28 research outputs found
Comparison of Prevalence of Synovitis by Ultrasound Assessment in Subjects Exposed or Not to Self-Reported Physical Overexertion: The Monday’s Synovitis
Objective. To compare the proportion of synovitis detected by ultrasonographic study (USS) of the hands, in subjects with no rheumatologic known disease according to self-reported level of overexertion performed the day before. Methods. 407 consecutive volunteers were enrolled in a twelve-month period and underwent an ultrasound assessment of the hand. All studies were performed on Monday or Friday. Subjects were grouped according to their self-reported overexertion carried out the day before. Presence or absence of ultrasonographic findings compatible with synovitis was compared between groups. Results. 95.8% of those tested on Friday had made no overexertion the day before the study, while 30.2% of those assessed on Monday declared to have carried out an overexertion. Presence of carpal synovial hypertrophy, synovial fluid/effusion, and power-Doppler signal was statistically higher in subjects who carried out an overexertion the day before the study than the rest of subjects when the dominant hand was assessed. Globally, presence of any synovitis ultrasonographic finding was statistically higher in subjects who were studied on Monday than Friday (34.9% versus 12.1%) and in subjects who self-reported an overexertion the day before compared to the rest of subjects (47.7 versus 11.5%). Conclusions. In general, we recommend performing the USS as many days as possible after the most recent overexertion
Associated factors to serious infections in a large cohort of juvenile-onset systemic lupus erythematosus from Lupus Registry (RELESSER).
Objective: To assess the incidence of serious infection (SI) and associated factors in a large juvenile-onset systemic lupus erythematosus (jSLE) retrospective cohort. Methods: All patients in the Spanish Rheumatology Society Lupus Registry (RELESSER) who meet =4 ACR-97 SLE criteria and disease onset <18 years old (jSLE), were retrospectively investigated for SI (defined as either the need for hospitalization with antibacterial therapy for a potentially fatal infection or death caused by the infection). Standardized SI rate was calculated per 100 patient years. Patients with and without SI were compared. Bivariate and multivariate logistic and Cox regression models were built to calculate associated factors to SI and relative risks. Results: A total of 353 jSLE patients were included: 88.7% female, 14.3 years (± 2.9) of age at diagnosis, 16.0 years (± 9.3) of disease duration and 31.5 years (±10.5) at end of follow-up. A total of 104 (29.5%) patients suffered 205 SI (1, 55.8%; 2-5, 38.4%; and =6, 5.8%). Incidence rate was 3.7 (95%CI: 3.2–4.2) SI per 100 patient years. Respiratory location and bacterial infections were the most frequent. Higher number of SLE classification criteria, SLICC/ACR DI score and immunosuppressants use were associated to the presence of SI. Associated factors to shorter time to first infection were higher number of SLE criteria, splenectomy and immunosuppressants use. Conclusions: The risk of SI in jSLE patients is significant and higher than aSLE. It is associated to higher number of SLE criteria, damage accrual, some immunosuppressants and splenectomy
Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee
Background To derive a list of opportunistic infections (OI) through the analysis of the juvenile idiopathic arthritis (JIA) patients in the Pharmachild registry by an independent Safety Adjudication Committee (SAC). Methods The SAC (3 pediatric rheumatologists and 2 pediatric infectious disease specialists) elaborated and approved by consensus a provisional list of OI for use in JIA. Through a 5 step-procedure, all the severe and serious infections, classified as per MedDRA dictionary and retrieved in the Pharmachild registry, were evaluated by the SAC by answering six questions and adjudicated with the agreement of 3/5 specialists. A final evidence-based list of OI resulted by matching the adjudicated infections with the provisional list of OI. Results A total of 772 infectious events in 572 eligible patients, of which 335 serious/severe/very severe non-OI and 437 OI (any intensity/severity), according to the provisional list, were retrieved. Six hundred eighty-two of 772 (88.3%) were adjudicated as infections, of them 603/682 (88.4%) as common and 119/682 (17.4%) as OI by the SAC. Matching these 119 opportunistic events with the provisional list, 106 were confirmed by the SAC as OI, and among them infections by herpes viruses were the most frequent (68%), followed by tuberculosis (27.4%). The remaining events were divided in the groups of non-OI and possible/patient and/or pathogen-related OI. Conclusions We found a significant number of OI in JIA patients on immunosuppressive therapy. The proposed list of OI, created by consensus and validated in the Pharmachild cohort, could facilitate comparison among future pharmacovigilance studies
Sustainable Development of Rural Settlements. Role of EU Funds in Managing Territorial Disparities
The paper aims to perform an up-to-date radiography of the rural settlements in Romania, focusing on the main dysfunctions related to: employment, social exclusion and risk of poverty, education, health and infrastructure. Based on the overview, the article is developing scenarios for reducing the above dysfunctions, setting the scene and involving the proper actors for improving the quality of life in rural settlements, together with the potential funds dedicated for the present and future programming period
Recomendaciones para el manejo del riesgo cardiovascular en pacientes con artritis reumatoide
Rheumatoid arthritis (RA) is an autoimmune disease primarily known for its joint involvement. However, it is a systemic disease which may potentially affect many other organs. Currently, the impact of RA on cardiovascular risk (CVR) has been demonstrated in multiple studies, both clinical and basic. The purpose of this guide is to enumerate the effects of RA on the cardiovascular system, the impact that RA treatments have on traditional cardiovascular risk factors (CVRF) and to design recommendations for the monitoring and management of such processes on RA patients.La artritis reumatoide (AR) es una enfermedad autoinmune conocida fundamentalmente por su afectación a nivel articular. Sin embargo, se trata de un proceso sistémico con capacidad de afectar muchos otros órganos. Actualmente, el impacto que tiene la AR sobre el riesgo cardiovascular (RCV) ha sido demostrado en múltiples estudios, tanto clínicos como básicos. La más reciente compilación de recomendaciones para el manejo del RCV en pacientes con AR fue publicada en 2010 con bibliografía publicada hasta 2008. El propósito de la presente guía es, en base a los trabajos más recientes, enumerar los efectos que tiene la AR sobre el sistema cardiovascular, la repercusión que tienen los tratamientos de la AR en los factores de riesgo cardiovascular (FRCV) tradicionales y diseñar unas recomendaciones para la vigilancia y manejo de dichos procesos en los pacientes con AR
Clinical Practice Guidelines for Diagnosis and Management of Hypersensitivity Reactions to Quinolones.
