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Objectives: Our objective is to carry out a clinical study of the performance of the preliminary European classification criteria for Sjögren Syndrome and that of the criteria proposed by the American European Consensus Group.Methods: Eighty-eight patients who had undergone a biopsy of the salivary gland on suspicion that they were suffering from Sjögren Syndrome were studied by two independent rheumatologists. Two pathologists independently revised the biopsies without knowing the diagnosis. With all of this information, the clinicians established, or did not establish, a diagnosis of primary Sjögren Syndrome or secondary Sjögren Syndrome. Finally, it was analysed whether or not the patients met the American European Consensus Group classification criteria and the preliminary European criteria for primary Sjögren Syndrome and secondary Sjögren Syndrome, and their sensitivity and specificity with respect to the clinical diagnosis were determined.Results: Clinicians estimated that 35 cases (39.8%) had primary Sjögren Syndrome (kappa 0.718) and 17 cases (19.3%) had secondary Sjögren Syndrome (kappa 0.761). The specificity and sensitivity of American European Consensus Group criteria, with regard to the clinical diagnosis, for primary Sjögren Syndrome were 97.2% and 48.6%, respectively. For secondary Sjögren Syndrome, the specificity was 97.2% and the sensitivity 64.7%. The preliminary European criteria for primary Sjögren Syndrome demonstrated a lesser specificity (75%), but a higher sensitivity (65.7%). In secondary Sjögren Syndrome the specificity reached 97.2% with sensitivity at 70.6%.Conclusions: These results underline the difficulty in applying the Sjögren Syndrome classification criteria from the American European Consensus Group and the preliminary European criteria, in the diagnosis of individual patients. [ABSTRACT FROM AUTHOR]

Purpose: Cystoid macular edema (CME) is a leading cause of blindness. This study assessed the efficacy and safety of tocilizumab (TCZ) in refractory CME., Design: Retrospective case series., Methods: Patients with CME secondary to noninfectious uveitis who had inadequate response to corticosteroids and at least 1 conventional immunosuppressive drug, and in most cases to other biological agents, were studied. CME was defined as central retinal thickness greater than 300 μm. The primary outcome measure was macular thickness. Intraocular inflammation, best-corrected visual acuity (BCVA), and corticosteroid-sparing effect were also analyzed., Results: A total of 25 patients (mean ± standard deviation age 33.6 ± 18.9 years; 17 women) with CME were assessed. Underlying diseases associated with uveitis-related CME are juvenile idiopathic arthritis (n = 9), Behçet disease (n = 7), birdshot retinochoroidopathy (n = 4), idiopathic (n = 4), and sarcoidosis (n = 1). The ocular patterns were panuveitis (n = 9), anterior uveitis (n = 7), posterior uveitis (n = 5), and intermediate uveitis (n = 4). Most patients had CME in both eyes (n = 24). TCZ was used in monotherapy (n = 11) or combined with conventional immunosuppressive drugs. Regardless of the underlying disease, compared to baseline, a statistically significant improvement in macular thickness (415.7 ± 177.2 vs 259.1 ± 499.5 μm; P = .00009) and BCVA (0.39 ± 0.31 vs 0.54 ± 0.33; P = .0002) was obtained, allowing us to reduce the daily dose of prednisone (15.9 ± 13.6 mg/day vs 3.1 ± 2.3 mg/day; P = .002) after 12 months of therapy. Remission was achieved in 14 patients. Only minor side effects were observed after a mean follow-up of 12.7 ± 8.34 months., Conclusion: Macular thickness is reduced following administration of TCZ in refractory uveitis-related CME., (Copyright © 2019 Elsevier Inc. All rights reserved.)

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

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

To develop and evaluate a web application based on multimedia animations, combined with a training program, to improve the prescription of exercises in spondyloarthritis (SpA). After a review of exercises included in the main clinical trials and recommendations of international societies, a multidisciplinary team-rehabilitators, rheumatologists, physiotherapists, computer scientists and graphic designers-developed a web application for the prescription of exercises (EJES-3D). Once completed, this was presented to 12 pairs of rehabilitators-rheumatologists from the same hospital in a workshop. Knowledge about exercise was tested in rheumatologists before and 6 months after the workshop, when they also evaluated the application. The EJES-3D application includes 38 multimedia videos and allows prescribing predesigned programs or customizing them. A patient can consult the prescribed exercises at any time from a device with internet connection (mobile, tablet, or computer). The vast majority of the evaluators (89%) were satisfied or very satisfied and considered that their expectations regarding the usefulness of the web application had been met. They highlighted the ability to tailor exercises adapted to the different stages of the disease and the quality and variety of the videos. They also indicated some limitations of the application and operational problems. The EJES-3D tool was positively evaluated by experts in SpA, potentially the most demanding group of users with the most critical capacity. This allows a preliminary validation of the contents, usefulness, and ease of use. Analyzing and correcting the errors and limitations detected is allowing us to improve the EJES-3D tool.

