Predictors of disease worsening defined by progression of organ damage in diffuse systemic sclerosis: a European Scleroderma Trials and Research (EUSTAR) analysis

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dc.contributor.authorBecker, Mike
dc.contributor.authorGraf, Nicole
dc.contributor.authorSauter, Rafael
dc.contributor.authorAllanore, Yannick
dc.contributor.authorCurram, John
dc.contributor.authorDenton, Christopher P.
dc.contributor.authorKhanna, Dinesh
dc.contributor.authorMatucci-Cerinic, Marco
dc.contributor.authorPena, Janethe de Oliveira
dc.contributor.authorPope, Janet E.
dc.contributor.authorDistler, Oliver
dc.contributor.authorMatucci-Cerinic, Marco
dc.contributor.authorGuiducci, Serena
dc.contributor.authorWalker, Ulrich
dc.contributor.authorJaeger, Veronika
dc.contributor.authorBannert, Bettina
dc.contributor.authorLapadula, Giovanni
dc.contributor.authorBecvarare, Radim
dc.contributor.authorCutolo, Maurizio
dc.contributor.authorValentini, Gabriele
dc.contributor.authorSiegert, Elise
dc.contributor.authorRednic, Simona
dc.contributor.authorAllanore, Yannick
dc.contributor.authorMontecucco, C.
dc.contributor.authorCarreira, Patricia E.
dc.contributor.authorNovak, Srdan
dc.contributor.authorCzirjak, Laszlo
dc.contributor.authorVarju, Cecilia
dc.contributor.authorChizzolini, Carlo
dc.contributor.authorAllai, Daniela
dc.contributor.authorKucharz, Eugene J.
dc.contributor.authorCozzi, Franco
dc.contributor.authorRozman, Blaz
dc.contributor.authorMallia, Carmel
dc.contributor.authorGabrielli, Armando
dc.contributor.authorBancel, Dominique Farge
dc.contributor.authorAiro, Paolo
dc.contributor.authorHesselstrand, Roger
dc.contributor.authorMartinovic, Duska
dc.contributor.authorBalbir-Gurman, Alexandra
dc.contributor.authorBraun-Moscovici, Yolanda
dc.contributor.authorHunzelmann, Nicolas
dc.contributor.authorPellerito, Raffaele
dc.contributor.authorCaramaschi, Paola
dc.contributor.authorBlack, Carol
dc.contributor.authorDamjanov, Nemanja
dc.contributor.authorHenes, Joerg
dc.contributor.authorOrtiz Santamaria, Vera
dc.contributor.authorHeitmann, Stefan
dc.contributor.authorSeidel, Matthias
dc.contributor.authorPereira Da Silva, Jose Antonio
dc.contributor.authorStamenkovic, Bojana
dc.contributor.authorSelmi, Carlo Francesco
dc.contributor.authorTikly, Mohammed
dc.contributor.authorDenisov, Lev N.
dc.contributor.authorMueller-Ladner, Ulf
dc.contributor.authorEngelhart, Merete
dc.contributor.authorHachulla, Eric
dc.contributor.authorRiccieri, Valeria
dc.contributor.authorIonescu, Ruxandra Maria
dc.contributor.authorMihai, Carina
dc.contributor.authorSunderkoetter, Cord
dc.contributor.authorKuhn, Annegret
dc.contributor.authorSchett, Georg
dc.contributor.authorDistler, Joerg
dc.contributor.authorMeroni, Pierluigi
dc.contributor.authorIngegnoli, Francesca
dc.contributor.authorMouthon, Luc
dc.contributor.authorDe Keyser, Filip
dc.contributor.authorSmith, Vanessa
dc.contributor.authorCantatore, Francesco Paolo
dc.contributor.authorCorrado, Ada
dc.contributor.authorUllman, Susanne
dc.contributor.authorIversen, Line
dc.contributor.authorPozzi, Maria Rosa
dc.contributor.authorEyerich, Kilian
dc.contributor.authorHein, Ruediger
dc.contributor.authorKnott, Elisabeth
dc.contributor.authorWiland, Piotr
dc.contributor.authorSzmyrka-Kaczmarek, Magdalena
dc.contributor.authorSokolik, Renata
dc.contributor.authorMorgiel, Ewa
dc.contributor.authorMadej, Marta
dc.contributor.authorJose Alegre-Sancho, Juan
dc.contributor.authorKrummel-Lorenz, Brigitte
dc.contributor.authorSaar, Petra
dc.contributor.authorAringer, Martin
dc.contributor.authorGuenther, Claudia
dc.contributor.authorAnne, Erler
dc.contributor.authorWesthovens, Rene
dc.contributor.authorDe langhe, Ellen
dc.contributor.authorLenaerts, Jan
dc.contributor.authorAnic, Branimir
dc.contributor.authorBaresic, Marko
dc.contributor.authorMayer, Miroslav
dc.contributor.authorUprus, Maria
