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Objective To describe the development of an Environmental contextual factors (EF) Item Set (EFIS) accompanying the disease specific Assessment of SpondyloArthritis international Society Health Index (ASAS HI). Method First, a candidate item pool was developed by linking items from existing questionnaires to 13 EF previously selected for the International Classification of Functioning, Disability and Health (ICF) /ASAS Core Set. Second, using data from two international surveys, which contained the EF item pool as well as the items from the ASAS HI, the number of EF items was reduced based on the correlation between the item and the ASAS HI sum score combined with expert opinion. Third, the final English EFIS was translated into 15 languages and cross-culturally validated. Results The initial item pool contained 53 EF addressing four ICF EF chapters: products and technology (e1), support and relationship (e3), attitudes (e4) and health services (e5). Based on 1754 responses of axial spondyloarthritis patients in an international survey, 44 of 53 initial items were removed based on low correlations to the ASAS HI or redundancy combined with expert opinion. Nine items of the initial item pool (range correlation 0.21–0.49) form the final EFIS. The EFIS was translated into 15 languages and field tested in 24 countries. Conclusions An EFIS is available complementing the ASAS HI and helps to interpret the ASAS HI results by gaining an understanding of the interaction between a health condition and contextual factors. The EFIS emphasizes the importance of support and relationships, as well as attitudes of the patient and health services in relation to self-reported health.

Resumen La artritis psoriasica (APs) es una enfermedad inflamatoria sistemica cronica que afecta a la piel, las estructuras musculoesqueleticas y otros organos y sistemas, comprometiendo la funcionalidad, la calidad de vida y reduciendo la expectativa de vida de los pacientes. Es una enfermedad compleja que requiere atencion y manejo especializado y oportuno. Las alternativas para el tratamiento de las manifestaciones de la APs se han incrementado y, adicionalmente, el efecto de los distintos agentes sobre manifestaciones especificas ha sido aclarado en estudios recientes, por lo tanto, es conveniente incorporar la evidencia disponible para construir una estrategia en el tratamiento de estos pacientes. El Colegio Mexicano de Reumatologia selecciono una comision para evaluar estas distintas alternativas y generar recomendaciones. Metodos El grupo de estudio incluyo a 16 reumatologos y tres dermatologos certificados, que fueron seleccionados de diferentes instituciones de salud y regiones del pais. Se conformo un comite ejecutivo que coordino las reuniones y un comite de expertos que selecciono los criterios de busqueda en la literatura, elaboro las preguntas de investigacion, califico la calidad de la evidencia y genero las recomendaciones en los distintos dominios de la enfermedad con base en la metodologia GRADE. Resultados Se generaron 24 recomendaciones actualizadas para el tratamiento de pacientes con APs. Las recomendaciones establecen el papel de los medicamentos disponibles actualmente en nuestro pais. Se enfatiza la importancia del control adecuado de la enfermedad, individualizando el perfil de involucramiento de cada paciente en cada uno de los seis dominios potencialmente afectados por la enfermedad. Ademas, se establece la secuencia en la eleccion de los tratamientos disponibles para cada dominio, basada en su eficacia, perfil de seguridad y accesibilidad. Conclusiones Con este documento de consenso se podra mejorar la atencion de los pacientes con APs. Las recomendaciones se generaron de acuerdo con la mejor informacion disponible y en consideracion del sistema de salud de Mexico.

Objective To assess concordance among criteria for inactive disease (ID) and low disease activity (LDA) in juvenile idiopathic arthritis (JIA) and to seek factors driving discordance. Methods The frequency of fulfillment of existing criteria was evaluated in information on 10,186 patients extracted from 3 cross-sectional data sets. Patients were divided up according to the functional phenotypes of oligoarthritis and polyarthritis. Concordance between criteria was examined using weighted Venn diagrams. The role of each individual component in explaining discordance between criteria was assessed by calculating the absolute number and percentage of instances in which the component was responsible for discrepancy between definitions. Results Criteria for ID were met by 28.6–41.1% of patients with oligoarthritis and by 24.0–33.4% of patients with polyarthritis. Criteria for LDA were met by 44.8–62.4% of patients with oligoarthritis and by 44.6–50.4% of patients with polyarthritis. There was a 57.9–62.3% overlap between criteria for ID and a 67.9–85% overlap between criteria for LDA. Parent and physician global assessments and acute-phase reactants were responsible for the majority of instances of discordance among criteria for ID (8.7–15.5%, 10.0–12.3%, and 10.8–17.3%, respectively). Conclusion We found fair concordance between criteria for ID and LDA in JIA, with the main drivers of discordance for ID being physician and parent global assessments and acute-phase reactants. This observation highlights the need for further studies aimed to evaluate the impact of subjective physician and parent perception of disease remission and of laboratory measures of inflammatory activity on the definition of ID.

Objective To report the 2‐year efficacy and safety of tocilizumab (TCZ) in patients with polyarticular‐course juvenile idiopathic arthritis (JIA). Methods Patients ages 2–17 years with active polyarticular‐course JIA, in whom treatment with methotrexate was unsuccessful, received 16 weeks of open‐label intravenous TCZ in part 1 (once every 4 weeks: 8 mg/kg or 10 mg/kg for body weight [BW] 1 of the remaining JIA CRVs by >30%) at week 16 were randomly assigned (1:1) to receive TCZ or placebo in part 2. Patients remained in part 2 until either week 40 or the occurrence of JIA flare. Upon starting part 3, all patients received open‐label TCZ. At week 104 of the study, efficacy was assessed using JIA‐ACR50/70/90 response rates (defined as 50%, 70%, or 90% improvement, respectively), achievement of inactive disease, and the Juvenile Arthritis Disease Activity Score in 71 joints (JADAS‐71). Safety was assessed in the all‐exposure population per 100 patient‐years of exposure. Results Overall, 188 patients entered part 1, 166 patients entered part 2, and 160 patients entered part 3. By week 104, among the 188 patients in the modified intent‐to‐treat group who received TCZ, JIA‐ACR50/70/90 response rates were 80.3%/77.1%/59.6%, respectively, the median JADAS‐71 score decreased from 3.6 at week 40 to 0.7 at week 104, 51.1% of patients had achieved inactive disease, and 31 of 66 patients who had been receiving glucocorticoids discontinued them. Adverse event (AE) and serious AE rates were 406.5 per 100 patient‐years and 11.1 per 100 patient‐years, respectively. The infection rate was 151.4 per 100 patient‐years, and the serious infection rate was 5.2 per 100 patient‐years. Conclusion Patients treated with TCZ for polyarticular‐course JIA showed high‐level disease control for up to 2 years. The TCZ safety profile was consistent with that previously reported.

espanolObjetivo Desarrollar un documento de consenso para estandarizar los terminos, abreviaturas y acronimos en espanol empleados en el campo de las espondiloartritis (EspA). Metodos Se creo un grupo de trabajo internacional compuesto por todos los miembros de Assessment of SpondyloArthritis International Society (ASAS) nativos de habla espanola, miembros del comite ejecutivo del Grupo para el estudio de la Espondiloartritis de la Sociedad Espanola de Reumatologia (GRESSER), 2 metodologos, 2 linguistas de la Real Academia Nacional de Medicina de Espana (RANM) y 2 pacientes de la Coordinadora Espanola de Asociaciones de Espondilitis (CEADE). Se realizo una revision de la literatura de los ultimos 15 anos (publicaciones, el CIE y CIF, guias, consensos y recomendaciones) para identificar los terminos, abreviaturas y acronimos discrepantes. Mediante un Delphi de 3 rondas y una reunion presencial, se discutieron, seleccionaron y acordaron los terminos, abreviaturas y acronimos a utilizar. Durante todo este proceso se siguieron las recomendaciones de la RANM basadas en el Diccionario panhispanico de terminos medicos. Resultados Se consensuaron 46 terminos, abreviaturas y acronimos. Se acepto la traduccion al espanol para 6 terminos y 6 abreviaturas empleados para nombrar o clasificar la enfermedad y para 6 terminos y 4 abreviaturas relacionados con las EspA. Se acordo no traducir 15 acronimos por estar ya establecidos, pero al mencionarlos, se recomendo seguir esta estructura: tipo de acronimo en espanol y acronimo y forma extensa en ingles. Con respecto a 7 terminos o abreviaturas asociados a acronimos, se acordo traducir solo la forma extensa y se consensuo una traduccion. Conclusiones Con esta estandarizacion del lenguaje de las EspA se pretende establecer un uso comun de la nomenclatura en espanol para las EspA. Su implementacion sera muy beneficiosa, evitando malentendidos y consumo de recursos. EnglishObjective 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 Espanola de Reumatologia (GRESSER), two methodologists, two linguists from the Real Academia Nacional de Medicina de Espana (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.

