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We analyzed the practical consequences of applying an adjusted FRAX® for recent fractures in a FLS. After analyzing 2777 patients, we concluded that the adjusted FRAX® is irrelevant when calculating FRAX® with DXA and is only useful for fractures of the humerus when DXA is not available.A FRAX® adjusted to fractures less than 2 years old has been proposed. The objective of this work was to analyze the clinical implications of applying the adjusted FRAX® instead of the classic FRAX® in a fracture liaison service (FLS) unit.Adults aged 50 years or older with fragility fractures (hip, spine, humerus, and forearm) that occurred in the 12 months prior to the baseline visit were included. We recorded demographic data, type of fracture, DXA, classic FRAX®, and FRAX® adjusted for recent fractures and indications for anti-osteoporotic medication (AOM) following the guidelines of the Spanish Society of Rheumatology.A total of 2777 patients were included, mean age 73 years, 84% women. The type of fracture was as follows: forearm (n = 958; 34.5%), hip (n = 781; 28.1%), humerus (n = 642; 23.1%), and spine (n = 397, 14.3%). DXA was performed in 2134 cases (76.8%). A total of 2522 patients (90.8%) were candidates for AOM (100% involving the hip and spine, 83% forearm, and 85% humerus). FRAX®-hip ≥ 3% increased from 1601 to 1775 cases (57.6 to 64%). The average FRAX®-hip (SD) increased from 5.7 (6) to 7.5 (9) (4.6 to 8.8 in males and 5.9 to 7.3 in females). The percentage of forearm fracture candidates for AOM, with or without DXA, did not change after FRAX®-hip adjustment, while the number of patients with humerus fractures increased from 59 to 80% in those who did not have DXA. In the entire sample, FRAX®-adjusted led to an indication of AOM for 15 additional patients (0.5% of major fractures): 14 with a humerus fracture and 1 with a forearm fracture.The adjusted FRAX® for recent fractures in an FLS unit in an adjusted FRAX® is irrelevant when calculating FRAX® with DXA; in fact, it is only useful for fractures of the humerus when DXA is not available.

Long-term adherence to antiosteoporosis medication (AOM) in the setting of a fracture liaison service (FLS) are not well known. Patients ≥ 50 with hip fracture seen in an FLS and recommended for treatment to prevent new fractures were analyzed. Baseline data included demographics, identification mode, previous treatment and FRAX items. Patient records were reviewed 3–8 years later, and these data were collected: (1) survival; (2) major refracture; (3) initiation of treatment, proportion of days covered (PDC) and persistence with AOM. 372 patients (mean age, 79 years; 76% women) were included. Mean follow-up was 47 months, 52 patients (14%) had a refracture (22 hip) and 129 (34.5%) died. AOM was started in 283 patients (76.0%). Factors associated with initiation of AOM were previous use of bisphosphonate (OR 9.94; 95% CI 1.29–76.32) and a lower T-score lumbar (OR 0.80; 95% CI 0.65–0.99). Persistence decreased to 72.6%, 60% and 47% at 12, 36 and 60 months. A PDC > 80% was confirmed in 208 patients (55.7%) and associated with previous use of bisphosphonate (OR 3.38; 95% CI 1.34–8.53), treatment with denosumab (OR 2.69; 95% CI:1.37–5.27), and inpatient identification (OR 2.26; 95% CI 1.18–4.34). Long-term persistence with AOM was optimal in patients with hip fracture seen at an FLS. A PDC > 80% was associated with inpatient identification and prescription of denosumab.

Introduction Rheumatoid arthritis (RA) is the most frequent chronic polyarthritis. The current goal of RA treatment is to achieve clinical remission. Objective The goal of this study was to determine the prevalence of remission in a cohort of patients from clinical practice, and to identify potentially modifiable factors associated with remission. Methods A retrospective study was performed on a cohort of RA patients seen at the first consultation at the HUGC Rheumatology Service Dr. Negrin (HUGCDN) between first of January 2000 and thirtieth of April 2014. Sustained remission was defined as DAS28 less than 2.6 in the last two available visits in the medical history. Results A total of 463 patients were consecutively included, most (75%) women, with a mean age at the onset of RA of 50 years and a mean duration of the disease at follow-up of 8 years. 46% of the patients achieved sustained remission. Multiple logistic regression analyses found male sex (P = .031, OR 1.7, 95% CI 1.05–2.82), diagnosis in the first year of symptoms (P = .023, OR 1.7, 95% CI 1.07–2.69) and the initial DAS28 (P = .035) to be independent predictors for sustained remission. Conclusions The 46% of the patients with RA followed in the HUGC Dr. Negrin are in persistent remission, being the early diagnosis a modifiable factor predictor of remission. Thus, an objective of the Rheumatology Service should be to improve the diagnostic delay of RA in the health area.

The objective of the study was to assess the ESSDAI index characteristics in the SJOGRENSER cohort (Spanish Rheumatology Association’s registry of patients with Primary Sjogren Syndrome [PSS]). SJOGRENSER is a prospective multicentric study on a cohort of Spanish patients with PSS who meet the 2002 American–European consensus from rheumatology units. 298 variables were studied in patients for the inclusion of the study from an anonymous list from each department. The ESSDAI (EULAR Sjogren’s syndrome disease activity index) includes 12 domains and measures systematic activity in PSS patients. Each domain is divided into 3–4 levels, (0: no activity; 1: low activity; 2: moderate activity; 3: high activity) and is attributed a weight. Each domain score is obtained by multiplying the activity level by the weight assigned. According to ESSDAI: low activity

We analyzed the long-term persistence of treatment in a FLS. During follow-up, 15.2% of patients had a refracture and 23.8% died. At the 5-year checkup, 74% had started treatment (associated with female sex, previous use of bisphosphonate, and referral to an osteoporosis clinic). Persistence at 1 and 5 years was 70.6% and 46.5%, respectively. To analyze the long-term persistence of treatment in a fracture liaison service (FLS). Patients ≥ 50 years with a fragility fracture attended between 2012 and 2016 who were recommended for treatment to prevent new fractures were included. Baseline data included demographics, type of fracture, previous treatment, and FRAX® items. Five years later, patient records were reviewed and the following data were collected: [1] survival; [2] refracture; [3] initiation of treatment, persistence, and medication possession ratio (MPR) > 80%. We included 888 patients, mean age 75 years, 83% women, and mean follow-up 56 months. During follow-up, 135 patients (15.2%) had a refracture (109 major fractures, 50 hip refractures) and 212 patients died (23.8%); at the 5-year checkup, 657 patients (74%) had started some type of treatment. Factors associated with the start of treatment were female sex (OR 2.10; 95% CI: 1.42–3.11), previous use of bisphosphonate (OR 3.91; 95% CI: 2.23–6.86), and referral to an osteoporosis clinic (OR 1.46; 95% CI: 1.02–2.07). Persistence decreased from 70.6% at 12 months to 46.5% at 60 months. An MPR > 80% was confirmed in 449 patients, 68.3% of whom were under treatment. A total of 521 and 447 patients received treatment for at least 24 and 36 months, respectively (79.3% and 68.0% of those who started treatment). Patients with fragility fractures attended at an FLS showed optimal long-term persistence of treatment. These data can help healthcare managers better calculate the cost-effectiveness of implementing the FLS model.

Objective: To describe the incidence of bacteremia in a large multicentric cohort of patients with systemic lupus erythematosus (SLE) and their clinical characteristics and to identify risk factors. Methods: All bacteremic episodes from the Spanish RELESSER registry were included. Clinical and laboratory characteristics concerning bacteremia and SLE status, as well as comorbidities at the time of infection, were retrospectively collected. A comparison with sex- and age-matched SLE controls without bacteremia was made. A logistic regression was conducted. Results: The study included 114 episodes of bacteremia in 83 patients. The incidence rate was 2.7/1000 patient-years. At the time of bacteremia, the median age was 40.5 (range: 8-90) years, and 88.6% of patients were female. The Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index was 4 [interquartile range (IQR) 8]; 41% had an SLE flare (66% severe); Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index was 3 (IQR 4). A comorbidity was recorded in 64% of cases. At the time of bacteremia, 88.6% received corticosteroids (68.6% > 10 mg/day) and 57% immunosuppressors. Gram-negative bacilli, most frequently Escherichia coli (29.8%), caused 52.6% of the episodes. The bacteremia-related mortality was 14% and bacteremia was recurrent in 27.2% of cases. A dose-response relationship was found between corticosteroids and bacteremia risk. In the multivariate analysis, these factors were associated with bacteremia: elevated creatinine (OR 1.31, 95% CI 1.01-1.70; p = 0.045), diabetes (OR 6.01, 95% CI 2.26-15.95; p < 0.001), cancer (OR 5.32, 95% CI 2.23-12.70; p < 0.001), immunosuppressors (OR 6.35, 95% CI 3.42-11.77; p < 0.001), and damage (OR 1.65, 95% CI 1.31-2.09; p < 0.001). Conclusion: Bacteremia occurred mostly in patients with active SLE and was frequently associated with severe flares and corticosteroid use. Recurrence and mortality were high. Immunosuppressors, comorbidities, and disease-related damage were associated with bacteremia. This work was supported by the Spanish Foundation of Rheumatology. JMPR is supported by grant 316265 (BIOCAPS) from the European Union 7th Framework Programme (FP7/ REGPOT-2012-2013.1) and FIS/ISCIII-Fondo Europeo de Desarrollo regional (FEDER) (Grant number PI11/02857).