dc.contributor.authorOtsa, Kati
dc.contributor.authorYavuz, Sule
dc.contributor.authorRadominski, Sebastiao Cezar
dc.contributor.authorMueller, Carolina de Souza
dc.contributor.authorAzevedo, Valderilio Feijo
dc.contributor.authorPopa, Sergei
dc.contributor.authorZenone, Thierry
dc.contributor.authorStebbings, Simon
dc.contributor.authorHighton, John
dc.contributor.authorMathieu, Alessandro
dc.contributor.authorVacca, Alessandra
dc.contributor.authorStamp, Lisa
dc.contributor.authorChapman, Peter
dc.contributor.authorO'Donnell, John
dc.contributor.authorSolanki, Kamal
dc.contributor.authorDoube, Alan
dc.contributor.authorVeale, Douglas
dc.contributor.authorO'Rourke, Marie
dc.contributor.authorLoyo, Esthela
dc.contributor.authorLi, Mengtao
dc.contributor.authorRosato, Edoardo
dc.contributor.authorAmoroso, Antonio
dc.contributor.authorGigante, Antonietta
dc.contributor.authorOksel, Fahrettin
dc.contributor.authorYargucu, Figen
dc.contributor.authorTanaseanu, Cristina-Mihaela
dc.contributor.authorPopescu, Monica
dc.contributor.authorDumitrascu, Alina
dc.contributor.authorTiglea, Isabela
dc.contributor.authorFoti, Rosario
dc.contributor.authorVisalli, Elisa
dc.contributor.authorBenenati, Alessia
dc.contributor.authorAmato, Giorgio
dc.contributor.authorAncuta, Codrina
dc.contributor.authorChirieac, Rodica
dc.contributor.authorVilliger, Peter
dc.contributor.authorAdler, Sabine
dc.contributor.authorDan, Diana
dc.contributor.authorde la Pena Lefebvre, Paloma Garcia
dc.contributor.authorRodriguez Rubio, Silvia
dc.contributor.authorValero Exposito, Marta
dc.contributor.authorSibilia, Jean
dc.contributor.authorChatelus, Emmanuel
dc.contributor.authorGottenberg, Jacques Eric
dc.contributor.authorChifflot, Helene
dc.contributor.authorLitinsky, Ira
dc.contributor.authorDel Galdo, Francesco
dc.contributor.authorVenalis, Algirdas
dc.contributor.authorSaketkoo, Lesley Ann
dc.contributor.authorLasky, Joseph A.
dc.contributor.authorKerzberg, Eduardo
dc.contributor.authorMontoya, Fabiana
dc.contributor.authorCosentino, Vanesa
dc.contributor.authorLimonta, Massimiliano
dc.contributor.authorBrucato, Antonio Luca
dc.contributor.authorLupi, Elide
dc.contributor.authorSpertini, Francois
dc.contributor.authorRibi, Camillo
dc.contributor.authorBuss, Guillaume
dc.contributor.authorMartin, Thierry
dc.contributor.authorGuffroy, Aurelien
dc.contributor.authorPoindron, Vincent
dc.contributor.authorChung, Lori
dc.contributor.authorSchmeiser, Tim
dc.contributor.authorZebryk, Pawel
dc.contributor.authorRiso, Nuno
dc.contributor.authorRiemekasten, Gabriela
dc.contributor.authorRezus, Elena
dc.contributor.authorPuttini, Piercarlo Sarzi
dc.date.accessioned2019-10-27T09:41:25Z
dc.date.available2019-10-27T09:41:25Z
dc.date.issued2019
dc.departmentEge Üniversitesien_US
dc.description.abstractObjectives 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.en_US
dc.description.sponsorshipBayer AGBayer AGen_US
dc.description.sponsorshipThis 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.en_US
dc.identifier.doi10.1136/annrheumdis-2019-215145en_US
dc.identifier.endpage1248en_US
dc.identifier.issn0003-4967
dc.identifier.issn1468-2060
dc.identifier.issue9en_US
dc.identifier.pmid31227488en_US
dc.identifier.startpage1242en_US
dc.identifier.urihttps://doi.org/10.1136/annrheumdis-2019-215145
dc.identifier.urihttps://hdl.handle.net/11454/28624
dc.identifier.volume78en_US
dc.identifier.wosWOS:000485946700028en_US
dc.identifier.wosqualityQ1en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherBmj Publishing Groupen_US
dc.relation.ispartofAnnals of the Rheumatic Diseasesen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.titlePredictors of disease worsening defined by progression of organ damage in diffuse systemic sclerosis: a European Scleroderma Trials and Research (EUSTAR) analysisen_US
dc.typeArticleen_US

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