Although low back pain (LBP) is a high-impact health condition, its burden has not been examined from the syndemic perspective. To compare and assess clinical, socioeconomic, and geographic factors associated with LBP prevalence in low-income and upper-middle-income countries using syndemic and syndemogenesis frameworks based on network and cluster analyses. Analyses were performed by adopting network and cluster design, whereby interrelations among the individual and social variables and their combinations were established. The required data was sourced from the databases pertaining to the six Latin-American countries. Database searches yielded a sample of 55,724 individuals (mean age 43.38 years, SD = 17.93), 24.12% of whom were indigenous, and 60.61% were women. The diagnosed with LBP comprised 6.59% of the total population. Network analysis showed higher relationship individuals’ variables such as comorbidities, unhealthy habits, low educational level, living in rural areas, and indigenous status were found to be significantly associated with LBP. Cluster analysis showed significant association between LBP prevalence and social variables (e.g. Gender inequality Index, Human Development Index, Income Inequality). LBP is a highly prevalent condition in Latin-American populations with a high impact on the quality of life of young adults. It is particularly debilitating for women, indigenous individuals, and those with low educational level, and is further exacerbated by the presence of comorbidities, especially those in the mental health domain. Thus, the study findings demonstrate that syndemic and syndemogenesis have the potential to widen the health inequities stemming from LBP in vulnerable populations.

Objective: To describe longitudinal changes in patient-reported outcomes (PROs) in children with polyarticular-course juvenile idiopathic arthritis (pJIA) treated with subcutaneous abatacept. Methods: Secondary analysis of a single-arm, open-label 24-month study of patients ages 6-17 years and 2-5 years. PROs included Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI), parent global assessment of child well-being (PaGA), pain assessment, and Activity Limitation Questionnaire (ALQ). Clinical outcomes included 50% or greater improvement in JIA American College of Rheumatology (ACR) criteria, clinically inactive disease, and Juvenile Arthritis Disease Activity Score. Results: For the 6- to 17-year-old (n = 173) and 2- to 5-year-old (n = 46) cohorts, respectively, median (Q1, Q3) changes from baseline in CHAQ-DI at months 4 and 24 were -0.3 (-0.8, 0.0) and -0.5 (-1.0, -0.1), and -0.4 (-0.8, 0.0) and -0.5 (-1.0--0.1). Median pain scores were below cutoff threshold for clinically relevant pain (

Syndemics are a framework that documents health inequities and vulnerabilities in populations with rheumatic diseases. Compared with other approaches, syndemics are able to conjunctly consider epidemiological, biological, sociodemographic and economic factors, and their interactions.ObjectiveTo estimate health inequity and vulnerability among Indigenous and non-Indigenous populations with rheumatic and musculoskeletal diseases (RMD) in Latin America using the syndemic approach.DesignThis is a secondary analysis of a previously published large-scale study on the prevalence of RMD.SettingStudies carried out in five Latin American countries (Argentina, Colombia, Ecuador, Mexico and Venezuela). Health inequity and vulnerability in RMD were identified through a syndemic approach using network and cluster analysis.ParticipantsA total of 44 560 individuals were studied: 29.78% self-identified as Indigenous, 60.92% were female, the mean age was 43.25 years. Twenty clusters were identified in the Indigenous population and 17 in the non-Indigenous population.ResultsThe variables associated with RMD among Indigenous populations were rurality, public health system, high joint biomechanical stress, greater pain, disability and alcoholism; and among non-Indigenous people they were being a woman, urban origin, older age, private health system, joint biomechanical stress, greater pain and disability. We identified different health inequities among patients with RMD (ie, lower educational attainment, more comorbidities), associated with factors such as Indigenous self-identification and rural residence.ConclusionsA syndemic approach enables us to identify health inequities in RMD, as shown by higher prevalence of comorbidities, disability and socioeconomic factors like lower educational attainment. These inequities exist for the overall population of patients with RMD, although it is more evident in Indigenous groups with added layers of vulnerability.

This paper presents the preliminary tests of a novel system prototype for the physical assessment of mobility in patients with Ankylosing Spondylitis (AS). The system combines multi-inertial sensors arrays with Kalman Filters-based pose estimation for monitoring spine mobility in patients with AS. This system allows detecting movements with more reliable information than the manual clinical evaluation.

Spondyloarthritis (SpA) is a group that includes a wide spectrum of clinically similar diseases manifested by oligoarticular arthritis and axial or peripheral ankylosis. Although axial SpA is predominant in Caucasians and adult-onset patients, juvenile-onset and Latin American patients are characterized by severe peripheral arthritis and particularly foot involvement. The peripheral involvement of SpA can vary from tarsal arthritis to the most severe form named ankylosing tarsitis (AT). Although the cause and etiopathogenesis of axSpA are often studied, the specific characteristics of pSpA are unknown. Several animal models of SpA develop initial tarsitis and foot ankylosis as the main signs, emphasizing the role of foot inflammation in the overall SpA spectrum. In this review, we attempt to highlight the clinical characteristics of foot involvement in SpA and update the knowledge regarding its pathogenesis, focusing on animal models and the role of mechanical forces in inflammation.

To identify synovitis and tenosynovitis active by using the Ultrasound 7 (US 7) scoring system in patients with rheumatoid arthritis (RA) in clinical remission induced by synthetic disease-modifying antirheumatic drugs (DMARDs).This is a multicentric, cross-sectional, observational study including 94 RA patients18 years old who were in remission as defined by the 28-joints disease activity score (DAS28)2.6 induced by synthetic DMARD during at least 6 months. Patients with a previous or current history of biologic DMARD treatment were not included in the study. Demographic and clinical data were collected by the local rheumatologist; the US evaluation was performed by a calibrated rheumatologist, who intended to detect grayscale synovitis and power Doppler (PD) using the 7-joint scale. Intra and inter-reader exercises of images between 2 ultrasonographers were realized.Patients' mean age was 49.1±13.7 years; 83% were women. The mean disease duration was 8±7 years and remission lasted for 27.5±31.8 months. The mean DAS28 score was 1.9±0.66. Grayscale synovitis was present in 94% of cases; it was mild in 87.5% and moderate in 12.5%. Only 12.8% of the patients had PD. The metatarsophalangeal, metacarpophalangeal, and carpal joints of the dominant hand were the joints more frequently affected by synovitis. Tenosynovitis by grayscale was observed in 9 patients (9.6%). The intra and inter-reading kappa value were 0.77, p0.003 (CI 95%, 0.34-0.81) and 0.81, p0.0001 (CI 95%, 0.27-0.83) respectively.Low percentage of synovitis and tenosynovitis active were founded according to PD US by 7 score in RA patients under synthetic DMARDs during long remission. This score has benefit because evaluate tenosynovitis, another element of subclinical disease activity.

Objectives Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We characterized efficacy and safety of tofacitinib in Mexican patients from RA Phase 3 and long-term extension (LTE) studies. Methods Data from Mexican patients with RA and an inadequate response to disease-modifying antirheumatic drugs (DMARDs) were taken from four Phase 3 studies (pooled across studies) and one open-label LTE study of tofacitinib. Patients received tofacitinib 5 or 10 mg twice daily, adalimumab (one Phase 3 study) or placebo (four Phase 3 studies) as monotherapy or in combination with conventional synthetic DMARDs. Efficacy up to Month 12 (Phase 3) and Month 36 (LTE) was assessed by American College of Rheumatology 20/50/70 response rates, Disease Activity Score (erythrocyte sedimentation rate), and Health Assessment Questionnaire-Disability Index. Safety, including incidence rates (IRs; patients with events/100 patient-years) for adverse events (AEs) of special interest, was assessed throughout the studies. Results 119 and 212 Mexican patients were included in the Phase 3 and LTE analyses, respectively. Tofacitinib-treated patients in Phase 3 had numerically greater improvements in efficacy responses versus placebo at Month 3. Efficacy was sustained in Phase 3 and LTE studies. IRs for AEs of special interest were similar to those with tofacitinib in the global and Latin American RA populations. Conclusions In Mexican patients from the tofacitinib global RA program, tofacitinib efficacy was demonstrated up to Month 12 in Phase 3 studies and Month 36 in the LTE study, with a safety profile consistent with tofacitinib global population.

Some studies have suggested children with juvenile onset spondyloarthritis (JoSpA) have a relatively poor outcome compared to other juvenile idiopathic arthritis (JIA) categories, in regards to functional status and failure to attain remission. Thus, in the interest of earlier recognition and risk stratification, awareness of the unique characteristics of this group is critical. Herein, we review the clinical burden of disease, prognostic indicators and outcomes in JoSpA. Of note, although children exhibit less axial disease at onset compared to adults with spondyloarthritis (SpA), 34–62% have magnetic resonance imaging (MRI) evidence for active inflammation in the absence of reported back pain. Furthermore, some studies have reported that more than half of children with “enthesitis related arthritis” (ERA) develop axial disease within 5 years of diagnosis. Axial disease, and more specifically sacroiliitis, portends continued active disease. The advent of TNF inhibitors has promised to be a “game changer,” given their relatively high efficacy for enthesitis and axial disease. However, the real world experience in various cohorts since the introduction of more widespread TNF inhibitor usage, in which greater than a third still have persistently active disease, suggests there is still work to be done in developing new therapies and improving the outlook for JoSpA.