Fracture Liaison Service (FLS) model for secondary prevention of fractures has demonstrated its cost-effectiveness using decision models. We analyze the impact of a FLS on pharmaceutical expenditures for osteoporosis (OP) in real-world circumstances.Expenditures on OP medications from January 2011 to January 2017 were compiled. Pharmaceutical expenditures in the southern area of Gran Canaria were used as a control group to measure the impact of implementing an FLS in the northern area. We estimated generalized least squares regressions with interrupted time-series analysis where two interventions were considered: March 2012 (implementation of the FLS) and March 2016 (incorporation of nursing staff for inpatients with hip fracture).The northern area incurred greater expenditures for group I and II drugs. The difference in bisphosphonates expenditures between areas varied from 10.5% higher in the northern area pre-FLS to 11.2% post-FLS and 18.3% since March 2016. However, interrupted time series models do not find a significant impact of implementation of FLS on the pharmaceutical expenditures for either drug group.The implantation of an FLS did not lead to an increase in pharmaceutical expenditures for OP over the 5-year period compared to the standard care provided for secondary fracture preventions.

To describe variability in the prescription of biologics (B-DMARDs) for patients with rheumatoid arthritis (RA) in hospitals in Spain, and to explore which characteristics of the patient, the doctor and the hospital are associated with this variability. Cross-sectional multicentric study in 46 rheumatology services of the National Health System. Medical records of 1188 randomly selected patients were reviewed. The association of each variable with B-DMARD prescription was analyzed using simple logistic regressions. Multilevel logistic regression models were created to analyze variability among centers. 36.8% of patients had received B-DMARD. The proportion of patients being treated with B-DMARDs varied between 3.6 and 71.4% depending on the center. Association of prescription of B-DMARD with patient age (OR = 0.958, 95% CI = 0.947-0.968, p

A high quality colonoscopy is key in preventing colorectal cancer, but the risk of colorectal cancer (CRC) exists. The aims of the study were to investigate the incidence, characteristics and predictive factors of post-colonoscopy colorectal cancer (PCCRC).A retrospective and prospective observational study was designed. A population undergoing colonoscopy between 1-01-1997 and 31-12-2014 was included. We analysed demographic variables, characteristics of the diagnostic colonoscopy of CRC, of the previous ones and the lesions found in them. To compare the PCCRC group versus the CRC group without previous colonoscopy, the Student's t-test and multiple logistic regression were used to determine predictive factors of PCCRC (SPSSA total of 56,984 colonoscopies, 1,977 CRC and 132 patients (mean 70.8 years old, 56.8% male) with at least one colonoscopy in 10 years before were registered (PCCRC). Seventy and a half percent of the previous colonoscopies were completed and 63.7% had an adequate bowel preparation. Predictive factors of PCCRC were personal history of polyps (OR 35.01; 95% CI 11.1-110.8; P.001), previous CRC (OR 176.64; 95% CI 51.5-606.1); P.001), family history of CRC (OR 3.14; 95% CI 1.5-6.4); P=.002) and proximal CRC (OR 3.15; 95% CI 2.1-4.9; P.001).PCCRC rate in 10 years was 6.7%. An adequate follow-up and a high-quality colonoscopy could prevent PCCRC, especially in patients with risk factors.

To analyze the influence of tobacco smoking on systemic lupus erythematosus (SLE) clinical features and damage. Cross-sectional and retrospective, case-control study comparing SLE patients with and without tobacco exposure. Cumulative clinical data and comorbidities were collected, and severity (Katz index) and damage (SLICC/ACR damage index) (SDI) indices were calculated. Pack-years (PY) was used to estimate lifetime tobacco exposure. A logistic regression was carried out to explore the impact of tobacco use on retinal damage. 216 patients were included. The mean age was 49 years (± 12.7), 93% were females, and median disease duration was 17 years [interquartile range (IQR):9-25]. Fifty-three percent of patients were smokers at some point. The median PY was 13 (IQR: 6-20.5). Only 54.8% of active smokers recalled having been informed of the negative effects of smoking, versus 83.3% of never smokers ( 0.001). In a bivariant analysis, an association between tobacco use at any time and discoid lupus [OR: 3.5(95%CI 1.5-8.9); p = 0.002] photosensitivity [OR: 2.06(95%CI 1.16-3.7); p = 0.01] and peripheral arteriopathy (p = 0.007) was found. Considering SDI item by item, a significant association with retinal damage, adjusted for age [OR: 1.03(95%CI 1-1.07); p = 0.04], was found. Using PYs, an association was found with discoid lupus (p = 0.01), photosensitivity (p = 0.03) and peripheral arteriopathy (p = 0.01), global SDI 0 (p = 0.002) and retinal damage (p = 0.02). In a multivariate analysis exploring factors associated with retinal damage, any previous smoking history and SDI remained associated with retinal damage. Tobacco smoking is associated with cutaneous manifestations and damage and is an independent predictor of retinal damage in SLE patients.

SummaryBackground Information on the safety of tumour necrosis factor (TNF) antagonists frequently arises from their use in rheumatic diseases, their first approved indications, and is later applied to psoriasis. Whether the risk of biological therapy is similar in psoriasis and rheumatoid arthritis has been considered a priority research question. Objectives To compare the safety profile of anti-TNF drugs in patients with rheumatoid arthritis and psoriasis. Methods We compared two prospective safety cohorts of patients with rheumatoid arthritis and psoriasis that share methods (BIOBADASER and BIOBADADERM). Results There were 1248 serious or mortal adverse events in 16 230 person-years of follow-up in the rheumatoid arthritis cohort (3171 patients), and 124 in the 2760 person-years of follow-up of the psoriasis cohort (946 patients). Serious and mortal adverse events were less common in patients with psoriasis than in rheumatoid arthritis (incidence rate ratio of serious adverse events in psoriasis/rheumatoid arthritis: 0·6, 95% confidence interval 0·5–0·7). This risk remained after adjustment for sex, age, treatment, disease, hypertension, diabetes, hypercholesterolaemia and simultaneous therapy with methotrexate (hazard ratio 0·54, 95% confidence interval 0·47–0·61), and after excluding patients receiving corticosteroids. Patients with rheumatoid arthritis showed a higher rate of infections, cardiac disorders, respiratory disorders and infusion-related reactions, whereas patients with psoriasis had more skin and subcutaneous tissue disorders and hepatobiliary disorders. Conclusions Patients with rheumatoid arthritis clinical practice have almost double the risk of serious adverse events compared with patients with psoriasis, with a different pattern of adverse events. Safety data from rheumatoid arthritis should not be fully extrapolated to psoriasis. These differences are likely to apply to other immune-mediated inflammatory diseases.

The aim of this study was to explore the variability in hospital admissions of patients with spondyloarthritis (SpA) in Spain, and the centre factors that may influence that variability. Descriptive cross-sectional study, part of the emAR II study, performed in Spain (2009-2010). Health records of patients with a diagnosis of SpA and at least one visit to the rheumatology units within the previous 2 years were reviewed. Variables related to hospital admissions, to the SpA, and to the patient and centre were collected. A multilevel logistic regression analysis of random intercept with non-random slopes was performed to assess variability between centres. From 45 centres, 1168 patients' health records were reviewed. Main SpA forms were ankylosing spondylitis (55.2 %) and psoriatic arthritis (22.2 %). A total of 248 admissions were registered for 196 patients (19.2 %, n = 1020). An adjusted variability of 17.6 % in hospitalizations between centres was noted. The following hospital-related factors showed a significant association with admissions: the total number of admissions of the centre, the existence of electronic admission, and the availability of ultrasound in rheumatology. However, these factors only explained 42.9 % of the inter-centre variability. The risk of a patient with SpA of being admitted could double (median OR 2.09), depending on the hospital where the patient was being managed. Hospital admissions of patients with SpA varied between hospitals due to centre characteristics. Further studies are needed to ascertain which specific factors may be causing the variation, as studied variables explained less than half of the variability.

