Milena Gobbo

A model for the development and implementation of a national plan for the optimal management of early spondyloarthritis: the Esperanza Program

Objectives To evaluate the performance of a healthcare programme in early spondyloarthritis (SpA). Methods Based on previous analyses and expectations of a nominal group, the following were set: (1) minimum standards to create early SpA units; (2) standard operating procedures; and (3) eight performance indicators that can be measured in real time using a web-based platform. Results At the end of the evaluation of the programme the expected level of performance was achieved in three of the indicators: ‘referral reliability’ (standard (S) >50%, real value (RV) 92%), ‘accessibility’ (S >90%, RV=91%) and ‘duration of first visit’ (S >50%, RV=53%). The performance in the remaining indicators was inferior: ‘success of referral criteria’ (S >50%, RV=28%), ‘clinical reports issued’ (S >90%, RV=25%), ‘feedback guarantee’ (S >85%, RV=2%), ‘missing data’ (S <10%, RV=24%) and ‘frequency of review’ (S >90%, RV=84%). Explanations for the low performance are provided. Conclusions It is possible to implement a large-scale programme that is measurable.

Validity of the Ankylosing Spondylitis Disease Activity Score (ASDAS) in patients with early spondyloarthritis from the Esperanza programme

Objectives To evaluate the validity of the Ankylosing Spondylitis Disease Activity Score (ASDAS) in early spondyloarthritis (SpA) in comparison with conventional clinical measures of disease activity. Methods Six hundred and seventy-six incident cases of early SpA from the Esperanza programme were included. Patients were categorised into high and low disease activity states based on patient and physician global assessment scores and on the physicians decision to start treatment with a disease-modifying antirheumatic drug or tumour necrosis factor blocker. The discriminant ability of ASDAS-C-reactive protein (CRP) and ASDAS-erythrocyte sedimentation rate (ESR) was tested using standardised mean differences between patients with high and low disease activity. Convergent validity was tested by Pearson correlation between ASDAS versions and other measures of disease activity. Results ASDAS-ESR and ASDAS-CRP showed good correlation with BASDAI (r=0.79 and 0.74, respectively). Both indices correlated well with the patient global assessment (r=0.70 in both indices) and moderately with the physician global score (r=0.46 and 0.47, respectively). CRP and ESR showed poor correlation with patient- and physician-derived measures. ASDAS performed similarly across the global SpA sample, ankylosing spondylitis (AS), non-radiographic axial SpA and peripheral SpA. Conclusions ASDAS performed as a valid activity score even being slightly better than the Bath Ankylosing Spondylitis Disease Activity Index in its ability to discriminate between high and low disease activity in early SpA. ASDAS performed similarly in AS, early forms of SpA, non-radiographic axial SpA and peripheral SpA.

Performance of the Assessment of Spondyloarthritis International Society criteria for the classification of spondyloarthritis in early spondyloarthritis clinics participating in the ESPERANZA programme

OBJECTIVE The objective of this study was to analyse the performance of the Assessment of SpondyloArthritis International Society (ASAS) criteria for the classification of SpA in early SpA clinics. METHODS We used a cross-sectional study of patients referred to early SpA units within the ESPERANZA programme (a Spanish nationwide health management programme designed to provide excellence in diagnosis and care for early SpA). Patients were eligible if they were <45 years of age and had any of the following: (i) a 2-year history of inflammatory back pain; (ii) back or joint pain with psoriasis, anterior uveitis, radiographic sacroiliitis, family history of SpA or positive HLA-B27; or (iii) asymmetric arthritis. We excluded patients for whom imaging (X-rays/MRI) or HLA-B27 results were not available. We analysed the performance (sensitivity and specificity) of different classification criteria sets, taking the rheumatologists opinion as the gold standard. RESULTS The analysis included 775 patients [mean age 33 (s.d. 7) years; 55% men; mean duration of symptoms 11 (s.d. 6) months]; SpA was diagnosed in 538 patients (69.5%). A total of 274 (67.9%) patients with chronic back pain met the ASAS axial criteria, 76 (56.3%) patients with arthritis but not chronic back pain fulfilled the ASAS criteria for peripheral SpA and 350 (65.1%) fulfilled all the ASAS criteria. The sensitivity and specificity of the ASAS criteria set were 65% and 93%, respectively (axial criteria: sensitivity 68%, specificity 95%). The sensitivity and specificity for the ESSG and Amor criteria were 58% and 90% and 59% and 86%, respectively. CONCLUSION Despite performing better than the Amor or ESSG criteria, the ASAS criteria may be limited to detection of early forms, particularly in populations in which MRI is not extensively available or in populations with a low prevalence of HLA-B27.

