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PubMed: 30852552, Objectives To determine whether progressive skin fibrosis is associated with visceral organ progression and mortality during follow-up in patients with diffuse cutaneous systemic sclerosis (dcSSc). Methods We evaluated patients from the European Scleroderma Trials and Research database with dcSSc, baseline modified Rodnan skin score (mRSS) ?7, valid mRSS at 12±3 months after baseline and ?1 annual follow-up visit. Progressive skin fibrosis was defined as an increase in mRSS >5 and ?25% from baseline to 12±3 months. Outcomes were pulmonary, cardiovascular and renal progression, and all-cause death. Associations between skin progression and outcomes were evaluated by Kaplan-Meier survival analysis and multivariable Cox regression. Results Of 1021 included patients, 78 (7.6%) had progressive skin fibrosis (skin progressors). Median follow-up was 3.4 years. Survival analyses indicated that skin progressors had a significantly higher probability of FVC decline ?10% (53.6% vs 34.4%; p, Bayer Bayer, 1Department of Rheumatology, University Hospital Zurich, Zurich, switzerland 2Graf Biostatistics, Winterthur, switzerland 3Clinical Development Pulmonology, Bayer Us llC, Whippany, new Jersey, Usa 4Data science and analytics, Bayer plc, Reading, UK 5Rheumatology a Department, Paris Descartes University, inseRM U1016, sorbonne, Paris Cité, Cochin Hospital, Paris, France 6Division of Rheumatology, University of Florence, Florence, italy 7Department of Medicine, Division of Rheumatology, University of Western Ontario, st. Joseph’s Health Care, london, Western Ontario, Canada 8Department of Rheumatology, Royal Free Hospital, University College london, london, UK 9scleroderma Program, Department of internal Medicine, Division of Rheumatology, University of Michigan, ann arbor, Michigan, Usa Acknowledgements The authors thank nicole schneider for excellent administration and data entry into the eUsTaR cohort. Medical writing assistance was provided by adelphi Communications ltd (Bollington, UK), funded by Bayer aG (Berlin, Germany)., This study was supported by a grant from Bayer aG.

OBJECTIVE: Systemic sclerosis (SSc) is a heterogeneous connective tissue disease that is typically subdivided into limited cutaneous SSc (lcSSc) and diffuse cutaneous SSc (dcSSc) depending on the extent of skin involvement. This subclassification may not capture the entire variability of clinical phenotypes. The European Scleroderma Trials and Research (EUSTAR) database includes data on a prospective cohort of SSc patients from 122 European referral centers. This study was undertaken to perform a cluster analysis of EUSTAR data to distinguish and characterize homogeneous phenotypes without any a priori assumptions, and to examine survival among the clusters obtained. METHODS: A total of 11,318 patients were registered in the EUSTAR database, and 6,927 were included in the study. Twenty-four clinical and serologic variables were used for clustering. RESULTS: Clustering analyses provided a first delineation of 2 clusters showing moderate stability. In an exploratory attempt, we further characterized 6 homogeneous groups that differed with regard to their clinical features, autoantibody profile, and mortality. Some groups resembled usual dcSSc or lcSSc prototypes, but others exhibited unique features, such as a majority of lcSSc patients with a high rate of visceral damage and antitopoisomerase antibodies. Prognosis varied among groups and the presence of organ damage markedly impacted survival regardless of cutaneous involvement. CONCLUSION: Our findings suggest that restricting subsets of SSc patients to only those based on cutaneous involvement may not capture the complete heterogeneity of the disease. Organ damage and antibody profile should be taken into consideration when individuating homogeneous groups of patients with a distinct prognosis. ispartof: ARTHRITIS & RHEUMATOLOGY vol:71 issue:9 pages:1553-1570 ispartof: location:United States status: published

PubMed: 31227488, Objectives Mortality and worsening of organ function are desirable endpoints for clinical trials in systemic sclerosis (SSc). The aim of this study was to identify factors that allow enrichment of patients with these endpoints, in a population of patients from the European Scleroderma Trials and Research group database. Methods Inclusion criteria were diagnosis of diffuse SSc and follow-up over 12±3 months. Disease worsening/organ progression was fulfilled if any of the following events occurred: new renal crisis; decrease of lung or heart function; new echocardiography-suspected pulmonary hypertension or death. In total, 42 clinical parameters were chosen as predictors for the analysis by using (1) imputation of missing data on the basis of multivariate imputation and (2) least absolute shrinkage and selection operator regression. Results Of 1451 patients meeting the inclusion criteria, 706 had complete data on outcome parameters and were included in the analysis. Of the 42 outcome predictors, eight remained in the final regression model. There was substantial evidence for a strong association between disease progression and age, active digital ulcer (DU), lung fibrosis, muscle weakness and elevated C-reactive protein (CRP) level. Active DU, CRP elevation, lung fibrosis and muscle weakness were also associated with a significantly shorter time to disease progression. A bootstrap validation step with 10 000 repetitions successfully validated the model. Conclusions The use of the predictive factors presented here could enable cohort enrichment with patients at risk for overall disease worsening in SSc clinical trials. © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ., Bayer Bayer, United Kingdom Université Paris Descartes Li Ka Shing Foundation, LKSF University of Michigan, U-M, 1Department of Rheumatology and the Centre of experimental Rheumatology, University Hospital Zurich, Zurich, switzerland 2Graf Biostatistics, Winterthur, switzerland 3Big Data institute, li Ka shing Centre for Health information and Discovery, nuffield Department of Medicine, University of Oxford, Oxford, UK 4Rheumatology a Department, Paris Descartes University, sorbonne Paris Cité, Cochin Hospital, Paris, France 5Data science and analytics, Bayer plc, Reading, UK 6UCl Division of Medicine, Royal Free Campus, london, UK 7Division of Rheumatology, Department of internal Medicine, University of Michigan scleroderma Program, University of Michigan, ann arbor, Michigan, Usa 8Department of experimental and Clinical Medicine, University of Florence, Florence, italy 9Bayer Us llC, Whippany, new Jersey, Usa 10Department of Medicine, Division of Rheumatology, University of Western Ontario, st. Joseph’s Health Care, london, Ontario, Canada Acknowledgements The R-code for the linear Mi-lassO was received from Qixuan Chen.21 Medical writing assistance was provided by adelphi Communications ltd (Bollington, UK), funded by Bayer aG (Berlin, Germany)., Contributors study conception and design, acquisition of data, analysis and interpretation of data and drafting and revising the article: OD and MB; analysis and interpretation of data: OD, MB, Rs and nG. all authors have critically reviewed and approved the final submitted version to be published. Funding This study was supported by a grant from Bayer aG. Bayer employees are coauthors of this paper and supported the study design and interpretation of the data, but otherwise Bayer had no influence on the study., Competing interests MOB declares no conflict of interest. OD has had consultancy relationships with actelion, Bayer, Biogen idec, Boehringer ingelheim, Chemomab, espeRare foundation, Genentech/Roche, GsK, inventiva, italfarmaco, lilly, medac, Medimmune, Mitsubishi Tanabe Pharma, Pharmacyclics, novartis, Pfizer, sanofi, sinoxa and UCB in the area of potential treatments of scleroderma and its complications. OD has received research funding from actelion, Bayer, Boehringer ingelheim, Mitsubishi Tanabe Pharma and Roche in the area of potential treatments of scleroderma and its complications. OD has a patent for mir-29 licensed for the treatment of systemic sclerosis. DK has consultancy relationships and/or has received grant/research support from Bayer, Bristol-Myers squibb, Boehringer ingelheim, Genentech/Roche, niH, Pfizer, sanofi-aventis Pharmaceuticals, actelion Pharmaceuticals Us, Chemomab, Corbus, Covis, Cytori, eicos, eMD serono, Gilead, GlaxosmithKline, and UCB Pharma. He is a shareholder of eicos. CPD has consultancy relationships with and/or has received speakers’ bureau fees from actelion Pharmaceuticals Us, Bayer aG, GlaxosmithKline, Csl Behring, Merck serono, Roche Pharmaceuticals, Genentech and Biogen iDeC inc., inventiva, sanofi-aventis Pharmaceuticals and Boehringer ingelheim. JeP has consultancy relationships with and/or has received grant/research support from actelion, Bayer aG, Bristol-Myers squibb, Merck, Pfizer inc. and Roche. MM-C has consultancy relationships and/ or has received grant/research support from Pfizer, Bristol-Myers squibb, actelion, UCB Pharma, Bayer, Chemomab, Genentech/Roche, inventiva and lilly. Ya has consultancy relationships with and/or has received grant/research support from actelion, Pharmaceuticals Us, Bayer aG, Bristol-Myers squibb, inventiva, Medac, Pfizer inc., Roche Pharmaceuticals, Genentech and Biogen iDeC inc., sanofi-aventis Pharmaceuticals and servier. JdOP and JC are employees of Bayer. nTG has nothing to disclose.