A fracture liaison service in Spain is able to maintain 73 % of the patients on antiresorptive 2 years after the fracture. The purpose of this study was to evaluate the 2-year effectiveness of a program for the secondary prevention of fractures. Fragility fractures in patients over 50 attending the emergency room in our centre are captured by the recruitment system of a secondary prevention program. The unit is attended by a nurse, coordinated by two rheumatologists and with the collaboration of primary care consisted of a training program and annual meetings. The outcome of the program was analysed 2 years after implementation, including: (1) percentage of attendees/eligible; (2) percentage of attendees who start treatment with antiresorptive; (3) percentage of patients who retain treatment after 6, 12, 18 and 24 months; and (4) factors associated to adherence. After 2 years of implementation, the program detected 1674 patients with fracture, of whom 759 finally entered the program (57 % of eligible). After 3 months, 82 % of patients prescribed an antiresorptive started treatment. After a year, 52 % of the patients in the program, 72 % of those of a prescribed treatment, were taking antiresorptives. Adherence at 24 months among those who had prescribed anti-fracture drugs was 73 %. Factors associated with adherence at 12 months were female sex (76 vs 45 %; p = 0.01) and previous treatment with antiresorptive (86 vs 68 %; p = 0.02). In Spain, a program designed to prevent secondary fragility fractures based on the collaboration between primary care and rheumatology seems effective in terms of recruitment of patients and adherence to treatment in the mid/long-term.

Objective: To describe the variability in the prescription of non-biologic disease-modifying antirheumatic drugs (nbDMARDs) for the treatment of spondyloarthritis (SpA) in Spain and to explore which factors relating to the disease, patient, physician, and/or center contribute to these variations. Methods: A retrospective medical record review was performed using a probabilistic sample of 1168 patients with SpA from 45 centers distributed in 15/19 regions in Spain. The sociodemographic and clinical features and the use of drugs were recorded following a standardized protocol. Logistic regression, with nbDMARDs prescriptions as the dependent variable, was used for bivariable analysis. A multilevel logistic regression model was used to study variability. Results: The probability of receiving an nbDMARD was higher in female patients [OR ¼ 1.548; 95% confidence interval (CI): 1.208–1.984], in those with elevated C-reactive protein (OR ¼ 1.039; 95% CI: 1.012–1.066) and erythrocyte sedimentation rate (OR ¼ 1.012; 95% CI: 1.003–1.021), in those with a higher number of affected peripheral joints (OR ¼ 12.921; 95% CI: 2.911–57.347), and in patients with extra-articular manifestations like dactylitis (OR ¼ 2.997; 95% CI: 1.868–4.809), psoriasis (OR ¼ 2.601; 95% CI: 1.870–3.617), and enthesitis (OR ¼ 1.717; 95% CI: 1.224–2.410). There was a marked variability in the prescription of nbDMARDs for SpA patients, depending on the center (14.3%; variance 0.549; standard error 0.161; median odds ratio 2.366; p o 0.001). After adjusting for patient and center variables, this variability fell to 3.8%. Conclusion: A number of factors affecting variability in clinical practice, and which are independent of disease characteristics, are associated with the probability of SpA patients receiving nbDMARDs in Spain.

An observational study was carried out in two hospitals in patients > 65 years admitted for hip fracture. At 6 months, 15% of patients in the hospital with orthogeriatric standard care and 75% in the hospital with fracture liaison service were receiving bisphosphonates. Many patients with fractures are discharged without preventive therapy against further fractures. We sought to compare the effectiveness of an orthogeriatric fracture liaison service (FLS), outpatient FLS, and the standard care after hip fractures in prevention of future fractures. An observational study was carried out in two hospitals in patients > 65 years of age, admitted between March and July 2016 for fractures. The Candelaria hospital (HUNSC) has no specific protocol for secondary prevention, while at the Negrin Hospital (HUGCDN), an FLS nurse visits the inpatients, gathers metabolic history, instructs regarding the diet, exercises, and fall prevention, and completes a discharge report regarding osteoporosis treatment. The prescription rate of osteoporosis treatment was analyzed at admission, discharge, and 6 months after discharge. We also analyzed the data of patients with hip fractures who attended the outpatient FLS before March 2016. We included a total of 185 inpatients with a mean age of 82 years and 73% were women. At admission, 8% of the patients in HUNSC and 10% in HUGCDN were receiving bisphosphonates. At discharge, the percentages were 8 and 96%, while at 6 months they were 15 and 75%, respectively (p

Objective.To determine the incidence of pneumonia and associated factors in a single-center systemic lupus erythematosus (SLE) cohort.Methods.We included all our SLE patients [1997 American College of Rheumatology (ACR) criteria] with ≥ 1 pneumonia event, and 196 age and sex-matched SLE controls with no pneumonia events. Cumulative clinical data, weighted Systemic Lupus International Collaborating Clinics/ACR damage index (wSLICC/ACR-DI), comorbidities, and risk factors for pneumonia were retrospectively collected. The standardized incidence ratio (SIR) of pneumonia was estimated. Polymorphisms at genes coding for mannose binding lectin (MBL), MBL-associated serine protease 2, Fc-gamma receptors, and surfactant proteins A1, A2, and D were determined, and their potential association with pneumonia was analyzed. Patients with and without pneumonia were compared using a multivariate logistic regression model for adjustment of pneumonia-associated factors.Results.Thirty-six of 232 patients with SLE had experienced ≥ 1 pneumonia event. SIR for pneumonia was 5.1 (95% CI 3.5–7.4; p < 0.0001). Excluding patients receiving immunosuppressive therapy at the time of pneumonia (13%), associations were found for Katz Severity Index (KSI) (p = 0.016), wSLICC/ACR-DI (p = 0.044), number of SLE criteria (p = 0.005), hospital admissions (p < 0.001), FCGR2A HH genotype (p = 0.03), previous use of immunosuppressive therapy (p = 0.049), cutaneous ulcers (p < 0.001), and vasculitis (p = 0.008) in bivariate analyses. In the multivariate analysis adjusted to previous immunosuppressive treatment, only KSI and FCGR2A HH genotype remained statistically significant (p = 0.05 and p = 0.03, respectively).Conclusion.The incidence of pneumonia in patients with SLE is higher than that in the general population, and particularly high in severe SLE, regardless of immunosuppressive therapy. The HH genetic variant of FCGR2A appears to predispose patients with SLE to pneumonia.

The aim of this study was to analyze the longitudinal practice patterns of prophylaxis of glucocorticoid-induced osteoporosis in patients with polymyalgia rheumatica (PMR). Patients diagnosed with PMR were collected retrospectively in two rheumatology departments. In addition to demographic and diagnostic criteria, the chart review included the following information at baseline and at follow-up: doses of prednisone, prescription of calcium, vitamin D and bisphosphonates, bone mass measurement (BMD) and fragility fractures. We analyzed the percentage of patients undergoing BMD and were prescribed a bisphosphonate over the years. We evaluated 158 patients: 117 of them were women, mean age was 73 years, and they had an average follow-up of 4.8 years. 104 patients (66 %) received osteoporosis medication during the first visit, 44 of them were given bisphosphonate. During follow-up, another 30 treatments with bisphosphonate were added (46 % overall) while 37 cases (23 %) received no treatment with calcium or bisphosphonate. BMD was performed in 111 patients (69 %; 53 % of males and 76 % of females). Factors associated with the use of bisphosphonates were female sex (OR 4.4, 95 % CI 4.02-4.86), BMD (OR 2.4, 95 % CI 2.05-2.78) and commencement of treatment after the year 2005 (54 vs 37 %, OR 1.93, 95 % CI 1.60-2.26). No significant differences were found with age, initial doses of prednisone or the hospital. According to recent prevention guidelines, treatment with biphosphonate should have been administered in more than 90 % of patients. Although prophylaxis of glucocorticoid-induced osteoporosis in patients with PMR has increased in the recent years, many patients do not receive prophylaxis with bisphosphonate during the first visit.

