Response to secukinumab on synovitis using Power Doppler ultrasound in psoriatic arthritis: 12-week results from a phase III study, ULTIMATE.

OBJECTIVES: To investigate the dynamics of response of synovitis to IL-17A inhibition with secukinumab in patients with active PsA using Power Doppler ultrasound. METHODS: The randomized, placebo-controlled, Phase III ULTIMATE study enrolled PsA patients with active ultrasound synovitis and clinical synovitis and enthesitis having an inadequate response to conventional DMARDs and naïve to biologic DMARDs. Patients were randomly assigned to receive either weekly subcutaneous secukinumab (300 or 150 mg according to the severity of psoriasis) or placebo followed by 4-weekly dosing thereafter. The primary outcome was the mean change in the ultrasound Global EULAR and OMERACT Synovitis Score (GLOESS) from baseline to week 12. Key secondary endpoints included ACR 20 and 50 responses. RESULTS: Of the 166 patients enrolled, 97% completed 12 weeks of treatment (secukinumab, 99%; placebo, 95%). The primary end point was met, and the adjusted mean change in GLOESS was higher with secukinumab than placebo [-9 (0.9) vs -6 (0.9), difference (95% CI): -3 (-6, -1); one-sided P=0.004] at week 12. The difference in GLOESS between secukinumab and placebo was significant as early as one week after initiation of treatment. All key secondary endpoints were met. No new or unexpected safety findings were reported. CONCLUSION: This unique ultrasound study shows that apart from improving the signs and symptoms of PsA, IL-17A inhibition with secukinumab leads to a rapid and significant reduction of synovitis in PsA patients. TRIAL REGISTRATION: ClinicalTrials.gov; NCT02662985.

Identification of clinical phenotypes of peripheral involvement in patients with spondyloarthritis, including psoriatic arthritis: a cluster analysis in the worldwide ASAS-PerSpA study.

OBJECTIVE: To identify clusters of peripheral involvement according to the specific location of peripheral manifestations (ie, arthritis, enthesitis and dactylitis) in patients with spondyloarthritis (SpA) including psoriatic arthritis (PsA), and to evaluate whether these clusters correspond with the clinical diagnosis of a rheumatologist. METHODS: Cross-sectional study with 24 participating countries. Consecutive patients diagnosed by their rheumatologist as PsA, axial SpA or peripheral SpA were enrolled. Four different cluster analyses were conducted: one using information on the specific location from all the peripheral manifestations, and a cluster analysis for each peripheral manifestation, separately. Multiple correspondence analyses and k-means clustering methods were used. Distribution of peripheral manifestations and clinical characteristics were compared across the different clusters. RESULTS: The different cluster analyses performed in the 4465 patients clearly distinguished a predominantly axial phenotype (cluster 1) and a predominantly peripheral phenotype (cluster 2). In the predominantly axial phenotype, hip involvement and lower limb large joint arthritis, heel enthesitis and lack of dactylitis were more prevalent. In the predominantly peripheral phenotype, different subgroups were distinguished based on the type and location of peripheral involvement: a predominantly involvement of upper versus lower limbs joints, a predominantly axial enthesitis versus peripheral enthesitis, and predominantly finger versus toe involvement in dactylitis. A poor agreement between the clusters and the rheumatologist's diagnosis as well as with the classification criteria was found. CONCLUSION: These results suggest the presence of two main phenotypes (predominantly axial and predominantly peripheral) based on the presence and location of the peripheral manifestations.

Prevalence and distribution of peripheral musculoskeletal manifestations in spondyloarthritis including psoriatic arthritis: results of the worldwide, cross-sectional ASAS-PerSpA study.

OBJECTIVES: To characterise peripheral musculoskeletal involvement in patients with spondyloarthritis (SpA) including psoriatic arthritis (PsA), across the world. METHODS: Cross-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. RESULTS: A 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%). CONCLUSION: These 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.

