Quantification of bone marrow edema by MRI of the sacroiliac joints in patients diagnosed with axial spondyloarthritis: results from the ESPeranza cohort.

OBJECTIVE: To evaluate whether the quantification of bone marrow edema (BMO) of the sacroiliac (SI) joints by magnetic resonance imaging (MRI) improves capacity for axial spondyloarthritis (axSpA) classification in comparison with the assessment of sacroiliitis by Assessment of SpondyloArthritis international Society (ASAS) classification criteria. METHOD: This prospective study from the ESPeranza cohort involved 66 subjects with an available MRI of the SI joints at baseline. This subgroup includes patients with axSpA (n = 28), peripheral spondyloarthritis (n = 10), and other diagnoses that were not spondyloarthritis (n = 28). Measures of diagnostic usefulness [area under the curve (AUC), sensitivity, specificity, Youden's J statistic, positive and negative likelihood ratios (LR+ and LR-)] were calculated for MRI of the SI joints according to ASAS criteria and for MRI quantified by means of SCAISS (Spanish tool for semi-automatic quantification of sacroiliac inflammation by MRI in spondyloarthritis). This analysis was stratified in patients who were human leucocyte antigen (HLA)-B27 positive and negative. RESULTS: The AUC value with BMO quantification was 0.919 [95% confidence interval (CI) 0.799-1] for HLA-B27-positive patients and 0.884 (95% CI 0.764-1) for HLA-B27-negative patients. A SCAISS cut-off point of 80 units obtained a specificity of 94.4% and LR+ 7.5, while assessment by ASAS criteria showed a specificity value of 90% and LR+ 6.4. CONCLUSION: For patients with suspected axSpA, quantification of BMO improves the predictive capacity of MRI of the SI joints, for both HLA-B27-positive and HLA-B27-negative patients. Axial spondyloarthritis (axSpA) has a dramatic impact on physical function and quality of life (1). Despite its significant impact, patients with axSpA are normally diagnosed several years after presenting symptoms (2). In this respect, magnetic resonance imaging (MRI) of the sacroiliac (SI) joints has gained significance over the past decade, particularly in the early stages of the disease. Nowadays, imaging tests and human leucocyte antigen (HLA)-B27 testing are among the most important diagnostic procedures for patients with suspected axSpA.

Tofacitinib in psoriatic arthritis patients: skin signs and symptoms and health-related quality of life from two randomized phase 3 studies.

BACKGROUND: Psoriatic arthritis (PsA) is a chronic, systemic immune-mediated inflammatory musculoskeletal disease. The onset of dermatologic symptoms often precedes rheumatic manifestations. Tofacitinib is an oral Janus kinase inhibitor for the treatment of PsA that has been shown to improve dermatologic symptoms in patients with PsA. OBJECTIVES: To investigate the efficacy of tofacitinib in improving dermatologic endpoints in adult patients with active PsA. METHODS: This analysis included data from two placebo-controlled, double-blind, phase 3 studies in patients with active PsA and an inadequate response (IR) to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD) who were tumor necrosis factor inhibitor (TNFi)-naïve (OPAL Broaden; NCT01877668) or an IR to ≥1 TNFi (OPAL Beyond; NCT01882439). Patients had active plaque psoriasis at screening and received a stable dose of one csDMARD during the study. Patients were randomized to tofacitinib 5 mg twice daily (BID), 10 mg BID, adalimumab 40 mg subcutaneous injection once every 2 weeks (OPAL Broaden only) or placebo (to Month 3). Dermatologic endpoints: Psoriasis Area and Severity Index (PASI) total score; PASI90 overall; PASI75 and PASI90 by baseline PASI severity; Physician's Global Assessment of Psoriasis; Nail Psoriasis Severity Index; Dermatology Life Quality Index total and sub-dimension scores; Itch Severity Item; and Patient's Global Joint and Skin Assessment-Visual Analog Scale-Psoriasis question. RESULTS: In patients with active PsA, including those stratified by mild or moderate/severe dermatologic symptoms, greater improvements from baseline and percentage of responders were observed in tofacitinib-treated patients vs. placebo for the majority of analyzed dermatologic endpoints at Months 1 and 3, and improvements were maintained to Month 12 in OPAL Broaden and Month 6 in OPAL Beyond. Similar effects were observed in adalimumab-treated patients vs. placebo in OPAL Broaden across dermatologic endpoints. CONCLUSIONS: Tofacitinib provides a treatment option for patients with active PsA, including the burdensome dermatologic symptoms of PsA.