ObjectivesTo characterise peripheral musculoskeletal involvement in patients with spondyloarthritis (SpA) including psoriatic arthritis (PsA), across the world.MethodsCross-sectional study with 24 participating countries. Patients with a diagnosis of axial SpA (axSpA), peripheral SpA (pSpA) or PsA according to their rheumatologist were included. The investigators were asked which diagnosis out of a list of six (axSpA, PsA, pSpA, inflammatory bowel disease-associated SpA, reactive arthritis or juvenile SpA (Juv-SpA)) fitted the patient best. Peripheral manifestations (ie, peripheral joint disease, enthesitis, dactylitis and root joint disease), their localisation and treatments were evaluated.ResultsA total of 4465 patients were included (61% men, mean age 44.5 years) from four geographic areas: Latin America (n=538), Europe plus North America (n=1677), Asia (n=975) and the Middle East plus North Africa (n=1275). Of those, 78% had ever suffered from at least one peripheral musculoskeletal manifestation; 57% had peripheral joint disease, 44% had enthesitis and 15% had dactylitis. Latin American had far more often peripheral joint disease (80%) than patients from other areas. Patients with PsA had predominantly upper limb and small joint involvement (52%).Hip and shoulder involvement was found in 34% of patients. The prevalence of enthesitis ranged between 41% in patients with axSpA and 65% in patients with Juv-SpA. Dactylitis was most frequent among patients with PsA (37%).ConclusionThese results suggest that all peripheral features can be found in all subtypes of SpA, and that differences are quantitative rather than qualitative. In a high proportion of patients, axial and peripheral manifestations coincided. These findings reconfirm SpA clinical subtypes are descendants of the same underlying disease, called SpA.

Objective The aim was to assess the safety and efficacy of up to 156 weeks of ixekizumab (an IL-17A antagonist) treatment in PsA patients. Methods In a phase III study, patients naïve to biologic treatment were randomized to placebo, adalimumab 40 mg every 2 weeks (ADA; active reference) or ixekizumab 80 mg every 2 weeks (IXEQ2W) or every 4 weeks (IXEQ4W) after an initial dose of 160 mg. At week 24 (week 16 for inadequate responders), ADA (after 8-week washout) and placebo patients were re-randomized to IXEQ2W or IXEQ4W. Outcomes were evaluated using a modified non-responder imputation [linear extrapolation for radiographic progression (modified total Sharp score = 0)] during extended treatment until week 156. Results Of 417 patients, 381 entered the extension, and 243 of 381 (63.8%) completed the 156-week study. Incidence rates of treatment-emergent and serious adverse events, respectively, were 38.0 and 5.2 with IXEQ2W (n = 189) and 38.1 and 8.0 with IXEQ4W (n = 197). One death occurred (IXEQ4W). With IXEQ2W and IXEQ4W, respectively, the response rates persisted to week 156 as measured by the ACR response ≥20% (62.5 and 69.8%), ≥50% (56.1 and 51.8%) and ≥70% (43.8 and 33.4%), psoriasis area and severity index (PASI) 75 (69.1 and 63.5%), PASI 90 (64.5 and 51.2%) and PASI 100 (60.5 and 43.6%). Inhibition of radiographic progression also persisted to week 156 in 61% of IXEQ2W and 71% of IXEQ4W patients. Conclusion In this 156-week study of ixekizumab, the safety profile remained consistent with previous reports, and improvements in signs and symptoms of PsA were observed, including persistent low rates of radiographic progression. Trial registration ClinicalTrials.gov, http://clinicaltrials.gov, NCT01695239, EudraCT 2011-002326-49.

ObjectiveTo determine the association between endoplasmic reticulum aminopeptidase (ERAP)1 and ERAP2 single-nucleotide polymorphisms (SNPs) and human leukocyte antigens (HLA)-B27+ or HLA-B15+ patients with spondyloarthritis (SpA).Methods104 patients with SpA according to Assessment of Spondyloarthritis International Society criteria were included in the study. HLA typing was performed by PCR. The polymorphisms were determined by real-time PCR on genomic DNA using customised probes for SNPs rs27044, rs17482078, rs10050860 and rs30187 in ERAP1, and rs2910686, rs2248374 and rs2549782 in ERAP2.Results70 of the104 patients with SpA were HLA-B27+ and 34 were HLA-B15+. The distribution of ERAP1 and ERAP2 SNPs between the HLA-B15+ and HLA-B27+ patients with SpA did not reveal differences. Likewise, no differences in the frequencies of ERAP1 SNP haplotypes and alleles HLA-B15 or HLA-B27 were found. Interestingly, however, the frequencies of three particular haplotypes formed by ERAP2 SNPs rs2549782/rs2248374/rs2910686 varied between HLA-B15+ and HLA-B27+ patients: the ERAP2 SNPs haplotype TGT was more common in HLA-B15+ patients with SpA (OR 2.943, 95% CI 1.264 to 6.585; P=0.009), whereas the ERAP2 SNP haplotypes TGC and CAT were more associated with HLA-B27+ patients with SpA: (OR 4.483, 95% CI 1.524 to 13.187; p=0.003) and (OR 9.014, 95% CI 1.181 to 68.807; p=0.009), respectively.ConclusionAn association was found between HLA-B15+ patients with SpA and haplotype TGT of ERAP2 SNPs. On the other hand, HLA-B27+ patients with SpA were associated with ERAP2 haplotypes TGC and CAT. These associations could be related to the clinical presentation of the disease, specifically with a peripheral or axial predominance, respectively.

ObjectivesTo evaluate construct validity, interpretability, reliability and responsiveness as well as determination of cut-off points for good and poor health within the original English version and the 18 translations of the disease-specific Assessment of Spondyloarthritis international Society Health Index (ASAS HI) in 23 countries worldwide in patients with spondyloarthritis (SpA).MethodsA representative sample of patients with SpA fulfilling the ASAS classification criteria for axial (axSpA) or peripheral SpA was used. The construct validity of the ASAS HI was tested using Spearman correlation with several standard health outcomes for axSpA. Test–retest reliability was assessed by intraclass correlation coefficients (ICCs) in patients with stable disease (interval 4–7 days). In patients who required an escalation of therapy because of high disease activity, responsiveness was tested after 2–24weeks using standardised response mean (SRM).ResultsAmong the 1548 patients, 64.9% were men, with a mean (SD) age 42.0 (13.4) years. Construct validity ranged from low (age: 0.10) to high (Bath AnkylosingSpondylitisFunctioning Index: 0.71). Internal consistency was high (Cronbach’s α of 0.93). The reliability among 578 patients was good (ICC=0.87 (95% CI 0.84 to 0.89)). Responsiveness among 246 patients was moderate-large (SRM=−0.44 for non-steroidal anti-inflammatory drugs, −0.69 for conventional synthetic disease-modifying antirheumatic drug and −0.85 for tumour necrosis factor inhibitor). The smallest detectable change was 3.0. Values ≤5.0 have balanced specificity to distinguish good health as opposed to moderate health, and values ≥12.0 are specific to represent poor health as opposed to moderate health.ConclusionsThe ASAS HI proved to be valid, reliable and responsive. It can be used to evaluate the impact of SpA and its treatment on functioning and health. Furthermore, comparison of disease impact between populations is possible.

Spondyloarthritis is an autoinflammatory rheumatic disease in which arthritis and osteoproliferation lead the patients who suffer from it to chronic disability. This disease is associated with the expression of class I MHC molecule HLA-B27, which tends to be misfolded in the endoplasmic reticulum and, therefore, expressed in aberrant forms. This phenomena lead to endoplasmic reticulum stress, which in time, evokes a whole response to cellular injury. Under these conditions, the molecules involved in restoring cell homeostasis play a key role. Such is the case of the "heat-shock proteins", which usually regulate protein folding, but also have important immunomodulatory functions, as well as some roles in tissue modeling. In this review, we attempt to summarize the involvement of cell stress and heat-shock proteins in the homeostatic disturbances and pathological conditions associated with this disease.