Consenso ASAS en nomenclatura en español para las espondiloartritis / Assessment of SpondyloArthritis International Society (ASAS) consensus on Spanish nomenclature for spondyloarthritis

OBJETIVO: Desarrollar un documento de consenso para estandarizar los términos, abreviaturas y acrónimos en español empleados en el campo de las espondiloartritis (EspA). MÉTODOS: Se creó un grupo de trabajo internacional compuesto por todos los miembros de Assessment of SpondyloArthritis International Society (ASAS) nativos de habla española, miembros del comité ejecutivo del Grupo para el estudio de la Espondiloartritis de la Sociedad Española de Reumatología (GRESSER), 2 metodólogos, 2 lingüistas de la Real Academia Nacional de Medicina de España (RANM) y 2 pacientes de la Coordinadora Española de Asociaciones de Espondilitis (CEADE). Se realizó una revisión de la literatura de los últimos 15 años (publicaciones, el CIE y CIF, guías, consensos y recomendaciones) para identificar los términos, abreviaturas y acrónimos discrepantes. Mediante un Delphi de 3 rondas y una reunión presencial, se discutieron, seleccionaron y acordaron los términos, abreviaturas y acrónimos a utilizar. Durante todo este proceso se siguieron las recomendaciones de la RANM basadas en el Diccionario panhispánico de términos médicos. RESULTADOS: Se consensuaron 46 términos, abreviaturas y acrónimos. Se aceptó la traducción al español para 6 términos y 6 abreviaturas empleados para nombrar o clasificar la enfermedad y para 6 términos y 4 abreviaturas relacionados con las EspA. Se acordó no traducir 15 acrónimos por estar ya establecidos, pero al mencionarlos, se recomendó seguir esta estructura: tipo de acrónimo en español y acrónimo y forma extensa en inglés. Con respecto a 7 términos o abreviaturas asociados a acrónimos, se acordó traducir solo la forma extensa y se consensuó una traducción. CONCLUSIONES: Con esta estandarización del lenguaje de las EspA se pretende establecer un uso común de la nomenclatura en español para las EspA. Su implementación será muy beneficiosa, evitando malentendidos y consumo de recursos

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

Levels of satisfaction with rheumatoid arthritis treatment and associated alignment between physicians and patients across Latin America.

INTRODUCTION: Discordance (misalignment) regarding treatment satisfaction may exist in real-life clinical practice between patients and their physicians. We aimed to assess physician and patient treatment satisfaction levels and associated degree of misalignment in rheumatoid arthritis (RA). METHOD: A point-in-time, multinational survey of patients and physicians was conducted in Latin America from December 2014 to October 2015. Physician- and patient-reported satisfaction levels with current RA treatment, alignment levels in satisfaction perception, and factors associated with satisfaction misalignment were assessed through bivariate and logistic regression analyses. RESULTS: Participating physicians (N = 114) completed 555 patient record forms (PRFs); 372 patients completed self-complete questionnaires (PSC). A total of 346 physician-patient pairs were analyzed. Physicians reported satisfaction with current disease control in 270/346 (78.0%) PRFs; patients reported such satisfaction in 286/346 (82.7%) PSCs. Physician-patient alignment was observed in 78.6% of pairs. Compared with aligned patients, misaligned patients were younger, more likely to have moderate or severe disease (physician subjectively defined), deteriorating or unstable disease (physician subjectively defined), been exposed to a greater number of advanced therapy lines (biologic or Janus kinase inhibitor), greater current pain, a current acute episode, poorer health, and greater disability and impairment. Misaligned patients were less likely to be in remission. Logistic regression analysis revealed that misaligned patients were more likely to experience greater activity impairment. CONCLUSIONS: High treatment satisfaction and alignment were observed among RA patients and their physicians in Latin America. Misaligned patients were more likely to report more severe disease and were less likely to be in remission. Addressing misalignment may lead to improved RA disease control.Key Points• High treatment satisfaction was observed among RA patients and their treating physicians in Latin America.• One-fifth of physician-patient pairs were misaligned in treatment satisfaction.• Patients misaligned with their physicians reported higher disease activity, lower quality of life, and greater disability than those who were aligned with their physicians.• Understanding and addressing misalignment in treatment satisfaction may improve outcomes in this patient population.

Physician-patient alignment in satisfaction with psoriatic arthritis treatment in Latin America.

