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Clinical aspects

 

An observational cohort study of patients with newly diagnosed digital ulcer disease secondary to systemic sclerosis registered in the EUSTAR database

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29

 

  1. Actelion Pharmaceuticals Ltd., Departments of Epidemiology and Observational Studies, and Global Market Access and Pricing, Allschwil, Switzerland.
  2. Basel University Department of Rheumatology, Felix Platter-Spital, Basel, Switzerland.
  3. Actelion Pharmaceuticals Ltd., Departments of Epidemiology and Observational Studies, and Global Market Access and Pricing, Allschwil, Switzerland.
  4. Numerus Statistics Ltd., Tübingen, Germany.
  5. Actelion Pharmaceuticals Ltd., Departments of Epidemiology and Observational Studies, and Global Market Access and Pricing, Allschwil, Switzerland.
  6. Basel University Department of Rheumatology, Felix Platter-Spital, Basel, Switzerland.
  7. Department of Biomedicine, Section of Rheumatology, University of Florence, Florence, Italy.
  8. Servicio de Reumatologia, Hospital Universitario 12 de Octubre, Madrid, Spain.
  9. Department of Rheumatology and Immunology, University of Pécs, Pécs, Hungary.
  10. Department Clinica Medica, Università Politecnica delle Marche, Ancona, Italy.
  11. Rheumatology and Clinical Immunology Service, Spedali Civili di Brescia, Brescia, Italy.
  12. Rheumatology Unit, University of Verona, Verona, Italy.
  13. Institute of Rheumatology, University of Belgrade Medical School, Belgrade, Serbia.
  14. Department of Rheumatology, Justus- Liebig-University, Bad Nauheim, Germany.
  15. Department of Internal Medicine and Medical Specialities, Sapienza University of Rome, Rome, Italy.
  16. Department of Rheumatology, Cantacuzino Hospital, Carol Davila University, Bucharest, Romania.
  17. Clinical Immunology Unit, Sapienza University of Rome, Rome, Italy.
  18. AOU Rheumatology Unit, Department of Medical Sciences, University of Cagliari, Cagliari, Italy.
  19. Department of Internal Medicine, Centre Hospitalier, Valence, France.
  20. University Hospital, Alexandria, Egypt.
  21. Department of Rheumatology, Gr. T. Popa University of Medicine and Pharmacy, Iasi, Romania.
  22. Department of Rheumatology, University of Genoa, Genoa, Italy.
  23. University of Medicine and Pharmacy Iuliu Hatieganu, Cluj Napoca, Romania.
  24. Division of Rheumatology, Chris Hani Baragwanath Academic Hospital, Johannesburg, South Africa.
  25. Rheumatology Unit, Istituto Clinico Humanitas, University of Milan, Rozzano, Italy.
  26. Clinica Medica, Azienda Ospedaliera San Gerardo, University of Milano, Bicocca, Italy.
  27. Rheumatology Unit, Azienda Ospedaliera Universitaria Policlinico V.E., Catania, Italy.
  28. Basel University Department of Rheumatology, Felix Platter-Spital, Basel, Switzerland. ulrich.walker@usb.ch
  29. EUSTAR Co-investigators

CER8055
2015 Vol.33, N°4 ,Suppl.91
PI 0047, PF 0054
Clinical aspects

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PMID: 26243652 [PubMed]

Received: 23/10/2014
Accepted : 30/04/2015
In Press: 05/08/2015
Published: 31/08/2015

Abstract

OBJECTIVES:
This study describes clinical characteristics, prognostic factors, and quality of life in patients with newly diagnosed (incident) digital ulcers (DU).
METHODS:
Observational cohort study of 189 consecutive SSc patients with incident DU diagnosis identified from the EUSTAR database (22 centres in 10 countries). Data were collected from medical charts and during one prospective visit between 01/2004 and 09/2010.
RESULTS:
Median age at DU diagnosis was 51 years, majority of patients were female (88%), and limited cutaneous SSc was the most common subtype (61%). At incident DU diagnosis, 41% of patients had one DU and 59% had ≥2 DU; at the prospective visit 52% had DU. Pulmonary arterial hypertension (PAH) and multiple DU at diagnosis were associated with presence of any DU at the prospective visit (odds ratios: 4.34 and 1.32). During the observation period (median follow-up was 2 years) 127 patients had ≥1 hospitalisation. The event rate of new DU per person-year was 0.66, of DU-associated complications was 0.10, and of surgical or diagnostic procedures was 0.12. At the prospective visit, patients with ≥1 DU reported impairment in daily activities by 57%, those with 0 DU by 37%. The mean difference between patients with or without DU in the SF-36 physical component was 2.2, and in the mental component 1.4. DU patients were not routinely prescribed endothelin receptor antagonists or prostanoids.
CONCLUSIONS:
This real world cohort demonstrates that DU require hospital admission, and impair daily activity. PAH and multiple DU at diagnosis were associated with future occurrence of DU.

Rheumatology Article