Differential involvement of synovial adipokines in pain and physical function in female patients with knee osteoarthritis. A cross-sectional study.

OBJECTIVE: Adipokines have been reported to play a role in the development, progression and severity of knee osteoarthritis but the influence of the different adipokines are not well known. The aim of this study was to evaluate the association between different synovial fluid adipokines with pain and disability knee osteoarthritis patients. METHODS: Cross-sectional study with systematic inclusion of 115 symptomatic primary knee osteoarthritis female patients with ultrasound-confirmed joint effusion. Age, physical exercise, symptoms duration and different anthropometric measurements were collected. Radiographic severity was evaluated according to Kellgren-Lawrence scale. Pain and disability were assessed by WOMAC-total, -pain, -function subscales and Knee injury and Osteoarthritis Outcome Score (KOOS) pain and function scales. Seven adipokines and three inflammatory markers were measured by ELISA in synovial fluid. Partial Correlation Coefficient (PCC) and corresponding 95% confidence interval were used as a measure of association. RESULTS: Leptin, osteopontin and inflammatory factors, especially TNF-alpha, were associated to pain and function. After adjustment for potential confounders including inflammatory factors and all adipokines, an association was found for adiponectin with pain (PCC 0.240 [0.012, 0.444]) and for resistin and visfatin with function (PCC 0.336 [0.117, 0.524] and -0.262 [-0.463, -0.036]). No other adipokines or inflammatory markers were statistically and independently associated. An association between physical exercise and pain and disability remained after adjustment, whereas an attenuation of the influence of anthropometric measurements was observed. CONCLUSIONS: Different patterns of association between synovial fluid adipokines were observed regarding pain and disability in knee osteoarthritis patients. Specifically, adiponectin was associated to pain while resistin and visfatin were mainly related to function.

Promoting patient-centred care in psoriatic arthritis: a multidisciplinary European perspective on improving the patient experience.

Patients with psoriatic arthritis (PsA) may not be optimally treated. The impact of the disease extends beyond skin and joint symptoms, impairing quality of life. This indicates that the adoption of a patient-focused approach to PsA management is necessary. An expert multidisciplinary working group was convened, with the objective of developing an informed perspective on current best practice and needs for the future management of PsA. Topics of discussion included the barriers to current best practice and calls to action for the improvement of three areas in PsA management: early and accurate diagnosis of PsA, management of disease progression and management of the impact of the condition on the patient. The working group agreed that, to make best use of the available of diagnostic tools, clinical care recommendations and effective treatments, there is a clear need for healthcare professionals from different disciplines to collaborate in the management of PsA. By facilitating appropriate and rapid referral, providing high quality information about PsA and its treatment to patients, and actively involving patients when choosing management plans and setting treatment goals, management of PsA can be improved. The perspective of the working group is presented here, with recommendations for the adoption of a multidisciplinary, patient-focused approach to the management of PsA.

High prevalence of cardiovascular co-morbidities in patients with symptomatic knee or hand osteoarthritis.

OBJECTIVES: To evaluate the frequency of cardiovascular events (CVEs) and metabolic syndrome (MetS) in patients with symptomatic knee or hand osteoarthritis (OA). METHOD: A cross-sectional study conducted by rheumatologists in a primary care setting. Consecutive symptomatic patients with primary knee or hand OA were included and patients with soft tissue conditions served as the control group. Hypertension, diabetes mellitus, obesity, dyslipidaemia, and CVEs consisting of myocardial infarction, angina, or cerebrovascular disease were recorded. RESULTS: A total of 254 OA patients (184 with knee OA and 70 with hand OA) and 254 control patients were included. The frequency of obesity was higher in all OA groups and hypertension was more frequent in knee OA. MetS was significantly more frequent in patients with OA as a whole group and in knee or hand OA groups separately (p < 0.001, p = 0.002, and p = 0.007, respectively, vs. control group), with odds ratio (OR) 2.4, 95% confidence interval (CI) 1.26-4.55 in the OA group, OR 2.29, 95% CI 1.15-4.54 in the knee OA group, and OR 2.67, 95% CI 1.15-6.19 in the hand OA group. A higher prevalence of CVEs in the three OA groups was observed compared with the control group. CONCLUSIONS: A high frequency of MetS and CVEs was observed in OA patients in a primary care setting.

