Predictors of disease worsening defined ...
Type de document :
Article dans une revue scientifique: Article original
PMID :
URL permanente :
Titre :
Predictors of disease worsening defined by progression of organ damage in diffuse systemic sclerosis: a european scleroderma trials and research (eustar) analysis
Auteur(s) :
Becker, Mike [Auteur]
Graf, Nicole [Auteur]
Sauter, Rafael [Auteur]
Allanore, Yannick [Auteur]
Curram, John [Auteur]
Denton, Christopher P. [Auteur]
Khanna, Dinesh [Auteur]
Matucci-Cerinic, Marco [Auteur]
De Oliveira Pena, Janethe [Auteur]
Pope, Janet E. [Auteur]
Distler, Oliver [Auteur]
Graf, Nicole [Auteur]
Sauter, Rafael [Auteur]
Allanore, Yannick [Auteur]
Curram, John [Auteur]
Denton, Christopher P. [Auteur]
Khanna, Dinesh [Auteur]
Matucci-Cerinic, Marco [Auteur]
De Oliveira Pena, Janethe [Auteur]
Pope, Janet E. [Auteur]
Distler, Oliver [Auteur]
Titre de la revue :
Annals of the Rheumatic Diseases
Nom court de la revue :
Ann. Rheum. Dis.
Date de publication :
2019-06-21
ISSN :
1468-2060
Discipline(s) HAL :
Sciences du Vivant [q-bio]
Résumé en anglais : [en]
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 ...
Lire la suite >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. 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. 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. The use of the predictive factors presented here could enable cohort enrichment with patients at risk for overall disease worsening in SSc clinical trials.Lire moins >
Lire la suite >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. 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. 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. The use of the predictive factors presented here could enable cohort enrichment with patients at risk for overall disease worsening in SSc clinical trials.Lire moins >
Langue :
Anglais
Audience :
Internationale
Vulgarisation :
Non
Date de dépôt :
2024-01-30T10:27:03Z