Objective.To analyze sociodemographic and clinic-related factors associated with the use of orthopedic surgical procedures in rheumatoid arthritis (RA), focusing on the potential role of new biologic therapies.Methods.A retrospective medical record review was performed in a probability sample of 1272 patients with RA from 47 units distributed in 19 Spanish regions. Sociodemographic and clinical features, use of drugs, and arthritis-related joint surgeries were recorded following a standardized protocol.Results.A total of 94 patients (7.4%) underwent any orthopedic surgery during their disease course, with a total of 114 surgeries; 47 (41.2%) of these surgeries were total joint replacement (TJR). The median time to first orthopedic procedure was 7.9 years from the onset of RA symptoms, and the rate of orthopedic surgery (excluding TJR) was 4.5 procedures per 100 person-years from the beginning of RA, while the rate of TJR was 2.25 interventions per 100 person-years. A higher risk of undergoing an orthopedic surgical procedure was associated with taking nonsteroidal antiinflammatory drugs (NSAID) in the previous 2 years, female sex, longterm disease, and the presence of extraarticular complications. The risk factors for undergoing a TJR were being old, having a longterm disease, and taking biologic therapies.Conclusion.In the era of biologics, our national audit found a low percentage of patients who underwent orthopedic surgery, probably reflecting a thorough management of the RA. Sociodemographic factors, longterm RA, extraarticular complications, and NSAID were associated with orthopedic surgery.

Objective To assess intercentre variability in the ACR core set measures, DAS28 based on three variables (DAS28v3) and Routine Assessment of Patient Index Data 3 in a multinational study. Methods Seven thousand and twenty-three patients were recruited (84 centres; 30 countries) using a standard protocol in the Quantitative Standard Monitoring of Patients with RA study. Analysis of variance (ANOVA) and mixed-effect analysis of covariance models were used to model the relationship between study centre and different patient-reported and physician-reported RA activity measures. These models were built to adjust for the remaining ACR core set measure (for each ACR core set measure or each composite index), socio-demographics and medical characteristics. ANOVA and analysis of covariance models yielded similar results, and ANOVA tables were used to present variance attributable to recruiting centre. Results The proportion of variances attributable to recruiting centre was lower for patient reported outcomes (PROs: pain, HAQ, patient global) compared with objective measures (joint counts, ESR, physician global) in all models. In the full model, variance in PROs attributable to recruiting centre ranged from 1.53% for patient global to 3.71% for HAQ compared with objective measures that ranged from 5.92% for physician global to 9.25% for ESR; and was lower for Routine Assessment of Patient Index Data 3 (2.6%) compared with DAS28v3 (11.75%). Conclusion Intercentre variability in PROs is lower than objective measures of RA activity demonstrating that PROs may be more comparable across centres, and the need for standardization of objective measures.

To determine the value of ultrasonography in the assessment of patients with idiopathic carpal tunnel syndrome (CTS) and poor outcome after carpal tunnel release.A total of 88 consecutive patients with CTS (104 hands) underwent open surgical release of the median nerve. Ultrasound (US) examination was performed blind to any patient's data. The median nerve area at tunnel inlet and outlet, the retinaculum distance, and the flattening ratio were measured. The main outcome variable was the patient's overall satisfaction using a five-point Likert scale (1 = worse, 2 = no change, 3 = slightly better, 4 = much better, 5 = cured) at 3 months postoperatively. Pre- and postoperative ultrasonographic findings in relation to clinical outcome were analysed.Improvement (scores 4 or 5 on the Likert scale) was recorded in 75 hands (72%). After carpal tunnel release, the cross-sectional area at tunnel inlet decreased from a mean of 14.2 to 13.3 mm2 in the group with clinical improvement and also from a mean of 12.5 to 11.6 mm2 in the group with no change or slight improvement. No significant changes in the cross-sectional area at tunnel outlet, retinaculum distance, and flattening ratio were observed.Reduction of the median nerve cross-sectional area at tunnel inlet at 3 months after carpal tunnel release was similar in patients reporting cure or great improvement and in those with slight or no improvement. Ultrasonography is of limited value in assessment of patients with poor outcome after median nerve release.

Background and aims: An evaluation is made of the utility of fecal calprotectin in predicting relapse in patients with inflammatory bowel disease (IBD). The possible differences in its predictive capacity in Crohn's disease (CD) versus ulcerative colitis (UC), and the different phenotypes, are also examined. Methods: This is a prospective study with 135 patients diagnosed with IBD in clinical remission for at least 3 months. The patients submitted a stool sample within 24 hours after the baseline visit, for the measurement of fecal calprotectin. All patients were followed-up on for one year. Results: Sixty-six patients had CD and 69 UC. Thirty-nine (30%) suffered from relapse. The fecal calprotectin concentration was higher among the patients with relapse than in those that remained in remission: 444 µg/g (95% CI 34–983) versus 112 µg/g (95% CI 22–996); p 200 µg/g relapsed 4 times more often than those with lower marker concentrations. In UC, calprotectin > 120 µg/g was associated with a 6-fold increase in the probability of disease activity outbreak. The predictive value was similar in UC and CD with colon involvement and inflammatory pattern. In this group, calprotectin > 120 µg/g predicted relapse risk with a sensitivity of 80% and a specificity of 60%. Relapse predictive capacity was lower in patients with ileal disease. Conclusions: Fecal calprotectin may be a useful marker for predicting relapse in patients with IBD. Its predictive value is greater in UC and CD with colon involvement and inflammatory pattern, compared with ileal CD. * Abbreviations : CRP : C-reactive protein CD : Crohn's disease CDAI : Crohn's Disease Activity Index ESR : erythrocyte sedimentation rate IBD : inflammatory bowel disease TW : Truelove Witts UC : ulcerative colitis

ObjectivesTo assess the changes in carotid intima-media thickness (IMT) and the associated risks factors in patients with low severity systemic lupus erythematosus (SLE).MethodsCommon carotid IMT measurements were obtained by ultrasound from 101 patients with SLE at an interval of 2 years. Cardiovascular risk factors, disease activity, accumulated damage, severity (Katz index) and biochemical parameters (including high sensitivity C-reactive protein, interleukin 6, C3a, C4a, C5a and homocysteine) were also assessed. Multiple linear regression was used to assess the effect of these variables on the end IMT measurement (eIMT) adjusted to the baseline measurement (bIMT).ResultsThe cohort comprised 94.1% women, with a mean age at entry of 41.5 years and a mean disease duration of 12.1 years. An increase of 0.078 mm in IMT was detected over 2 years, from a mean bIMT of 0.37 mm to a mean eIMT of 0.44 mm (pConclusionsIMT significantly increases over 2 years in patients with SLE. Age, baseline IMT, C3, C5a anaphylatoxin and homocysteine are all associated risk factors, supporting a role for complement and homocysteine in the early stages of premature SLE-associated atherosclerosis.

The purpose of this study was to examine whether several allelic variants in the polymorphic interleukin (IL)-10 promoter region were related with an increased risk of developing systemic lupus erythematosus (SLE) in Spanish patients from Canary Islands. Microsatellites (MS) at positions -4000 and -1200 (IL10R and IL10G, respectively) and single nucleotide polymorphisms (SNPs) (MS) at positions -1082G/A, -819C/T and -592C/A of the IL-10 promoter were analysed in patients with SLE and healthy controls from Canary Islands (Spain). We found that SNPs but not MS were associated with SLE. The GCC haplotype frequency was significantly higher in SLE patients (0.43) than in healthy donors (0.33) [P = 0.02; OR = 1.50 (95% CI = 1.06-2.14)], whereas the ACC haplotype was less represented in patients (0.28 vs. 0.37) [P = 0.02; OR = 0.64 (95% CI = 0.44-0.92)]. To assess the functional role of genotypes, serum IL-10 levels from patients and controls were quantified by ELISA. Also, the lipopolysaccharide-induced IL-10 secretion by monocytes from healthy controls was evaluated in vitro. Serum IL-10 levels were higher in patients [median (interquartile range) = 2.8 pg/mL (1.8-4.2)] than in controls [0.9 pg/mL (0-3.5)] (P = 0.02), but no association was observed between serum IL-10 levels or lipopolysaccharide-induced IL-10 secretion and the IL-10 promoter haplotypes. These data suggest that the IL-10 promoter haplotype that produces higher levels of cytokine is associated with SLE in patients from Canary Islands.