INTRODUCTION: Physician-patient misalignment may exist in real-life clinical practice. We aimed to assess physician and patient treatment satisfaction levels and associated degree of misalignment in psoriatic arthritis (PsA). METHOD: Data from a cross-sectional survey of patients and their physicians conducted in Latin America were analyzed. Physician-reported and patient-reported satisfaction levels with current PsA treatment, alignment in satisfaction levels, and factors associated with satisfaction misalignment were assessed through bivariable and multivariable regression analyses. RESULTS: A total of 179 physician-patient pairs were analyzed. Physicians reported satisfaction with current disease control in 87.7% (n = 157) of cases; patients reported satisfaction in 91.1% (n = 163 of cases). A total of 82.1% of physician-patient pairs were aligned. Compared with aligned patients, misaligned patients were older and more likely to have moderate or severe disease, deteriorating or unstable disease, a past hospital procedure, current or past psoriasis symptoms, greater current pain, a current acute episode, poorer health and quality of life, greater impairment, poorer medication compliance, to consider PsA a major daily burden, and to believe that PsA treatments were ineffective. Misaligned patients were less likely to be in remission. Logistic regression analysis revealed that misaligned patients were older, and more likely to consider PsA a major daily burden and PsA treatments as ineffective. CONCLUSIONS: High levels of treatment satisfaction and alignment were observed among PsA patients and their physicians in Latin America. Patients in this study nevertheless experienced a considerable clinical and quality-of-life burden, especially the misaligned patients. Addressing misalignment may lead to improved PsA disease control.Key points• High treatment satisfaction was observed among PsA patients and their treating physicians in Latin America.• Patients experienced a considerable clinical and quality-of-life burden, especially the misaligned patients.• One-fifth of physician-patient pairs were misaligned regarding satisfaction.• Understanding and addressing misalignment may improve outcomes in this patient population.

Assessment of SpondyloArthritis International Society (ASAS) Consensus on Spanish Nomenclature for Spondyloarthritis. / Consenso ASAS en nomenclatura en español para las espondiloartritis.

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.

Long-term safety of sarilumab in rheumatoid arthritis: an integrated analysis with up to 7 years' follow-up.

OBJECTIVE: Sarilumab is a human monoclonal antibody that blocks IL-6 from binding to membrane-bound and soluble IL-6 receptor-α. We assessed the long-term safety of sarilumab in patients from eight clinical trials and their open-label extensions. METHODS: Data were pooled from patients with rheumatoid arthritis who received at least one dose of sarilumab in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs; combination group) or as monotherapy (monotherapy group). Treatment-emergent adverse events (AEs) and AEs and laboratory values of special interest were assessed. RESULTS: 2887 patients received sarilumab in combination with csDMARDs and 471 patients received sarilumab monotherapy, with mean exposure of 2.8 years and 1.7 years, maximum exposure 7.3 and 3.5 years, and cumulative AE observation period of 8188 and 812 patient-years, respectively. Incidence rates per 100 patient-years in the combination and monotherapy groups, respectively, were 9.4 and 6.7 for serious AEs, 3.7 and 1.0 for serious infections, 0.6 and 0.5 for herpes zoster (no cases were disseminated), 0.1 and 0 for gastrointestinal perforations, 0.5 and 0.2 for major adverse cardiovascular events, and 0.7 and 0.6 for malignancy. Absolute neutrophil counts <1000 cells/mm3 were recorded in 13% and 15% of patients, respectively. Neutropenia was not associated with increased risk of infection or serious infection. Analysis by 6-month interval showed no signal for increased rate of any AE over time. CONCLUSION: The long-term safety profile of sarilumab, either in combination with csDMARDs or as monotherapy, remained stable and consistent with the anticipated profile of a molecule that inhibits IL6 signalling.

Long-term safety and efficacy of sarilumab plus methotrexate on disease activity, physical function and radiographic progression: 5 years of sarilumab plus methotrexate treatment.