Experiencia de 4 años de funcionamiento de una unidad multidisciplinar de psoriasis y artritis psoriásica / Multidisciplinary Psoriasis and Psoriactic Arthritis Unit: Report of 4 years’ Experience

INTRODUCCIÓN Y OBJETIVOS: La afectación articular en los pacientes con psoriasis puede llegar hasta el 30%. El diagnóstico y tratamiento precoz de la artropatía puede influenciar su evolución. El objetivo de nuestro trabajo es describir la experiencia de la unidad multidisciplinar de psoriasis y artritis psoriásica de nuestro hospital en el periodo 2009-2012. MATERIAL Y MÉTODOS: Elaboración de un programa asistencial y docente. En una primera fase se consensuaron los criterios de derivación a la futura unidad y se realizaron varias reuniones conjuntas para formar y concienciar a los especialistas. En una segunda fase se estableció una agenda de visitas conjunta psoriasis-reumato-dermato (PSORD) con periodicidad mensual. A partir de 2011 se desarrolló un programa formativo abierto a dermatólogos y reumatólogos interesados en crear un modelo de colaboración similar. RESULTADOS: Durante el periodo revisado se han efectuado 259 visitas (71% primeras, 8% no presentados) con una media de 8 (2-14) visitas por sesión. El 63% de visitas eran derivaciones de reumatología. En un 32% de casos hubo algún cambio en el diagnóstico y en un 47% cambios en el tratamiento. También se han hecho 3 cursos con participación de 15 médicos de 6 hospitales, y en 3 de ellos se han creado unidades parecidas. CONCLUSIONES: Este modelo ha comportado una mejora en el manejo de los pacientes que presentan problemas diagnósticos y/o de control de la enfermedad. También ha aumentado el diagnóstico precoz de la artritis y ha permitido indicar un tratamiento precoz. Además ha aumentado la colaboración entre ambas especialidades y el modelo creado se ha podido exportar a otros hospitales

INTRODUCTION AND OBJECTIVES: Up to 30% of patients with psoriasis develop joint disease, the course of which can be improved by early diagnosis and treatment. The aim of this study was to describe our experience with a new multidisciplinary psoriasis and psoriatic arthritis unit over a period of 4 years (2009-2012). MATERIAL AND METHODS: Implementation of a PSOriasis Rheumatology and Dermatology unit (PSORD) to provide patient care and physician training. In the first phase of the project, referral criteria for the unit were defined and several meetings were organized to train and prepare the specialists involved in the program. In the second phase, a schedule was drawn up for monthly patient visits with the PSORD team. Starting in 2011, training was offered to dermatologists and rheumatologists from other hospitals interested in implementing a similar model. RESULTS: A total of 259 visits (71% first visits, 8% no-shows) were scheduled during the period analyzed, with a median of 8 visits (range, 2-14 visits) per session. Sixty-three percent of the patients were referred from the rheumatology department. Diagnosis and treatment were modified in 32% and 47% of cases, respectively. Three training courses were held with 15 physicians from 6 hospitals, 3 of which created similar units. CONCLUSIONS: The PSORD model improved the management of difficult-to-diagnose and/or uncontrolled disease, the early diagnosis and treatment of psoriatic arthritis, and collaboration between dermatologists and rheumatologists. Finally, the model lends itself to being exported to other settings

Multidisciplinary psoriasis and psoriatic arthritis unit: report of 4 years' experience.

INTRODUCTION AND OBJECTIVES: Up to 30% of patients with psoriasis develop joint disease, the course of which can be improved by early diagnosis and treatment. The aim of this study was to describe our experience with a new multidisciplinary psoriasis and psoriatic arthritis unit over a period of 4 years (2009-2012). MATERIAL AND METHODS: Implementation of a PSOriasis Rheumatology and Dermatology unit (PSORD) to provide patient care and physician training. In the first phase of the project, referral criteria for the unit were defined and several meetings were organized to train and prepare the specialists involved in the program. In the second phase, a schedule was drawn up for monthly patient visits with the PSORD team. Starting in 2011, training was offered to dermatologists and rheumatologists from other hospitals interested in implementing a similar model. RESULTS: A total of 259 visits (71% first visits, 8% no-shows) were scheduled during the period analyzed, with a median of 8 visits (range, 2-14 visits) per session. Sixty-three percent of the patients were referred from the rheumatology department. Diagnosis and treatment were modified in 32% and 47% of cases, respectively. Three training courses were held with 15 physicians from 6 hospitals, 3 of which created similar units. CONCLUSIONS: The PSORD model improved the management of difficult-to-diagnose and/or uncontrolled disease, the early diagnosis and treatment of psoriatic arthritis, and collaboration between dermatologists and rheumatologists. Finally, the model lends itself to being exported to other settings.