Objective Blau syndrome and early-onset sarcoidosis are NOD2 gene–associated chronic autoinflammatory diseases characterized by skin rash, arthritis, and/or eye involvement, with noncaseating granulomata as their pathologic hallmark. This study was undertaken to describe the expanded clinical phenotype, treatment outcomes, and NOD2 gene mutation analysis in a Spanish cohort with pediatric granulomatous arthritis, a chronic disease resembling Blau syndrome/early-onset sarcoidosis. Methods Clinical, laboratory, and treatment data on the 12 patients in the cohort were obtained through direct interviews. NOD2 gene analysis was performed in a central laboratory, by bidirectional sequencing. Cytokine levels were measured using the human Flex-Set cytokine bead array. Results The classic Blau syndrome/early-onset sarcoidosis triad of skin rash, arthritis, and recurrent uveitis was identified in 5 patients (41.7%), whereas 7 patients (58.3%) presented with fewer than 3 of the classic features. Novel atypical manifestations such as persistent fever and myocardiopathy were also observed. NOD2 analysis revealed 1 heterozygous mutation in each patient, and familial studies confirmed its full penetrance. Of the 12 cases, 58.3% were sporadic, due to de novo mutations. Four different missense mutations on exon 4 were detected. Two of them (R334W and R334Q) were recurrent mutations and were found in 77.8% of the Spanish families, whereas the other 2 (C495Y and R587C) were novel. In the patient who received anakinra treatment, all clinical inflammatory symptoms improved and plasma cytokine levels normalized. Conclusion These findings indicate that the expanding clinical heterogeneity of the disease (that is, the presentation of incomplete forms of the classic triad and atypical manifestations) and the high prevalence of sporadic cases should alert clinicians to the possible genetic basis of the condition and support the inclusion of DNA analysis as a diagnostic test. The positive response to anakinra observed in 1 patient suggests a new potential therapeutic approach that merits further investigation, and suggests that the pathogenesis of pediatric granulomatous arthritis may involve interleukin-1–mediated events.

Objective. To report baseline articular, functional and ocular findings of the first international prospective cohort study of Blau syndrome (BS). Methods. Three-year, multicentre, observational study on articular, functional (HAQ, Childhood HAQ and VAS global and pain), ophthalmological, therapeutic and radiological data in BS patients. Results. Baseline data on the first 31 recruited patients (12 females and 19 males) from 18 centres in 11 countries are presented. Of the 31 patients, 11 carried the p.R334W NOD2 mutation, 9 the p.R334Q and 11 various other NOD2 missense mutations; 20 patients were sporadic and 11 from five BS pedigrees. Median disease duration was 12.8 years (1.1-57). Arthritis, documented in all but one patient, was oligoarticular in 7, polyarticular in 23. The median active joint count was 21. Functional capacity was normal in 41%, mildly impaired in 31% and moderate-severe in 28% of patients. The most frequently involved joints at presentation were wrists, ankles, knees and PIPs. On radiographs, a symmetrical non-erosive arthropathy was shown. Previously unknown dysplastic bony changes were found in two-thirds of patients. Ocular disease was documented in 25 of 31 patients, with vitreous inflammation in 64% and moderate-severe visual loss in 33%. Expanded manifestations (visceral, vascular) beyond the classic clinical triad were seen in 52%. Conclusion. BS is associated with severe ocular and articular morbidity. Visceral involvement is common and may be life-threatening. Bone dysplastic changes may show diagnostic value and suggest a previously unknown role of NOD2 in bone morphogenesis. BS is resistant to current drugs, suggesting the need for novel targeted therapies.

The aim of the present study was to analyse the patterns of treatment adjustment in rheumatoid arthritis (RA) patients with active disease in routine clinical care. This was a cross-sectional study of consecutive patients with RA conducted in five hospitals. Activity scales (DAS28-ESR) and function (HAQ) were measured, as well as whether ultrasound was performed as part of the assessment. Treatment decision (no changes/reduction/intensification) and time to the next scheduled visit were the outcomes variables. Associated factors were analysed by multilevel regression models. A total of 343 patients were included (77 % women, mean age 57 years, mean RA duration 10 years), of whom 44 % were in remission by DAS28. Treatment was continued in 202 (59 %) patients, reduced in 57 (16 %), and intensified in 83 (24 %). In the 117 patients with active RA (DAS28 ≥ 3.2), treatment was intensified in 61 (52 %). Factors associated with treatment intensification were physician and patient VAS, and DAS28, but not the centre. In the multilevel regression analysis with intensification of treatment as dependent variable, the following factors were significantly associated: DAS28 [OR 3.67 (95 % CI 2.43–5.52)], patient VAS [OR 1.04 (95 % CI 1.01–1.08)], and have performed an ultrasound [OR 3.36 (95 % CI 1.47–7.68)]. Factors associated with time to the next scheduled visit (an average of 4.3 months) were patient and physician VAS, DAS28, and centre. In clinical practice, half of the patients with active RA maintain or reduce the treatment. The decision to intensify treatment in active RA as recommended by a treat-to-target strategy is complex in practice.

Background: Cyclooxygenase 2 (COX-2) overexpression is a frequent but not universal event in colorectal cancer. It has been suggested that COX-2 protein expression is reduced in colorectal cancer with a defective mismatch repair (MMR) system, a phenomenon commonly associated with hereditary nonpolyposis colorectal cancer (HNPCC) but also present in up to 15% of sporadic tumors. Aim: To assess COX-2 expression in a large series of fully characterized colorectal cancer patients with respect to the MMR system and to dissect the mechanisms responsible for altered COX-2 expression in this setting. Patients and Methods: MMR-deficient colorectal cancer were identified in a nationwide, prospective, multicenter study (EPICOLON project). Control MMR-proficient colorectal cancer patients were randomly selected. COX-2 expression was evaluated by immunohistochemistry. Personal and familial characteristics, as well as MSH2/MLH1 expression and germ line mutations, were evaluated. Results: One hundred fifty-three patients, 46 with MMR deficiency and 107 with MMR proficiency, were included in the analysis. Overall, tumor COX-2 overexpression was observed in 107 patients (70%). COX-2 overexpression was observed in 85 patients (79%) with a MMR-proficient system, but only in 22 patients (48%) with a MMR-deficient colorectal cancer (P < 0.001). The lack of COX-2 overexpression was independently associated with a MMR-deficient system (odds ratio, 3.89; 95% confidence interval, 1.78-8.51; P = 0.001) and a poor degree of differentiation (OR, 3.83; 95% CI, 1.30-11.31; P = 0.015). In the subset of patients with a MMR-deficient colorectal cancer, lack of COX-2 overexpression correlated with a poor degree of differentiation, no fulfillment of Amsterdam II criteria, absence of MSH2/MLH1 germ line mutations, presence of tumor MSH2 expression, and lack of tumor MLH1 expression. CpG island promoter hypermethylation of COX2 was observed in 6 of 18 (33%) tumors lacking COX-2 expression in comparison with 2 of 28 (7%) tumors expressing this protein (P = 0.04). Conclusions: Up to half of MMR-deficient colorectal cancer do not show COX-2 overexpression, a fact observed almost exclusively in patients with sporadic forms. COX2 hypermethylation seems to be responsible for gene silencing in one third of them. These results suggest the potential utility of nonsteroidal anti-inflammatory drugs in HNPCC chemoprevention and may explain the lack of response of this approach in some sporadic tumors.

Background : Biliary diseases represent particular diagnostic and therapeutic problems in elderly patients. Methods : Patients 90 years of age or older who underwent ERCP from January 1993 to September 2001 were studied retrospectively. Results : A total of 126 patients underwent 147 ERCP procedures (range 1–5 per patient). Twelve additional ERCPs were performed in 9 of the patients during follow-up because of recurrent symptoms. A total of 159 procedures were, therefore, available for analysis. The most frequent indications were suspicion of bile duct stones (46.8%) and obstructive jaundice (35.7%). Midazolam (95.6%) was used for conscious sedation and hyoscine (74.8%) for duodenal ileus. Patient tolerance of the procedure was good in 92.4% of sessions. Diagnoses included bile duct stones (54%), bile duct dilatation without any apparent obstruction (11.9%), and malignant stenosis (9.5%). Therapeutic procedures were indicated in 95.6% of diagnosed patients and completed in 96.3% of cases. Complications occurred in association with 2.5% of the ERCP procedures; the procedure-related mortality rate was 0.7%. Conclusions : ERCP in elderly patients is practicable. The complication rate is low, and therapeutic efficacy is good.