Objective: In MOBILITY (NCT01061736), sarilumab significantly reduced disease activity, improved physical function and inhibited radiographic progression at week 52 versus placebo in patients with rheumatoid arthritis (RA) and an inadequate response to methotrexate. We report 5-year safety, efficacy and radiographic outcomes of sarilumab from NCT01061736 and the open-label extension (EXTEND; NCT01146652), in which patients received sarilumab 200 mg every 2 weeks (q2w) + methotrexate. Methods: Patients (n=1197) with moderately to severely active RA were initially randomised to placebo, sarilumab 150 mg or sarilumab 200 mg subcutaneously q2w plus weekly methotrexate for 52 weeks. Completers were eligible to enrol in the open-label extension and receive sarilumab 200 mg q2w + methotrexate. Results: Overall, 901 patients entered the open-label extension. The safety profile remained stable over 5-year follow-up and consistent with interleukin-6 receptor blockade. Absolute neutrophil count <1000 cells/mm3 was observed but not associated with increased infection rate. Initial treatment with sarilumab 200 mg + methotrexate was associated with reduced radiographic progression over 5 years versus sarilumab 150 mg + methotrexate or placebo + methotrexate (mean±SE change from baseline in van der Heijde-modified Total Sharp Score: 1.46±0.27, 2.35±0.28 and 3.68±0.27, respectively (p<0.001 for each sarilumab dose versus placebo)). Clinical efficacy was sustained through 5 years according to Disease Activity Score (28-joint count) using C reactive protein, Clinical Disease Activity Index (CDAI) and Health Assessment Questionnaire-Disability Index. The number of patients achieving CDAI ≤2.8 at 5 years was similar among initial randomisation groups (placebo, 76/398 (19%); sarilumab 150 mg, 68/400 (17%); sarilumab 200 mg, 84/399 (21%)). Conclusion: Clinical efficacy, including inhibition of radiographic progression, reduction in disease activity and improvement in physical function, was sustained with sarilumab + methotrexate over 5 years. Safety appeared stable over the 5-year period.

Prevalence of Comorbidities and Risk Factors for Comorbidities in Patients with Spondyloarthritis in Latin America: A Comparative Study with the General Population and Data from the ASAS-COMOSPA Study.

OBJECTIVE: Increased risk of comorbidities has been reported in spondyloarthritis (SpA). The objective of this study was to determine the prevalence and risk of developing comorbidities in patients with SpA in 3 Latin American (LA) countries, and to compare that prevalence with the general population. METHODS: Data were analyzed from 390 patients with SpA enrolled in the Assessment of SpondyloArthritis international Society of Comorbidities in SpA study from Argentina, Colombia, and Mexico. Age- and sex-standardized prevalence (95% CI) was estimated for arterial hypertension (AHT), tuberculosis (TB), and malignancies. Age- and sex-specific data from the general population were obtained from the Cardiovascular Risk Factor Multiple Evaluation in Latin America (CARMELA) study for AHT, the Global TB report, and the GLOBOCAN project for malignancies. Data analyzed for AHT were confined to Colombia and Mexico. The prevalence in patients with SpA was compared with the prevalence in the general population per age- and sex-specific stratum, resulting in standardized risk ratios (SRR). RESULTS: In total, 64% of the patients with SpA were male, with a mean age of 45 years (SD 14.7). The most common comorbidities in the 3 LA countries were AHT (25.3%, 95% CI 21.2-30.0), hypercholesterolemia (21.5%, 95% CI 17.6-26.0), and osteoporosis (9.4%, 95% CI 6.8-12.9). AHT prevalence in Colombia and Mexico was 21.4% (95% CI 15.4-28.9) and was higher than the general population (12.5%, 95% CI 11.4-13.7), resulting in an SRR of 1.5. TB prevalence in the 3 LA countries was 3.3% (95% CI 1.8-5.7), which was significantly higher than in the general population (0.32%), leading to an SRR of 10.3. The prevalence of malignancies was not increased. CONCLUSION: Patients with SpA in LA are at increased risk of AHT and TB in comparison to the general population. While this sample of patients may not be entirely representative of the patient population in each country, a systematic evaluation of these comorbidities in all patients with SpA still may help to monitor these conditions better.

Patient-reported outcomes from a phase III study of baricitinib in patients with conventional synthetic DMARD-refractory rheumatoid arthritis.

OBJECTIVES: To evaluate the effect of baricitinib on patient-reported outcomes (PROs) in patients with active rheumatoid arthritis (RA) and an inadequate response or intolerance to conventional synthetic disease-modifying antirheumatic drugs. METHODS: In this phase III study, patients were randomised 1:1:1 to placebo (N=228), baricitinib 2 mg once daily (QD, N=229) or baricitinib 4 mg QD (N=227). PROs included the Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, measures from patient electronic daily diaries (duration and severity of morning joint stiffness (MJS), Worst Tiredness, Worst Joint Pain), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), SF-36, EuroQol 5-D index scores and visual analogue scales (VAS) and the Work Productivity and Activity Impairment Questionnaire-RA. The primary time point for the study was week 12. Treatment comparisons were assessed with logistic regression for categorical measures and analysis of covariance for continuous variables. RESULTS: Statistically significant improvements were observed for both baricitinib groups versus placebo in HAQ-DI, PtGA, pain, daily diary measures, EuroQoL index scores and SF-36 physical component score at week 12 and for those measures when assessed at week 24. Baricitinib 2 mg and baricitinib 4 mg were statistically significantly improved versus placebo for the EuroQoL VAS and FACIT-F, respectively, at week 24. CONCLUSIONS: Baricitinib 2 or 4 mg provided significant improvement versus placebo in PROs across different domains of RA, including physical function, MJS, fatigue, pain and quality of life. TRIAL REGISTRATION NUMBER: NCT01721057; Results.

