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Purpose We assessed the efficacy and safety of biologic therapy in severe and refractory Peripheral Ulcerative Keratitis (PUK). Design Open-label multicenter study of biologic-treated patients with severe PUK refractory to conventional immunosuppressive drugs. Subjects We studied 34 patients (44 affected eyes) (24 women/10 men; mean age, 55.26±17.4 years). PUK was associated with a well-defined condition in 29 of them (rheumatoid arthritis [n = 20], psoriatic arthritis [n = 2], inflammatory bowel disease [n = 2], Behcet disease [n = 1], granulomatosis with polyangiitis [n = 1], microscopic polyangiitis [n = 1], systemic lupus erythematosus [n = 1] and axial spondyloarthritis [n = 1]). Besides topical and oral systemic glucocorticoids, patients had received: methylprednisolone pulses [n = 9], and conventional immunosuppressive drugs, mainly methotrexate [n = 18], and leflunomide [n = 7]. Eleven patients had required ocular surgery prior to biologic therapy. Methods Following biologic therapy, baseline main outcomes were compared with those found at 1st week, 1st and 6th months and 1st year. Main outcome measures Efficacy and safety of biologic therapy. Efficacy was analyzed by the assessment of corneal inflammation (corneal thinning, central keratolysis and ocular perforation); other causes of ocular surface inflammation (scleritis, episcleritis); intraocular inflammation (uveitis); visual acuity and glucocorticoid sparing effect. Results The first biologic agents used were anti-TNFα drugs (n = 25); adalimumab (n = 16), infliximab (n = 8), etanercept (n = 1), and non-TNFα agents (n = 9); rituximab (n = 7), tocilizumab (n = 1) belimumab (n = 1) and abatacept (n = 1). During the follow-up, switching to a second biologic agent was required in 12 of the 25 (48%) patients treated with anti-TNFα drugs. However, no switching was required in those undergoing biologic therapy different from anti-TNFα agents. The main outcome variables showed a rapid and maintained improvement after a mean follow-up of 23.7 ± 20 months. Major adverse effects were tachyphylaxis, relapsing respiratory infections, supraventricular tachycardia, pulmonary tuberculosis and death, one each. Conclusions Biologic therapy is effective and relatively safe in patients with severe and refractory PUK. Non-anti-TNFα agents appear to be effective in these patients.

This study aimed at determining socio-demographic and clinical factors of primary Sjögren syndrome (pSS) associated with osteoporosis (OP) and fragility fracture. SJOGRENSER is a cross-sectional study of patients with pSS, classified according to American European consensus criteria developed in 33 Spanish rheumatology departments. Epidemiological, clinical, serological and treatment data were collected and a descriptive analysis was conducted. Bivariate and multivariate analyses were performed using a binomial logistic regression to study the factors associated with OP and fragility fracture in pSS. 437 patients were included (95% women, with a median age of 58.6 years). 300 women were menopausal (76.4%). Prevalence of OP was 18.5% [in men (N = 21) this measured 19%]. A total of 37 fragility fractures were recorded. In the multivariate analysis, there was an association between OP and age: in the 51-64 age range (menopausal women), the OR measured 9.993 (95% CI 2301-43,399, p = 0.002); In the age 64 years group, OR was 20.610 (4.679-90.774, p 0.001); between OP and disease duration, OR was 1.046 (1.008-1085, p = 0.017); past treatment with corticosteroids, OR 2.548 (1.271-5.105, p = 0.008). Similarly, an association was found between fragility fractures and age: in the 51-64 age group, OR measured 5.068 (1.117-22,995, p = 0.035), age 64 years, OR was 7.674 (1.675-35,151, p 0.009); disease duration, OR 1.049 (CI 1.003-1097, p 0.036) and the ESSDAI index, OR 1.080 (1.029-1134, p = 0.002). Patients with pSS can develop osteoporosis and fragility fractures over the course of the disease. Age, corticosteroids treatment and disease duration were associated with the development of OP. Disease duration and ESSDAI were associated with the development of fractures in patients with pSS.

[ES] El objetivo de este estudio es analizar los acontecimientos adversos acaecidos en una cohorte de pacientes con Artritis Reumatoide tratados con fármacos anti-TNFα en la práctica diaria y su asociación con factores genéticos, clínicos o sociodemográficos., [EN] The aim of this study is to analyze adverse events occurring in a cohort of patients with rheumatoid arthritis treated with anti-TNF drugs in daily practice and its association with genetic, clinical, or demographic.