Hypovitaminosis D as a risk factor of hip fracture severity.

SUMMARY: In a cross-sectional study including 324 patients older than 65 years admitted to our hospital for osteoporotic hip fracture, we found that those patients with a more severe vitamin D deficiency had more severe osteoporotic hip fractures (Garden grades III-IV and Kyle III-IV). INTRODUCTION: To identify possible differences in baseline characteristics of patients with different types of osteoporotic hip fracture. METHODS: Cross-sectional study including consecutive individuals over 65 admitted to our hospital for osteoporotic hip fracture over a year. Demographic data, fracture type, comorbidities, history of osteoporosis, functional capacity, nutritional status and vitamin D storage were evaluated. RESULTS: We included 324 patients (83 ± 7 years, 80% women). Two hundred sixteen patients (67%) had vitamin D deficiency (25OHD3 <25 ng/ml). In patients with severe femoral neck or intertrochanteric fractures (Garden III-IV and Kyle III-IV), vitamin D deficiency was more frequent (74%) and severe (25OHD3 20 ± 15 ng/ml) than in patients with less severe fractures (57%, 25OHD3 26 ± 21 ng/ml). Forty-three percent of patients had previous fractures. Only 15% of patients had been previously diagnosed with osteoporosis and 10% were receiving treatment. Patients receiving vitamin D supplements have higher 20OHD3 levels and less severe fractures. CONCLUSIONS: Although vitamin D levels are not different between patients with intracapsular or extracapsular hip fractures, a more severe vitamin D deficiency seems to be associated to more severe osteoporotic hip fractures. A prior vitamin D supplementation could avoid a higher severity of these fractures.

Fibromyalgia in patients with ankylosing spondylitis: prevalence and utility of the measures of activity, function and radiological damage.

OBJECTIVES: To determine the prevalence of fibromyalgia (FM) in ankylosing spondylitis (AS). To evaluate the effect of FM on the measures of activity in AS. To analyse predictive factors in order to identify this group of patients. PATIENTS AND METHODS: A cross-sectional study based on 462 patients with definite ankylosing spondylitis included in the REGISPONSER. Sociodemographic data, clinical features, Bath AS disease activity index (BASDAI), Bath AS functional index (BASFI), Bath AS radiology index (BASRI), Stoke modified index (Sasss-m), laboratory data, Short-Format 12 (SF-12), AS specific quality of life (ASQoL), Fibromyalgia Impact Questionnaire (FIQ) and treatments used were all documented. To diagnose FM, the ACR 1990 criteria had to be fulfilled. All statistical tests were performed using STATA. RESULTS: The prevalence of fibromyalgia in all AS was 4.11%. Among the women with AS, the prevalence of FM increased to 10.83%. The BASDAI, BASFI and total BASRI were strongly influenced by the presence of FM. The inverse relationship between BASDAI or BASFI and total BASRI was taken to generate a ratio. Accordingly, if the patient presented BASDAI/BASRI ≥1.5 or BASFI/BASRI ≥1.08, the probability of having FM was very high. CONCLUSIONS: There is an increased risk of FM in females with AS. The fact of having FM distorts the measures of activity and functional damage of AS. As a result, it is possible that some patients with AS and FM are being overtreated. The BASDAI/BASRI and BASFI/BASRI ratios are very useful to identify these patients.

Relationship between spinal mobility and disease activity, function, quality of life and radiology. A cross-sectional Spanish registry of spondyloarthropathies (REGISPONSER).

OBJECTIVE: To determine the relationship between anthropometric measurements and disease activity, functional capacity, quality of life and radiology in Spanish patients with ankylosing spondylitis (AS). PATIENTS AND METHODS: A cross-sectional study was made of 842 patients with definite ankylosing spondylitis (REGISPONSER). Sociodemographic data, spinal mobility measurements, Bath AS disease activity index (BASDAI), nocturnal pain, Bath AS radiology index (BASRI), Bath AS functional index (BASFI), the Short-Format 12 (SF-12) and the AS specific quality of life (ASQoL) questionnaire were applied. Pearson correlation coefficient analysis and regression models were constructed. RESULTS: There was moderate correlation between fingertip-to-floor distance and lateral cervical rotation with the BASFI (p<0.01). Good correlation was evident between wall-occiput distance and lateral cervical rotation with the BASRI (p<0.01). Moderate correlation was found between chest expansion, the Schober modified test and fingertip-to-floor distance with the total BASRI (p<0.01). The anthropometric measurement with the lowest correlation value was lateral lumbar flexion. Significant association was found between the Schober modified test and BASFI, BASDAI and BASRI (R(2) = 0.37; p<0.001); chest expansion and BASFI, BASDAI and BASRI (R(2) = 0.25; p<0.001); wall-occiput distance and BASFI, BASRI and ASQoL (R(2) = 0.44; p<0.001); fingertip-to-floor distance and BASFI and BASRI (R(2) = 0.30; p<0.001); and lateral cervical rotation and BASFI and BASRI (R(2) = 0.34; p<0.001). CONCLUSION: In our study, wall-occiput distance and lateral cervical rotation showed the strongest correlation to BASRI. Similarly, fingertip-to-floor distance and lateral cervical rotation exhibited the closest correlation to BASFI.