Uso apropiado de los antiinflamatorios no esteroideos en reumatología: documento de consenso de la Sociedad Española de Reumatología y el Colegio Mexicano de Reumatología

Resumen Objetivos Elaborar recomendaciones para el uso apropiado de AINE en reumatologia. Metodos Se utilizo una metodologia modificada de RAND/UCLA. Se seleccionaron dos grupos de panelistas, uno por el CMR y otro por la SER. A partir de grupos nominales, se obtuvieron propuestas de recomendaciones, que fueron sometidas a la prueba de acuerdo entre los reumatologos de ambas sociedades mediante encuesta Delphi a dos rondas. Del analisis de la segunda ronda Delphi, se extrajeron las recomendaciones finales y posteriormente se reviso el nivel de evidencia y el grado de acuerdo de la recomendacion segun el Centro de Medicina Basada en la Evidencia de Oxford. Finalmente, se efectuo revision sistematica de cinco recomendaciones sin acuerdo. Resultados Se presentan recomendaciones sobre el uso seguro de los AINE en las enfermedades reumaticas, con base en la mejor evidencia disponible, la opinion de expertos, el acuerdo entre reumatologos y la revision de la literatura. La tendencia es disminuir la frecuencia, la duracion y la dosis de AINE en favor de medidas no farmacologicas, analgesicos o farmacos modificadores de los sintomas o del curso de la enfermedad. Ademas, es obligado identificar perfiles de mayor riesgo de toxicidad, en especial gastrointestinal y cardiovascular. Se recomiendan pautas de actuacion y monitorizacion en los diferentes grupos de riesgo y en pacientes con empleo de antiagregantes plaquetarios, anticoagulacion o con terapias concomitantes. El porcentaje de acuerdo es elevado en la mayoria de los casos. Conclusiones Los AINE son medicamentos seguros y eficaces en el tratamiento de las afecciones reumaticas. No obstante, dado su perfil de riesgo, es necesario individualizar su uso.OBJECTIVE To develop guidelines for the appropriate use of NSAIDs in rheumatology. METHODS We used a methodology modified from the one developed by RAND/UCLA. Two groups of panellists were selected, one by the CMR and another by the SER. Recommendations were proposed from nominal groups and the agreement to them was tested among rheumatologists from both societies by a tworound Delphi survey. The analysis of the second Delphi round supported the generation of the final set of recommendations and the assignment of a level of agreement to each of them. Systematic reviews of five recommendations in which the agreement was low or was divided were also carried out. RESULTS Here we present recommendations for the safe use of NSAIDs in rheumatic diseases, based on the best available evidence, expert opinion, the agreement among rheumatologists, and literature review. The trend is to reduce the frequency, duration and dose of NSAIDs in favour of non-pharmacological measures, analgesic drugs or disease modifying drugs. In addition, the recommendations help to identify profiles for increased toxicity, with an emphasis on gastrointestinal and cardiovascular risks. The recommendations deal with the course of action and monitoring in different risk groups and in patients using antiplatelet or anticoagulant drugs. The overall level of agreement is high. CONCLUSIONS The NSAIDs are safe and effective drugs for the treatment of rheumatic diseases. However, it is necessary to individualize its use according to their risk profile.