Objective. To analyze the clinical relevance of the levels of TNFαblockers and anti-drug antibodies (anti-drug Ab) in patients with rheumatoid arthritis (RA) and spondyloarthritis (SpA) treated with adalimumab (ADA), etanercept (ETA), or infliximab (INF) for a prolonged period of time.Methods. Clinical characteristics (disease activity, and adverse events), serum TNFαblockers, and anti-drug Ab levels were evaluated in 62 RA and 81 SpA patients treated with TNFαblockers for a median of 28 months.Results. Anti-ADA Ab were detected in 1 (4.0%) and anti-INF Ab in 14 out of 57 (24.6%) RA and SpA patients. Patient with anti-ADA Ab and 57.1% patients with anti-INF Ab were considered nonresponders to treatment. Anti-ETA Ab were not found in any of 61 ETA treated patients. Anti-ADA and anti-INF Ab levels differ between responders and nonresponders(P>0.05). Three (5.3%) patients with high serum anti-INF Ab levels developed infusion related reactions. Patients with anti-INF Ab more often required changing to another biologic drug (OR 11.43 (95% CI 1.08–120.93)) and treatment discontinuation (OR 9.28 (95% CI 1.64–52.52)).Conclusion. Patients not responding to treatment had higher serum anti-ADA and anti-INF Ab concentrations. Anti-INF Ab formation is related to increased risk of infusion related reactions, changing to another biologic drug, and treatment discontinuation.

Straipsnyje analizuojama sveikatos sąlygojamos gyvenimo kokybės raidos prioritetinis pasiskirstymas miesto visuomenėje. Tyrimui naudotas PSO klausimynas WHOQOL-100. Apklausta 1233 Vilniaus miesto gyventojai. Duomenys apdoroti standartiniu klausimyno analizės algoritmu. Tyrimas patvirtino sveikata sąlygojamos gyvenimo kokybės raidos tendenciją: didėjant amžiui gyvenimo kokybės sričių vidutinės reikšmės mažėja. Gyvenimo kokybė vidutinės reikšmės svyravo nuo 8 iki 15 punktų 4-20 punktų skalėje. Prioritetine gyvenimo kokybės sritimi buvo nustatyta nepriklausomumo sritis. Didelės įtakos šiai sričiai turėjo nepriklausomumo nuo medicinos ir vaistų nebuvimas, sveikatos ir socialinės priežiūros sistemos funkcionavimo veiksmingumas. Prasčiausiai įvertinta aplinkos sritis. Didesnės įtakos šiai sričiai turėjo sveikatos ir socialinės priežiūros kokybė, kurios lygis svyravo nuo 12,95 jauname amžiuje iki 11,49 balo 60 metų amžiuje. Su amžiumi mažėjo fizinis žmonių saugumas. Jo reikšmė kito nuo 13,41 iki 11,21 balo. Finansiniai ištekliai kito nuo 13,72 iki 11,74 balo. Kitos sritys užėmė tarpines vietas tarp nepriklausomumo ir aplinkos sričių. Article analyzes health stipulated quality of life priority and development distribution among urban society. The study was carried out using the Quality of life questionnaire WHOQOL-100. 1233 citizens were interviewed of the Vilnius city. Data was processed by using conventional analysis algorithm of the questionnaire. This study confirmed the health development tendency caused by the quality of life: the mean of quality of life areas value decreases, increasing age. Mean values of quality of life ranged from 8 to 15 points in the scale of 4-20 points. The priority area of the quality of life was defined by independence area. Significant impact of this area had independence of medical and medicine absence, and efficiency system functioning of health and social care. Worst rated environment area. Health and social care quality had bigger influence to the quality of health and social care, which level ranged from 12,95 in the young age to 11,49 points of the 60 years age. With the age decreasing physical security of the people. Its value ranged from 13.41 to 11.21 points. Financial resources ranged from 13,72 to 11,74 point. Other areas occupied an intermediate position between independence and environmental.