Disability measured by the modified health assessment questionnaire in early rheumatoid arthritis: prognostic factors after two years of follow-up.

OBJECTIVE: To analyze the rate and baseline prognostic factors of disability measured by the modified HAQ (MHAQ), in a series of patients with early rheumatoid arthritis (RA) after two years of therapy with a structured algorithm using disease-modifying anti-rheumatic drugs (DMARDs). METHODS: One hundred and five patients (81% female) with early RA (disease duration <2 years) treated with the same therapeutic protocol using gold salts and methotrexate in a step-up strategy, together with methylprednisolone (4 mg/day), were followed up for two years. The outcome was the absence of disability (MHAQ=0) after two years of DMARD therapy. Clinical, biological, immunogenetic and radiographic data (Larsen score) were analyzed at study entry and at 12 and 24 months of follow-up. RESULTS: The MHAQ decreased significantly at 6 months after initiation of DMARD therapy and the reduction was maintained at 24 months (mean+/-SD: 0.97+/-0.56 at baseline, 0.51+/- 0.57 at month 6 and 0.45+/-0.5 at month 24). No disability (MHAQ=0) was observed in 26.6% of patients after two years of follow-up. Age, MHAQ>0.5, DAS28>5.1, VAS pain, positive rheumatoid factor and ESR at baseline were associated with disability in the univariate analysis. In the logistic regression analysis, only age (OR: 1.058, 95%CI 1.017; 1.101 p<0.006), rheumatoid factor status (OR: 3.772 95%CI 1.204; 11.813, p<0.02) and MHAQ>0.5 (OR:4.023, 95%CI 1.373; 11.783, p<0.02) were associated with disability (MHAQ>0) at two years. CONCLUSION: In a series of early RA patients treated with a structured algorithm using DMARDs and very low doses of glucocorticoids, no disability was observed in a quarter of patients after two years. Age, rheumatoid factor positivity and MHAQ>0.5 were independent predictors of disability at two years.

Noonan syndrome associated with systemic lupus erythematosus.

Noonan syndrome (NS) is a developmental disorder characterised mainly by cardiac defects and craniofacial dysmorphia. An association between NS and some autoimmune diseases, such as thyroiditis and systemic lupus erythematosus (SLE), has been suggested. We report the case of a 28-year-old man with a diagnosis of NS and autoimmune hypothyroidism who developed symptoms and immunologic features of SLE.

Sexual dysfunction in fibromyalgia patients.

OBJECTIVE: To investigate the prevalence of sexual dysfunction in female patients with fibromyalgia (FM), the impact of FM on sexual activity and the factors associated with sexual dysfunction in these patients. METHODS: Thirty-one consecutive women with FM were enrolled; two groups of 20 aged-matched healthy women and 26 patients with rheumatoid arthritis (RA) were used as controls. Demographic features were recorded in all patients. A cross-sectional analysis of pain (100-mm VAS scale), anxiety and depression (as determined by the STAI and Beck Depression Inventory scales, respectively) was performed. Sexual function was assessed by the Changes in Sexual Functioning Questionnaire (CSFQ). RESULTS: FM and RA patients showed a significantly higher rate of sexual dysfunction compared to healthy controls. Sexual dysfunction was more frequent among FM patients (97%) than in RA patients (84%) but without statistical differences. A univariate analysis showed that age (p=0.0002), marital (p=0.036) and work status (p=0.048), pain intensity (p=0.007), level of anxiety (p=0.002), level of depression (p=0.0005), were significantly associated with sexual dysfunction in FM. However, only the intensity of depression was associated with the sexual dysfunction in patients with FM in the multivariate analysis (p=0.012). CONCLUSIONS: Sexual function was very frequently and severely affected in patients with FM and this impairment appeared to be particularly associated with the degree of depression. The recognition of this dysfunction and its inclusion for the multidisciplinary management of FM may contribute to improve quality of life of these patients.

