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

(2015) ANNALS OF THE RHEUMATIC DISEASES. 74(6). p.1124-1131
Author
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Abstract
Objectives: To identify predictive parameters for the progression of skin fibrosis within 1year 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 122months. 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 (15months), 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 1year 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.
Keywords
THICKNESS PROGRESSION RATE, Qualitative Research, Outcomes Research, Systemic Sclerosis, EULAR SCLERODERMA TRIALS, DOUBLE-BLIND, ORGAN INVOLVEMENT, CLINICAL-TRIALS, D-PENICILLAMINE, SCORE, METHOTREXATE, VARIABILITY, PLACEBO

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MLA
Maurer, Britta et al. “Prediction of Worsening of Skin Fibrosis in Patients with Diffuse Cutaneous Systemic Sclerosis Using the EUSTAR Database.” ANNALS OF THE RHEUMATIC DISEASES 74.6 (2015): 1124–1131. Print.
APA
Maurer, B., Graf, N., Michel, B. A., Müller-Ladner, U., Czirják, L., Denton, C. P., Tyndall, A., et al. (2015). Prediction of worsening of skin fibrosis in patients with diffuse cutaneous systemic sclerosis using the EUSTAR database. ANNALS OF THE RHEUMATIC DISEASES, 74(6), 1124–1131.
Chicago author-date
Maurer, Britta, Nicole Graf, Beat A Michel, Ulf Müller-Ladner, László Czirják, Christopher P Denton, Alan Tyndall, et al. 2015. “Prediction of Worsening of Skin Fibrosis in Patients with Diffuse Cutaneous Systemic Sclerosis Using the EUSTAR Database.” Annals of the Rheumatic Diseases 74 (6): 1124–1131.
Chicago author-date (all authors)
Maurer, Britta, Nicole Graf, Beat A Michel, Ulf Müller-Ladner, László Czirják, Christopher P Denton, Alan Tyndall, Carola Metzig, Vivian Lanius, Dinesh Khanna, Oliver Distler, the EUSTAR co-authors, Filip De Keyser, and Vanessa Smith. 2015. “Prediction of Worsening of Skin Fibrosis in Patients with Diffuse Cutaneous Systemic Sclerosis Using the EUSTAR Database.” Annals of the Rheumatic Diseases 74 (6): 1124–1131.
Vancouver
1.
Maurer B, Graf N, Michel BA, Müller-Ladner U, Czirják L, Denton CP, et al. Prediction of worsening of skin fibrosis in patients with diffuse cutaneous systemic sclerosis using the EUSTAR database. ANNALS OF THE RHEUMATIC DISEASES. 2015;74(6):1124–31.
IEEE
[1]
B. Maurer et al., “Prediction of worsening of skin fibrosis in patients with diffuse cutaneous systemic sclerosis using the EUSTAR database,” ANNALS OF THE RHEUMATIC DISEASES, vol. 74, no. 6, pp. 1124–1131, 2015.
@article{8039058,
  abstract     = {Objectives: To identify predictive parameters for the progression of skin fibrosis within 1year 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 122months. 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 (15months), 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 1year 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.},
  author       = {Maurer, Britta and Graf, Nicole and Michel, Beat A and Müller-Ladner, Ulf and Czirják, László and Denton, Christopher P and Tyndall, Alan and Metzig, Carola and Lanius, Vivian and Khanna, Dinesh and Distler, Oliver and EUSTAR co-authors, the and De Keyser, Filip and Smith, Vanessa},
  issn         = {0003-4967},
  journal      = {ANNALS OF THE RHEUMATIC DISEASES},
  keywords     = {THICKNESS PROGRESSION RATE,Qualitative Research,Outcomes Research,Systemic Sclerosis,EULAR SCLERODERMA TRIALS,DOUBLE-BLIND,ORGAN INVOLVEMENT,CLINICAL-TRIALS,D-PENICILLAMINE,SCORE,METHOTREXATE,VARIABILITY,PLACEBO},
  language     = {eng},
  number       = {6},
  pages        = {1124--1131},
  title        = {Prediction of worsening of skin fibrosis in patients with diffuse cutaneous systemic sclerosis using the EUSTAR database},
  url          = {http://dx.doi.org/10.1136/annrheumdis-2014-205226},
  volume       = {74},
  year         = {2015},
}

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