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Ann Rheum Dis. 2016 Oct;75(10):1743-8. doi: 10.1136/annrheumdis-2015-208024. Epub 2016 Mar 25.

Prediction of improvement in skin fibrosis in diffuse cutaneous systemic sclerosis: a EUSTAR analysis.

Collaborators (186)

Cerinic MM, Guiducci S, Walker U, Lapadula G, Iannone F, Becvar R, Sierakowsky S, Cutolo M, Sulli A, Valentini G, Cuomo G, Vettori S, Riemekasten G, Siegert E, Rednic S, Nicoara I, Kahan A, Vlachoyiannopoulos P, Montecucco C, Caporali R, Carreira PE, Novak S, Czirják L, Varju C, Chizzolini C, Kucharz EJ, Kotulska A, Kopec-Medrek M, Widuchowska M, Cozzi F, Rozman B, Mallia C, Coleiro B, Gabrielli A, Farge D, Wu C, Marjanovic Z, Faivre H, Hij D, Dhamadi R, Airò P, Hesselstrand R, Wollheim F, Wuttge DM, Andréasson K, Martinovic D, Balbir-Gurman A, Braun-Moscovici Y, Trotta F, Lo Monaco A, Hunzelmann N, Pellerito R, Mauriziano O, Bambara LM, Caramaschi P, Black C, Denton C, Damjanov N, Henes J, Ortiz Santamaria V, Heitmann S, Krasowska D, Seidel M, Burkhardt H, Himsel A, Salvador MJ, Silva JA, Stamenkovic B, Stankovic A, Banja N, Tikly M, Ananieva LP, Denisov LN, Müller-Ladner U, Frerix M, Tarner I, Scorza R, Engelhart M, Strauss G, Nielsen H, Damgaard K, Mendoza AZ, de la Puente C, Sifuentes Giraldo WA, Midtvedt Ø, Reiseter S, Hachulla E, Launay D, Valesini G, Riccieri V, Ionescu RM, Opris D, Groseanu L, Cornateanu RS, Ionitescu R, Gherghe AM, Soare A, Gorga M, Bojinca M, Schett G, Distler JH, Beyer C, Meroni P, Ingegnoli F, Mouthon L, De Keyser F, Smith V, Cantatore FP, Corrado A, Pozzi MR, Eyerich K, Hein R, Knott E, Wiland P, Szmyrka-Kaczmarek M, Sokolik R, Morgiel E, Madej M, Krummel-Lorenz B, Aringer M, Günther C, Westhovens R, de Langhe E, Lenaerts J, Anic B, Baresic M, Mayer M, Radominski SC, de Souza Müller C, Azevedo VF, Agachi S, Groppa L, Chiaburu L, Russu E, Popa S, Zenone T, Stebbings S, Highton J, Stamp L, Chapman P, O'Donnell J, Solanki K, Doube A, Veale D, O'Rourke M, Loyo E, Li M, Rosato E, Amoroso A, Gigante A, Tanaseanu CM, Popescu M, Dumitrascu A, Tiglea I, Foti R, Chirieac R, Ancuta C, Villiger P, Adler S, de la Peña Lefebvre PG, Rubio SR, Exposito MV, Sibilia J, Chatelus E, Gottenberg JE, Chifflot H, Litinsky I, Venalis A, Butrimiene I, Venalis P, Rugiene R, Karpec D, Saketkoo LA, Lasky JA, Kerzberg E, Montoya F, Cosentino V, Limonta M, Brucato AL, Lupi E, Spertini F, Ribi C, Buss G, Pasquali JL, Martin T, Gorse A.

Author information

1
Division of Rheumatology, University Hospital Zurich, Zurich, Switzerland Department of Internal Medicine and Rheumatology, Cantacuzino Hospital, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.
2
Division of Rheumatology, University Hospital Zurich, Zurich, Switzerland.
3
Graf biostatistics, Winterthur, Switzerland.
4
Department of Internal Medicine and Rheumatology, Cantacuzino Hospital, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.
5
Department of Rheumatology and Internal Medicine, Medical University of Bialystok, Bialystok, Poland.
6
Department of Rheumatology, University Paris Descartes and Cochin Hospital, Paris, France.

Abstract

OBJECTIVES:

Improvement of skin fibrosis is part of the natural course of diffuse cutaneous systemic sclerosis (dcSSc). Recognising those patients most likely to improve could help tailoring clinical management and cohort enrichment for clinical trials. In this study, we aimed to identify predictors for improvement of skin fibrosis in patients with dcSSc.

METHODS:

We performed a longitudinal analysis of the European Scleroderma Trials And Research (EUSTAR) registry including patients with dcSSc, fulfilling American College of Rheumatology criteria, baseline modified Rodnan skin score (mRSS) ≥7 and follow-up mRSS at 12±2 months. The primary outcome was skin improvement (decrease in mRSS of >5 points and ≥25%) at 1 year follow-up. A respective increase in mRSS was considered progression. Candidate predictors for skin improvement were selected by expert opinion and logistic regression with bootstrap validation was applied.

RESULTS:

From the 919 patients included, 218 (24%) improved and 95 (10%) progressed. Eleven candidate predictors for skin improvement were analysed. The final model identified high baseline mRSS and absence of tendon friction rubs as independent predictors of skin improvement. The baseline mRSS was the strongest predictor of skin improvement, independent of disease duration. An upper threshold between 18 and 25 performed best in enriching for progressors over regressors.

CONCLUSIONS:

Patients with advanced skin fibrosis at baseline and absence of tendon friction rubs are more likely to regress in the next year than patients with milder skin fibrosis. These evidence-based data can be implemented in clinical trial design to minimise the inclusion of patients who would regress under standard of care.

KEYWORDS:

Epidemiology; Outcomes research; Systemic Sclerosis

PMID:
27016052
PMCID:
PMC5036205
DOI:
10.1136/annrheumdis-2015-208024
[Indexed for MEDLINE]
Free PMC Article

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