The cost-effectiveness of infliximab in the treatment of ankylosing spondylitis in Spain. Comparison of clinical trial and clinical practice data.

OBJECTIVE: To estimate the cost-effectiveness of treating ankylosing spondylitis (AS) with infliximab (Remicade) in Spain for up to 40 years. METHODS: A previously published disease model was adapted to the Spanish setting using resource consumption from a cross-sectional burden of an illness study in 601 patients in Spain. Cost-effectiveness estimates were based on a placebo-controlled clinical trial as well as an open clinical study in Spain. In the model, patients with insufficient response to treatment at 12 weeks [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) <4 or > or =50% reduction] discontinue treatment. The results are presented in 2005 euros, from societal and health-care payer perspectives. RESULTS: In the societal perspective, infliximab treatment dominates standard treatment in both analyses. In the perspective of the health-care system, with the assumption that, over the long term, functional ability of patients on treatment would decline at half the natural rate, the cost per quality-adjusted life year (QALY) gained was estimated at EUR 22 519 (double-blind trial) and EUR 8866 (open study). Assuming that patients' function on treatment remains stable, the cost-effectiveness ratios are EUR 15 157 and EUR 5307, respectively. Under the most conservative assumption (no effect of treatment on progression), the ratios are EUR 31 721 and EUR 13 659, respectively. In addition, the results are sensitive to the time horizon and discontinuation rates. CONCLUSIONS: Our results indicate that infliximab therapy for patients with active AS should be cost-effective both in the societal perspective (dominating) and in the perspective of the health-care system (ranges from EUR 5300 to EUR 32 000 per QALY) in Spain.

Prognostic markers of clinical remission in early rheumatoid arthritis after two years of DMARDs in a clinical setting.

OBJECTIVE: To analyze the rate and baseline prognostic factors of clinical remission in a series of patients with early rheumatoid arthritis (RA) after 2 years of therapy based on a structured algorithm using disease-modifying anti-rheumatic drugs (DMARDs) in a clinical setting. To determine whether a good therapeutic response at 6 months of therapy is associated with remission at 2 years. METHODS: One hundred and five patients (81% female) with early RA (disease duration < 2 years) treated with the same therapeutic protocol using gold salts and methotrexate in a step-up strategy, together with methylprednisolone (4 mg/day), were followed up for 2 years. The outcome variable was clinical remission after 2 years of DMARD therapy using the 28-joint disease activity score (DAS28 < 2.6). Clinical, biological, immunogenetic and radiographic data (Larsen score) were analyzed at study entry and after 6, 12, 18 and 24 months of follow-up. Therapeutic response was analyzed using the ACR and EULAR criteria. RESULTS: Remission was observed in 34 patients (32.4%) after 2 years of follow-up. A baseline DAS28 score < 5.1 (p = 0.004), hemoglobin (p = 0.04) and male gender (p = 0.02) were associated with remission in the univariate analysis. In the multivariate logistic regression analysis, only a DAS28 < 5.1 was associated with remission at 2 years (OR 4.1, 95% CI: 1.56;10.77, p = 0.004). The percentage of ACR50 responses after 6 months was significantly higher in patients with remission at 2 years than in those without (66.7% vs 43.3%; p = 0.04). Similar results were obtained when analyzing the good EULAR response (50% vs 20.9%; p = 0.003). Furthermore, when the therapeutic response at 6 months was included in the logistic regression model, only an ACR50 response (OR 3.9, 95% CI 1.14;13.38, p = 0.03) and a good EULAR response (OR 6.23, 95% CI 1.61; 24.04, p = 0.008), but not an ACR20 response or a whole EULAR response were significantly associated with remission. CONCLUSION: In a series of early RA patients treated using a structured algorithm with DMARDs and very low doses of glucocorticoids, clinical remission was observed in one-third of patients after 2 years. Low or moderate disease activity (DAS28 < 5.1) at baseline and a good therapeutic response during the first months of therapy predicts clinical remission at 2 years.

Disease pattern of spondyloarthropathies in Spain: description of the first national registry (REGISPONSER) extended report.