Introduction Les patients avec un diagnostic clinique de spondyloarthrite (SpA) (en incluant le rhumatisme psoriasique – Rhpso) peuvent avoir des symptomes principalement peripheriques ou principalement axiaux. Cependant, des chevauchements entre ces symptomes sont frequents et ils n’existent pas de sous-groupes clairement definis. L’objectif de cette etude a ete d’identifier des groupes des manifestations musculosquelettiques peripheriques selon leur localisation anatomique dans le spectre des SpA (en incluant le Rhpso). Patients et methodes Etude transversale et internationale avec 24 pays participants. Des patients consecutifs avec un diagnostic de SpA axiale (axSpA), SpA peripherique (pSpA), rhumatisme psoriasique (Rhpso), SpA associe a maladie inflammatoire de l’intestin (SpA-MICI), arthrite reactive (ReA) et SpA juvenile ont ete eligibles. Une analyse de cluster pour chaque manifestation peripherique musculosquelettique (affection articulaire peripherique, enthesite et dactylite) a ete realisee en utilisant des donnees sur la localisation anatomique de ces symptomes observes a n’importe quel moment de la maladie. La distribution de ces manifestations peripheriques et les caracteristiques cliniques ont ete comparees entre les differents clusters. Resultats Un total de 4465 patients ont ete inclus. Trois clusters ont ete trouves selon la localisation de l’affection articulaire, nommes « arthrite rare (a) », « principalement membres inferieurs (b) » et « principalement mains (c) ». Les patients du groupe « a » avaient, en comparaison avec les groupes « b » et « c », une prevalence plus importante d’hommes (63,9 % vs 51,3 % vs 41,5 %), de HLA-B27 (79,8 % vs 48,2 % vs 34,8 %) et de diagnostic de axSpA (67,2 % vs 20,9 % vs 23,7 %), mais une prevalence plus basse de psoriasis (23,2 % vs 67,8 % vs 59,6 %) et de diagnostic de Rhpso (17,2 % vs 61,7 % vs 58,5 %). Entre les clusters « b » et « c », l’uveite etait plus frequente chez le premier (15,7 % vs 8,7 %), tandis que la maladie inflammatoire de l’intestin etait plus frequente chez le deuxieme (3,5 % vs 6,7 %). Concernant la localisation de l’enthesite, nous avons trouve aussi 3 clusters, nommes « enthesite du talon (d) », « enthesite axiale (e) » et « polyenthesite (f) ». Les patients du cluster « f » avaient une frequence plus eleve de fibromyalgie concomitante (41,3 % vs 17,4 % vs 31,3 %), de psoriasis (48,3 % vs 28,4 % vs 23,4 %) et de Rhpso (40,8 % vs 22,7 % vs 21,5 %) en comparaison avec les groupes « d » et « e », mais une prevalence moindre d’hommes (40 % vs 61,9 % vs 56,2 %) et de diagnostic d’axSpA (37,5 % vs 61,4 % vs 64,1 %). Finalement, nous avons trouve 3 clusters selon la localisation des dactylites : « absence de dactylite (g) », « principalement orteils (h) » et « principalement doigts (i) ». Le groupe « g » a montre, en comparaison avec les groupes « h » et « i », la plus grande prevalence d’hommes (61,4 % vs 51,4 % vs 52,9 %), de HLA-B27 (66,6 % vs 52,5 % vs 50,0 %) et de diagnostic d’axSpA (62,6 % vs 20 % vs 11,8 %), mais la plus basse frequence de psoriasis (26,9 % vs 68,6 % vs 79,4 %) et de diagnostic de Rhpso (21,5 % vs 65,7 % vs 52,9 %). Conclusion Cette etude suggere la presence de groupes heterogenes d’affection peripherique chez des patients atteints de SpA (et Rhpso) sans groupes clairement definis, ce qui confirme un clair chevauchement entre les differents sous-types de SpA.

Background/objective Peripheral neuropathies (PN) are heterogeneous nerve disorders; frequently rheumatic patients have neuropathic symptoms. In some rheumatic diseases (RD) PN are secondary to nerve compression while others are related to metabolic abnormalities, inflammation or vasculitis. Our aim was to explore the frequency of neuropathic symptoms with three neuropathy questionnaires (NQ) and nerve conduction studies (NCS) in RD. Methods This is a cross-sectional study in patients with any RD attending for the first time to a rheumatology outpatient clinic. We included all patients who accepted to participate and who answered three NQ and received a physical evaluation. Twenty patients were randomly selected to perform NCS and 10 healthy subjects were included as controls. The topographic diagnoses were: mononeuropathy, multiplex mononeuropathy, and/or polyneuropathy. Statistical analysis descriptive statistics (mean, median, standard deviation, interquartile range and frequency, odds ratios and Pearson correlation test). Results One hundred patients and 10 healthy subjects were included. Sixty-nine were female, mean age 40.6 ± 15.7 years. Rheumatic diagnoses were: systemic lupus erythematosus (26%), rheumatoid arthritis (16%), gout (14%), and osteoarthritis (11%). Fifty-two patients had neuropathic signs during physical examination and 67% had positive questionnaires with variable scores among several RD. Abnormal NCS was reported in 14 patients (70%): 6 (42.8%) median nerve mononeuropathies, 4 (28.5%) multiplex mononeuropathies and 4 (28.5%) polyneuropathies. None of the healthy subjects had neuropathy (NQ, physical evaluation, or NCS). Risk of being NCS positive is higher when the patients were NQ positive. Conclusion PN has variable distribution and high frequency in patients with RD; NQ+ increases the risk of presenting NCS+ for PN.

Introduction and objectives There is limited data that characterizes osteoarthritis (OA) patients who experience moderate to severe pain despite analgesic treatment in Mexico. In this study, we estimate the real-world prevalence of inadequate pain relief (IPR) among individuals with knee and/or hip OA who have been prescribed analgesic therapy and characterize this patient population for each country separately. Materials and methods This is a multinational, multi-site, cross-sectional, observational study. Participating physicians enrolled patients over 50 years of age with diagnosed knee and/or hip OA who had been prescribed topical and/or oral pain medication for at least 30 days prior to study visit, extracted data from their medical charts, and collected patient data using established questionnaires. Results 301 patients treated by 35 physicians in Mexico were enrolled in the study. More than half of the patients (53%) met the definition of IPR. Patients with IPR were significantly older (66.8 vs. 63.5 years, p = 0.002) and were more likely to be obese (24.2% vs. 11.9%, p = 0.006). Patients in the IPR group were more likely to report moderate/severe problems across all 5 dimensions of the EQ-5D and reported higher scores, indicating worse outcomes, on all three WOMAC subscales. Patients in the IPR group also reported reduced work productivity and greater treatment dissatisfaction compared to patients without IPR. Discussion and conclusions IPR is highly prevalent among individuals with knee and/or hip OA in Mexico. Patients with IPR experience decreased health-related quality of life HRQoL and work productivity, impaired function, and poor treatment satisfaction. Health care professionals need to be aware of the high prevalence of IPR, work toward improving OA patient management, and facilitate early intervention or changes in drug and other treatment modalities.

Objectives Expression of α4β7 integrin can identify gut-homing immune cells. This study aimed to determine the expression of Toll-like receptor 2 (TLR2) and TLR4 in α4β7-positive leukocytes of patients with axial SpA (axSpA). Methods We analysed the frequencies of α4β7-positive T cells, Tγδ cells and monocytes in 14 patients with axSpA and 14 healthy controls, together with the expression of TLR2 and TLR4 by flow cytometry. Also, the concentration of faecal calprotectin was measured in all patients and controls. Results We found significantly higher percentages of α4β7-positive T (P = 0.026) and Tγδ cells (P = 0.0118) in the patients with axSpA than in controls; these cells showed differential expression of TLR2 and TLR4 when compared with α4β7-negative cells. Such differences were not correlated with disease activity or faecal calprotectin concentration. Conclusion There is an increase in circulating α4β7-positive T and Tγδ cells in patients with axSpA. These cells differentially express TLR2 and TLR4.

Objective.To revise the current juvenile idiopathic arthritis (JIA) International League of Associations for Rheumatology (ILAR) classification criteria with an evidence-based approach, using clinical and routine laboratory measures available worldwide, to identify homogeneous clinical groups and to distinguish those forms of chronic arthritis typically seen only in children from the childhood counterpart of adult diseases.Methods.The overall project consists of 4 steps. This work represents Step 1, a Delphi Web-based consensus and Step 2, an international nominal group technique (NGT) consensus conference for the new provisional Pediatric Rheumatology International Trials Organization JIA classification criteria. A future large data collection of at least 1000 new-onset JIA patients (Step 3) followed by analysis and NGT consensus (Step 4) will provide data for the evidence-based validation of the JIA classification criteria.Results.In Step 1, three Delphi rounds of interactions were implemented to revise the 7 ILAR JIA categories. In Step 2, forty-seven questions with electronic voting were implemented to derive the new proposed criteria. Four disorders were proposed: (a) systemic JIA; (b) rheumatoid factor–positive JIA; (c) enthesitis/spondylitis-related JIA; and (d) early-onset antinuclear antibody–positive JIA. The other forms were gathered under the term “others.” These will be analyzed during the prospective data collection using a list of descriptors to see whether the clustering of some of them could identify homogeneous entities.Conclusion.An international consensus was reached to identify different proposed homogeneous chronic disorders that fall under the historical termJIA. These preliminary criteria will be formally validated with a dedicated project.

