Objective To describe clinical characteristics of patients with rheumatic and musculoskeletal diseases (RMDs) and immunosuppressive therapies with Coronavirus disease 2019 (COVID-19) at an academic rheumatology center in Madrid and to identify baseline variables associated with a severe infection requiring hospitalization. Methods We identified SARS-CoV-2 positive cases by polymerase chain reaction performed at our center within an updated RMDs database in our clinic. Additional RMDs patients were identified when they contacted the clinic because of a positive infection. Data extraction included diagnosis, demographics, immunosuppressive treatment, comorbidities, and laboratory tests. Comparisons between patients with or without hospitalization were performed. Multivariate logistic regression was used to analyze associations between baseline variables and need for hospitalization. Results A total of 62 patients with COVID-19 and underlying RMDs were identified by April 24, 2020. Median age was 60.9 years, and 42% men. Forty-two patients required hospitalization; these were more frequently men, older and with comorbidities. There were no statistically significant between-group differences for rheumatologic diagnosis and for baseline use of immunosuppressive therapy except for glucocorticoids that were more frequent in hospitalized patients. Total deaths were 10 (16%) patients. In multivariate analysis, male sex (odds ratio [OR], 8.63; p = 0.018), previous lung disease (OR, 27.47; p = 0.042), and glucocorticoids use (> 5 mg/day) (OR, 9.95; p = 0.019) were significantly associated to hospitalization. Conclusion Neither specific RMD diagnoses or exposures to DMARDs were associated with increased odds of hospitalization. Being male, previous lung disease and exposure to glucocorticoids were associated with higher odds of hospitalization in RMDs patients.
ObjectiveTo determine the optimal ultrasound (US) cut-off values for cranial and extracranial arteries intima media thickness (IMT) to discriminate between patients with and without giant cell arteritis (GCA).MethodsRetrospective observational study including patients referred to an US fast-track clinic. All patients underwent bilateral US examination of the cranial and extracranial arteries including the IMT measurement. Clinical confirmation of GCA after 6 months was considered the gold standard for diagnosis. A receiver operating characteristic (ROC) analysis was performed to select the cut-off values on the basis of the best tradeoff values between sensitivity and specificity.ResultsA total of 157 patients were included, 47 (29.9%) with clinical confirmation of GCA after 6 months. 41 (87.2%) of patients with GCA had positive US findings (61.7% had cranial and 44.7% extracranial involvement). The best threshold IMT values were 0.44 mm for the common temporal artery; 0.34 mm for the frontal branch; 0.36 mm for the parietal branch; 1.1 mm for the carotid artery and 1 mm for the subclavian and axillary arteries. The areas under the ROC curves were greater for axillary arteries 0.996 (95% CI 0.991–1), for parietal branch 0.991 (95% CI 0.980–1), for subclavian 0.990 (95% CI 0.979–1), for frontal branch 0.989 (95% CI 0.976–1), for common temporal artery 0.984 (95% CI 0.959–1) and for common carotid arteries 0.977 (95% CI 0.961–0.993).ConclusionIMT cut-off values have been identified for each artery. These proposed IMT cut-off values may help to improve the diagnostic accuracy of US in clinical practice.
Objective Salivary gland ultrasound (SGU) is a reliable technique for assessing the salivary glands in patients with primary Sjögren's syndrome (pSS). The aim of this study was to elucidate the relationship between SGU findings and autoimmunity in patients with pSS. Methods Patients with pSS underwent an SGU assessment. The patients were classified into three groups according to their autoimmunity profile: the complete positive group (positive rheumatoid factor, antinuclear antibodies, and anti-Ro/anti-La antibodies), the partial seropositive group (positivity of at least one autoantibody but not all), and the seronegative group. Results In total, 93 patients were evaluated. Eighty-six (92.5%) were female, and their median age was 49.5 years. The median disease duration was 12.3 years. Pathological SGU findings were present in 32 (34.4%) patients [25 of 36 (78.1%) in the complete positive group and 7 of 44 (21.9%) in the partial positive group]. Patients with pathological SGU findings had a shorter disease duration and slightly higher European League Against Rheumatism Sjögren's syndrome disease activity index. Conclusions The autoimmunity profile and pathological SGU findings are strongly associated with each other in patients with pSS. However, the disease duration does not seem to be related to pathological SGU findings.