OBJECTIVE: The national registry of spondyloarthropathies (REGISPONSER) is launched to classify patients with this group of diseases treated in Spanish rheumatology clinics. This manuscript describes the methodological and organizational background as well as characteristics of patients finally included, and provides a comparative analysis between characteristics of both ankylosing spondylitis and undifferentiated spondyloarthropathy groups of patients. PATIENTS AND METHODS: Twelve members of the GRESSER group have participated in the registry, for a one-year recruitment period. All consecutively registered adult patients treated in their clinics met the classification criteria of the European Spondyloarthropathies Study Group (ESSG). Data collected reflect the socio-demographic characteristics, as well as disease activity and functional status, clinical form at onset, treatment used and quality of life; all measured by standard instruments. RESULTS: Throughout 1 yr, 1385 patients have been included in the registry: 939 males (68%) and 440 females (32%), with an average age of 47 +/- 13 years (mean +/- s.d.), and an average disease duration of 12 +/- 9 years. Diagnoses of the included patients were: AS (n = 842, 61%), PsA (n = 290, 21%), u-SpA (n = 205, 15%), reactive arthritis (n = 16, 1.2%), inflammatory bowel disease arthritis (n = 13, 0.9%) and JCA-spondyloathropathy (n = 13, 0.9%). Regarding clinical form, 54% had axial disease, 20% peripheral disease, 24% mixed disease and 0.6% isolated enthesitic form. Low-back pain was the first symptom reported in 53% of the patients, and most common extra-articular disease manifestations were psoriasis (25%), anterior uveitis (16%) and intestinal inflammatory disease (4%). Some kind of work disability was reported by 353 patients (25.5%). CONCLUSIONS: Such databases are very useful to obtain information about characteristics of SpA patients treated in a certain location or following a specific treatment practice, and provide a tool for assessing the impact of the disease. Data collected in this registry provide an appropriate clinical and demographic profile of patients suffering from SpA in Spain.

Colecalciferol o calcidiol. ¿Qué metabolito utilizar en el déficit de Vitamina D? / Calciol or cholecalciferol. What metabolite should be used in vitamin D deficit?

Introducción. La hipovitaminosis D es frecuente entre la población de nuestro país. El tratamiento sustitutivo del déficit de vitamina D se puede realizar con colecalciferol o con calcidiol, pero se desconoce si estos dos metabolitos tienen una eficacia equivalente. En este estudio nos propusimos como objetivos, en primer lugar valorar la eficacia de una pauta de calcidiol para corregir en un corto plazo el déficit de vitamina D y compensar el hiperparatiroidismo secundario en pacientes con hipovitaminosis D, y en segundo lugar comparar la eficacia de dos pautas, una con calcidiol y otra con colecalciferol para mantener normales los niveles séricos de vitamina D y mantener compensado el hiperparatiroidismo secundario en pacientes con niveles ya previamente normalizados de 25-OHD3. Pacientes y métodos. Estudio prospectivo con inclusión consecutiva de todos los individuos que presentaban déficit de vitamina D, procedentes de una consulta ambulatoria de reumatología. Al inicio, y durante un mes, se realizó un tratamiento con calcidiol (16.000 UI vía oral en dosis única semanal y durante 4 semanas) para normalizar niveles de 25-OHD3. Se realizaron determinaciones en sangre (calcio, fósforo, fosfatasa alcalina, 25-OHD3 y hormona paratiroidea intacta [PTHi]) y en orina (calciuria de 24 horas) al inicio y fin del tratamiento. Los pacientes que normalizaron niveles de 25-OHD3 se incluyeron en un protocolo prospectivo aleatorizado, para mantener niveles de 25-OHD3 (con 800 UI de colecalciferol y calcio 1 g mínimo /día, o calcidiol 16.000 UI/3 semanas y el mismo aporte de calcio a diario) durante un año. A los 3,6 y 12 meses se realizaron controles analíticos. Resultados. Se incluyeron en el estudio 129 pacientes con una edad media de 72,4 [10] años. El valor medio de 25-OHD3 basal fue de 16 [5] ng/ml y el de PTHi 76 [42]. El 52% de los pacientes presentaba hiperparatiroidismo secundario. Tras el tratamiento inicial se observó normalización de los niveles de 25-OHD3 en 124 casos (96%) e hiperparatiroidismo secundario en 15 pacientes (19%). Ambos tratamientos mantuvieron unos niveles séricos de 25-OHD3 en la normalidad, pero significativamente más elevados con calcidiol (p < 0,001 a los 3, 6 y 12 meses). En un porcentaje de pacientes el tratamiento fue insuficiente para mantener los niveles de 25-OHD3, sobre todo en el grupo de colecalciferol (19% frente a 4% a los 6 meses; p= 0,04, y 18% frente a 0% a los 12 meses; p= 0,006). Conclusiones. Una pauta de 16.000 UI semanales de calcidiol, durante 4 semanas, es sumamente útil para normalizar los niveles séricos de 25-OHD3 y de PTH en pacientes con déficit de vitamina D. Calcidiol y colecalciferol son metabolitos eficaces para mantener normalizados los niveles de 25-OHD3 y de PTHi