Gender differences among patients with primary ankylosing spondylitis and spondylitis associated with psoriasis and inflammatory bowel disease in an iberoamerican spondyloarthritis cohort.

The aim of the study was to compare clinical manifestations, disease activity, functional capacity, spinal mobility, and radiological findings between men and women from a multicenter, multiethnic Ibero-American cohort of patients with Spondyloarthritis (SpA).This observational cross-section study included 1264 consecutive SpA patients who fulfilled the modified New York criteria for ankylosing spondylitis (AS). Demographic, clinical, and radiologic data were evaluated. Categorical data were compared by X or Fisher's exact tests and continuous variables by ANOVA with post-hoc tests.Primary AS was diagnosed in 1072 patients, psoriatic spondylitis in 147, and spondylitis associated to inflammatory bowel disease (IBD) in 45 patients. Overall, male patients were significantly younger, had longer diagnostic delay, lower disease activity, worse spinal mobility, better quality of life, and more severe radiologic damage. Dactylitis and enthesitis, as well as swollen joint count, were significantly more common among women. In primary AS, there was a marked male predominance (76.2%). Among patients with psoriatic spondylitis, male predominance was lower (57.8%), but was also associated with worse spinal mobility and more severe radiologic damage. In the total population, male patients with primary AS referred higher permanent work disability (13.2% vs 6.9%; P < 0.05), although no difference was observed in psoriatic or IBD spondylitis according to the gender.Among Ibero-American SpA patients, there are some differences in clinical and radiological manifestations, men showing more structural damage, whereas women more active disease. These data suggest that the phenotype of SpA differs between genders. This can influence the subsequent diagnostic approach and therapeutic decisions.

Secukinumab: a promising therapeutic option in spondyloarthritis.

Psoriatic arthritis (PsA) is the second most common chronic inflammatory joint disease. Ankylosing spondylitis (AS) is another less common but equally chronic and disabling spondyloarthritis (SpA). Therapeutic agents for the treatment of these diseases have been somewhat lacking as compared with those available for rheumatoid arthritis, which represents a significant challenge for both the treating physician and the pharmaceutical industry. A promising development for our understanding of the physiopathology of PsA and AS involves new targets to interrupt IL-17 and IL-12/IL-23 pathways. Up to 30-40 % of SpA patients have inadequate or poor response, or are intolerant to anti-TNF therapies. Therefore, there has been a clear unmet medical need in an important group of these patients. As a result, new therapeutic targets have emerged for the treatment of both axial and peripheral SpA. Interleukin 17 (IL-17) is a pro-inflammatory cytokine that is increased in psoriatic lesions as well as in the synovial fluid of patients with PsA and in sites of enthesitis in SpA. IL-23 has been shown to play an important role in the polarization of CD4+ T-cells to become IL-17 producers. Based on these evidences, blockade of the cytokine IL-17 or its receptors was considered to have therapeutic implications for the treatment of psoriasis, as well as PsA and AS.This article presents a thorough review of an IL-17 A blocking agent, its mechanism of action, its clinical efficacy and its therapeutic safety.

Rheumatic manifestations in inflammatory bowel diseases: a link between GI and rheumatology.

Musculoskeletal symptoms are the most frequent extra-intestinal manifestations of inflammatory bowel disease (IBD), ranging between 10 and 40 % of cases. Pathogenesis is still unclear, although several factors have been associated (genetic, environmental, and immunologic pathways). Rheumatic manifestations in IBD patients are heterogeneous, including axial and peripheral involvement, dactylitis, enthesitis, uveitis, as well as skin involvement. Currently, magnetic resonance imaging and ultrasonography are important tools for detecting early pathological changes in IBD patients with suspected rheumatic disease. New advances into the genetics and pathophysiology have provided more effective and targeted therapy for IBD patients with rheumatic manifestations. Given the high prevalence, awareness of the musculoskeletal symptoms is essential to avoid a misdiagnosis. Finally, an interdisciplinary approach of IBD patients, including rheumatologist and gastroenterologist, will improve the quality of life these patients.

