Prediction of worsening of skin fibrosis in patients with diffuse cutaneous systemic sclerosis using the EUSTAR database

Publikation: Beitrag in FachzeitschriftForschungsartikelBeigetragenBegutachtung

Beitragende

  • EUSTAR co-authors - (Autor:in)
  • Medizinische Klinik und Poliklinik 3
  • Klinik und Poliklinik für Dermatologie
  • University of Zurich
  • Graf Biostatistics
  • Justus Liebig University Giessen
  • University of Pecs
  • University College London
  • Universität Basel
  • Bayer AG
  • University of Michigan, Ann Arbor
  • Università degli Studi di Firenze
  • University of Bari
  • Karlsuniversität Prag
  • Medical University of Białystok
  • University of Genoa
  • Department of Clinical and Experimental Medicine F-Magrassi II
  • Charité – Universitätsmedizin Berlin
  • Iuliu Hatieganu University of Medicine and Pharmacy
  • Université Paris Cité
  • National and Kapodistrian University of Athens
  • IRCCS Fondazione Policlinico San Matteo - Pavia
  • Complutense University
  • University Hospital Centre Rijeka
  • Hôpitaux universitaires de Genève
  • Medical University of Silesia in Katowice
  • Università degli studi di Padova
  • University of Ljubljana
  • Stella Maris
  • Marche Polytechnic University
  • Assistance publique – Hôpitaux de Paris
  • Medizinische Klinik und Poliklinik 3
  • Technische Universität Dresden

Abstract

Objectives To identify predictive parameters for the progression of skin fibrosis within 1 year in patients with diffuse cutaneous SSc (dcSSc). Methods An observational study using the EUSTAR database was performed. Inclusion criteria were dcSSc, American College of Rheumatology (ACR) criteria fulfilled, modified Rodnan skin score (MRSS) ≥7 at baseline visit, valid data for MRSS at 2nd visit, and available follow-up of 12±2 months. Worsening of skin fibrosis was defined as increase in MRSS >5 points and ≥25% from baseline to 2nd visit. In the univariate analysis, patients with progressive fibrosis were compared with non-progressors, and predictive markers with p<0.2 were included in the logistic regression analysis. The prediction models were then validated in a second cohort. Results A total of 637 dcSSc patients were eligible. Univariate analyses identified joint synovitis, short disease duration (≤15 months), short disease duration in females/patients without creatine kinase (CK) elevation, low baseline MRSS (≤22/51), and absence of oesophageal symptoms as potential predictors for progressive skin fibrosis. In the multivariate analysis, by employing combinations of the predictors, 17 models with varying prediction success were generated, allowing cohort enrichment from 9.7% progressive patients in the whole cohort to 44.4% in the optimised enrichment cohort. Using a second validation cohort of 188 dcSSc patients, short disease duration, low baseline MRSS and joint synovitis were confirmed as independent predictors of progressive skin fibrosis within 1 year resulting in a 4.5-fold increased prediction success rate. Conclusions Our study provides novel, evidence-based criteria for the enrichment of dcSSc cohorts with patients who experience worsening of skin fibrosis which allows improved clinical trial design.

Titel in Übersetzung
Vorhersage einer Verschlechterung der Hautfibrose bei Patienten mit diffuser kutaner systemischer Sklerose mithilfe der EUSTAR-Datenbank

Details

OriginalspracheEnglisch
Seiten (von - bis)1124-1131
Seitenumfang8
FachzeitschriftAnnals of the rheumatic diseases
Jahrgang74
Ausgabenummer6
PublikationsstatusVeröffentlicht - 8 Mai 2015
Peer-Review-StatusJa

Externe IDs

PubMed 24981642
ORCID /0000-0002-4330-1861/work/151982017