To assess the plasma apolipoprotein B/apolipoprotein A1 ratio and its potential association with cardiovascular events (CVE) in patients with rheumatoid arthritis (RA).A baseline analysis was made of the CARdiovascular in rheuMAtology Project (CARMA), a 10-year prospective study evaluating the presence of at least one CVE in 775 Spanish patients with RA. Of them, 29 had already experienced CVE prior to the inclusion in the study. We assessed the association between the elevation of the apoB/apoA1 ratio with the presence of CVE according to a logistic regression model for possible confounding factors. We also analysed the main parameters of activity of RA and parameters related to lipid metabolism. RA patients were classified according to treatment: patients treated with disease-modifying anti-rheumatic drugs without biologics and those undergoing biologic therapy (anti-TNF-α, anti-IL-6 receptor, and other biologic agents).The apoB/apoA1 ratio of patients who had experienced CVE was higher than that of patients without previous CVE (0.65 vs. 0.60). However, the difference between both subgroups did not reach statistical significance (p=0.197). It was also the case after the multivariate analysis [OR: 1.48 (95% CI: 0.15-14.4); p=0.735]. RA patients from the group with CVE were more commonly receiving lipid-lowering treatment with statins than those without CVE history (41.4% vs. 20%, p=0.005). High HAQ and high atherogenic index were significantly associated with the presence of CVE. There was no statistical association between the type of biologic therapy used in RA and the presence of CVE.No association between ApoB/apoA1 ratio and CVE was found at the baseline visit of patients with RA from the CARMA study.

Background:Giant cell arteritis (GCA) may be divided into cranial, and extracranial GCA. Tocilizumab (TCZ) has shown efficacy and safety in GCA and other large-vessel vasculitis (LVV) (1-5).Objectives:To compare the efficacy of TCZ in cranial and extracranial GCA.Methods:Multicenter observational study of 312 patients with GCA treated with TCZ. They were divided into 3 groups a) only cranial (cGCA), b) only extracranial (ecGCA), c) mixed affection (mixGCA). GCA was diagnosed by a) ACR criteria, and/or b) positive temporal artery biopsy, and/or c) LVV by imaging. Remission and sustained remission was defined according to EULAR definitions (1). In ecGCA and mixGCA we also studied the improvement (complete or partial) by imaging techniques.Results:We studied 312 patients (218 females; mean age, 73.4±9.6 years). TABLE shows the main features of the 3 groups. Remission at month 6 was higher in cGCA, as well as the sustained remission at month12 (FIGURE). At 18 and 24months, were similar in the 3 groups. Improvement by imaging techniques was partial/complete at 6,12,18 and 24 months, in 50%/0%,71%/0%, 61%/15% and 67%/17% respectively, in ecGCA, and in 75%/0%,53%/18%, 64%/12% and 50%/28% in mixGCA.Table 1.Main features of 312 patients at TCZ onset.Cranial GCA(n=152)Extracranial GCA(n=49)Mixed GCA(n=111)Cranial vs Extracranial GCApAge at TCZ onset, years, mean± SD76.0±8.265.4±12.273.5±8.10.000*Sex, female/male, n (% female)105/47 (69)33/16 (67)80/31 (72)0.960Time from diagnosis to TCZ onset (months, median [IQR]6 [2-21]7 [2-20]9 [3-25]0.765Biopsy-proven GCA, n (%)87/128 (68)0 (0)50/87 (57)0.000*Systemic manifestations at TCZ onset109 (72)32 (65)84 (76)0.501Fever, n (%)18 (12)1 (2)8 (7)0.048*Constitutional syndrome, n (%)52 (34)16 (33)47 (42)0.933PmR, n (%)88 (58)29 (59)71 (64)0.999Ischemic manifestations at TCZ onset117 (77)0 (0)70 (63)0.000*Visual involvement, n (%)31 (20)0 (0)16 (14)0.000*Headache, n (%)103 (85)0 (0)63 (57)0.000*Jaw claudication, n (%)39 (26)0 (0)21 (19)0.000*Acute phase reactantsESR, mm/1st hour, median [IQR]28 [9-53]24 [10-43]28 [15-48]0.462CRP, mg/dL, median [IQR]1.2 [0.3-3.4]0.7 [0.4-1.8]1.6 [0.4-3.8]0.153Prednisone dose at TCZ onset, mean ± SD26.2±17.615.4±14.220.1±14.90.000*TCZmono/TCZcombo, n (% TCZ mono)116/36 (76)26/23 (53)69/42 (62)0.003*Follow-up (months), mean ± SD27.3±21.132.7±23.327.9±22.00.143Figure 1.Remission and sustained remission of cGCA, ecGCA and mixGCA according to EULAR (1). In the first 3 months we only could assess cGCA because in ecGCA and mixGCA a control imaging was not performedConclusion:TCZ seems to be effective in all phenotypes but it is faster in cGCA in reaching remission. However, improvement by imaging techniques was partial and very rarely complete in ecGCA and mixGCA.References:[1]Hellmich B, et al. Ann Rheum Dis. 2020; 79: 19-30.[2]Stone JH, et al. N Engl J Med. 2017; 377: 317-28.[3]Calderón-Goercke M, et al. Semin Arthritis Rheum 2019; 49:126-35. https://doi.org/10.1016/j.semarthrit.2019.01.003.[4]Prieto Peña D et al. Clin Exp Rheumatol 2020 Nov 27. PMID: 33253103.[5]Loricera J, et al. Clin Exp Rheumatol 2016; 34:S44-53. PMID: 27050507Disclosure of Interests:Lara Sanchez-Bilbao: None declared, Javier Loricera: None declared, Vicente Aldasoro: None declared, Juan Pablo Valdivieso-Achá: None declared, Ignacio Villa-Blanco: None declared, Olga Maiz: None declared, Rafael Melero: None declared, Clara Moriano: None declared, Julio Sánchez: None declared, Eugenio de Miguel: None declared, Eva Perez-Pampín: None declared, Juan Ramón De Dios: None declared, Juan Carlos Nieto González: None declared, Eva Galíndez-Agirregoikoa: None declared, Patricia Moya: None declared, Francisca Sivera: None declared, José Luis Andréu Sánchez: None declared, Valvanera Pinillos: None declared, Andrea García-Valle: None declared, Paloma Vela-Casasempere: None declared, Noelia Alvarez-Rivas: None declared, Marcelino Revenga: None declared, Sara Manrique Arija: None declared, Carlos Fernández-López: None declared, Enrique Raya: None declared, Cristina Hidalgo: None declared, Ruth López-González: None declared, Cristina Campos Fernández: None declared, Antonio Juan-Mas: None declared, Beatriz Arca: None declared, Iñigo Rua-Figueroa: None declared, María Dolors Boquet: None declared, Antonio García: None declared, Adela Gallego: None declared, Eva Salgado-Pérez: None declared, Miguel A González-Gay Speakers bureau: Abbvie, Pfizer, Roche, Sanofi, Lilly, Celgene and MSD, Grant/research support from: Abbvie, MSD, Jansen and Roche, Ricardo Blanco Speakers bureau: Abbvie, Lilly, Pfizer, Roche, Bristol-Myers, Janssen, UCB Pharma and MSD, Grant/research support from: Abbvie, MSD and Roche