Se derivan adecuadamente las espondiloartropatías desde primaria a especializada

OBJECTIVE To evaluate the degree of agreement between primary care physicians and rheumatologists when evaluating the referral criteria in patients with suspected early spondyloarthropathy (Spa). MATERIAL AND METHODS Patients with suspected early Spa (according to predefined clinical referral criteria) were sent by primary care physicians to early Spa units (where a rheumatologist evaluated the same criteria and confirmed the diagnosis) through an on-line platform. We assessed the agreement between primary care physicians and rheumatologists regarding the predefined clinical referral criteria among patients with definitive Spa using the kappa index (k). RESULTS Eight hundred and two patients were analysed, 8.31% of whom were incorrectly referred to the rheumatologist. The degree of agreement regarding the predefined clinical referral criteria was poor for inflammatory back pain (k=0,16; 95% confidence interval [95% CI] 0,09-0,23), radiographic sacroiliitis (k=0,31; 95% CI 0,211-0,428), back or joint pain (k=0,21; 95% CI 0,14-0,29); mild for asymmetric arthritis (k=0,51; 95% CI 0,43-0,59), positive HLA B27 (k=0,59; 95% CI 0,52-0,67) and family history (k=0,50; 95% CI 0,415-0,604); and it was good or very good for anterior uveitis (k=0,81; 95% CI 0,68-0,93), inflammatory bowel disease (k=0,87; 95% CI 0,79-0,96) and psoriasis (k=0,73; 95% CI 0,65-0,81),. CONCLUSIONS The degree of agreement between primary care physicians and rheumatologists regarding the predefined clinical referral criteria was variable. Agreement was very poor for variables like inflammatory back pain, which are crucial for the diagnosis of Spa. Training programs for primary care physicians are important in order for them to correctly identify early Spa patients.

Appropriate Use of Non-steroidal Anti-inflammatory Drugs in Rheumatology: Guidelines From the Spanish Society of Rheumatology and the Mexican College of Rheumatology

Abstract Objective To develop guidelines for the appropriate use of NSAIDs in rheumatology. Methods We used a methodology modified from the one developed by RAND/UCLA. Two groups of panellists were selected, one by the CMR and another by the SER. Recommendations were proposed from nominal groups and the agreement to them was tested among rheumatologists from both societies by a 2-round Delphi survey. The analysis of the second Delphi round supported the generation of the final set of recommendations and the assignment of a level of agreement to each of them. Systematic reviews of 5 recommendations in which the agreement was low or was divided were also carried out. Results Here we present recommendations for the safe use of NSAIDs in rheumatic diseases, based on the best available evidence, expert opinion, the agreement among rheumatologists, and literature review. The trend is to reduce the frequency, duration, and dose of NSAIDs in favour of non-pharmacological measures, analgesic drugs, or disease modifying drugs. In addition, the recommendations help to identify profiles for increased toxicity, with an emphasis on gastrointestinal and cardiovascular risks. The recommendations deal with the course of action and monitoring in different risk groups and in patients using antiplatelet or anticoagulant drugs. The overall level of agreement is high. Conclusions The NSAIDs are safe and effective drugs for the treatment of rheumatic diseases. However, it is necessary to individualize its use according to their risk profile.

Fibromyalgia Health Assessment Questionnaire: evaluación de la sensibilidad al cambio

OBJECTIVE To analyze the responsiveness of the Fibromyalgia Health Assessment Questionnaire (FHAQ) in a group of patients with fibromyalgia (FM). METHODS Observational, prospective and longitudinal study related to the project ICAF was taken part in 15 Spanish centers. 232 patients were included and diagnosed of FM: 98.3% were women, the mean age was 47 years old, they were analyzed at a basal visit and 3 months visit, afterwards an appropriated treatment was prescribed. The statistical analysis was performed including: mean comparison, mean standardized response (RME), basal standard media (DE), intraclass correlation coefficient (R), standard error of the mean (EEM), minimal detectable difference (DMD) and percentage change in real. RESULTS The difference in mean comparison of the FHAQ in the baseline visit and the 3 months visit was of 0.098 (95% CI: 0.034–0.16), with a P<.003. Nevertheless the RME was 0.21, a slightly change, the DE=0.57, R=0.81, EEM=0.25, and the DMD=0.69. The percentage change in real was 17% (39 patients). But the sense of the change was positive in 28 cases (less punctuation in the 3 months visit) and negative in other 11 cases (higher punctuation in the 3 months visit). CONCLUSIONS The punctuation in the 3 months visit was significant better than the basal, but the results of this study do not let it to consider that the FHAQ have enough change susceptibility to recommend it in longitudinal studies. The well knowing fact, some patients can become worse with the treatment prescribed would be to the detriment of the FHAQ psychometric value.