Straipsnyje analizuojama sveikatos sąlygojamos gyvenimo kokybės sisteminė struktūra ir jos raida su amžiumi. Tyrimui naudotas PSO klausimynas WHOQOL-100. Apklausta 1233 Vilniaus miesto gyventojai. Imtis reprezentatyvi tikimybinė. Duomenys analizuoti faktorinės analizės metodu skaičiuojant koreliacijas tarp visų klausimyno rodiklių. Buvo išskirti šeši latentiniai veiksniai, kurie paaiškino 45,55 proc. bendrosios dispersijos. Nors gauta sisteminė struktūra skyrėsi nuo klausimyno tiesinės struktūros, tyrimas patvirtino raidos tendenciją: didėjant amžiui gyvenimo kokybė prastėja. Prioritetiniu latentiniu veiksniu buvo išskirta įsitikinimų pozicija, kurią formavo dvasinio ir socialinio turinio rodikliai. Jis paaiškino 10,51 proc. bendros dispersijos. Sisteminėje raidoje taip pat svarbų vaidmenį atlieka medicinos paslaugų poreikio latentinis veiksnys, kuris didėja su amžiumi ir ypač sustiprėja po 50 metų amžiaus. Rezultatai rodė, kad apie penkiasdešimtuosius gyvenimo metus įvyksta visų latentinių veiksnių kokybinis virsmas link neigiamų reikšmių. Tai rodo, kad apie 50-sius gyvenimo metus sustiprėja sveikatos sąlygojamos gyvenimo kokybės socialinė rizika. Article analyzes health stipulated quality of life systemic structure and its development with the age. The study was carried out using the Quality of life questionnaire WHOQOL-100. 1233 citizens were interviewed of the Vilnius city. Data was analysed by using method of factor analysis to calculate correlation between all indicators in the questionnaire. Six latent factors were identified in which was explained common dispersion of 45,55 percent. Although being received a systematic structure which was different from the liner structure of the questionnaire. The study proved tendency of the development: increasing age, quality of life decline. Priority latent factor was isolated position of belief which was shaped by the spiritual and social indicators. It does explained the common dispersion of 10,51 percent. In Systemic evolution as well as the important role of the latent demand for medical services is a factor which increases with age and especially worse after 50 years of age. The results showed that in the fifty’s years of life occurs a qualitative transformation of latent factors toward negative values. This shows that in 50 years of life the health stipulated social risk of quality of life are strengthens.

Mc 2009. Microscopy Conference, Graz, Austria. 30 August - 4 September 2009. First Joint Meeting Of Dreiländertagung And Multinational Congress On Microscopy.

