scholarly journals Identification of new biomarkers to promote personalised treatment of patients with inflammatory rheumatic disease: protocol for an open cohort study

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e019325 ◽  
Author(s):  
Tina Marie Kringelbach ◽  
Bente Glintborg ◽  
Estrid V Hogdall ◽  
Julia Sidenius Johansen ◽  
Merete Lund Hetland

IntroductionThe introduction of biological disease-modifying antirheumatic drugs (bDMARDs) has improved the treatment of inflammatory rheumatic diseases dramatically. However, bDMARD treatment failure occurs in 30%–40% of patients due to lack of effect or adverse events, and the tools to predict treatment outcomes in individual patients are currently limited. The objective of the present study is to identify diagnostic, prognostic and predictive biomarkers, which can be used to (1) diagnose inflammatory rheumatic diseases early in the disease course with high sensitivity and specificity, (2) improve prognostication or (3) predict and monitor treatment effectiveness and tolerability for the individual patient.Methods and analysisThe present study is an observational and translational open cohort study with prospective collection of clinical data and biological materials (primarily blood) in patients with inflammatory rheumatic diseases treated in routine care. Patients contribute with one cross-sectional blood sample and/or are enrolled for longitudinal follow-up on initiation of a new DMARD (blood sampling after 0, 3, 6, 12, 24, 36, 48, 60 months of treatment). Other biological materials will be collected when accessible and relevant. Demographics, disease characteristics, comorbidities and lifestyle factors are registered at inclusion; DMARD treatment and outcomes are collected repeatedly during follow-up. Currently (July 2017), >5000 samples from approximately 3000 patients have been collected. Data will be analysed using appropriate statistical analyses.Ethics and disseminationThe protocol is approved by the Danish Ethics Committee and the Danish Data Protection Agency. Participants give written and oral informed consent. Biomarkers will be evaluated and published according to the Reporting Recommendations for Tumour Marker (REMARK) prognostic studies, Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) and the Standards for Reporting of Diagnostic Accuracy (STARD) guidelines. Results will be published in peer-reviewed scientific journals and presented at international conferences.Trial registration numberNCT03214263.

Medicina ◽  
2020 ◽  
Vol 56 (8) ◽  
pp. 392
Author(s):  
Dalia Miltinienė ◽  
Giedrė Deresevičienė ◽  
Birutė Nakčerienė ◽  
Valerija Edita Davidavičienė ◽  
Edvardas Danila ◽  
...  

Background and objective: With an increase in survival rates among rheumatic patients, comorbidities and infections, in particular, have gained more importance, especially after the introduction of biologicals to the treatment algorithms. Tuberculosis (TB) infection has always been given a special attention in patients with rheumatic diseases (RD). Although Lithuanian population has one of the highest TB incidence rates among European countries, the incidence of TB in the rheumatic patients’ population is still unknown. The aim of this study was to assess the incidence rate of TB in an inflammatory RD retrospective cohort and to compare that rate with a rate in a general population. Material and Methods: Patients with the first-time diagnosis of inflammatory RD during the period between 1 January 2012 and 31 December 2017 were identified from the Lithuanian Compulsory Health Insurance Information System database SVEIDRA. All cases were cross-checked with Health Information center at the Institute of Hygiene, for the vital status of these patients and date of death if the fact of death was documented, and with Tuberculosis Register operated by Vilnius University Hospital Santaros Klinikos, for the confirmation of TB cases. Sex and age standardized incidence ratios (SIR) were calculated by dividing the observed numbers of TB among rheumatic patients by the expected number of cases, calculated using national rates from Lithuanian Department of Statistics Official Statistics website. Results: Overall, 8779 patients with newly diagnosed RD were identified during the 2013–2017 period, these included 458 patients who used biological disease modifying drugs (bDMARDs). The mean duration of the follow-up period was 2.71 years. The cohort consisted mainly of women (70%) and a half of the cohort were rheumatoid arthritis (RA) patients (53%). Mean age of patients at the time of RD diagnosis was 56 years (range = 18–97 years). There were 9 TB cases identified during 23,800 person years of follow-up: 2 cases among them were treated with bDMARDs. The mean calculated annual TB incidence in RD cohort was 37.81 per 100,000 person years, which is consistent with the incidence rate predicted by national estimates, with a resultant SIR of 0.90 (0.41–1.70). The unadjusted hazard ratio for bDMARD use versus no bDMARD use was 4.54 (0.94; 21.87) in a total cohort and very similar in rheumatoid arthritis cohort; in both cohorts, it was not a statistically significant risk. Conclusions: Here, we present the first nationwide cohort study to assess the incidence of TB in a broad spectrum of inflammatory RD. Although limited by short follow-up period, this study shows that TB incidence in RD cohort does not exceed TB incidence in the general Lithuanian population.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1182.2-1182
Author(s):  
E. Wiebe ◽  
D. Freier ◽  
D. Huscher ◽  
R. Biesen ◽  
S. Hermann ◽  
...  