Objective: To compare the prevalence of the main comorbidities in two large cohorts of patients with Primary Sjogren's Syndrome (pSS) and Systemic Lupus Erythematosus (SLE), with focus on cardiovascular (CV) diseases. Methods: Cross-sectional multicenter study where the prevalence of more relevant comorbidities in two cohorts was compared. Patients under follow-up from the SJOGRENSER (Spanish Rheumatology Society Register of pSS) and RELESSER (Spanish Rheumatology Society Register of SLE) registries, and who fulfilled the 2002-AECG and 1997-ACR classification criteria, respectively, were included. A binomial logistic regression analysis was carried out to explore potential differences, making general adjustments for age, sex and disease duration and specific adjustments for each variable, including CV risk factors and treatments, when it was judged appropriate. Results: A total of 437 pSS patients (95% female) and 2,926 SLE patients (89% female) were included. Mean age: 58.6 (p55-p75: 50.0-69.9) and 45.1 years (36.4-56.3), respectively (p

Objectives:Since obesity has been associated with higher inflammatory burden and worse response to therapy in patients with chronic inflammatory joint diseases (CIJDs), we aimed to confirm the potential association between body mass index (BMI) and disease activity in a large series of patients with CIJDs included in the Spanish CARdiovascular in rheuMAtology (CARMA) registry.Methods:Baseline data assessment of patients included from the CARMA project, a 10-year prospective study of patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA) attending outpatient rheumatology clinics from 67 Spanish hospitals. Obesity was defined when BMI (kg/m2) was>30 according to the WHO criteria. Scores used to evaluate disease activity were DAS28 in RA, BASDAI in AS, and modified DAS for PsA.Results:Data from 2,234 patients (775 RA, 738 AS and 721 PsA) were assessed. The mean±SD BMI at the baseline visit were: 26.9±4.8 in RA, 27.4±4.4 in AS and 28.2±4.7 in PsA. Multivariate analyses shown a positive association between BMI and disease activity in patients with RA (β-coefficient: 0.029; 95% CI: 0.01-0.05; p=0.007) and in those with PsA (β-coefficient: 0.036; 95% CI: 0.015-0.058; p=0.001). By contrast, there was no significant association between BMI and disease activity in patients with AS (β-coefficient: 0.001; 95% CI: -0.026-0.03; p=0.926).In patients with RA, female gender (β-coefficient: 0.546; 95% CI: 0.316-0.775; pBesides BMI, female gender (β-coefficient: 0.720; 95% CI: 0.524-0.916; pAs observed in RA and PsA, female gender was also associated with disease activity patients with AS (β-coefficient: 0.565; 95% CI: 0.299-0.832; pConclusion:BMI is associated with disease activity in RA and PsA but not in AS. Since obesity is a potentially modifiable factor, disease activity was associated with female gender and RF status in RA and with Psoriasis Area Severity Index and enthesitis in PsA. Adequate control over body weight may improve the outcome of patients with CIJDs and, therefore, weight control should be included in the strategy of management of these patients.Disclosure of Interests:Ruth López-González: None declared, Jesús Alejandro Valero Jaimes: None declared, Maria Auxiliadora Martin-Martinez: None declared, Santos Castañeda: None declared, Carmen García Gomez: None declared, Fernando Sánchez-Alonso: None declared, Carlos Gonzalez Juanatey: None declared, Eva Revuelta-Evrad: None declared, Carolina Perez-Garcia: None declared, Vicenç Torrente Segarra: None declared, Trinidad Pérez Sandoval: None declared, Javier Llorca: None declared, Miguel A González-Gay Grant/research support from: Pfizer, Abbvie, MSD, Speakers bureau: Pfizer, Abbvie, MSD

