to the first one. The aim of this study was to evaluate treatment response in a clinical setting based on HAQ improvement and EULAR response criteria in RA patients who were switched to a second or a third TNF antagonist due to failure with the first one., Methods: This was an observational, prospective study of a cohort of 417 RA patients treated with TNF antagonists in three university hospitals in Spain between January 1999 and December 2005. A database was created at the participating centres, with well-defined operational instructions. The main outcome variables were analyzed using parametric or non-parametric tests depending on the level of measurement and distribution of each variable., Results: Mean (+/- SD) DAS-28 on starting the first, second and third TNF antagonist was 5.9 (+/- 2.0), 5.1 (+/- 1.5) and 6.1 (+/- 1.1). At the end of follow-up, it decreased to 3.3 (+/- 1.6; Delta = -2.6; p > 0.0001), 4.2 (+/- 1.5; Delta = -1.1; p = 0.0001) and 5.4 (+/- 1.7; Delta = -0.7; p = 0.06). For the first TNF antagonist, DAS-28-based EULAR response level was good in 42% and moderate in 33% of patients. The second TNF antagonist yielded a good response in 20% and no response in 53% of patients, while the third one yielded a good response in 28% and no response in 72%. Mean baseline HAQ on starting the first, second and third TNF antagonist was 1.61, 1.52 and 1.87, respectively. At the end of follow-up, it decreased to 1.12 (Delta = -0.49; p < 0.0001), 1.31 (Delta = -0.21, p = 0.004) and 1.75 (Delta = -0.12; p = 0.1), respectively. Sixty four percent of patients had a clinically important improvement in HAQ (defined as > or = -0.22) with the first TNF antagonist and 46% with the second., Conclusion: A clinically significant effect size was seen in less than half of RA patients cycling to a second TNF antagonist.