Tyrimo tikslas. Adaptuoti Lietuvoje gyvenimo kokybės klausimyną „SF-36“, įvertinti reumatoidiniu artritu sergančiųjų ir kontrolinės grupės psichometrinius bei gyvenimo kokybės rodiklius. Metodai ir medžiaga. Gyvenimo kokybės klausimyno „SF-36“ kalbinė ir kultūrinė adaptacija atlikta remiantis tarptautiniame gyvenimo kokybės tyrimo projekte nurodytais etapais. „SF-36“ klausimyno psichometrinių rodiklių vertinimui naudoti Vilniaus reumatoidinio artrito (502 ligoniai) registro bei kontrolinės grupės (83 asmenys) duomenys. „SF-36“ klausimyno stabilumas įvertintas, nustačius skalių homogeniškumą, vidinį pastovumą ir skalių stabilumą laike, apskaičiavus vidinį klasės koreliacijos koeficientą. Įvertintas „SF-36“ klausimyno išorinis, turinio ir konstrukcinis pagrįstumas. Įvertinta sergančiųjų reumatoidiniu artritu ir kontrolinės grupės gyvenimo kokybė. Rezultatai. Vykdant daugiapakopę kalbinę ir kultūrinę „SF-36“ klausimyno adaptaciją, pa¬rengtas galutinis jo variantas. Įvertinant „SF-36“ klausimyno homogeniškumą, stipri ir vidutinė koreliacija tarp kiekvienos srities klausimų dominavo kontrolinėje grupėje (r=0,51–0,71) ir reumatoidiniu artritu sergančiųjų grupėje (r=0,57-0,83). Abiejose tiriamųjų grupėse visose srityse nustatytas pakankamai geras klausimyno „SF-36“ vidinis pastovumas (Kronbach α=0,79–0,85). Visose klausimyno srityse nustatytas geras stabilumas laiko atžvilgiu, išskyrus energingumo ir gyvybingumo sritį (r=0,074). Nustatytas geras klausimyno išorinis ir turinio... [toliau žr. visą tekstą] Objective. To adapt the Lithuanian “SF-36” questionnaire, to assess psychometric and life quality criteria for patients with rheumatoid arthritis and for control group. Material and methods. Linguistic and cross-cultural adaptation of the Lithuanian “SF-36“ questionnaire was made on the basis of the stages referred to in the international project of health quality assessment. For the evaluation of psychometric criteria, data from Vilnius rheumatoid arthritis register (502 patients) and those of the control group (83 people) were used. The reliability of “SF-36” questionnaire was assessed by determining homogeneity, internal consistency of scales and scale stability in time and by calculating the intraclass correlation coefficient. Face, contents and construct validity of the “SF-36” questionnaire has been evaluated, as well as the quality of life of patients with rheumatoid arthritis and those of the control group. Results. After making linguistic and cultural adaptation of the questionnaire, its final version has been prepared. In assessing the homogeneity of “SF-36”, a high and middle-sized correlation between different items of the questionnaire has been noticed in the control group (r=0.51–0.71) and in patients with rheumatoid arthritis (r=0.57–0.83). Internal consistency for the items was also good enough (Kronbach α=0.79–0.85) for both tested groups. Stability in time was high for all items of the questionnaire, for the exception of vitality (r=0.074). Face and... [to full text]

To compare the health-related quality of life between patients with rheumatoid arthritis and systemic lupus erythematosus and a control group. Eighty-eight patients with rheumatoid arthritis, 40 patients with systemic lupus erythematosus and 40 women who did not suffer from any inflammatory joint disease (control group) participated in this comparative study. The questionnaires they completed included information about their sociodemographic status and comorbidities. Patients with rheumatoid arthritis and systemic lupus erythematosus were assessed for pain (visual analogical scale), extra-articular manifestations, and disease activity; also they completed questionnaires for the evaluation of physical function (Health Assessment Questionnaire – HAQ) and burden of arthritis (Arthritis Impact Measurement Scale). All groups under investigation completed the health-related quality questionnaire SF-36 (Medical Outcomes Study Short Form-36) validated in Lithuania. Results. The study of health-related quality of life of women with rheumatic disease showed that patients with systemic lupus erythematosus had stronger pain (p=0.017). It was also found that the activity of patients with rheumatoid arthritis was more limited because of emotional problems (p=0.038). No significant differences were found in other areas of life quality. It was recognized that in comparison to other groups, the quality of life of the control group was better (p=0.000) from the point of view of physical activity, limitations of activity because of physical problems, pain, overall health status and social relations. The psychological status of the latter was undoubtedly worse. Conclusions. In this study it was found that all patients with rheumatoid arthritis and systemic lupus erythematosus had evaluated most of the aspects of health-quality very similarly. Significant differences have been determined when assessing pain and limitation of activity because of emotional problems.