Objectives:Primary Sjögren´s Syndrome (pSS) is characterized by hyperactivity of the B cell, with the consequent production of autoantibodies. The presence of anti-Ro and anti-La has been associated with extraglandular manifestations and lymphoma development. The aim of this study is to evaluate the frequency of different serological profiles in patients of SJOGRENSER registry and to assess whether the combination of antibodies and serological markers are associated with the development of systemic disease and the systemic illness and/or the development of systemic disease and complications.Methods:SJOGRENSER is a transversal multicenter study with pSS patients (patients who meet 2002 pSS classification criteria); it is collected demographic, clinical, serological data and the activity index: ESSDAI and ESSPRI. It was established three serological profiles: 1. ANA/Ro+ with La/RF-; 2. ANA/Ro/La+ with RF-; 3. ANA/Ro/La/RF+. A descriptive analysis was done, with means and standard deviations, frequencies and proportions. Student t for quantitative variables and Chi2 for qualitative ones were performed to evaluate differences between groups, it was considered a p Results:Four hundred and thirty-seven patients were included, the most frequent serological patterns observed were: ANA/Ro/La/RF+ 221 patients (50.5%), ANA/Ro/La+ 61 patients (13.9%) and ANA/Ro+ 60 patients(13.7%). There were only two patients with ANA/La +. The ESSDAI score was significantly associated with the profile ANA/Ro/La/RF+ (6 vs 4, p=0.007) and the group with the ANA/Ro/La+ profile reached an ESSDAITable 1.Serological markers associated with the development of systemic diseaseInvolvementProfile 1ANA +Anti-Ro +Anti-La -RF –n=60N° (%)Profile 2ANA +Anti-Ro +Anti-La +RF –n= 61N° (%)Profile3ANA +Anti-Ro +Anti-La +RF +n= 221N°(%)pESSDAI index4460.007ESSDAI44 (73.3)48 (78.7)139 (63.2)0.043ESSPRI index6.15.35.00.007Constitutional syndrome5 (8.3)9 (14.8)51 (23.1)0.023Lymphadenopathy8 (13.3)9 (14.8)37 (16.7)0.790Glandular14 (23.3)16 (26.2)87 (39.4)0.024Articular49 (81.7)40 (65.6)187 (84.6)0.004Lung3 (5.0)4 (6.6)29 (13.2)0.100Kidney0 (0)5 (8.2)31 (14.1)0.006Peripheral nervous system5 (8.3)6 (9.8)18 (8.2)0.918Central nervous system4 (6.7)7 (11.5)13 (5.9)0.320Hematological24 (40.0)26 (42.6)147 (66.5)Biologic5 (8.3)4 (6.6)26 (11.8)0.428Lymphoma1 (1.7)2 (3.3)3 (1.4)0.598In contrast to the ESSPRI index was lower significantly associated with the profile ANA/Ro/La/RF+ and higher in the ANA/Ro+ (5 vs 6.1, p=0.007). The presence of antiLa and/or RF to the profile ANA/Ro+ rises the percentage of patients with constitutional syndrome, glandular, kidney and hematological affectation with statistically significant differences. The percentage of patients with articular involvement it was similar in the profiles ANA/Ro+ and ANA/Ro/La/RF +.The multinomial analysis showed that the profile ANA/Ro/La/RF+ was associated with higher ESSDAI values (OR=1.09 (1.01-1.17)). The hematological involvement was associated with the profiles ANA/Ro/La/FR+ (OR= 2.76 (1.46-5.22)). Higher scoring of ESSPRI was associated with the profile ANA/Ro+ (OR=0.79 (0.69-0.91)).Conclusion:The most frequent serological profile was ANA/Ro/La/RF+ and it was associated with higher ESSDAI score. The presence of antiLa and/or RF with an ANA/Ro+ increased the presence of systemic involvement. The ANA/Ro+ profile was associated with a higher level of ESSPRI.Disclosure of Interests:None declared