Objectives: To evaluate the efficacy of etoricoxib in patients with axial ankylosing spondyloarthritis (AS) refractory to traditional NSAIDs., Methods: This was an open label, multicentric, randomised, prospective (4 weeks with and open extension to 6 months), non-controlled study. Consecutive patients with axial AS refractory to traditional NSAID eligible for anti-TNF-α therapy were selected. The primary outcomes were the rate of patients with good clinical response (not eligible for anti-TNF-α therapy after etoricoxib) and the Assessment of Spondyloarthritis International Society response criteria for biologic therapies (ASASBIO) response at 4 weeks. Secondary outcomes included: ASAS20 and 40 responses, ASDAS-CRP response, BASDAI, BASFI, back and night back pain, global patient and physician assessment of the disease, and biologic parameters like C-reactive protein (CRP) at 2, 4 weeks and 6 months., Results: A total of 57 axial AS patients were recruited, 46 men, with mean age of 43 years. After 4 weeks of treatment, 26 patients (46%) achieved a good clinical response and 11 (20%) an ASASBIO response. These results at 24 weeks were 19 (33%) and 13 (23%) respectively. All individual clinical variables improved significantly after 4 weeks of treatment. CRP serum levels decreased after 4 weeks but reached no statistical significance, although 30% of patients showed a normalisation of CRP., Conclusions: Etoricoxib provided a clear clinical improvement in around a third of patients with axial AS refractory to traditional NSAIDs. Special care should be required when deciding to start anti-TNF-α therapy; it seems reasonable to keep in mind these results of etoricoxib treatment.

To define and give priory to standards of care in patients with spondyloarthritis (SpA). A systematic literature review on SpA standards of care and a specific search in relevant and related sources was performed. An expert panel was established who developed the standards of care and graded their priority (high, mild, low, or no priority) following qualitative methodology and Delphi process. An electronic survey was sent to a representative sample of 167 rheumatologists all around the country, who also gave priority to the standards of care (same scale). A descriptive analysis is presented. The systematic literature review retrieved no article specifically related to SpA patients. A total of 38 standards of care were obtained-12 related to structure, 20 to process, and 6 to result. Access to care, treatment, and safety standards of care were given a high priority by most of rheumatologists. Standards not directly connected to daily practice were not given such priority, as standards which included a time framework. The standards generated for the performance evaluation (including patient and professionals satisfaction) were not considered especially important in general. This set of standards of care should help improve the quality of care in SpA patients.

Objectives: To test the reliability of the Berlin MRI scoring method and the effect of a calibration exercise on the score's reliability among untrained readers in MRI examinations of patients with established ankylosing spondylitis (AS)., Methods: Eleven rheumatologists read blinded images of 20 AS patients before and after a two-day workshop on the Berlin MRI scoring method. Reliability (intra- and inter-reader) and concordance with the expert (all measured by intraclass correlation coefficient (ICC)) were compared before and after 2 weeks of the training. Feasibility in terms of time and difficulty was also measured., Results: The mean Berlin score increased from (mean ± standard deviation) 5.04 ± 6.41 before to 6.40±7.08 after the calibration exercise (p<0.01). Inter-reader ICC decreased from 0.83 (95% CI: 0.75-0.93) to 0.78 (95% CI: 0.66-0.90), and intra-reader ICC from 0.89 (95% CI: 0.84-0.94) to 0.87 (95% CI: 0.82-0.92). Agreement with an experienced reader improved after the calibration exercise, with ICC = 0.59 (95% CI 0.45-0.76) before vs. ICC = 0.65 (95% CI 0.50-0.80) after training., Conclusions: The Berlin method is a reliable scoring method for assessment of spinal inflammatory activity by using MRI in patients with AS, even in the hands of inexperienced readers. A calibration exercise can improve feasibility and sensitivity of the scoring method.

