Bosentan in clinical practice for treating digital and other ischemic ulcers in Spanish patients with systemic sclerosis: IBER-DU Cohort Study

The Journal of Rheumatology, 06/06/2011

Ivorra JAR et al. – Previously reported results of bosentan efficacy in DU management are reproducible in clinical practice. This efficacy is maintained in the longterm followup. Bosentan treatment was well tolerated and adverse events were comparable with those observed in previous reports.

Methods

  • Multicenter, noninterventional retrospective cohort study
  • Data collected retrospectively from patients with DU, with or without PAH, who were initiating bosentan therapy in 2003 (n = 26) or 2004 (n = 41) and followed until May 2005
  • Data were obtained from centers prescribing bosentan
  • Relevant measures included number of DU, occurrence of new DU, overall DU clinical status (improved, stabilized, worsened), and bosentan-associated AEs

Results

  • 67 patients with SSc and DU or other ulcers included
  • PAH was also present in 12 patients (18%)
  • At start of bosentan treatment, median number of DU per patient was 3.0
  • Median change in number of DU -3.6 and -5.0 at 12 and 24 months
  • 68% of patients did not develop any new DU at 12 months
  • DU clinical status reported at 12 months for 22 patients: 18 patients (81.8%) improved and 4 (18.2%) stabilized
  • Median treatment duration 13.0 months
  • Main AE was increase of aminotransferase, observed in 5 patients (7%), leading to discontinuation of treatment in 3 patients (4.4%)

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