Background:Patients with a diagnosis of Spondyloarthritis (SpA) and Psoriatic Arthritis (PsA) may have predominant axial or peripheral symptoms, and the frequency and distribution of these symptoms may determine the clinical diagnosis by the rheumatologist (“clinical clusters”). Clustering analysis represents an unsupervised exploratory analysis which tries to identify homogeneous groups of cases (“statistical clusters”) without prior information about the membership for any of the cases.Objectives:To identify “statistical clusters” of peripheral involvement according to the specific location of these symptoms in the whole spectrum of SpA and PsA (without prior information about the diagnosis of the patients), and to evaluate whether these “statistical clusters” are in agreement with the “clinical clusters”.Methods:Cross-sectional and multicentre study with 24 participating countries. Consecutive patients considered by their treating rheumatologist as suffering from either PsA, axial SpA (axSpA) or peripheral SpA (pSpA) were enrolled. Four different cluster analyses were conducted: the first one using information about the specific location from all the peripheral musculoskeletal manifestations (i.e., peripheral arthritis, enthesitis and dactylitis), and thereafter a cluster analysis for each peripheral manifestation individually. Multiple correspondence analyses and k-means clustering methods were used. Distribution of peripheral manifestations and clinical characteristics were compared across the different clusters.Results:4465 patients were included in the analysis. Two clusters were found with regard to the location of all the peripheral manifestations (Fig. 1). Cluster 1 showed a low prevalence of peripheral manifestations in comparison with cluster 2; however, when peripheral involvement appeared in cluster 1, this was mostly represented by arthritis of hip, knee and ankle, as well as enthesitis of the heel. Patients from cluster 1 showed a higher prevalence of males (63% vs 44%), HLA-B27 positivity (69% vs 38%) and axial involvement (80% vs 52%), as well as more frequent diagnosis of axSpA (66% vs 21%) and more frequently fulfilling the ASAS axSpA criteria (69% vs. 41%). Patients from cluster 2 showed a higher prevalence of psoriasis (63% vs 25%), a more frequent diagnosis of PsA (61% vs 19%), and they fulfilled more frequently the peripheral ASAS (26% vs 11%) and the CASPAR criteria (57% vs 19%).Figure 1.Distribution of the peripheral involvement across clustersThree clusters were found with regard to the location of the peripheral arthritis. Clusters 2 and 3 showed a high prevalence of peripheral joint disease, although this was located more predominantly in the lower limbs in cluster 2, and in the upper limbs in cluster 3. Cluster 1 showed a higher prevalence of males, HLA-B27 positivity, axial involvement, a lower presence of psoriasis, a more frequent diagnosis of axSpA and fulfilling the ASAS axSpA criteria in comparison with clusters 2 and 3, respectively. Clusters 2 and 3 showed a higher prevalence of enthesitis and dactylitis in comparison with cluster 1, a more frequent diagnosis of PsA and fulfillment of the CASPAR criteria.Information about the location of enthesitis exhibited three groups: cluster 1 showed a very low prevalence of enthesitis, while cluster 2 and 3 showed a high prevalence of enthesitis, with a predominant involvement of axial enthesis in cluster 2 and peripheral enthesitis in cluster 3.Finally, the analysis of dactylitis also exhibited three clusters that showed a very low prevalence of dactylitis, predominantly toes and predominantly fingers involvement, respectively.Conclusion:These results suggest the presence of heterogeneous patterns of peripheral involvement in SpA and PsA patients without clearly defined groups, confirming the clear overlap of these peripheral manifestations across the different underlying diagnoses.Acknowledgements:This study was conducted under the umbrella of ASAS with unrestricted grant of Abbvie, Pfizer, Lilly, Novartis, UCB, Janssen and Merck.Disclosure of Interests:None declared

Background:Atherosclerotic cardiovascular diseases (ASCVD), metabolic syndrome and hyperuricemia due to an increment in their incidence world-wide, but information regarding the 10-year estimated risk in gout vs. healthy subjects is scarce.Objectives:To assess baseline the 10-year cardiovascular risk and high-risk status in gout patients compared to healthy controls.Methods:Data from 494 gout paired to controls in a ratio of 1:1 matched with age, sex and body mass index (BMI) and stratified by normal (≤ 24.9 Kg/m2), overweight (25 - 29.9 Kg/m2) and obese (≥30 Kg/m2). Controls were asymptomatic subjects attending a preventive clinic in Mexico City. We used the Framingham Risk Score for Coronary Heart Disease (FRS-CHD) and the 2013 American College of Cardiology/American Heart Association (2013 ACC/AHA). Additionally, high risk status was defined according to pre-defined cutoff points for FRS-CHD (≥ 20%) and ACC/AHA 2013 (≥7.5%).Results:Data from 494 gout and 494 controls. Gout patients were male 97.4%, 47 (SD ± 13) years, mean BMI of 28.4 (SD ± 4.31) Kg/m2. Age, sex, and BMI and subgroups were equilibrated (p=NS). Gout patients had higher 10-year estimated risk vs. controls nevertheless, only FRS-CHD reached statistically significant difference with 9.38 vs. 7.5 ± 5.74 (pConclusion:Normal BMI or overweight Mexican patients with gout may be at higher 10-year estimated cardiovascular risk compared to matched age, gender and BMI healthy controls. Obese gout subjects are at high risk with non-statistical significance scores for FRS-CHD or 2013 ACC/AHA compared to controls.References:[1]Acosta-Cázares B, Escobedo-de la Peña J. High burden of cardiovascular disease risk factors in Mexico: An epidemic of ischemic heart disease that may be on its way?. American Heart Journal. 2010;160:230-6.[2]Sánchez Rodríguez A, Moreno-Del Castillo C, Prado Anaya CA et al. ESTIMATED 10-YEAR CARDIOVASCULAR RISK WITH FRAMINGHAM RISK AND 2013 ACC/AHA IN GOUT AND HEALTHY MEXICAN SUBJECTS: A CASE-CONTROL STUDY WITH A PROPENSITY SCORE-MATCHED ANALYSIS J Clin Rheumatol: 2019;25:S1–S96.[3]Bevis M, Blagojevic-Bucknall M, Mallen C, Hider S, Roddy E. Comorbidity cluster in people with gout: an observational cohort study with linked medial record review. Rheumatology (Oxford). 2018 Apr 17.[4]Andrés M, Bernal JA, Sivera F, Quilis N, Carmona L, Vela P, Pascual E. Cardiovascular risk of patients with gout seen at rheumatology clinics following a structured assessment. Ann Rheum Dis. 2017;76:1263-8.Disclosure of Interests:None declared.

Background:Power Doppler ultrasonography is a sensitive imaging tool to assess synovitis in psoriatic arthritis (PsA).1,2 ULTIMATE (NCT02662985) is the first large, randomised, double-blind placebo-controlled phase IIIb study in PsA, using ultrasound to evaluate early response to secukinumab on synovitis. The use of the standardised and reliable global EULAR-OMERACT composite ultrasound synovitis score at patient level (GLOESS) as the primary endpoint showed the early and significant benefit of secukinumab vs. placebo on synovitis at week 12.3Objectives:To investigate the responsiveness and discriminative validity of GLOESS compared to clinical outcomes on joints at week 12 and report ultrasound and clinical efficacy data up to week 24.Methods:This is a 52-week study with a 12-week double-blind, placebo-controlled period followed by 12-week open-label (OL) and 6-month OL extension. All placebo patients were switched to secukinumab (300 or 150 mg) at week 12.3 Discriminative validity of GLOESS was analysed post-hoc: within-group responsiveness was assessed by comparing its standardised response mean (SRM) to that of core set of ACR response in the initial secukinumab group over 12 and 24 weeks. Mean change from baseline up to week 12 of GLOESS was determined with mixed-effect model repeated measures analysis (MMRM) and from week 12-24 as observed. 24 week efficacy outcomes included ACR responses, HAQ-DI, PASI response and resolution of dactylitis. These outcomes were exploratory and reported either according to non-responder imputation (ACR response), or as observed (HAQ-DI, PASI response and resolution of dactylitis).Results:Of 166 patients enrolled, a total of 155 patients (93%) completed 24 weeks of treatment (secukinumab, 79 patients 95%; placebo, 76 patients 92%). Mean change from baseline to week 24 in GLOESS was similar in the initial secukinumab and placebo-secukinumab groups. A continued improvement in GLOESS was observed in the secukinumab group, with catch-up improvement in the placebo group after switch to active therapy (Figure 1). Both SRM of GLOESS and ACR core components over 12 and 24 weeks were high (Table 1). Similar clinical response rates were reported for clinical joint count, skin, dactylitis and function at week 24 in secukinumab and placebo switchers groups (Table 1).Conclusion:These analyses highlight the responsiveness and high discriminative validity of GLOESS in PsA, resembling that of key clinical PsA manifestations and physical function.References:[1]D’Agostino MA and Coates LC. J Rheumatol. 2019;46:337–9.[2]Uson J, et al. Rheumatol Clin. 2018;14:27–35.[3]D’Agostino MA, et al. Arthritis Rheumatol. 2020;72 (suppl 10).Figure 1.Mean change from baseline in GLOESS by treatment through Week 24Table 1.Responsiveness of GLOESS - analysed by standardised response mean and efficacy outcomes at week 24Standardised response mean(Initial secukinumab)Efficacy of secukinumabWeek0–12(N = 83)Week0–24(N = 83)Responders(%)Secukinumabweek 0–24(N = 83)Placebo switchersweek 12–24(N = 83)GLOESS1.051.06ACR208774Tender joint count1.031.35ACR506449Swollen joint count0.911.18ACR703423Patient global assessment of disease activity1.371.55HAQ-DI*8063Physician global assessment of disease activity1.592.39PASI 75†7259Pain1.321.53PASI 90†6245HAQ-DI score1.321.32Resolutionof dactylitis (LDI=0)6759*HAQ-DI response is defined as an improvement of at least 0.35 score points compared to baseline (change ≤ −0.35)†N value for PASI response in secukinumab and placebo groups are 36 and 33; respectively. PASI response was calculated for patients with BSA ≥ 3 %.BSA, Body Surface Area; LDI, Leeds Dactylitis IndexDisclosure of Interests:Maarten Boers Consultant of: BMS, Novartis, Pfizer, GSK, Philip G Conaghan Speakers bureau: AbbVie, AstraZeneca, BMS, Eli Lilly, Galapagos, Gilead, Novartis and Pfizer, Consultant of: AbbVie, AstraZeneca, BMS, Eli Lilly, Galapagos, Gilead, Novartis and Pfizer, Georg Schett Speakers bureau: AbbVie, BMS, Celgene, Janssen, Eli Lilly, Novartis, Roche and UCB, Peter Mandl Speakers bureau: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Roche and UCB, Grant/research support from: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Roche and UCB, Esperanza Naredo Speakers bureau: AbbVie, Roche, BMS, Pfizer, UCB, Eli Lilly, Novartis, Janssen, and Celgene, Consultant of: AbbVie, Novartis and BMS, Grant/research support from: Eli Lilly, Filip van den Bosch Speakers bureau: AbbVie, Celgene, Janssen, Eli Lilly, Galapagos, Merck, Novartis, Pfizer, and UCB Pharma, Consultant of: AbbVie, Celgene, Janssen, Eli Lilly, Galapagos, Merck, Novartis, Pfizer, and UCB Pharma, Ruben Burgos-Vargas: None declared, Anne-Marie Duggan Employee of: Novartis, Punit Goyanka Employee of: Novartis, Corine Gaillez Shareholder of: Novartis and BMS, Employee of: Novartis, Maria-Antonietta D’Agostino Speakers bureau: Sanofi, Novartis, BMS, Janssen, Celgene, Roche, AbbVie, UCB, and Eli Lilly, Consultant of: Sanofi, Novartis, BMS, Janssen, Celgene, Roche, AbbVie, UCB, and Eli Lilly