To determine the incidence and risk factors of first cardiovascular event (CVE) in patients with chronic inflammatory rheumatic diseases (CIRD).Analysis of data after 2.5 years of follow-up from the prospective study CARMA project, that includes patients with CIRD [rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA)] and matched individuals without CIRD from 67 hospitals in Spain. CVE cumulative incidence per 1000 patients was calculated after 2.5 years from the start of the project. Weibull proportional hazard model was used to calculate hazard ratio (HR) and 95% confidence interval (95% CI) of the risk factors.2595 (89.1%) patients completed the 2.5 years of follow-up visit. Cumulative incidence of CVE in patients with CIRD was 15.30 cases per 1000 patients (95% CI: 12.93-17.67), being higher in the subgroup with AS; 22.03 (95% CI: 11.01-33.04). Patients with AS (HR: 4.11; 95% CI: 1.07-15.79), those with older age (HR: 1.09; 95% CI: 1.05-1.13), systolic hypertension (HR: 1.02; 95% CI: 1.00-1.04) and long duration of the disease (HR: 1.07; 95% CI: 1.03-1.12) were at higher risk of first CVE during the 2.5 years of follow-up. In contrast, female gender was a protective factor (HR: 0.43; 95% CI: 0.18-1.00).Among CIRD patients prospectively followed-up at rheumatology outpatient clinics, those with AS show higher risk of first CVE. Besides cardiovascular risk factors, such as hypertension, being a man and older as well as having a long disease duration increase the risk of CVE in patients with CIRD.

Background This study shows that treatment with biologic drugs, including ant-TNF drugs, in NION associated to IMIDs, refractory to conventional treatment, seems to be effective. These results must be confirmed in prospective and randomised trials. Objectives Our aim was to compare anti-TNFα vs Rituximab (RTX) in refractory PUK. Methods Multicenter study of 24 patients with PUK. All of them presented inadequate response to corticosteroids and at least 1 systemic traditional immunosuppressive drug. Anti-TNFα were used in 17 patients: Adalimumab (n=9) 40 mg/sc every 1–2 weeks, infliximab (IFX) (n=7) 3–5 mg/kg iv/4–6 weeks, etanercept (n=1) 50 mg/week. RTX was used in 7 patients 1–2 g i.v. every 6 or 12 months. The main outcomes were Best Corrected Visual Acuity (BCVA), signs of inflammation (scleritis and episcleritis), progression to corneal thinning, central keratolysis and ocular perforation. Results We studied 24 patients/32 affected eyes. The underlying diseases in the anti-TNFα group were Rheumatoid Arthritis (RA) (n=14), Psoriatic Arthritis (n=2) and Behcet Disease (n=1); and in the RTX group: RA (n=5), granulomatous polyangiitis (n=1) and microscopic polyangiitis (n=1). At baseline there were no significant differences between both groups in general features or in ocular involvement (table 1). Before biologic therapy they had received the following systemic drugs (anti-TNFα vs RTX) i.v. methylprednisolone (2 vs 4), doxycycline (7 vs 1), ascorbic acid (2 vs 0), MTX (11 vs 4), AZA (1 vs 2) and others (7 vs 3). In addition,10 patients, in both groups, had required surgery: amniotic membrane (n=5), penetrating keratoplasty (n=2), conjunctival resection (n=2), tissue adhesives (n=2), conjunctival flap (n=1) and lamellar keratoplasty (n=1). Once the treatment was initiated the ocular outcome was similar (table 1). After a mean follow-up of 22.53±22.60 (anti-TNFα) and 22.28±8.28 months with RTX the following severe side effects were observed: supraventricular tachycardia (n=1) with RTX and pulmonary tuberculosis (n=1) with IFX. Conclusions In this study, anti-TNFα therapy and RTX were equally effective for the treatment of peripheral ulcerative keratitis associated to rheumatic diseases refractory to conventional treatment. Disclosure of Interest None declared