Colorectal cancers (CRCs) that have microsatellite instability (MSI) and mutL homolog 1 (MLH1) immunoloss are observed in 3 clinical scenarios: Lynch syndrome (LS), sporadic MSI CRC, and Lynch-like syndrome (LLS). v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) mutational analysis is used to differentiate LS from sporadic MSI CRC. The role of MLH1 promoter methylation status for the differential diagnosis of these clinical forms is not well established. The objectives of this study were: 1) to analyze MLH1 promoter methylation in MLH1-deficient CRCs by pyrosequencing, and 2) to assess its role in the differential diagnosis of MLH1-deficient CRCs.In total, 165 CRCs were analyzed, including LS (n = 19), MSI BRAF-mutated CRC (n = 37), MSI BRAF wild-type CRC (n = 60), and a control group of CRCs without MSI (microsatellite stable [MSS] CRC; n = 49). MLH1 promoter methylation status was analyzed by pyrosequencing, and the ability of different strategies to identify LS was assessed.The average ± standard deviation methylation in LS (9% ± 7%) was significantly lower than that in MSI BRAF-mutated CRC (42% ± 17%; P .001) and in MSI BRAF wild-type CRC (25% ± 19%; P = .002). Somatic MLH1 hypermethylation was detected in 3 patients (15.8%) with LS, in 34 patients (91.9%) with MSI BRAF-mutated CRC, and in 37 patients (61.7%) with MSI BRAF wild-type tumors. Patients with MSI BRAF wild-type, unmethylated tumors (ie, LLS) had a stronger family history of CRC than those who had tumors with MLH1 methylation (P .05). The sensitivity for ruling out LS was 100% for BRAF analysis, 84.2% for MLH1 methylation analysis, and 84.2% for the combination of both analyses.Somatic MLH1 promoter methylation occurs in up to 15% of LS CRCs. Somatic BRAF analysis is the most sensitive strategy for ruling out LS. Patients who have CRCs with loss of MLH1 protein expression and neither BRAF mutation nor MLH1 methylation resemble patients with LS.

Hypotension and renal failure are well-known complications in patients with obstructive jaundice (OJ) undergoing surgery or experiencing an infection. In 1960, Williams et al 1 showed that the volume of blood that had to be withdrawn from animals with OJ to produce shock was significantly less than in normal controls. Dawson 2 drew attention to the increasing problem of renal failure in patients undergoing surgery for OJ, and suggested that preoperative infusion of mannitol could prevent postoperative renal dysfunction. The use of mannitol infusion, however, has not been validated by prospective studies, 3 and emphasis has been placed on extracellular fluid depletion 4,5 and myocardial dysfunction 6 as causes of hemodynamic disturbances in patients with OJ. Experimental and human studies 7–9 have shown that obstruction of the biliary tract is associated with elevated plasma concentrations of the atrial natriuretic peptide (ANP). These occur despite the moderate volume depletion that is a hallmark of OJ. 4,9 In experimental studies, the most probable origin of increased ANP concentrations was found to be the heart. 8,10 Further investigations showed that increased plasma ANP concentrations return to normal bile flow is restored. 9,11 We conducted this study to investigate whether cardiac function correlates with liver function test results in patients with OJ and whether decreasing ANP concentrations after biliary drainage reflect an improvement of cardiac function. 12,13 Brain natriuretic peptide (BNP) plasma concentrations were also investigated because recent data suggest that they may be a better marker of heart failure development than ANP. 14

Postoperative renal dysfunction in obstructive jaundice (OJ) patients has been associated with hypovolemia and depletion of the extracellular water compartment (ECW). The aim of the study was to evaluate the preoperative status of body compartments in OJ patients measured by two methods. In a prospective study 39 OJ patients (11 benign and 28 malignant obstructions) were investigated, with 15 healthy subjects used as a control group (CG). Bioelectrical impedance analysis (BIA) determinations and values derived from anthropometric measurements were used to assess body compartment status. The coefficient of variation of BIA was below 4% in both OJ and CG subjects. No differences were found in intracellular water. However total body water (TBW) and ECW were reduced in OJ patients (50.5 +/- 4.6 vs. 56 +/- 8% body weight, p = 0.05; and 21 +/- 4.5 vs. 23.8 +/- 2.5% body weight, p0.05, respectively). There were no differences between benign and malignant obstructions. Seventy four percent of OJ patients had an ECW volume below the mean +/- 2 SD in the CG subjects. Anthropometric and BIA determinations correlated closely for TBW measurements in both CG (r = 0.92, p0.001) and OJ patients (r = 0.91, p0.001). Bland-Altman analysis also showed that for TBW the BIA was in agreement with anthropometry. In the present study, BIA offered a good correlation with anthropometric determinations and was a reliable method for body fluid disturbances assessment in jaundiced patients.

Background: The aim of this study was to evaluate the results of endoscopic sphincterotomy in patients with hepatic hydatid cysts that have ruptured into the biliary tract. Methods: Over a 10-year period, 25 patients (11 men, 14 women, mean age 60 years) underwent treatment; 13 with no prior surgery were treated for biliary obstruction. Postoperative treatment was undertaken in 12 cases because of persistent drainage (8), duct obstruction (3), and postoperative pancreatitis (1). Results: In patients who had not undergone previous surgery, cholangiographic findings were hydatid vesicles in the biliary tract (6), dilation of the biliary tract (3), biliary fistula (2), distal stenosis (1), and purulent bile content after sphincterotomy (1). In all of these cases, sphincterotomy resolved duct obstruction with no complications. All patients with persistent postoperative drainage had a fistula tract between the biliary duct and the cavity, which was resolved by endoscopic treatment in all 8. The 3 patients with postoperative biliary obstruction had hydatid vesicles in the biliary tract, one with a long stenosis resembling sclerosing cholangitis, whereas the patient with postoperative pancreatitis had a distal stenosis. Satisfactory results were obtained with endoscopic sphincterotomy, although 1 patient required a biliary prosthesis. Conclusion: Endoscopic sphincterotomy resolves biliary obstruction and postoperative fistulae in most patients with hepatic hydatid cysts that have ruptured into the biliary tract. In some cases, a biliary prosthesis may be required. (Gastrointest Endosc 1998;48:593-7.)

a b s t r a c t Objective: To assess the influence of the implementation of a program for secondary prevention of osteoporotic fractures on prescribing bisphosphonates and persistent short-term treatment. Patients and methods: Patients >50 years of age with fragility fracture attended in the emergency depart- ment were enrolled in an observational study. The program consisted of (1) training of primary care physicians, (2) baseline visit: questionnaire on osteoporosis, bone densitometry and patient education, (3) patient referral to primary care, except those with multiple fractures or requiring special study or therapy, who were referred to a specialist, and (4) follow-up by checking prescriptions in electronic records, and a telephone survey. The outcome variable was the percentage of patients who, on having been prescribed bisphosphonates, still adhered to the treatment at 3 months. Results: Of the 532 patients with inclusion criteria, 202 (39%) refused to participate. Those who refused to take part had a higher mean age (P

The purpose of this study is to evaluate an intervention program in smoker patients. We selected consecutive active smoker patients with rheumatoid arthritis, spondyloarthritis, or connective tissue diseases. The intervention consisted of the following: (1) a baseline visit, which included verbal and written advice by the rheumatologist, emphasizing the practical benefits of smoking cessation. Patients completed a questionnaire that included smoking dependence tests and previous attempts to quit. (2) A follow-up visit to the nurse in the 3rd month for reinforcement and the receiving of pharmacological treatment to help patients quit smoking. The primary outcome was total abstinence in the last 7 days of a phone interview at 3, 6, and 12 months. The secondary outcome was a reduction in cigarette consumption by at least 50 %. A total of 945 patients were screened. About 185 (19.5 %) were current smokers, and 152 were included for intervention. In the previous 5 years, the mean annual withdrawal rate was 4.6 %. The smoking cessation rate was 11.8, 14.4, and 15.7 % at 3, 6, and 12 months (OR compared with previous cessation rate 3.8 (CI 95 % 1.8–8.1)). Twenty-nine patients (19 %) reduced ≥50 % of the cigarette consumption at 12 months. The linear regression analysis showed that a score of less dependence (p = 0.03) and previous attempts to quit smoking (p = 0.04) were significantly associated with definitive smoking cessation at 12 months. One out of six patients quit smoking with the aid of an educational program which included verbal and written advice by the rheumatologist and the nurse. As far as we know, this is the first interventional study in smoker patients with arthritis.

In patients who have undergone partial gastric resections, the difficulty of performing endoscopic retrograde cholangiopancreatography (ERCP) is increased due to the resulting anatomic abnormality.To review our experience of ERCP in patients with Billroth II gastrectomy and other types of gastrectomy (Billroth I and indeterminate) in our center.We included all patients with Billroth II gastrectomy or other types of gastrectomy undergoing ERCP in a 19-year period.We included 233 patients (91% men and 9% women) from 1993 to 2012. A total of 88.4% of the patients had undergone Billroth II and 11.6% had undergone other types of gastrectomy, with an ERCP success rate of 51.9% and 55.6%, respectively. The most common causes of failure were inability to cannulate (44%) and failure to identify the papilla (39.6%). The final diagnosis was choledocholithiasis in 31.8%. The mean number of sessions was 1.09. The complications rate was 2.6%.The success of ERCP is influenced by the technical difficulty. For this reason, the success rate in our center was slightly over 50%, but with few complications.