Author(s): de Lautour, Hugh; Taylor, William J; Adebajo, Ade; Alten, Rieke; Burgos-Vargas, Ruben; Chapman, Peter; Cimmino, Marco A; da Rocha Castelar Pinheiro, Geraldo; Day, Ric; Harrold, Leslie R; Helliwell, Philip; Janssen, Matthijs; Kerr, Gail; Kavanaugh, Arthur; Khanna, Dinesh; Khanna, Puja P; Lin, Chingtsai; Louthrenoo, Worawit; McCarthy, Geraldine; Vazquez-Mellado, Janitzia; Mikuls, Ted R; Neogi, Tuhina; Ogdie, Alexis; Perez-Ruiz, Fernando; Schlesinger, Naomi; Ralph Schumacher, H; Scire, Carlo A; Singh, Jasvinder A; Sivera, Francisca; Slot, Ole; Stamp, Lisa K; Tausche, Anne-Kathrin; Terkeltaub, Robert; Uhlig, Till; van de Laar, Mart; White, Douglas; Yamanaka, Hisashi; Zeng, Xuejun; Dalbeth, Nicola | Abstract: To establish consensus for potential remission criteria to use in clinical trials of gout.Experts (n = 88) in gout from multiple countries were invited to participate in a web-based questionnaire study. Three rounds of Delphi consensus exercises were conducted using SurveyMonkey, followed by a discrete-choice experiment using 1000Minds software. The exercises focused on identifying domains, definitions for each domain, and the timeframe over which remission should be defined.There were 49 respondents (56% response) to the initial survey, with subsequent response rates ranging from 57% to 90%. Consensus was reached for the inclusion of serum urate (98% agreement), flares (96%), tophi (92%), pain (83%), and patient global assessment of disease activity (93%) as measurement domains in remission criteria. Consensus was also reached for domain definitions, including serum urate (l0.36 mm), pain (l2 on a 10-point scale), and patient global assessment (l2 on a 10-point scale), all of which should be measured at least twice over a set time interval. Consensus was not achieved in the Delphi exercise for the timeframe for remission, with equal responses for 6 months (51%) and 1 year (49%). In the discrete-choice experiment, there was a preference towards 12 months as a timeframe for remission.These consensus exercises have identified domains and provisional definitions for gout remission criteria. Based on the results of these exercises, preliminary remission criteria are proposed with domains of serum urate, acute flares, tophus, pain, and patient global assessment. These preliminary criteria now require testing in clinical data sets.

ObjectivesTo review and update the existing definition of a positive MRI for classification of axial spondyloarthritis (SpA).MethodsThe Assessment in SpondyloArthritis International Society (ASAS) MRI working group conducted a consensus exercise to review the definition of a positive MRI for inclusion in the ASAS classification criteria of axial SpA. Existing definitions and new data relevant to the MRI diagnosis and classification of sacroiliitis and spondylitis in axial SpA, published since the ASAS definition first appeared in print in 2009, were reviewed and discussed. The precise wording of the existing definition was examined in detail and the data and a draft proposal were presented to and voted on by the ASAS membership.ResultsThe clear presence of bone marrow oedema on MRI in subchondral bone is still considered to be the defining observation that determines the presence of active sacroiliitis. Structural damage lesions seen on MRI may contribute to a decision by the observer that inflammatory lesions are genuinely due to SpA but are not required to meet the definition. The existing definition was clarified adding guidelines and images to assist in the application of the definition.ConclusionThe definition of a positive MRI for classification of axial SpA should continue to primarily depend on the imaging features of ‘active sacroiliitis’ until more data are available regarding MRI features of structural damage in the sacroiliac joint and MRI features in the spine and their utility when used for classification purposes.

Introduction La distribution des manifestations peripheriques musculosquelettiques chez tous les sous-types de spondyloarthrite (SpA) et leurs caracteristiques ont ete peu etudiees. De plus, tres peu d’etudes ont evalue la distribution des manifestations peripheriques selon la region geographique. L’objectif de cette etude a ete de comparer la prevalence, les caracteristiques et les traitements des manifestations musculosquelettiques peripheriques chez les patients atteints de tous sous-types possibles de SpA ainsi que leur distribution selon la region geographique. Patients et methodes Etude transversale avec 24 pays participants. Des patients consecutifs avec un diagnostic de SpA axiale (axSpA), SpA peripherique (pSpA), rhumatisme psoriasique (Rhpso), SpA associe a maladie inflammatoire de l’intestin (SpA-MICI), arthrite reactive (ReA) et SpA juvenile etaient eligibles pour l’etude. La prevalence des manifestations peripheriques (affection articulaire peripherique, enthesite, dactylite, tarsite et affection des articulations racines) leur localisation et leur traitement ont ete evalues, ainsi que leur distribution dans les differentes regions du monde. Resultats Un total de 4465 patients (61 % hommes, âge moyenne 45 ans) ont ete inclus appartenant a quatre regions : Amerique Latine (n = 538), Europe et Amerique du Nord (n = 1677), Asie (n = 975), Moyen-Orient et Afrique du Nord (n = 1275). La prevalence des diagnostics etait axSpA (60,9 %), Rhpso (23,1 %), pSpA (9,7 %), SpA-MICI (2,5 %), ReA (1,3 %), et Juv-SpA (1,3 %). Parmi la totalite des patients, 78,3 % avaient eu au moins une manifestation peripherique ; 56,9 % au moins une affection articulaire peripherique, 44,3 % une enthesite, 33,7 % une affection des articulations racines, 15,3 % une dactylite et 7,7 % une tarsite. Les patients d’Amerique Latine avaient la prevalence la plus haute d’affection articulaire peripherique (79,9 %), d’enthesite (68,8 %), de dactylite (25,5 %) et de tarsite (23,6 %), tandis que la prevalence d’affection des articulations des racines des membres etait plus elevee chez les patients d’Asie (57,4 %). L’affection articulaire peripherique etait plus frequente chez les patients avec pSpA (94,7 %) et moins souvent chez les patients avec axSpA (36,0 %). Les patients atteints de Rhpso avaient plus souvent une atteinte polyarticulaire (58,9 %) tandis que les axSpA avaient une atteinte surtout mono-articulaire (20,1 %). L’atteinte des petites articulations des membres superieurs etait plus souvent observee chez les patients avec Rhpso (52,0 %) tandis que l’atteinte des grosses articulations des membres inferieurs etait plus souvent chez les MICI-SpA (55,9 %) et pSpA (51,2 %). Parmi les patients avec atteinte des articulations proximales, la hanche etait surtout observee dans les axSpA (86 %) tandis que l’epaule etait plus frequente au cours du Rhpso (60,9 %). Les patients atteints de axSpA avaient la prevalence la plus basse d’enthesite (40,9 %) et de dactylite (6,0 %) ; cependant, les dactylites etaient plus souvent localises aux pieds au cours de la axSpA et aux mains au cours des ReA et SpA-MICI. Conclusion Cette etude suggere que toutes ces manifestations musculosquelettiques peripheriques peuvent etre trouvees dans tous les sous-types de SpA (en incluant le Rhpso), avec seulement des differences quantitatives. Ces resultats confirment le chevauchement entre les differentes entites et suggerent que la probabilite de trouver ces manifestations depend de la maladie sous-jacente. En plus, ces resultats confirment la grande variabilite dans l’expression de la maladie entre pays.