Background Plasma concentrations of lipoprotein (a) (Lp(a)), a lipoprotein with atherogenic and thrombogenic properties, have a strong genetic basis, although high concentrations of Lp(a) have also been reported in the context of inflammation, as in rheumatoid arthritis (RA). Few studies evaluate the impact of biologic therapies (BT) on Lp(a) in RA, taking into account that with these new therapies a better control of inflammation is achieved. Objective The aim of the study was to evaluate the plasma concentrations of Lp(a) in Spanish RA patients on BT attending rheumatology outpatient clinics. Methods Baseline analysis of the CARdiovascular in rheuMAtology project, a 10-year prospective study, evaluating the risk of cardiovascular events in RA and other forms of inflammatory arthritis. RA patients were classified according to treatment: no biologic, anti-tumor necrosis factor, anti-interleukin-6 receptor tocilizumab (TCZ), and other biologic (rituximab or abatacept). A model of linear multivariate regression was built in which the dependent variable was Lp(a) concentration and the explanatory variable was BT. The model was adjusted for confounding factors. Results Seven hundred and seventy-five RA patients were analyzed. Plasma concentrations of total cholesterol and triglyceride were significantly higher in TCZ-treated patients. Nevertheless, no significant difference in the atherogenic index between TCZ-treated patients and patients without BT was found. After adjusting for confounding factors, patients with BT had lower concentrations of Lp(a) than those without BT; however, only TCZ-treated patients achieved statistically significant differences (?: ?0.303, 95% confidence interval: ?0.558 to ?0.047; P = .02). Conclusions RA patients treated with TCZ show lower plasma concentrations of Lp(a) compared with patients without BT. This project has been supported by an unrestricted grant from Abbvie, Spain. The design, analysis, interpretation of results, and preparation of the article have been done independently of Abbvie. Dr González-Gay's studies have been supported by grants from “Fondo de Investigaciones Sanitarias” PI06/0024, PS09/00748, and PI12/00060 and RD12/0009/0013 (RIER) from “Instituto de Salud Carlos III” (ISCIII) (Spain).

a b s t r a c t Objective: To evaluate the degree of agreement between primary care physicians and rheumatologists when evaluating the referral criteria in patients with suspected early spondyloarthropathy (Spa). Material and methods: Patients with suspected early Spa (according to predefined clinical referral criteria) were sent by primary care physicians to early Spa units (where a rheumatologist evaluated the same criteria and confirmed the diagnosis) through an on-line platform. We assessed the agreement between primary care physicians and rheumatologists regarding the predefined clinical refererral criteria among patients with definitive Spa using the kappa index (k). Results: Eight hundred and two patients were analysed, 8.31% of whom were incorrectly referred to the rheumatologist. The degree of agreement regarding the predefined clinical referral criteria was poor for inflammatory back pain (k = 0.16; 95% confidence interval (95% CI) 0.09-0.23), radiographic sacroiliitis (k = 0.31; 95% CI 0.211-0.428), back or joint pain (k = 0.21; 95% CI 0.14-0.29); mild for asymmetric arthritis (k = 0.51; 95% CI 0.43-0.59), positive HLA B27 (k = 0.59; 95% CI 0.52-0.67) and family history (k = 0.50; 95%

The aim of this work was to assess the variability in the use of health-care resources, based on the number of visits to rheumatology departments by rheumatoid arthritis patients, in Spain, and its association with patient, physician and center characteristics. The sample consisted of patient records of men and women (aged 16 or older), with a clinical diagnosis of RA, who met the American Rheumatism Association 1987 revised criteria and who had been treated in a rheumatology department at a Spanish hospital with at least one visit to a rheumatologist during the two years preceding the date of the study. To analyze which variables were independently associated with the number of consultations, those with a statistically significant result in the bivariate analysis, or which were clinically relevant or deemed confounders, were used in the construction of a linear regression model. The records of 1188 RA patients were studied. The linear regression model explained the 26.67 % of the variability in the number of visits. The number of csDMARDs prescribed, the administration of biological therapy, corticoid prescription, the presence of nursing consultation, mean time to first visit in the department and attended population showed a positive significant association, while the presence of telephone consultation, distance from the hospital to the patient´s residence (≥20 km) and drug monitoring by rheumatology department + primary care physician or by other specialists were negatively associated with the number of consultations. We observed a high variability in the number of visits, which remains partially unexplained even after taking into account individual, physician and center characteristics.

To compare the prevalence of the main comorbidities in 2 large cohorts of patients with primary Sjögren's syndrome (SS) and systemic lupus erythematosus (SLE), with a focus on cardiovascular (CV) diseases.This was a cross-sectional multicenter study where the prevalence of more relevant comorbidities in 2 cohorts was compared. Patients under followup from SJOGRENSER (Spanish Rheumatology Society Registry of Primary SS) and RELESSER (Spanish Rheumatology Society Registry of SLE), and who fulfilled the 2002 American-European Consensus Group and 1997 American College of Rheumatology classification criteria, respectively, were included. A binomial logistic regression analysis was carried out to explore potential differences, making general adjustments for age, sex, and disease duration and specific adjustments for each variable, including CV risk factors and treatments, when appropriate.A total of 437 primary SS patients (95% female) and 2,926 SLE patients (89% female) were included. The mean age was 58.6 years (interquartile range [IQR] 50.0-69.9 years) for primary SS patients and 45.1 years (IQR 36.4-56.3 years) for SLE patients (P 0.001), and disease duration was 10.4 years (IQR 6.0-16.7 years) and 13.0 years (IQR 7.45-19.76 years), respectively (P 0.001). Smoking, dyslipidemia, and arterial hypertension were associated less frequently with primary SS (odds ratio [OR] 0.36 [95% confidence interval (95% CI) 0.28-0.48], 0.74 [95% CI 0.58-0.94], and 0.50 [95% CI 0.38-0.66], respectively) as were life-threatening CV events (i.e., stroke or myocardial infarction; OR 0.57 [95% CI 0.35-0.92]). Conversely, lymphoma was associated more frequently with primary SS (OR 4.41 [95% CI 1.35-14.43]). The prevalence of severe infection was lower in primary SS than in SLE (10.1% versus 16.9%; OR 0.54 [95% CI 0.39-0.76]; P 0.001).Primary SS patients have a consistently less serious CV comorbidity burden and a lower prevalence of severe infection than those with SLE. In contrast, their risk of lymphoma is greater.