Background:Rheumatic diseases are associated with increased systemic bone loss and fracture risk related to chronic inflammation, disease-specific, general and demographic risk factors as well as treatment with glucocorticoids (GC). Yet, there is evidence that GCs may, by adequately suppressing systemic inflammation, also have a positive effect on bone mineral density (BMD) and fracture risk1.Objectives:The purpose of this study was to investigate the prevalence of osteoporosis and fragility fractures in patients with inflammatory rheumatic diseases and to analyze the impact that treatment with GCs, other known risk factors and preventive measures have on bone health in these patients.Methods:Rh-GIOP is an ongoing prospective observational study collecting and analyzing disease- and bone-related data from patients with chronic inflammatory rheumatic diseases and psoriasis treated with GCs. In this cross-sectional analysis, we evaluated the initial visit of 1091 patients. A multivariate linear regression model with known or potentially influential factors adjusted for age and sex was used to identify predictors of BMD as measured by dual-energy X-ray absorptiometry (DXA). Multiple imputation was applied for missing baseline covariate data.Results:In the total cohort of 1091 patients (75% female of which 87.5% were postmenopausal) with a mean age of 62.1 (±13.2) years, the prevalence of osteoporosis by DXA was 21.7%, while fragility fractures have occurred in 31.2% of the study population (6.7% vertebral, 27.7% non-vertebral). Current GC therapy was common (64.9%), with a median daily dose of 5.0mg [0.0;7.5], a mean life-time total GC dose of 17.7g (±24.6), and a mean GC therapy duration of 7.8 years (±8.5). Bisphosphonates were the most commonly used anti-osteoporotic drug (12.6%).Multivariate analysis showed that BMD as expressed by the minimum T-Score at all measured sites was negatively associated with higher age, female sex and menopause as well as Denosumab and Bisphosphonate treatment. A positive association with BMD was found for body mass index as well as current and life-time (cumulative) GC dose. While comedication with proton-pump-inhibitors significantly predicted low bone mass, concomitant use of non-steroidal anti-inflammatory drugs showed a positive association with BMD. Of the measured bone-specific laboratory parameters, higher alkaline phosphatase levels were determinants of low DXA-values, while the association was positive for gamma-glutamyltransferase.BMD was neither predicted by duration of GC treatment nor by treatment with disease modifying anti-rheumatic drugs.Predictive variables for BMD differed at the respective anatomical site. While treatment with Denosumab predicted low bone mass at the lumbar spine and not at the femoral neck, the opposite was true for health assessment questionnaire (HAQ) score. Current and life-time GC-dose as well as direct sun-exposure of more than 30 minutes daily were positively associated with bone mass at the femoral sites only.Conclusion:This cross-sectional analysis of a prospective cohort study quantified the prevalence of osteoporosis and identified predictive variables of BMD in patients with rheumatic diseases.Multivariate analyses corroborated low BMD to be predicted by traditional factors like age, female sex and menopause but showed current and well as life-time GC dose to be positively associated with BMD in our cohort of patients with chronic inflammatory rheumatic diseases. This suggests that optimal management of disease activity with GCs might be beneficial in order to avoid bone loss due to inflammation.References:[1]Güler-Yüksel et al. “Glucocorticoids, Inflammation and Bone.” Calcified Tissue International (January 08 2018).Disclosure of Interests:Edgar Wiebe: None declared, Desiree Freier: None declared, Dörte Huscher: None declared, Robert Biesen: None declared, Sandra Hermann: None declared, Frank Buttgereit Grant/research support from: Amgen, BMS, Celgene, Generic Assays, GSK, Hexal, Horizon, Lilly, medac, Mundipharma, Novartis, Pfizer, Roche, and Sanofi.