Prevalence of comorbidities and evaluation of their screening in spondyloarthritis: results of the international cross-sectional ASAS-COMOSPA study.

BACKGROUND: Increased risk of some comorbidities has been reported in spondyloarthritis (SpA). Recommendations for detection/management of some of these comorbidities have been proposed, and it is known that a gap exists between these and their implementation in practice. OBJECTIVE: To evaluate (1) the prevalence of comorbidities and risk factors in different countries worldwide, (2) the gap between available recommendations and daily practice for management of these comorbidities and (3) the prevalence of previously unknown risk factors detected as a result of the present initiative. METHODS: Cross-sectional international study with 22 participating countries (from four continents), including 3984 patients with SpA according to the rheumatologist. STATISTICAL ANALYSIS: The prevalence of comorbidities (cardiovascular, infection, cancer, osteoporosis and gastrointestinal) and risk factors; percentage of patients optimally monitored for comorbidities according to available recommendations and percentage of patients for whom a risk factor was detected due to this study. RESULTS: The most frequent comorbidities were osteoporosis (13%) and gastroduodenal ulcer (11%). The most frequent risk factors were hypertension (34%), smoking (29%) and hypercholesterolaemia (27%). Substantial intercountry variability was observed for screening of comorbidities (eg, for LDL cholesterol measurement: from 8% (Taiwan) to 98% (Germany)). Systematic evaluation (eg, blood pressure (BP), cholesterol) during this study unveiled previously unknown risk factors (eg, elevated BP (14%)), emphasising the suboptimal monitoring of comorbidities. CONCLUSIONS: A high prevalence of comorbidities in SpA has been shown. Rigorous application of systematic evaluation of comorbidities may permit earlier detection, which may ultimately result in an improved outcome of patients with SpA.

Clinical and immunogenetic characterization in psoriatic arthritis patients.

In psoriatic arthritis (PsA), genetic factors play a substantial role in disease susceptibility as well as in its expression. This study aims to determine the distribution of class I and class II HLA antigens in PsA patients and secondly to analyze the influence of genetic factors in the clinical expression of the disease. Consecutive PsA patients (CASPAR criteria) with less than 1 year of disease duration were included. Sociodemographic and clinical data were recorded. Blood samples were obtained, DNA was extracted by polymerase chain reaction (PCR), and class I (A, B, and C) and class II (DR) HLA antigens were determined by oligotyping. A control group of 100 nonrelated healthy controls from the general population served as control. p values were corrected (pc) according to the number of alleles tested. A total of 73 patients were included, 37 were females (50.7 %) with a median disease duration of 72 months (interquartile range (IQR) 24-149). Thirty-three patients (45.2 %) had a family history of psoriasis. When analyzing all the class I and class II HLA antigens, a significantly higher frequency of B38 (odds ratio (OR) 2.95, p = 0.03) and Cw6 (OR 2.78, p = 0.009) was found in PsA patients compared to the control group. On the contrary, the HLA-A11 (OR 0.14, p = 0.04) and B7 (OR 0.31, p = 0.03) were significantly more frequent among healthy controls. Furthermore, B18 was significantly more frequent in patients with early arthritis onset (less than 40 years): seven patients (22.6 %) with early onset compared to two patients (4.8 %) with late onset (p = 0.03). No association between HLA-B27 and spondylitis or HLA-DR4 with polyarticular involvement was observed. The HLA-B38 and Cw6 alleles are associated with a greater PsA susceptibility in Argentine population.

Fatigue assessment and its impact in the quality of life of patients with ankylosing spondylitis.