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

To describe, in a 7-year follow-up study, the use of infliximab in patients with refractory posterior uveitis and scleritis.A 7-year follow-up case series study was performed. Patients with posterior uveitis and scleritis refractory to conventional therapies (steroids and at least one immunosuppressive agent) were included. Three infliximab intravenous doses of 5 mg/kg were administered at weeks 0, 2, and 6. Further infusions were allowed in patients undergoing a relapse of the uveitis after initial remission. All patients were followed up for at least 8 months. We defined uveitis improvement as an increase in the best-corrected visual acuity or an objective and significant improvement in retinal exudates and/or haemorrhages, cystoid macular oedema (CME), and vitreous haze. Infliximab-related adverse events, final prednisone doses, and the number of immunosuppressive agents used were recorded. A descriptive analysis was performed.A total of 11 patients (17 eyes were affected at baseline) were included, 63% were women, the mean age was 43+/-14 years, and the median follow-up was 80 months (p25-p75: 50-80). After infliximab treatment, six eyes maintained their basal visual acuity, nine eyes showed improvement, and two worsened (in the two patients diagnosed with choroiditis). Vitreous haze, active retinal vasculitis, and CME, but not chorioretinal lesions, improved in all patients. All patients tapered their daily steroid dose and the number of immunosuppressive agents. No infliximab-related adverse events were reported.Infliximab could be an effective and safe treatment in patients with posterior uveitis and scleritis refractory to conventional therapy.

Objetivo: Analizar el cambio en el tiempo hasta el primer tratamiento con farmacos modificadores de la enfermedad (FAME) desde el inicio de los sintomas en pacientes diagnosticados de artritis reumatoide (AR) a lo largo de dos decadas en Espana. Pacientes y metodo: Revision de historias clinicas de 865 pacientes diagnosticados de AR atendidos en centros de atencion especializada del Sistema Nacional de Salud en Espana. La variable principal fue el tiempo desde el inicio de los sintomas de la AR hasta la fecha del inicio del primer tratamiento con algun FAME. Las diferencias por ano desde el inicio de los sintomas o agrupaciones de 5 anos se compararon mediante la prueba de la x2, la t de Student y el analisis de la variancia. Resultados: Las caracteristicas clinicas y sociodemograficas se correspondieron con las tipicas de una muestra de corte transversal de pacientes diagnosticados de AR. La mediana del tiempo desde el inicio de los sintomas y el primer tratamiento con FAME fue de 14 (6-36) meses para el conjunto de la muestra. Se observo, sin embargo, una reduccion significativa del tiempo hasta el primer FAME en las ultimas dos decadas (­4,59 ± 0,2 meses por ano entre 1980 y 2000; p < 0,0001). Esta disminucion se debio principalmente a una reduccion en el tiempo hasta la primera visita con un especialista desde el inicio de los sintomas, con una reduccion comparativamente menor en el tiempo entre la primera visita y la primera prescripcion del FAME. Conclusiones: Entre los anos 1980 y 2000 se ha producido en Espana una disminucion muy significativa en el tiempo que tardan los pacientes con AR en recibir su primer FAME, motivada principalmente por una reduccion en el tiempo de acceso al especialista que prescribe estos tratamientos

To analyze changes in the lag time to first disease modifying antirheumatic drug (DMARD) prescription since onset of symptoms of rheumatoid arthritis (RA) over the last 2 decades in Spain.Review of medical records of 865 patients diagnosed with RA living in Spain and attended in specialty care settings of the National Health System. The principal variable was the lag time between the onset of symptoms of RA and the date of first DMARD therapy prescription. Analyses were performed by year and five-year periods and differences between groups were assessed by χ(2) test, Student t test and analysis of variance.Sociodemographic and clinical characteristics corresponded to a typical cross-sectional population of patients diagnosed with RA. The median lag time between symptom onset and first DMARD therapy was 14 months (6-36) for the whole group. However, a significant shortening of time to first DMARD was observed over the last two decades (-4.59±0.2 months by year; P001). Shortening of time to first DMARD was mainly due to a shortening of time to first visit with specialists since onset of symptoms with a smaller decrease in time from first visit to first prescription of a DMARD agent.A significant shortening in the lag time to first DMARD therapy was observed over the last 2 decades in Spain, being a significant reduction in the time to first visit with a specialists its major cause.