2021 ◽  
Vol 18 ◽  
Author(s):  
Marwa Hammad ◽  
Huny Bakry

Background: Autoimmune inflammatory rheumatic diseases have long been treated by conventional disease-modifying anti-rheumatic drugs. Biological therapy is a new era in the treatment of rheumatic diseases, but satisfaction and adherence to it is still not well tested. Aim: To assess the satisfaction and adherence to biological treatment among patients with autoimmune inflammatory rheumatic diseases. Methods: A cross sectional study was conducted among 56 patients suffering from inflammatory rheumatic diseases using Morisky 8 questionnaire and Treatment Satisfaction Questionnaire for Medication (TSQM) over a period of one month Results: About 76.8% of the patients had medium adherence and the underlying cause of missing doses was the unavailability of the drugs. The mean satisfaction with biological treatment was 62.7±6.9. Patients who did not receive formal education had significantly higher satisfaction with the biological treatment than others 64.94±5.01 at a P value 0.04 (<0.05). Conclusion: Patients with inflammatory rheumatic diseases in our study showed medium adherence and satisfaction. Authorities in the medical field are providing great help to these patients in need of biological therapy, but ensuring the availability of all doses of the biological treatment regimen is still necessary. Patient, family and nurse education programs are also necessary to maximize adherence and satisfaction.


2019 ◽  
Vol 19 (5) ◽  
pp. 1432-1443 ◽  
Author(s):  
Arthur J. Matas ◽  
Ann Fieberg ◽  
Roslyn B. Mannon ◽  
Robert Leduc ◽  
Joe Grande ◽  
...  

Author(s):  
Marine Gossin ◽  
Gerhard Gmel ◽  
Joseph Studer ◽  
Mathieu Saubade ◽  
Carole Clair

The objective of this study was to assess the association between tobacco/nicotine use and type and intensity of sport. Data were drawn from the second follow-up of the Cohort Study on Substance Use Risk Factors. Young Swiss men completed a questionnaire about tobacco/nicotine use (cigarette, vaping, snus, snuff), type and intensity of sport and other demographic and medical variables. Among the 5414 included participants (mean age 25.5), 3434 (63.4%) reported regularly practicing a sport. They had a lower rate of cigarette smoking (32.3%) compared with participants not practicing a sport (44.6%) but a higher rate of snus use (15.0% vs. 10.0%). In adjusted models, individual-sport participants were less likely to use snus and snuff (OR = 0.63, 95% CI = 0.51–0.77 and OR = 0.73, 95% CI = 0.61–0.88), compared with team-sport participants. The association was inversed for vaping users (OR = 1.54, 95% CI = 1.03–2.30). Furthermore, participants who practiced high-intensity sports had a lower likelihood to smoke cigarettes (OR = 0.63, 95% CI = 0.52–0.78) compared with low-intensity sports. Our findings suggest that type and intensity of sport are associated with tobacco/nicotine use. Youth who practice an individual sport are less likely to use snus or snuff and more likely to vape compared with a team sport. This could help better target smoking prevention in young people


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