The most frequently reported symptoms by patients with ankylosing spondylitis (AS) are pain, stiffness, and fatigue. Previous studies have estimated a 63% prevalence of fatigue in AS, with a low correlation of fatigue with pain and functional capacity. The objective of this study is to assess fatigue prevalence in AS patients and establish the main associated factors. A case-control study including AS patients according to New York modified criteria was carried out. The control group included individuals of the general population without rheumatic conditions, matched by gender, age, and socioeconomic level. Disease-related variables were recorded. Functional capacity, disease activity, and quality of life were assessed using Bath Ankylosing Spondylitis Funcional Index (BASFI), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and ankylosing spondylitis quality of life (ASQoL). CES-D questionnaire was used to evaluate depression and fatigue severity scale (FSS) to evaluate fatigue. Sixty-four consecutive AS patients and 95 controls were included. Patients' median age was 44 years (interquartile range (IQR), 33.25-53), 89.1% were male, and had a median disease duration of 17 years (IQR, 10.3-25). Fatigue prevalence in AS was 73.4% compared to 30.5% in the control group (p < 0.001; OR, 2.08 (95% CI, 1.53-2.83)). Furthermore, fatigue in AS correlated with ASQoL (r = 0.65), BASFI (r = 0.52), BASDAI (r = 0.52), and depression (r = 0.51), whereas no correlation with age or disease duration was found. In the linear regression analysis using fatigue as the dependent variable, depression was the only associated variable (p = 0.01). No association with age, gender, disease duration, BASDAI, BASFI, or presence of comorbidities was found. Finally, BASDAI fatigue question correlated with the FSS (r = 0.55). Fatigue was significantly more prevalent in AS than in healthy controls. The main determinant factor of fatigue was the presence of depression, explaining 30% of its variability. Recognizing these factors could have important therapeutic implications.

Prevalence of psoriatic arthritis in psoriasis patients according to newer classification criteria.

The aim of this study is to determine the prevalence of psoriatic arthritis (PsA) according to CASPAR criteria, ASAS peripheral and axial SpA criteria, and New York criteria for AS. The first 100 patients consecutively attending a psoriasis dermatology clinic were assessed. Demographic and clinical data were collected; all patients were questioned and examined for joint manifestations. Rheumatoid factor and radiographies of hands, feet, cervical spine, and pelvis for sacroiliac joints were obtained. X-rays were read independently by two experienced observers in blind fashion. Patients with objective joint manifestations, both axial and peripheral, were evaluated for fulfillment of CASPAR, ASAS peripheral and axial, and New York criteria. Median age 48 years; 93 % of patients had psoriasis vulgaris and 56 % nail involvement. Seventeen patients had peripheral arthritis as follows: nine mono/oligoarticular and eight polyarthritis. Median arthritis duration was 8 years. Seventeen percent of patients fulfilled CASPAR and ASAS peripheral criteria, 6 % New York, and 5 % ASAS axial criteria. Patients who met CASPAR criteria showed a significantly higher psoriasis duration compared to those without arthritis (M 16 vs. 10 years, p = 0.02), and a higher frequency of nail involvement (88.2 vs. 49.4 %, p = 0.003). Five patients (29.4 %) fulfilled ASAS axial criteria; all of them had peripheral involvement as follows: mono/oligoarticular in three patients and polyarticular in two. Patients with peripheral and axial involvement presented a significantly higher frequency of erythrodermic psoriasis compared to the other patients (35.3 vs. 1.2 %, p = 0.0006 and 80 vs. 16.7 %, p = 0.02). Prevalence of PsA, for CASPAR and ASAS peripheral criteria, was of 17 %. Five percent of patients met ASAS axial criteria, while 6 % met New York criteria. Worth noting, few patients without signs or symptoms of arthritis had radiological changes, both axial and peripheral, precluding a proper classification.

Adherence to treatment in patients with ankylosing spondylitis.

This study aims to determine the level of adherence to treatment in ankylosing spondylitis (AS) patients and to identify possible factors associated to lack of adherence. We included consecutive AS patients (NY modified criteria). Sociodemographic and clinical data were collected. Patients answered auto-reported questionnaires: Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Functional Index, Ankylosing Spondylitis Quality of Life, and Center for Epidemiological Studies Depression scale. Patients with rheumatoid arthritis (RA) (ACR'87 criteria) were assessed as the control group. The adherence of the studied groups to medical treatment and exercises was measured by means of two questionnaires: Compliance Questionnaire on Rheumatology (CQR) and Exercise Attitude Questionnaire-18 (EAQ-18). The study included 59 patients with AS and 53 patients with RA. Of the AS patients, 43 (72.9%) were male, median age 47 years (interquartile range (IQR) 33-57) and median disease duration of 120 months (IQR 33-57). Of the RA patients, 37 (69.8%) were female, had a median age of 56 years (IQR 43.5-60) and a median disease duration of 156 months (IQR 96-288). There were no significant differences in the results of the adherence questionnaires between both groups, with a total median of 68.42 for the CQR in both groups and of 40.7 in AS vs. 42.6 in RA for the EAQ. When dichotomizing patients as adherent and non-adherent, taking as good adherence a cut value in the CQR and EAQ higher than 60, adherence to pharmacological treatment was significantly higher in RA vs. AS (92.5 vs. 74.6%, p = 0.01) and there were no differences in the EAQ. On the uni- and multivariate analysis, lack of adherence to treatment was not associated to sex, age, disease duration, education, health insurance, depressive status, and disease activity parameters in neither group of patients. AS have an acceptable adherence to pharmacological treatment, although it is lower than RA patients; nonetheless, both groups show a lack of adherence to exercise.

