FRI0435 Management of digital ulcer disease varies across europe: Findings from the duo registry. (23rd January 2014)

• Record Type: Journal Article
• Authors: Matucci-Cerinic, M.; Guillevin, L.; Denton, C.P.; Schwierin, B.; Rosenberg, D.; Krieg, T.
• Is Part Of: Annals of the rheumatic diseases. Volume 71(2012)Supplement 3
• Page Start: 461
• Page End: 461
• Publication Date: 2014-01-23
• Subjects: Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2012-eular.2892
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Background: Digital ulcers (DU) are a frequent, persistent and debilitating manifestation of systemic sclerosis (SSc). The DUO Registry is a European, multicenter, prospective, observational cohort study of SSc patients with ongoing DU disease. Objectives: To describe and compare the management of SSc patients with ongoing DU disease across 4 European countries. Methods: The DUO Registry enrolls consenting patients with current, or a history of, DU. Patients are clinically assessed and receive medical care as determined by their physician. Since April 2008, data collected have included demographics, SSc and DU medical history, and complications/interventions, such as gangrene/medication, associated with DU. The demographics and treatment of patients in Italy, France, Germany and the UK up to May 2011 are described. Results: In total 2944 patients have enrolled in the DUO Registry, 1825 being from Italy (n=643), France (n=288), Germany (n=661) and the UK (n=233). Patient demographics were very similar; the mean age (range between countries) was 54.6 (54.0–55.4) years; patients were predominantly female, 82.1% (76.7–89.8%); the mean age of a first incidence of Raynaud's phenomenon was 39.8 (37.3–41.6) years; and average age at first DU was 46.9 (44.8–47.8) years. For all countries the rates of diffuse SSc (range 37.1–44.4%) and limited SSc (range 45.4–53.4%) were similar. However, the UK and Germany had a higher percentage of patients with overlap SSc/mixed connective tissue disease (8.6 and 9.5%, respectively) compared with Italy and France (4.7 and 4.5%, respectively). Previous use of parenteral prostanoid therapy was higher in Italy (82.4%) than France (52.5%), Germany (57.1%) or the UK (69.9%). For patients with one or more DU the ongoing use of pulmonary arterial hypertension (PAH)-related therapy; phosphodiesterase-5 inhibitors (PDE5-I), calcium channel blockers (CCB), prostacyclin (PGI2) and endothelin receptor antagonists (ERAs -primarily bosentan) are summarized in the table. Key differences in ongoing medication use between countries included a low rate of ERA use in the UK compared with the other countries, but a higher use of PDE-5I. A high rate of prostacyclin use was observed in Italy compared with the other countries. Patients also received general therapies; antibiotics (range between countries) (6.0–47.1%), immunosuppressants (21.1–37.7%), topical treatments (19.3–45.4%) and analgesic and anti-inflammatory drugs (52.5–66.2%). Use of these other therapies varied widely between each country. Interpretation of the frequency of use of ERAs and DU-specific therapies must be done with caution as selection bias based on the use of bosentan as a criterion for enrollment cannot be ruled out. Conclusions: This observational registry highlights the wide variation in the treatment of SSc-associated DU across Europe, and likely reflects the differences in access to therapy in different countries and healthcare environments. These findings draw attention to the need for a coordinated European approach in establishing the best management practice for these patients. Disclosure of Interest: M. Matucci-Cerinic Consultant for: Actelion Pharmaceuticals, L. Guillevin Paid Instructor for: Actelion Pharmaceuticals Ltd, C. Denton Grant/Research support from: Actelion Pharmaceuticals, Encysive Corporation, Consultant for: Actelion Pharmaceuticals, Encysive Corporation, B. Schwierin Employee of: Actelion Pharmaceuticals Ltd, D. Rosenberg Employee of: Actelion Pharmaceuticals Ltd, T. Krieg Consultant for: Actelion Pharmaceuticals Ltd, Paid Instructor for: Actelion Pharmaceuticals Ltd