Background:Ixekizumab has demonstrated efficacy in treating signs and symptoms of patients with non-radiographic axial spondyloarthritis (nr-axSpA).1The Assessment of SpondyloArthritis International Society Health Index (ASAS HI) is a composite measure consisting of 17 dichotomous items to assess overall functioning and health in patients with spondyloarthritis.2Objectives:To assess health outcomes using ASAS HI in patients with nr-axSpA treated with ixekizumab (IXE) for 52 weeks.Methods:COAST-X (NCT02757352) was a 52-week, randomized, double-blind, placebo (PBO)-controlled study enrolling adults with an established diagnosis of axSpA (ASAS classification criteria, but not modified New York criteria for sacroiliitis), had Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥4, back pain score ≥4, inflammation (sacroiliitis on magnetic resonance imaging [MRI] per ASAS criteria) or an elevated C-reactive protein [CRP] level >5 mg/L), and inadequate response or intolerance to nonsteroidal anti-inflammatory drugs. Patients were randomized 1:1:1 to receive PBO or 80 mg IXE every 4 weeks (Q4W) or every 2 weeks (Q2W). Changing background medications or switching to open-label IXE Q2W, or both, was allowed after week 16 at investigator discretion. Change from baseline in ASAS HI (score 0-17 with higher score indicating worse health) was analyzed using logistic regression analysis at Weeks 0, 4, 8, 16, 36, and 52. For the ASAS HI, the smallest detectable change was calculated as 3.0. Patients having an ASAS HI score ≤5 were defined as being in a good health state.3Comparisons between IXE treatments and PBO were made using logistic regression analysis. Non-responder imputation was used for missing data. Patients who switched to open label IXEQ2W were considered non-responders after they switched.Results:At baseline, ASAS HI scores were similar between the three groups (PBO 9.0 ± 3.7; IXE Q4W 8.6 ± 3.4; IXE Q2W 9.6 ± 3.4). Significantly more patients receiving IXE Q4W versus PBO achieved ASAS HI score ≤5 at Week 16 (pFigure.Improvement in ASAS HI scores through Week 52.A: Proportion of patients who achieved an ASAS HI score ≤5 in patients with baseline ASAS HI score >5. B: Proportion of patients who achieved ≥3-point improvement in ASAS HI in patients with baseline ASAS HI score ≥3. ***pConclusion:Ixekizumab improves overall functioning and health in patients with nr-axSpA as assessed by ASAS HI, with significantly more patients achieving good health status.References:[1]Deodhar A, van der Heijde D, Gensler LS, et al.Lancet. 2020; 395(10217):53-64.[2]Kiltz U, van der Heijde D, Boonen A, et al.Ann Rheum Dis. 2015;74(5):830-5.[3]Kiltz U, van der Heijde D, Boonen A, et al.Ann Rheum Dis. 2018;77(9):1311-7.Disclosure of Interests:Uta Kiltz Grant/research support from: AbbVie, Amgen, Biogen, Novartis, Pfizer, Consultant of: AbbVie, Biocad, Eli Lilly and Company, Grünenthal, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Novartis, Pfizer, Roche, UCB, Jessica A. Walsh Grant/research support from: AbbVie, Pfizer, Janssen, Consultant of: AbbVie, Novartis, Eli Lilly and Company, UCB, Ruben Burgos Vargas: None declared, Theresa Hunter Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Rebecca Bolce Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, David Sandoval Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Soyi Liu Leage Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Ann Leung: None declared, Xiaoqi Li Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Emily Blue Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Juergen Braun Grant/research support from: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Eli Lilly and Company, Medac, MSD (Schering Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi- Aventis, and UCB Pharma, Consultant of: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Eli Lilly and Company, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, and UCB Pharma, Speakers bureau: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Eli Lilly and Company, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, and UCB Pharma

Made available in DSpace on 2018-12-11T16:53:21Z (GMT). No. of bitstreams: 0 Previous issue date: 2018-06-01 Recent therapeutic advances in juvenile idiopathic arthritis (JIA) have made remission an achievable goal for most patients. Reaching this target leads to improved outcomes. The objective was to develop recommendations for treating JIA to target. A Steering Committee formulated a set of recommendations based on evidence derived from a systematic literature review. These were subsequently discussed, amended and voted on by an international Task Force of 30 paediatric rheumatologists in a consensus-based, Delphi-like procedure. Although the literature review did not reveal trials that compared a treat-to-target approach with another or no strategy, it provided indirect evidence regarding an optimised approach to therapy that facilitated development of recommendations. The group agreed on six overarching principles and eight recommendations. The main treatment target, which should be based on a shared decision with parents/patients, was defined as remission, with the alternative target of low disease activity. The frequency and timeline of follow-up evaluations to ensure achievement and maintenance of the target depend on JIA category and level of disease activity. Additional recommendations emphasise the importance of ensuring adequate growth and development and avoiding long-term systemic glucocorticoid administration to maintain the target. All items were agreed on by more than 80% of the members of the Task Force. A research agenda was formulated. The Task Force developed recommendations for treating JIA to target, being aware that the evidence is not strong and needs to be expanded by future research. These recommendations can inform various stakeholders about strategies to reach optimal outcomes for JIA. Clinica Pediatrica e Reumatologia Università degli Studi di Genova Istituto di Ricovero e Cura a Carattere Scientifico Istituto Giannina Department of Pediatrics Asklepios Klinik Sankt Augustin Department of Pediatric and Adolescents Medicine University Hospital of Cologne Division od Rheumatology University of Toronto Hospital for Sick Children Division of Rheumatology Cincinnati Children's Hospital Medical Center University of Cincinnati Department of Paediatric Immunology Wilhelmina Children's Hospital University Medical Center Utrecht University of Utrecht Rheumatology Unit Department of General Medicine Royal Children's Hospital Murdoch Children's Research Institute Department of Pediatric Rheumatology King Faisal Specialist Hospital and Research Center Alfaisal University Division of Pediatric Rheumatology Hospital Sant Joan de Déu Universitat de Barcelona Department of Allergology Rheumatology and Clinical Immunology University Medical Center Ljubljana Medical Faculty University of Ljubljana Division of Rheumatology Western University Children's Hospital London Health Sciences Centre Institute of Translational Medicine University of Liverpool Alder Hey Children's NHS Foundation Trust Rheumatology Department Hospital General de México Eduardo Liceaga Pediatric Rheumatology Azienda Ospedaliero Universitaria Meyer Division of Rheumatology Istituto di Ricovero e Cura a Carattere Scientifico Ospedale Pediatrico Bambino Gesù Pediatric Rheumatology and Immunology University of Muenster Department of Pediatrics Nippon Medical School Institute of Clinical Medicine Children's Hospital Helsinki University Hospital Paris-Descartes University IMAGINE Institute RAISE 22 National Reference Centre Necker-Enfants Malades Hospital Assistance Publique Hopitaux de Paris Clinica Pediatrica e Reumatologia Istituto di Ricovero e Cura a Carattere Scientifico Istituto Giannina Gaslini Servicio de Inmunología y Reumatología Hospital de Pediatría Garrahan Reumatologia Pediátrica São Paulo State University (UNESP) Department of Rheumatology ISIC Superspeciality Hospital Sir Ganga Ram Hospital Red Cross War Memorial Children's Hospital University of Cape Town Pediatric Rheumatology Seattle Children's Hospital and Research Center University of Washington Pediatric Rheumatology Unit Department of Pediatrics Meir Medical Center Tel Aviv University Sackler School of Medicine Division of Rheumatology Department of Medicine3 Medical University of Vienna Reumatologia Pediátrica São Paulo State University (UNESP)