BackgroundThe efficacy of Golimumab treatment in spondyloarthritis (SpA) has been widely documented.ObjectivesThe aim of this study was to analize the long-term retention rate of Golimumab and to identify independent predictors of retention in patients with SpA.MethodsProspective monocentric cohort of SpA patients treated with Golimumab according with clinical practice. Study was approved by local Ethics Committee. Demographic and clinical variables were analysed with Cox proportional hazard regression model.Results105 patients were included, 49 (46.7%) Ankylosing Spondylitis (AS), 40 (38.1%) non-radiographic axial SpA (nr-AxSpA) and 16 (15,2%) peripheral SpA. The baseline characteristics of the patients are shown in table 1. Follow-up time was 206.6 patients-year. Mean survival time was 47.2 months (95% CI: 39.4–54.9). Age, gender, HLA-B27, radiographic or nr-AxSpA and previous biological use were significant in the univariate analysis. Concomitant DMARD had no influence on Golimumab retention rate (HR: 1.2; 95% CI: 0.6–2.4; p: 0.6).Abstract SAT0273 – Table 1Baseline demographic and clinical characteristics of the patients.All (axial and peripheral SpA)ASnr-AxSpA Age -mean (SD)-years45.1 (13.2)51.1 (10.8)39,8 (10.1)Male gender (%)52 (49.5%)30 (61.2%)19 (47.5%)Mean evolution time (SD)- years11.8 (12.3)18.8 (10.1)7.3 (10.3)Positive HLA-B27 (%)73 (69.6%)44 (90.7%)21 (52.6%)Uveitis (%)17 (16.2%)12 (24.5%)4 (10.0%)Back pain -mean (SD)7.5 (7.0)6.5 (2.4)9.1 (10.7)BASDAI -mean (SD)6.2 (1.6)6.3 (2.1)6.2 (1.2)BASFI -mean (SD)5.8 (2.3)6.0 (2.4)5.4 (2.1)CRP mg/dl – mean (SD)1.1 (1.7)1.5 (2.1)0.65 (1.4)Concomitant DMARD (%)31 (29.8%)15 (31.3%)3 (7.5%)Biological Therapy naïve (%)48 (45.7%)15 (30.6%)24 (60%)Golimumab retention rate of patients with nr-AxSpA and objective inflammation (positive MRI or CRP) was not different compared to AS patients (p=0.19). Patients with nr-AxSpA without objective inflammation (negative MRI and CRP) had worse retention rate compared to AS patients (HR: 2.47; 95% CI: 1.09–5,57; p<0.03), figure 1. There was a numerically better Golimumab retention rate in patients treated previously with less number of biologicals, but did not reach statistical significance. 39/105 patients (37%) withdrew Golimumab treatment. 26/39 (66.7%) due to lack of efficacy, 6/39 (15.4%) due to adverse events and 7/39 (17.5%) due to other reasons.Abstract SAT0273 – Figure 1retention rateConclusionsReal-world Golimumab retention rate in patients with Spondyloarthritis was good and did not depend on concomitant treatment with DMARD. Patients with Ankylosing Spondylitis and non-radiographic axial SpA with objective inflammation had a better Golimumab retention rate than patients with non-radiographic axial SpA without objective inflammation. A better retention rate was expected in patients who had previously used less biological, but was not found.Disclosure of InterestNone declared
Contributors All authors made substantial contributions to the conception and design of this study. Study design was performed by JMC and IC. Subject recruitment and US examination were performed by JMC. JMC and LRCM collected the epidemiological and clinical data. JMC and IC performed the statistical analysis. JMC, JM-B, BS-B, IC, LRCM, LTF and JMA-G drafted the manuscript. All coauthors revised the final manuscript.
Objective:The aims of this study were to describe the long-term retention rate of golimumab (GLM) treatment in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and spondyloarthritis (SpA) in real life, and to analyze determinants of discontinuation. Methods:We conducted a single-center, medical records review study of all patients with RA, PsA, and SpA on GLM treatment attending a large rheumatology department from 2010 to 2017. Times from start to end of GLM treatment were collected, as well as sociodemographic, clinical, and safety variables. Golimumab retention rate was estimated by the Kaplan-Meier method, and comparison across diseases was analyzed with the Mantel-Haenszel statistic (log-rank test). Cox proportional hazards regression models were used to identify factors associated with GLM discontinuation.Results: In the study period, a total of 212 patients (61 RA, 48 PsA, 103 SpA) were prescribed GLM. Retention rates were 72% in the first year, 61% in the second, 56% in the third, and 38% at 5 years. Differences were statistically significant across diseases (median times to GLM discontinuation were 50.2, 46.0, and 38.7 months for RA, SpA, and PsA, respectively) and according to the number of previous biologic therapies (55.2 months in biologic-naive patients vs 14.0 months in patients with ≥2 previous biologics; p < 0.001). The use of concomitant conventional synthetic disease-modifying antirheumatic drugs was associated with a lower probability of discontinuation (hazards ratio [HR], 0.57; 95% confidence interval [CI], 0.33-0.97). Female sex (HR, 1.84; 95% CI, 1.07-3.17) and having used 2 biologics before GLM (HR, 2.99; 95% CI, 1.76-5.06) were associated with increased discontinuation rates. Twenty-three patients (10.9%) had at least 1 serious adverse event.Conclusions: In a real-life setting, GLM shows appropriate long-term safety-effectiveness ratio.