Adherencia al tratamiento de pacientes con artritis reumatoidea que reciben medicamentos biológicos / Treatment adherence in patients with rheumatoid arthritis receiving biologics

Introducción: Al igual que en otras enfermedades crónicas, la adherencia al régimen terapéutico de los pacientes con artritis reumatoidea (AR) es baja (entre 30 y 80%), dependiendo de la definición de adherencia y de la metodología empleada para medirla. En este estudio se propone determinar el nivel de adherencia al tratamiento en pacientes con AR que reciben DMAR biológicas e identificar factores asociados a la falta de cumplimiento a la terapia. Material y métodos: Se realizó un estudio analítico, observacional de corte transversal en donde se incluyeron pacientes consecutivos con AR según criterios de clasificación (ACR’87) que se encontraban recibiendo fármacos biológicos para el tratamiento de su enfermedad en los últimos seis meses y que asistieron a la consulta ambulatoria. Para la valoración de la adherencia a DMAR se utilizaron los cuestionarios CQR (Compliance Questionnaire on Rheumatology) y el cuestionario SMAQ (Simplified Medication Adherence Questionnaire). Resultados: Se encuestaron 345 pacientes. Mediante el cuestionario SMAQ se observó una adherencia del 50% (159 pacientes). El Cuestionario CQR tuvo un puntaje mediano de 78 puntos (RIC 67-86). El 47% (147 pacientes) fueron adherentes (CQR >80). Sobre los pacientes incluidos, 151 (48%) refirieron no haber tenido ningún retraso, pérdida o adelanto de la dosis del biológico en los últimos 6 meses de tratamiento. El 52% no adherentes tuvo como causas: 146 (46%) pérdida de al menos una dosis del biológico con una mediana de dosis perdidas de 2 (RIQ: 1-3); 117 (37%) tuvo al menos un retraso en las dosis del biológico y 8 (2%) delantó la dosis. Los factores asociados al no cumplimiento de la terapia biológica fueron el tipo de cobertura médica, que el paciente no haya notado mejoría y la esperanza de una rápida respuesta al tratamiento, y la falta de adherencia a DMAR

Introduction: As in other chronic diseases, adherence to the therapeutic regimen of patients with rheumatoid arthritis (RA) is low (between 30 and 80%), depending on the definition of adherence and the methodology used to measure it. This study aims to determine the level of adherence to treatment in patients with RA who receive biological DMARs and to identify factors associated with non-compliance with therapy. MATERIAL AND METHODS: An observational, cross-sectional, observational study was performed in which consecutive patients with RA according to classification criteria (ACR'87) who were receiving biological drugs for the treatment of their disease in the last six months were included Attended the outpatient appointment. The CQR (Compliance Questionnaire on Rheumatology) and SMAQ (Simplified Medication Adherence Questionnaire) questionnaires were used to assess adherence to DMAR. Results: A total of 345 patients were surveyed. A 50% adherence (159 patients) was observed through the SMAQ questionnaire. The CQR Questionnaire had a median score of 78 points (RIC 67-86). 47% (147 patients) were adherent (CQR> 80). Regarding the patients included, 151 (48%) reported not having had any delay, loss or advancement of the biological dose in the last 6 months of treatment. The 52% of non-adherents had as causes: 146 (46%) loss of at least one dose of the biological with a median of doses lost of 2 (RIQ: 1-3); 117 (37%) had at least one biological dose delay and 8 (2%) delayed the dose. Factors associated with non-compliance with biological therapy were the type of medical coverage, the patient's perceived improvement and the expectation of a rapid response to treatment, and lack of adherence to DMAR.