Pneumatic dilation and surgical myotomy are currently the procedures of choice to treat achalasia. The selection of one or other treatment depends on the experience of each center and patient preferences.To review the experience of pneumatic dilation in patients with achalasia in our center.We included all patients with a clinical, endoscopic and manometric diagnosis compatible with achalasia who underwent pneumatic dilation in a 19-year period. All dilations were routinely performed with a Rigiflex(®) balloon, usually at pressures of 250, 250 and 300mm Hg in three inflations of one minute, each separated by one minute. The success of the dilation was assessed on the basis of the patient's symptoms, the number of sessions, the need for surgery, and the presence of complications.A total of 171 patients were included, 53.2% men and 46.8% women, with a mean age of 51.53±17.78 years (16-87 years), from June 1993 to October 2012. A 35-mm balloon was used in 157 patients, a 30-mm balloon in 9 patients and a 40-mm balloon in 7 patients. A single dilation session was required in 108 patients, two sessions were required in 56 patients, with a mean time between the first and second sessions of 25.23±43.25 months (1-215 months), and 3 sessions were required in 7 patients with a mean time between the second and third sessions of 6.86±5.33 months (1-15 months). Outcome after dilation was successful in 81% of the patients. Of the 140 responders, 121 had complete response (complete disappearance of symptoms without recurrence) and 19 partial response (initial disappearance of symptoms with subsequent reappearance). Surgery (Heller myotomy) was required in 15.8% of the patients. Perforation occurred in 4 of the 171 patients as a complication of the technique; these perforations were satisfactorily resolved, two by conservative treatment and two by surgery. There was no mortality associated with the technique or its complications.In our series, pneumatic dilation had a high success rate. In most patients, a single session was required and the complications rate was low. These results show that this technique is safe and effective in these patients, avoiding a large number of surgical interventions.

Objective To estimate cut-off points and to establish response criteria for the Hospital Universitario La Princesa Index (HUPI) in patients with chronic polyarthritis. Methods Two cohorts, one of early arthritis (Princesa Early Arthritis Register Longitudinal [PEARL] study) and other of long-term rheumatoid arthritis (Estudio de la Morbilidad y Expresion Clinica de la Artritis Reumatoide [EMECAR]) including altogether 1200 patients were used to determine cut-off values for remission, and for low, moderate and high activity through receiver operating curve (ROC) analysis. The areas under ROC (AUC) were compared to those of validated indexes (SDAI, CDAI, DAS28). ROC analysis was also applied to establish minimal and relevant clinical improvement for HUPI. Results The best cut-off points for HUPI are 2, 5 and 9, classifying RA activity as remission if ≤2, low disease activity if >2 and ≤5), moderate if >5 and

Five patients with idiopathic interstitial nephritis and uveitis without bone marrow granulomas were followed-up for 1 year. Ophthalmological examination revealed bilateral anterior uveitis. Light microscopy of the renal tissue revealed predominant lymphocyte infiltration of the interstitium. Immunohistochemical analysis revealed a clear predominance of memory T lymphocytes (CD45RO+) in the interstitial and tubular infiltration. HLA typing, and immunophenotypic studies of peripheral blood mononuclear cells including absolute lymphocyte and monocyte counts were assessed. The patients' peripheral T-cell subpopulation did not significantly differ from control studies. With steroid treatment maintained during a period of 6-9 months renal function and uveitis responded dramatically in all patients. After 1-year follow-up, only 1 patient showed a relapse of uveitis, but there was complete clinical recovery of the nephritis in all 5 patients. The aim of this study was to describe the 1-year follow-up of 5 new cases of acute tubulointerstitial nephritis and uveitis syndrome, and assess some aspects of their cellular immunity.

Objective.We assessed the prevalence of patients with ankylosing spondylitis (AS), rating their state as acceptable (patient-acceptable symptom state; PASS), among 190 patients with AS seen in daily practice. Factors associated with PASS status and PASS thresholds for outcome measures were also analyzed.Methods.The characteristics of patients with affirmative and negative assignment to PASS were compared. Associated factors were estimated by logistic regression models and PASS thresholds by the 75th percentile and receiver-operating characteristic curve methods.Results.A total of 77% of patients rated their state as acceptable (95% CI 62–91). These patients were taking fewer nonsteroidal antiinflammatory drugs and corticosteroids, practiced more exercise, had less anxiety and depression, and had lower values of all patient-reported outcome measures, physicians’ assessment, AS Disease Activity Score (ASDAS) and C-reactive protein. Lower values of Bath AS Disease Activity Index and physician’s global assessment were independent factors associated with acceptable symptom state. High rates of anxiety and depression were found in patients not in PASS. The thresholds with the 75th percentile approach were 4.55 for the BASDAI and 2.84 for the ASDAS. Fifty-three percent of patients in PASS had a high or very high disease activity state according to ASDAS cutoff values.Conclusion.A high percentage of patients with AS in daily practice declared that their symptom state was acceptable. PASS status correlated with physician global assessment and BASDAI. PASS thresholds for common recommended outcome measures were relatively high and many patients in PASS had unacceptably high disease activity states according to ASDAS. Other factors such as psychological problems may influence a negative PASS state.

Sarcoidosis is a systemic disease that only exceptionally affects the gastrointestinal tract. We report the case of a man with systemic sarcoidosis who developed achalasia revealed by esophageal manometry, barium radiographs and echoendoscopy. No response was obtained with steroid therapy, and finally laparoscopic cardiomyotomy was performed with excellent results.

Objective. To assess the determinants of patients’ (PTGL) and physicians’ (MDGL) global assessment of rheumatoid arthritis (RA) activity and factors associated with discordance among them. Methods. A total of 7,028 patients in the Quantitative Standard Monitoring of Patients with RA study had PTGL and MDGL assessed at the same clinic visit on a 0 –10-cm visual analog scale (VAS). Three patient groups were defined: concordant rating group (PTGL and MDGL within 2 cm), higher patient rating group (PTGL exceeding MDGL by >2 cm), and lower patient rating group (PTGL less than MDGL by >2 cm). Multivariable regression analysis was used to identify determinants of PTGL and MDGL and their discordance. Results. The mean SD VAS scores for PTGL and MDGL were 4.01 2.70 and 2.91 2.37, respectively. Pain was overwhelmingly the single most important determinant of PTGL, followed by fatigue. In contrast, MDGL was most influenced by swollen joint count (SJC), followed by erythrocyte sedimentation rate (ESR) and tender joint count (TJC). A total of 4,454 (63.4%), 2,106 (30%), and 468 (6.6%) patients were in the concordant, higher, and lower patient rating groups, respectively. Odds of higher patient rating increased with higher pain, fatigue, psychological distress, age, and morning stiffness, and decreased with higher SJC, TJC, and ESR. Lower patient rating odds increased with higher SJC, TJC, and ESR, and decreased with lower fatigue levels. Conclusion. Nearly 36% of patients had discordance in RA activity assessment from their physicians. Sensitivity to the “disease experience” of patients, particularly pain and fatigue, is warranted for effective care of RA.

Colorectal cancer (CRC) is the second most common cancer in Western countries. Hereditary forms only correspond to 5% of CRC burden. Recently, genome-wide association studies have identified common low-penetrant CRC genetic susceptibility loci. Early-onset CRC (CRC50 years old) is especially suggestive of hereditary predisposition although 85-90% of heritability still remains unidentified. CRC50 patients (n = 191) were compared with a late-onset CRC group (CRC65 years old) (n = 1264). CRC susceptibility variants at 8q23.3 (rs16892766), 8q24.21 (rs6983267), 10p14 (rs10795668), 11q23.1 (rs3802842), 15q13.3 (rs4779584), 18q21 (rs4939827), 14q22.2 (rs4444235), 16q22.1 (rs9929218), 19q13.1 (rs10411210) and 20p12.3 (rs961253) were genotyped in all DNA samples. A genotype-phenotype correlation with clinical and pathological characteristics in both groups was performed. Risk allele carriers for rs3802842 [Odds ratio (OR) = 1.5, 95% confidence interval (CI) 1.1-2.05, P = 0.0096, dominant model) and rs4779584 (OR = 1.39, 95% CI 1.02-1.9, P = 0.0396, dominant model) were more frequent in the CRC50 group, whereas homozygotes for rs10795668 risk allele were also more frequent in the early-onset CRC (P = 0.02, codominant model). Regarding early-onset cases, 14q22 (rs4444235), 11q23 (rs3802842) and 20p12 (rs961253) variants were more associated with family history of CRC or tumors of the Lynch syndrome spectrum excluding CRC. In our entire cohort, sum of risk alleles was significantly higher in patients with a CRC family history (OR = 1.40, 95% CI 1.06-1.85, P = 0.01). In conclusion, variants at 10p14 (rs10795668), 11q23.1 (rs3802842) and 15q13.3 (rs4779584) may have a predominant role in predisposition to early-onset CRC. Association of CRC susceptibility variants with some patient's familiar and personal features could be relevant for screening and surveillance strategies in this high-risk group and it should be explored in further studies.