Background The ASAS-HI is a new instrument based in the International Classification of Functioning, Disability and Health to assess the impact of axSpA; ASAS-HI has been validated in Mexican patients. Objectives To investigate the status of health in Mexican patients with axSpA using the ASAS-HI Methods This is multicenter, cross-sectional study of 377/423 patients with axSpA (ASAS criteria) referred by 64 rheumatologists with private or institutional practice across the country in a period of six months. Sociodemographic and clinical data were collected at each site and analysed centrally. Results The ASAS imaging arm were fulfilled 87.5% and the clinical by 61.8%; HLA-B27 was positive in 80.1%; 71.6% were males; 51.9% received bDMARDs. Mean ages at onset and diagnoses were 25.8 (9.9) and 32.8 (11.7) years; median age was 41.6 (13.7) years. The correlation between ASAS-HI and BASDAI, BASFI, and EQ-5D was significant. ASAS-HI mean score was 6.4 (4.2); the cut off was six; values below six meant good health, which corresponded to 203 (53.84%) patients. Univariate analysis disclosed significant differences between groups in variables that were significant in the regression models (see below) and in health care coverage, enthesitis, joint counting, glucocorticoids, HLA-B27, sacroiliitis, BASMI, and ASDAS. In the multivariate analysis, two models were associated ASAS-HI: 1) sex, education, comorbidities, joint surgery, and physician global assessment; 2) BASDAI, BASFI, and EQ-5D Conclusions ASAS-HI cut off of six identified good health in 46.15% of patients with axSpA. ASAS-HI correlated with other measures of disease activity, functioning, and quality of life. In multivariate analysis, ASAS-HI associated with those measures as we all as with demographic and clinical variables. References [1] Kiltz U, van der Heijde D, Cieza A, Boonen A, Stucki G, Ustun B, et al. Developing and validating an index for measuring health in patients with ankylosing spondylitis. Rheumatology (Oxford). 2011;50(5):894–8. [2] Kiltz U, van der Heijde D, Boonen A, Bautista-Molano W, Burgos-Vargas R, Chiowchanwisawakit P, et al. Measuring impairments of functioning and health in patients with axial spondyloarthritis by using the ASAS Health Index and the Environmental Item Set: translation and cross-cultural adaptation into 15 languages. RMD Open. 2016;2(2):e000311. Acknowledgements We acknowledge 64 rheumatologists (grupo sacroiliacos) all over the country that participated in the study Disclosure of Interest None declared

Objective To develop a consensus to standardise 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 Espanola de Reumatologia (GRESSER), two methodologists, two linguists from the Real Academia Nacional de Medicina de Espana (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 standardisation, 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.

The Juvenile Arthritis Multidimensional Assessment Report (JAMAR) is a new parent/patient reported outcome measure that enables a thorough assessment of the disease status in children with juvenile idiopathic arthritis (JIA). We report the results of the cross-cultural adaptation and validation of the parent and patient versions of the JAMAR in the Paraguayan Spanish language. The reading comprehension of the questionnaire was tested in 10 JIA parents and patients. Each participating centre was asked to collect demographic, clinical data and the JAMAR in 100 consecutive JIA patients or all consecutive patients seen in a 6-month period and to administer the JAMAR to 100 healthy children and their parents. The statistical validation phase explored descriptive statistics and the psychometric issues of the JAMAR: the 3 Likert assumptions, floor/ceiling effects, internal consistency, Cronbach’s alpha, interscale correlations, and construct validity (convergent and discriminant validity). A total of 51 JIA patients (2% systemic, 27.4% oligoarticular, 37.2% RF negative polyarthritis, 33.4% other categories) and 100 healthy children, were enrolled. The JAMAR components discriminated well healthy subjects from JIA patients. Notably, there was no significant difference between healthy subjects and their affected peers in the school-related problem variable. All JAMAR components revealed good psychometric performances. In conclusion, the Paraguayan Spanish version of the JAMAR is a valid tool for the assessment of children with JIA and is suitable for use both in routine clinical practice and clinical research.

Objectives To determine, through a systematic review and meta-analysis, the prevalence of back pain (BP) and spondyloarthritis (SpA) in the adult general population and explore the heterogeneity between studies in and out Latin America (LATAM). Methods MEDLINE, Embase, BIREME, LILLACS and Web of Science were searched using a strategy combining key words and related database-specific subject terms to identify relevant cross-sectional studies based on COPCORD methodology published since 2006. Included articles were assessed for risk of bias and quality based on the STROBE statement. Prevalence figures for BP and SpA (European Spondyloarthropathy Study Group criteria) were analyzed according to female percentage of sampled individuals, mean age and sample size. A mixed effect model was used to obtain the combined prevalence and a meta-regression to estimate the effects of these variables. Prevalence stratified values were obtained according to its geographical location. Results 44 out of 127 papers in English, Spanish or Portuguese were selected. Of them, 16 contained BP or SpA prevalence data. Estimates for any Spa prevalence ranged from 0,1% to 2%, with an average of 0,3% (95% CI: 0,01%>0,05%). The random-effects pooled prevalence was 0,18% (0,06%>0,36%). The prevalence of BP was 6.54% (3.8%>9.2%) with a pooled value of 5.24% (2.6%>8.7%). In both cases the heterogeneity was significant (p 8.5%, p=0.9); on the contrary, for Spa, for non-LATAM studies, the pooled proportion was significant bigger (prevalence in LATAM 0.05%, 0.01%>0.012%; non-LATAM: 0.35%, 0.09%>0.78%, p=0.03) Conclusions We found significant variations in prevalence across this review. In particular, they related to sample size of BP studies. Similarly, there was a significant variation between LATAM versus other latitudes respect to the prevalence of SpA. The limited number of studies included in this meta-analysis however, prevents clear explanations of the mechanisms underlying these results. Disclosure of Interest None declared

Background Adherence is the extent to which the patient takes their medications and follow the directions prescribed by their doctor. It has two components: compliance (the degree or extent of conformity to the recommendations about day-to-day treatment by the provider with respect to the timing, dosage, and frequency) and persistence (the duration of time from initiation to discontinuation of therapy). The therapeutic alliance is the patient physician relationship that allows the patient to participate actively in their treatment. The reported adherence varies from 43 to 78% in patients with chronic diseases. In gout, the adherence varies from 10 to 46%. Objectives To evaluate the characteristics of adhesion in patients with gout. Methods Patients with gout from the GRESGO cohort were included. Sociodemographic, clinical, and treatment data were collected and the HAQ-DI, EuroQol-5d and a specific questionnaire of adherence and therapeutic alliance were applied. Results The study included 238 patients (97.1% male), whit a mean age of 47.7±12.7 years, educational level 9.2±4.2 years. The adherence index (prescribed doses/doses taken) was 86%. Only 28.6% never stopped treatment. 4.6% took the doses at the correct time. Most frequent causes of suspension were lack of supply (37%) and forgetfulness (30%). Only 5% buy all of their medications, 10% follow the lifestyle changes. 49.6% do not take the medication when they disagree with their doctor. Conclusions Despite having a good adherence index there are discrepancies with the qualitative answers, since more than 70% did not have good persistence and more than 90% did not comply with the schedule. Disclosure of Interest None declared

Objectives To determine the impact of individual and regional variables on the geographic distribution of RD across six Latin-American countries Methods This is a secondary multilevel analysis of cross-sectional data of COPCORD studies that investigated the prevalence of RD in Argentina, Colombia, Ecuador, Mexico, Peru, and Venezuela. Individual factors were sex, age, comorbidities, job status, and Health Assessment Questionnaire (HAQ) score. Contextual level variables were country and subject9s identification as indigenous. RD predictors, including individual and regional variables, particularly indigenous status were identified with logistic regression models. The effect of contextual variables was estimated with median odds ratio9s (OR) estimation. Results Most individuals included in this analysis came from urban areas (82.40%); their mean age was 43.12 years (95% CI 43.01–43.35); and 56.0% were women. Nearly all of them reported >1 comorbidity (94.70%) and 72.19% were economically active. The prevalence of any RD varied from 1.55% in Peru to 26.09% in Argentina. The mean prevalence of Rheumatoid Arthritis (RA) was 1.58 (range 0.64 to 2.47) (table 1). Aside comorbidities, individual level variables associated to any RD were sex (OR: 1.35; 95% CI 1.28–1.43), age (OR: 1.02; 95% CI 1.01 -1.03), and HAQ score (OR: 3.71; 95% CI 3.22–4.28). Crude comparisons showed significant variations among countries (p Conclusions There common factors associated to the prevalence of RD in the region, however, the estimation of its impact varies in significant way across countries and related to the fact of belong to an indigenous group indicating an increase in the estimated ORs. Acknowledgements National Council for Science and Technology (CONACYT);Colegio Mexicano de Reumatologia (Mexico). EsSalud (Peru). Universidad de Cuenca (Ecuador).ASOREUMA (Colombia). Federico Wilhelm Agricola Foundation (Argentina). PDVSA East, SUELOPETROL and Bristol-Myers Laboratory (Venezuela) Disclosure of Interest None declared

Aims: We compared etanercept 50 mg once weekly (ETN50)/methotrexate versus etanercept 25 mg (ETN25)/methotrexate or biologic-free methotrexate after response to ETN50/methotrexate in moderate rheumatoid arthitis patients from central/eastern Europe, Latin America and Asia. Methods: In a 36-week induction phase, methotrexate-resistant patients received ETN50/methotrexate. In a 52-week, double-blind phase, patients who achieved sustained Disease Activity Score in 28 joints low disease activity (LDA) were randomized to ETN50/methotrexate, ETN25/methotrexate or methotrexate. Results: Sustained Disease Activity Score in 28 joints LDA was achieved in 85% at week 36. LDA was achieved in 83, 81 and 50% with ETN50/methotrexate, ETN25/methotrexate and methotrexate and remission in 66, 61 and 31%, respectively, at week 88 (p < 0.0001). Conclusion: Etanercept/methotrexate therapy for 36 weeks effectively induced response in this moderate rheumatoid arthritis subpopulation. Conventional- and reduced-dose etanercept/me...