The consumption of quinolones as first-line treatment has increased in recent years, leading to an increase in the incidence of hypersensitivity reactions (HSRs) to this antibiotic group. Both diagnosis and management of HSRs to quinolones are complex and controversial. These practical guidelines aim to provide recommendations for effective clinical practice. The recommendations were drafted by an expert panel that reviewed the literature regarding HSRs to quinolones and analyzed controversies in this area. Most HSRs to quinolones are immediate and severe. The risk for HSRs is higher in patients who report allergy to ß-lactams, moxifloxacininduced anaphylaxis, and immediate reactions than in patients who report reactions to quinolones inducing other symptoms. The usefulness of skin tests in diagnosing HSRs to quinolones is controversial, with sensitivity and specificity varying between studies. Most in vitro tests are produced in-house, with no validated commercial options. The basophil activation test has proven useful for diagnosing immediate reactions, albeit with diverse results regarding sensitivity. Drug provocation testing is currently the gold standard for confirming or excluding the diagnosis and for finding safe alternatives, although it is contraindicated in patients with severe reactions. Cross-reactivity between quinolones has proven controversial in several studies, with the lowest cross-reactivity reported for levofloxacin. Desensitization may be considered in allergy to quinolones when no other alternatives are available
Safety and efficacy of intravenous belimumab in children with systemic lupus erythematosus: results from a randomised, placebo-controlled trial
Objectives: This ongoing Phase-2, randomised,
placebo-controlled, double-blind study evaluated the
efficacy, safety and pharmacokinetics of intravenous
belimumab in childhood-onset systemic lupus
erythematosus (cSLE).
Methods: Patients (5 to 17 years) were randomised
to belimumab 10 mg/kg intravenous or placebo every
4 weeks, plus standard SLE therapy. Primary endpoint:
SLE Responder Index (SRI4) response rate (Week 52).
Key major secondary endpoints: proportion of patients
achieving the Paediatric Rheumatology International
Trials Organisation/American College of Rheumatology
(PRINTO/ACR) response using 50 and ’30 alternative’
definitions (Week 52), and sustained response (Weeks
44 to 52) by SRI4 and Parent Global Assessment of
well-being (Parent-global). Safety and pharmacokinetics
were assessed. Study not powered for statistical
testing.
Results: Ninety-three patients were randomised
(belimumab, n=53; placebo, n=40). At Week 52, there
were numerically more SRI4 responders with belimumab
versus placebo (52.8% vs 43.6%; OR 1.49 (95% CI
0.64 to 3.46)). PRINTO/ACR 30 alternative (52.8% vs
27.5%; OR 2.92 (95% CI 1.19 to 7.17)) and PRINTO/
ACR 50 (60.4% vs 35.0%; OR 2.74 (95% CI 1.15 to
6.54)) responses were more frequent with belimumab
than placebo, as were sustained responses for SRI4
(belimumab, 43.4%; placebo, 41.0%; OR 1.08 (95% CI
0.46 to 2.52)) and Parent-global (belimumab, 59.1%;
placebo, 33.3%; OR 3.49 (95% CI 1.23 to 9.91)).
Serious adverse events were reported in 17.0% of
belimumab patients and 35.0% of placebo patients; one
death occurred (placebo). Week-52, geometric mean
(95% CI) belimumab trough concentration was 56.2
(45.2 to 69.8) µg/mL.
Conclusion: The belimumab intravenous
pharmacokinetics and benefit–risk profile in cSLE are
consistent with adult belimumab studies and the 10 mg/
kg every 4 weeks dose is appropriat