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OP0275 Nailfold Videocapillaroscopy and Other Predictive Factors Associated with New Digital Ulcers in Systemic Sclerosis: Data from the Cap Study
  1. M. Cutolo1,
  2. A. Herrick2,
  3. O. Distler3,
  4. M. Becker4,
  5. E. Beltran5,
  6. P. Carpentier6,
  7. C. Ferri7,
  8. M. Inanç8,
  9. P. Vlachoyiannopoulos9,
  10. H. Chadha-Boreham10,
  11. E. Cottreel10,
  12. T. Pfister10,
  13. D. Rosenberg10,
  14. J. Torres10,
  15. V. Smith11
  1. 1Rheumatology, Genova University, Genova, Italy
  2. 2Rheumatology, University of Manchester, Manchester, United Kingdom
  3. 3Rheumatology, University Hospital Zurich, Zurich, Switzerland
  4. 4Rheumatology and Immunology, Charité University Hospital, Berlin, Germany
  5. 5Hospital La Fe, Valencia, Spain
  6. 6Vascular Medicine, La Tronche Hospital, Grenoble, France
  7. 7Rheumatology, University of Modena & Reggio Emilia, Policlinico Modena, Modena, Italy
  8. 8Rheumatology, Istanbul University, Istanbul, Turkey
  9. 9Pathophysiology, Athens University, Athens, Greece
  10. 10Actelion Pharmaceuticals Ltd, Allschwil, Switzerland
  11. 11Rheumatology, Ghent University, Ghent, Belgium

Abstract

Background Digital ulcers (DU) are painful and disabling and affect almost 50% of patients with systemic sclerosis (SSc). Nailfold videocapillaroscopy (NVC) non-invasively assesses SSc-related micro-angiopathy and may be useful in predicting clinical progression of digital vasculopathy, especially DU.1-3

Objectives To identify NVC variables and other factors which predict the occurrence of new DU in SSc patients.

Methods International, prospective, cohort study in SSc. Eligibility was not restricted by medication use. Patients were enrolled in two strata: ‘DU History’ and ‘No DU History’. The No DU History patients had early disease (≤2 years). Descriptive variables were classified into bundles: demographics, clinical, SSc, DU and NVC characteristics. NVC variables for fingers II–V were evaluated locally in a standardised way. Patients were monitored up to 6 months. New DU were confirmed by the investigator. For each stratum, variables were analyzed by Univariate Logistic Regression (ULR) to assess their statistical significance (Wald χ2) and discriminatory ability (receiver operating characteristic [ROC] curve and area under the ROC curve [AUC]). Multivariate Logistic Regression (MLR) analysis was performed within defined clinically relevant bundles of statistically good-performing variables (Wald χ2 test statistic p<0.15 for linear terms and <0.05 for quadratic terms) based on ULR.

Results Of the 623 patients enrolled in 59 centres, 591 had data on DU outcome (new DU [Cases] or no new DU [Non-cases]) during the study. 468 (79%) patients had a DU history, of whom 103 (22%) developed new DU. 123 (21%) patients had no DU history, of whom 5 (4%) developed new DU. The present analysis focuses on the DU-history stratum. The mean age was 54.0 years, 79.5% were females, and 59.8% patients had limited cutaneous SSc. Cases had a lower mean of 4.2 capillaries per millimeter vs. 4.8 in Non-cases and a higher mean of 0.7 neoangiogeneses vs. 0.5 in Non-cases. The ULR AUC (Wald p-value) for number of capillaries, neoangiogeneses and DU at enrollment were 0.605 (0.002), 0.572 (0.013) and 0.678 (<0.001), respectively. Preliminary MLR analyses within bundles resulted in the following variables at enrollment: number of capillaries and neoangiogeneses, NVC pattern, number of DU, critical digital ischaemia, soft tissue infection, history of autoamputation, age, manual labour, presence of paronychia and heart involvement.

Conclusions The strongest predictors for new DU in SSc patients with DU history were NVC variables reflecting SSc microvasculopathy and number of DU at enrolment. The study showed that NVC imaging and assessment are feasible in multicentre trials. Further MRL analysis will identify the optimal combination of variables to predict new DU in SSc patients.

References

  1. Cutolo M et al. Nature Rev Rheumatol 2010;6:578–87

  2. Smith V et al. Ann Rheum Dis 2011;70:180–3

  3. Sebastiani M et al. Ann Rheum Dis 2012;71:67–70

Disclosure of Interest M. Cutolo Grant/research support from: Actelion Pharmaceuticals Ltd, Sanofi, Bristol-Meyers Squibb, A. Herrick Grant/research support from: Actelion Pharmaceuticals Ltd, Consultant for: Actelion Pharmaceuticals Ltd, Speakers bureau: Actelion Pharmaceuticals Ltd, O. Distler Grant/research support from: Actelion Pharmaceuticals Ltd, Pfizer, Ergonex, BMS, Sanofi-Aventis, United BioSource Corporation, Roche/Genentech, medac, Biovitrium, Boehringer Ingelheim Pharma, Novartis, 4 D Science, Active Biotech, Sinoxa, Consultant for: Actelion Pharmaceuticals Ltd, Pfizer, Ergonex, BMS, Sanofi-Aventis, United BioSource Corporation, Roche/Genentech, medac, Biovitrium, Boehringer Ingelheim Pharma, Novartis, 4 D Science, Active Biotech, Sinoxa, Speakers bureau: Actelion Pharmaceuticals Ltd, Pfizer, Ergonex, M. Becker Consultant for: Actelion Pharmaceuticals Ltd, E. Beltran: None Declared, P. Carpentier Consultant for: Actelion Pharmaceuticals Ltd, C. Ferri: None Declared, M. Inanç Grant/research support from: Actelion Pharmaceuticals Ltd, Consultant for: Actelion Pharmaceuticals Ltd, P. Vlachoyiannopoulos: None Declared, H. Chadha-Boreham Employee of: Actelion Pharmaceuticals Ltd, E. Cottreel Employee of: Actelion Pharmaceuticals Ltd, T. Pfister Employee of: Actelion Pharmaceuticals Ltd, D. Rosenberg Employee of: Actelion Pharmaceuticals Ltd, J. Torres Shareholder of: Syntax for Science SL, Consultant for: Actelion Pharmaceuticals Ltd, V. Smith Consultant for: Actelion Pharmaceuticals Ltd, Speakers bureau: Actelion Pharmaceuticals Ltd

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