Introduction. Hypovitaminosis D is frequent among the population of our country. Vitamin D deficiency replacement treatment may be done with cholecalciferol or with calcidiol but it is not known if these two metabolites have an equivalent efficacy. In this study, we propose the following objectives: first, evaluate the efficacy of a calcidiol regimen to correct a vitamin D deficiency in the short-term and compensate the secondary hyperparathyroidism in patients with hypovitaminosis D, and second, compare the efficacy of the two regimes, one with calcidiol and the other with cholecalciferol, to maintain serum levels of vitamin D normal and maintain the secondary hyperparathyroidism compensated in patients with levels of 25-OHD3 that have already been normalized. Patients and methods. Prospective study with consecutive enrolment of all the patients with vitamin D deficiency of outpatient rheumotology clinic. At the onset, and for one month, patients recieved calcidiol (16.000 IU orally in a single weekly dose and for 4 weeks) to normalized levels of 25-OHD3. Serum (calcium, phosphorus, alkaline phosphatase, 25-OHD3 and PTHi), and in urine (24-hour calciuria) analysis were performed at the onset and after the completion of treatment. Patients who normalized levels of 25-OHD3 were enrolled in a randomized prospective protocol to maintain levels of 25-OHD3, (with 800 IU of cholecalciferol plus calcium 1 g minimum/day or calcidiol 16.000 IU /3 weeks and the same daily suplementation of calcium), for one year. Laboratory controls were conducted at 3, 6 and 12 months. Results. 129 patients with a mean age of 72.4 [10] years were included in the study. The mean value of baseline 25-OHD3 was 16 [5] ng/ml and PTHi 76 [42]. 52% of the patients had secondary hyperparathyroidism. After the initial treatment, normalization of 25-OHD3 levels was observed in 124 cases (96%) and secondary hyperparathyroidism in 15 patients (19%). Both treatments maintained serum levels of 25-OHD3 within the nomal range, but they were significantly more elevated with calcidiol (p < 0.001 at 3, 6 and 12 months). Treatment was ineffective to maintain 25-OHD3 levels in some patients, mainly, in the cholecalciferol group (19% vs 4% at 6 months, p = 0.04, and 18% vs 0% at 12 months, p = 0.006). Conclusions. A regimen of 16.000 IU weekly of calcidiol for 4 weeks is very useful to normalize serum levels of 25-OHD3 and of PTH in patients with vitamin D deficiency. Both calcidiol and cholecalciferol are effective to maintain normalized levels of 25-OHD3 and PTHi

Prediction of major clinical response (ACR50) to infliximab in psoriatic arthritis refractory to methotrexate.

OBJECTIVES: To determine the predictive factors of clinical response to infliximab in patients with refractory psoriatic polyarthritis. METHODS: A multicentre open study which included 69 patients with psoriatic polyarthritis refractory to methotrexate (15 mg/week at least for 8 weeks). Patients were treated with infliximab 5 mg/kg every 8 weeks in addition to their stable doses of methotrexate. A major clinical response was defined by the ACR50 at week 38. Logistic regression analysis was performed to analyse which of the following measures at the start of treatment were associated with an ACR50 response: demographic and clinical characteristics, duration of disease, tender and swollen joint counts, involvement of large joints (knee or hip, or both), erythrocyte sedimentation rate, C reactive protein (CRP), Health Assessment Questionnaire disability index, axial involvement, and the presence of erosions at baseline. RESULTS: In an intention to treat analysis 30/69 (44%) patients achieved an ACR50 response. In the univariate analysis both the presence of large joint involvement and severe disability were associated with a poor clinical response. In a multivariate logistic regression analysis high CRP values were independently associated with a good therapeutic response (odds ratio (OR)=18.7; 95% confidence interval (CI) 1.8 to 181.6; p=0.011). In contrast, large joint involvement and severe disability were associated with a poor response, which reached significance for large joint involvement (OR=29.3; 95% CI 3.2 to 266.3; p=0.003). CONCLUSION: A lower disability and, in particular, the absence of large joint involvement and higher CRP serum levels at the start of infliximab treatment are factors that seem to influence the probability of achieving a good therapeutic response in patients with psoriatic arthritis.