Objectives To estimate the rate of demyelinating diseases in patients with rheumatic diseases treated with tumor necrosis factor (TNF) antagonists and to describe the cases reported to 3 different pharmacovigilance sources. Methods All confirmed cases of demyelinating disease, optic neuritis, and multiple sclerosis (MS) in patients with rheumatic diseases treated with TNF-antagonists were reviewed from 3 different sources: (1) the Spanish Registry of biological therapies in rheumatic diseases (BIOBADASER); (2) the Spanish Pharmacovigilance Database of Adverse Drug Reactions (FEDRA); and (3) a systematic review (PubMed, EMBASE, and the Cochrane Library). In BIOBADASER, the incidence rate per 1000 patients was estimated with a 95% confidence interval (95% CI). Results In 21,425 patient-years in BIOBADASER, there were 9 patients with confirmed demyelinating disease, 4 with optic neuritis, and 1 with MS. In addition, 22 patients presented polyneuropathies, paresthesias, dysesthesias, facial palsy, or vocal cord paralysis without confirmed demyelination. The incidence rate of demyelinating disease in patients with rheumatic diseases exposed to TNF-antagonists in BIOBADASER was 0.65 per 1000 patient-years (95% CI: 0.39-1.1). The incidence of MS in BIOBADASER was 0.05 (95% CI: 0.01-0.33), while the incidence in the general Spanish population was 0.02 to 0.04 cases per 1000. Compared with BIOBADASER, cases in FEDRA ( n = 19) and in the literature ( n = 48) tend to be younger, have shorter exposure to TNF-antagonists, and recover after discontinuation of the drug. Conclusions It is not clear whether TNF antagonists increase the incidence of demyelinating diseases in patients with rheumatic diseases. Differences between cases depending on the pharmacovigilance source could be explained by selective reporting bias outside registries.

To compare the routine use of musculoskeletal ultrasonography (MSUS) with traditional clinical care in daily practice at shoulder and hand level.An observational study was performed in four rheumatology departments. Within each department, 2 rheumatologists were selected; one rheumatologist used MSUS, and the other followed traditional rheumatology care. Consecutive patients with nontraumatic pain, hand numbness or disability, or pain and/or limitations in the shoulder were selected. We collected information regarding the clinical and MSUS diagnoses, changes in diagnosis and treatment following MSUS, local injections, the rheumatologist's satisfaction and the use of health care resources. A descriptive analysis was performed.A total of 168 patients were analysed, with 104 and 64 patients in the MSUS and traditional care groups, respectively. MSUS led to a diagnosis and therapeutic change in 53 (52%) and 55 patients (54%), respectively. The rate of local injection was 47% in the MSUS group (73% unexpected, 61% performed using US) compared with 21% in the traditional group (p=0.001). According to the rheumatologists, MSUS was useful in 72 cases (71%) and extremely useful in 20 cases (20%), and the rheumatologists reported a higher satisfaction with their patient evaluations (p0.001). The MSUS group required fewer additional tests (38% vs. 81%, respectively, p0.001), fewer medical visits (46% vs. 84%, p0.001), and lower direct costs (11 vs. 30 euros, p0.001) than the traditional care group.Compared with traditional care, the routine use of MSUS in rheumatology practice at hand and shoulder level can lead to important improvements in care, thereby reducing the number of additional tests and medical visits.

ObjectiveTo investigate in rheumatoid arthritis (RA) the rate and reason of discontinuation of tumour necrosis factor (TNF) antagonists over the past decade.MethodsRA patients in BIOBADASER 2.0 were stratified according to the start date of their first TNF antagonist into 2000–3, 2004–6 and 2007–9 interval years. Cumulative incidence function of discontinuation for inefficacy or toxicity was estimated with the alternative reason as competing risk. Competing risks regression models were used to measure the association of study groups with covariates and reasons for discontinuation. Association is expressed as subhazard ratios (SHR).Results2907 RA patients were included in the study. Competing risk regression for inefficacy shows larger SHR for patients starting treatment in 2004–6 (SHR 2.57; 95% CI 1.55 to 4.25) and 2007–9 (SHR 3.4; 95% CI 2.08 to 5.55) than for those starting in 2000–3, after adjusting for TNF antagonists, clinical activity and concomitant treatment. Competing risk regression analysis for adverse events revealed no differences across the three time intervals.ConclusionsIn RA, the discontinuation rate of TNF antagonists in the first year of treatment is higher more recently than a decade ago, inefficacy being the main reason for the increased rate. The rate of discontinuation for adverse events has remained stable.

Objectives. To assess the retention rate of TNF antagonists in elderly patients suffering from chronic arthropathies and to identify predictive variables of discontinuation by inefficacy or by adverse events (AEs). Methods. All patients treated with TNF antagonists in BIOBADASER 2.0, with a diagnosis of either RA or spondyloarthritis (SpA: AS and PsA) were included and classified as

Acute renal failure is a relevant complication in obstructive jaundice (OJ). The extracellular water volume (ECW) depletion and myocardial dysfunction affects haemodynamic and renal disturbance in patients with OJ.A prospective open randomised study was conducted to evaluate the effect of peridrainage saline infusion associated with dopamine administration on hormonal and renal function derangements in 102 patients with malignant OJ. Patients were randomly distributed according to whether (n=64) or not (n=38) received dopamine with saline solution before endoscopic biliary drainage. Furthermore, patients receiving dopamine were randomly distributed whether (n=31) or not (n=33) received additional dopamine administration during the postdrainage phase. Different parameters such as ECW, serum levels of aldosterone, renin, atrial natriuretic peptide (ANP), antidiuretic hormone (ADH), endothelin-1 (ET-1), urine PGE2 and creatinine clearance (CrCl) were analyzed.Fluid administration was accompanied by an increase in the ECW (p=0.01) and an improvement in the CrCl (p=0.01). Dopamine increased CrCl by 11% (p=0.04) and reduced urinary PGE2 concentration (p=0.02). After drainage, a transient worsening of CrCl was seen in patients on i.v. fluid infusion alone but not in dopamine groups (p=0.001). Improvement of CrCl after dopamine administration was found in patients with serum bilirubin16 mg/dl and sodium urine excretion145 mEq/l.The administration of dopamine associated with appropriate i.v. fluid infusion in the peridrainage period has an impact on renal function only in selected patients with malignant biliary obstruction. This effect is more relevant in patients with higher marked cholestasis.

Background: in recent years many factors have been shown to influence dose received by the patient during ERCP. Therefore it is necessary to update radio induced cancer risk. Objectives: to calculate lifetime attributable risk of cancer during ERCP. To compare the risk with the most common X-ray examinations. Design: descriptive study with 393 consecutive ERCP performed at one center. Equipment used was Philips BV pulsera. In each exploration demographic and anthropometric variables of the patient were collected. Dosimetric quantities were calculated from exposure parameters. Effective dose was estimated using specific conversion factors. Organ doses and radio induced cancer incidence was estimated. Results: dose area product was 0.82 mGym² (IQR 0.4-1.5) with an average fluoroscopy time of 2 minutes and 45 seconds. Entrance surface dose was 30.7 mGy (IQR 15-60.8) and effective dose was 0.44 mSv (IQR 0.2-0.9). Multivariate analysis identified that difficult papillary cannulation (β0.4; p = 0.009), patient age (β-0.01; p = 0.001) and therapeutic applied (β= 0.89; p < 0.001) influenced dose-area product. The ERCP dose would be equivalent to the radiation received by twenty chest radiographs and would be about fourteen times smaller than a barium enema or twenty times less than that received during an abdominal CT. Lifetime attributable risk of cancer incidence was 4.08 and 16.81 per million procedures in diagnostic and therapeutic ERCP respectively. Conclusions: from the radiological point of view, ERCP is a safe technique that uses low exposure levels compared to other explorations commonly used in medicine. It implies a reasonably low risk of radio induced cancer.