Resumen Este trabajo pretende realizar una revision de los articulos publicados en relacion con los factores asociados al desarrollo de efectos secundarios en pacientes con artritis reumatoide (AR) tratados con anti-factor de necrosis tumoral alfa (anti-TNFα). Los efectos secundarios asociados mas relevantes estudiados en este trabajo son los procesos infecciosos, los episodios cardiovasculares, el desarrollo de neoplasias y el riesgo de mortalidad.

To analyse the evidence on adherence to biologic therapies in rheumatoid arthris (RA), spondyloarthritis (SpA), and psoriatic arthritis (PsA).Systematic review of studies retrieved by a sensitive search strategy in MEDLINE database (1961 through March 2012). To be selected, studies had to include patients with RA, SpA, or PsA, treatment with intravenous or subcutaneous biologic therapies, and had to report on measures of adherence. By design, only randomised controlled trials (RCT) or high quality cohort studies with a control group were selected.A total of 24 studies were included, of which 12 reported results from national or local biologic registers, 9 were retrospective studies, 2 prospective studies, and only one was an RCT. Patients included were mostly women with diagnosis of RA or SpA and, less frequently, PsA. There was a great variability in the definition of adherence, measurement methods, and associated factors analysed. In general, adherence to etanercept was superior to that of other biologics, by the measures utilised. The main predictive factors - age, sex, comorbidity, baseline clinical condition, previous or concomitant use of DMARDs, anti-TNF in monotherapy or in combination with MTX - produced diverse, even divergent results across studies.There is a wide variability related to the adherence concept and its measurement, reflecting the complexity of the phenomenon. In order to draw more consistent conclusions about the relative value of predictive factors on adherence and persistence of biological therapy, larger controlled studies with better selection of variables and analysis of interactions are needed.

a b s t r a c t Objective: To evaluate the degree of agreement between primary care physicians and rheumatologists when evaluating the referral criteria in patients with suspected early spondyloarthropathy (Spa). Material and methods: Patients with suspected early Spa (according to predefined clinical referral criteria) were sent by primary care physicians to early Spa units (where a rheumatologist evaluated the same criteria and confirmed the diagnosis) through an on-line platform. We assessed the agreement between primary care physicians and rheumatologists regarding the predefined clinical refererral criteria among patients with definitive Spa using the kappa index (k). Results: Eight hundred and two patients were analysed, 8.31% of whom were incorrectly referred to the rheumatologist. The degree of agreement regarding the predefined clinical referral criteria was poor for inflammatory back pain (k=0.16; 95% confidence interval (95% CI) 0.09-0.23), radiographic sacroiliitis (k=0.31; 95% 0.211-0.428), back or joint pain (k=0.21; 95% CI 0.14-0.29); mild for asymmetric arthritis (k=0.51; 95% CI 0.43-0.59), positive HLA B27 (k=0.59; 95% CI 0.52-0.67) and family history (k=0.50; 95% CI 0.415-0.604); and it was good or very good for anterior uveitis (k=0.81; 95% CI 0.68-0.93), inflammatory bowel disease (k=0.87; 95% CI 0.79-0.96) and psoriasis (k=0.73; 95% CI 0.65-0.81). Conclusions: The degree of agreement between primary care physicians and rheumatologists regarding the predefined clinical referral criteria was variable. Agreement was very poor for variables like inflamma- tory back pain, which are crucial for the diagnosis of Spa. Training programs for primary care physicians are important in order for them to correctly identify early Spa patients.

To analyze sociodemographic and clinic-associated factors of patients with rheumatoid arthritis (RA) undergoing any orthopedic surgery (AOS) and total joint replacement (TJR) in Spain.A retrospective medical record review was performed in a probabilistic sample of 1379 RA patients from 46 centers distributed in 16 of 19 regions in Spain. Sociodemographic and clinical features, use of drugs, and arthritis-related joint surgeries were recorded following a standardized protocol. Gross domestic product (GDP) data were obtained from the National Statistical Index.Of 1379 patients, a total of 358 (26%) underwent one or more joint surgeries, and 194 (14%) had a TJR. The median time to first orthopedic procedure was 12.5 years from presentation of RA and the estimated rate was 5.6 surgeries per 100 person-years. The rate of AOS was increased in women, patients with RA with extraarticular complications, with longterm RA (10 yrs), with functional grade III-IV, and with persistent inflammatory disease. The risk factors for undergoing a TJR were longterm RA, functional grade III-IV, and extraarticular complications. Patients from regions with higher GDP per capita were more likely to undergo a procedure.Clinical variables reflecting disease activity and severity are predictors of orthopedic surgery, but geographic and socioeconomic variables were also independently associated with the rate of orthopedic surgery.