BackgroundBiologicals therapies have been used for the treatment of Systemic Lupus Erythematosus (SLE) but only Belimumab has been approved by the European Medicines Agency. Abatacept (ABA), a T-cell co-stimulation blocker, has been proposed as an effective treatment for SLE due to its mechanism of action. Three randomised clinical trials have been performed with ABA in patients with SLE. Although any of these trials met the primary outcome of efficacy, it is still considered as an “off-label” option when none of the other conventional therapies have worked.ObjectivesTo assess effectiveness and safety of ABA in patients diagnosed of SLE in a Rheumatology service from a tertiary care hospital in Madrid, Spain.MethodsWe performed an observational retrospective study in patients with SLE (according to the 1997 American College of Rheumatology classification criteria) who received treatment with ABA. We recorded demographic, clinical and laboratory parameters at the beginning of treatment, and after 6 and 12 months of treatment. We also recorded adverse events.ResultsWe included 8 patients, all of them women. The median age was 45.13 years (range 30–67 years) and the median time from SLE diagnosis to ABA treatment was 12.12 years (range 3–21 years). Three patients had an overlap disease with Rheumatoid Arthritis. The most frequent symptoms were arthritis (n=5), cutaneous (n=3) and neurological symptoms (n=5), specifically organic brain syndrome (n=4) and lupus headache (n=3). None of the patients had renal disease. In all patients ABA was use after anti-TNFα or Rituximab treatment. One patient discontinued ABA after 2 months due to inefficacy, so she was excluded from statistical analysis.Table 1 shows clinical and laboratory parameters at the beginning of treatment and after 6 and 12 months of treatment. After 6 months of treatment, disease activity according to SLEDAI decreased. One patient persisted with organic cerebral syndrome. After 12 months of treatment neurological symptoms showed a substantial improvement in every patient that presented them at the beginning. Four patients showed significant improvement of arthritis. Two patients experienced serious infections that required hospitalization.Table 1.Clinical and laboratory parameters0 months (n=7)6 months (n=7)12 months (n=7)SLEDAI (median)13.713.71*1.43*Prednisone dose (mg/ day) (median)6.785.713.57Anti-DNA antibody levels (UI/ml) (median)80.6122.77*20.21C3 (mg/dl) (median)95.9494.1398.94C4 (mg/dl) (median)11.6315.13*14.88*Wilcoxon's Signed Rank Test, *p<0.05. Baseline vs 6 months after treatment and baseline vs 12 months after treatment.ConclusionsABA was effective in our SLE patients. Clinical response was evident at 6 months and persisted at 12 months. ABA may be a therapeutic option in SLE patients with inadequate response to conventional therapies, specially if arthritis or neurological symptoms are present.ReferencesAringer M. Expert Opin Drug Saf. 2015;14:243–51.Ikeda K. Clin Dev Immunol. 2013;2013:697525.Disclosure of InterestNone declared
Juvenile idiopathic arthritis (JIA) is a chronic inflammatory disease that often requires biological therapy to control its activity. Medication persistence and adherence are important aspects on which we have scarce information. We performed a longitudinal, retrospective, and observational study based on data from the daily clinical management of JIA patients. We recorded clinical remission at 6 and 12 months. Persistence of biological therapy was evaluated using Kaplan–Meier curves, and adherence was assessed using the medication possession ratio (MPR). We included 68 patients who received biological therapy. Of these, 11 (16.2%) and 5 (7.4%) required a second and third drug, respectively. The persistence rate for biological therapy at 5 years was 64%, with no differences between the first and second lines. Adherence was high during the first year of treatment (MPR80: 96.3%) and also in the second and third years (MPR80: 85.2% and 91.8%, respectively). Persistence and adherence to biological therapy were remarkably high in our JIA cohort. Adherence to biological treatments could be related to a higher probability of fulfilling the Wallace remission criteria at 6 months, although this was not confirmed at 12 months.
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