Factores motivadores y barreras para implantar una vía clínica de atención precoz de espondiloartritis: estudio cualitativo con médicos de atención primaria

BACKGROUND AND OBJECTIVES Previous to the development of a clinical pathway (CP) for early spondyloarthritis (SpA), a qualitative study was performed to know the attitude of primary care physicians (PCP) with respect to CP implementation. METHODS 5 discussion groups (2 in Madrid, 2 in Barcelona and 1 in Sevilla) and 3 interviews in Bilbao, were performed. PCP with different profiles were included. Groups and interviews were carried out by experts on qualitative methodology. RESULTS PCP know little about CP. Motivations of professionals to work on a SpA CP were: to improve patients care, availability of a specialist consultant, possibility of learning and doing research, remuneration, and professional recognition. Objections to CP implementation were: extra work, excessive bureaucracy, absence of a specialist consultant, computer difficulties, and no remuneration. SpA knowledge by PCP was defective. PCP associated the term «spondylitis» with osteoarthritis, low-back pain, ankylosing spondylitis and psoriatic arthritis. They only referred patients to the rheumatologist to confirm the diagnosis, when patients complained and when treatment was ineffective. CONCLUSIONS For an optimal CP implementation, the following is deemed necessary: 1) a practical, simple program that eases the interaction with the rheumatologist without an increase on the PCP work load; 2) to provide continuous feedback by the specialist and 3) to provide knowledge on SpA to PCP.

THU0421 Influence of clinical, laboratory and image findings on the criteria-based diagnosis and classification of patients in new-onset spondyloarthritis units: Results from the esperanza cohort

Objectives To identify clinical, laboratory, and radiological findings that may increase the probability of making a diagnosis of spondyloarthritis (SpA) by the treating rheumatologist. Additionally, the association of the same variables with the fulfillment of ASAS criteria was analysed. Methods Cross-sectional study of all patients with new-onset SpA included in the participating units within the ESPERANZA program. Selection criteria for Esperanza were: Patients under 45 years of age with at least a two-year history of inflammatory back (IBP) pain; back or joint pain in the presence of psoriasis, anterior uveitis, radiographic sacroiliitis, family history of SpA or positive HLA-B27; or asymmetric arthritis. The dependent variable was the diagnosis by the treating rheumatologist from the SpA Unit and the fulfillment of the ASAS criteria for the second objective. The following were tested as predictive variables: sex, presence of IBP, talalgia, any enthesitis, arthritis, psoriasis, uveitis, inflammatory bowel disease (IBD), and good response to NSAIDs. As laboratory results, elevated CRP and HLA-B27, were also considered; for imaging, we also tested the presence of sacroiliitis on radiography (according to NY criteria) or on magnetic resonance imaging (MRI, according to ASAS definition). The association of these parameters to either a diagnosis of SpA or to the ASAS classification was analyzed by multivariate logistical regression analysis. Results 1179 patients in the ESPERANZA program were eligible for this analysis, among whom lumbar pain was the primary reason for referral (73.3%). The mean age of the population was 33.2±7.1 years with 53.8% men. The mean time from the onset of symptoms was less than one year (11.5±6.5 months). A diagnosis was made by the treating physician in 815 patients, who were then included in the analysis. 74% (603) of these patients were diagnosed with a SpA; additionally 52.6% met the ASAS criteria, peripheral ASAS in 31.3% and full ASAS in 69.7%. All parameters analyzed showed a statistically significant association with a diagnosis of SpA except for the presence of uveitis, IBD, and elevated C-RP levels. The parameters associated with higher odds were radiological sacroiliitis (OR 32.4), IBP (OR 28.9) and the presence of bone edema on MRI (OR 6.6). Similarly, in the classification by ASAS criteria, all parameters were statistically significantly associated except for the presence of IBD and increased acute-phase reactants; the parameters with the largest influence were sacroiliitis on radiograph (OR 60.5) and on MRI (OR 51.7), as well as positive HLA-B27 (OR 12.6). Conclusions The presence of sacroiliitis on image studies is the parameter that most significantly influences both the diagnosis and the classification of patients; this study demonstrates that sacroileitis on MRI plays a very important role in this sense. The presence of IBP is the clinical parameter that most influences the diagnosis of SpA and it has become apparent that HLA-B27 plays a very important role in the classification by ASAS criteria. Disclosure of Interest E. Tomero Grant/Research support from: ESPERANZA PROGRAM has been supported by an unrestricted grant from Pfizer, L. Carmona: None Declared, J. Mulero: None Declared, E. de Miguel: None Declared, M. Gobbo: None Declared, C. Martínez: None Declared