Objective: Due to the increasing use of biologic therapy in rheumatic diseases and the importance of its risk management, the Spanish Society of Rheumatology (SER) has promoted the development of recommendations based on the best evidence available. These recommendations should be a reference to rheumatologists and those involved in the treatment of patients who are using, or about to use biologic therapy irrespectively of the rheumatic disease., Methods: Recommendations were developed following a nominal group methodology and based on systematic reviews. The level of evidence and degree of recommendation were classified according to the model proposed by the Center for Evidence Based Medicine at Oxford. The level of agreement was established through a Delphi technique. Evidence from previous consensus and clinical guidelines was used., Results: We have produced recommendations on risk management of biologic therapy in rheumatic patients. These recommendations include indication risk management, risk management before the use of biologic therapy, risk management during follow-up, attitude to adverse events, and attitude to special situations., Conclusions: We present the SER recommendations related to biologic therapy risk management., (Copyright © 2011 Elsevier España, S.L. All rights reserved.)

Objective: To determine the prevalence of work disability in Spanish patients with ankylosing spondylitis (AS) and to identify factors related to it., Methods: A cross-sectional study based on data from Regisponser (National Spanish Registry of Patients with Spondyloarthropathy). Demographic and disease-related variables were collected. AS patients were classified as work-disabled according to the Spanish Social Security System criteria. Variables that discriminated between AS patients with and those without work disability were identified using chi-square test or unpaired t test when appropriate. Multiple logistic regression was performed., Results: In total 699 AS patients, age 48.7 +/- SD 12.7 years and with disease duration 14.1 +/- 10.1 years, were analyzed; 179 patients (25.6%) had permanent work disability. Several variables had significantly different values in patients with compared to those without work disability. In the regression model (pseudo R(2) = 0.26, p < 0.0001), age (p = 0.001), sex (p = 0.04), disease duration (p = 0.006), total Bath AS Radiological Index (p = 0.007), Bath AS Functional Index (BASFI; p = 0.007), and chest expansion (p = 0.03) retained an independent association with work disability. When BASFI was excluded from the model the independent association with sex did not remain, and a significant association with finger to floor distance was found (p = 0.040)., Conclusion: The prevalence of permanent work disability in Spanish patients with AS is significant, and the main factors related to it are age, disease duration, structural damage, and physical functioning. Longitudinal studies are needed to confirm these results.

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.

A multicentre, double-blind, randomised, parallel group study was undertaken to investigate the efficacy and safety of aceclofenac (123 patients, 100 mg twice daily) in comparison to piroxicam (117 patients, 20 mg once daily and placebo once daily) in patients with osteoarthritis of the knee. The treatment period of two months was preceded by a washout period of one week duration. On completion of the study, patients in both aceclofenac and piroxicam-treated groups exhibited significant improvement in pain intensity and functional capacity of the affected knee, as represented by the Osteoarthritis Severity Index (OSI) (p < 0.0001 and p < 0.001 respectively). This was further substantiated following the patient's assessment of pain intensity using the Visual Analogue Scale (VAS), in which significant improvements were demonstrated at all time points for each treatment group (p < 0.001). Although both treatment groups showed a significant improvement in all investigator's clinical assessments (functional exploration of the knee, knee flexion and extension (EXT)), there were no significant differences between the groups. There was, however, a more rapid improvement in knee flexion in the aceclofenac group after 15 days of treatment. Both aceclofenac and piroxicam were well tolerated by patients, the most commonly reported adverse events being gastrointestinal, although their incidence was low. Only 24 patients on aceclofenac, as opposed to 33 on piroxicam complained of dyspepsia, epigastralgia and pyrosis. While 7 patients in each group were withdrawn because of adverse events, only one patient with piroxicam was withdrawn because of severe upper gastrointestinal bleeding. Twice as many reports of fecal blood loss were made in the piroxicam group in comparison to the aceclofenac group. In summary, this study confirms the therapeutic efficacy of aceclofenac and suggests that it is a well-tolerated alternative NSAID to piroxicam in the treatment of osteoarthritis.

Two cases of acute calcific periarthritis of the fingers are described and some controversial clinical aspects of the syndrome discussed.

CRP levels in 194 serum samples from 43 SLE patients were measured. Patients with inactive disease have levels below 10 micrograms/ml; patients with active SLE have higher levels, but never over 50 micrograms/ml. In the presence of infection or inflammatory processes, regardless of the activity of SLE, the levels are significantly higher (p less than 0.05), and well over 50 micrograms/ml. Both active SLE patients and inactive SLE patients with local infections have levels between 10 micrograms/ml and 50 micrograms/ml. In this situation, the presence of anti-DNA antibodies strongly suggests disease activity (82% versus 9%, p less than 0.05). The clinical and physiopathological meaning of these findings is discussed.