FRI0292 Correlation biomarkers of cartilage and bone turnover with disease activity, ASDAS, function, quality of life, radiology and magnetic resonance imaging in patients with early spondiloarthritis

Objectives To determine the relationship between biomarkers and activity, functional capacity, quality of life and radiology in early SpA.To analyse the influence of sex, HLA B27, psoriasis, osteitis in MRI and involvement pattern on biomarkers[matrix metalloproteinase-3 (MMP-3), high sensitivity C-reactive protein (hsCRP), C Telopéptide (CTX) and D-Pyridoline] in early spondiloarthritis (SpA). Methods A cross-sectional study of baseline visits from 60 patients included in Esperanza program was performed. Patients analyzed were under 45 years old, with onset symptoms within the range of 3 to 24 months.All patients included met the following criteria: a) inflammatory back pain, or b) symmetric arthritis, or c) back pain/articular pain, in addition to at least one of the following: a) psoriasis, b) inflammatory bowel disease, c) anterior uveitis, d) radiographic sacroiliitis, e) family history ofspondylitis, psoriasis, IBD, or AU, f) HLA-B27 positive. Data collected: social/demographic, ESR, CRP, HLA-B27, BASDAI, ASDAS, BASFI, total BASRI and ASQol.MRI of sacroiliac joints (SIJs) was performed on 32 patients and activity was defined according to the ASAS Group definitions for active lesions on MRI. Serum MMP-3 (ELISA), CTX (Cromatogrphic), hsCRP (Nefelometric) and urinary D-pyridoline (QLIA) were measured in all patients. Analysis: Chi square was used to compare rates and U de Mann-Whitney to analyze continuous variables.Pearson correlation coefficient analysis was performed to examine the contribution of differents biomarkers. Results At baseline, atotal of 60 patients diagnosed of early SpA were included: 26 male (43.3%) and 34 female (56.7%),with age 32.4±6.7 years and disease duracion of 12.4±6.8 months. Twenty two percent of patients had tenían axial affectation, 63.6% peripheral, 4.5% mixed and 9% enthesitic pattern. HLA B27 was positive in 32.6% patients.Twenty two patients (68.7%) had active sacroiliitis by MRI. The values (mean ±SD) were: nocturnal pain (cm) 4.5±2.6; BASDAI (cm) 4.3±2.4; ASDAS 2.2±1.1; ESR (ml/h)14.7±14.6; CRP (mg/L) 5.3±9.4; BASFI (cm) 2.7±2.4; total BASRI 0.68±1.2 and ASQol 6.7±5. CTX (0.53 μgr/L vs. 0.24μgr/L; p=0.001) and MMP-3 (44.3 μgr/L vs. 24.7 μgr/L; p=0.001)were significantly higher in male than in female. CTX (r=0.4, p=0.01)and MMP-3 (r=0.5, p=0.01)showed correlation with arthritis.hsCRPshowed a significant correlation with the ESR level (r=0.3, p=0.04). MMP-3 and urinary D-pyridoline demonstrated a trend toward a positive correlation with ESR (r=0.3, p=0.08) and (r=0.2, p=0.08), respectively. hsCRP showed a trend toward a positive correlation with total BASRI (r=0.4, p=0.05) Conclusions In our study, the male sex is associated with higher levels of CTX and MMP-3 in early SpA, which may indicate higher radiographic damage in men. Previous papers found correlation between C Telopéptide and MMP-3 with radiographic damage (1,2). We found significant correlation between CTX and MMP-3 witn arthritis, as a biomarkers reflecting disease activity. References Maksymowych WP.Arthritis Rheum 2007, 56:1846-53. Vosse D. Rheumatology 2008, 47:1219-22. Disclosure of Interest R. Almodovar Grant/Research support from: “Esperanza Program has been supported by an unrestricted grant from Pfizer”, V. Rios: None Declared, S. Ocaña: None Declared, M. L. Casas: None Declared, M. Gobbo: None Declared, P. Zarco: None Declared, X. Juanola: None Declared, R. Mazzucchelli: None Declared, J. Quiros: None Declared