Bosentan in Clinical Practice for Treating Digital and Other Ischemic Ulcers in Spanish Patients with Systemic Sclerosis: IBER-DU Cohort Study

• Published in: Journal of rheumatology Vol. 38; no. 8; pp. 1631 - 1635
• Main Authors: ROMAN IVORRA, Jose Andrés, SIMEON, Carmen Pilar, ALEGRE SANCHO, Juan José, EGURBIDE, Maria Victoria, CASTILLO, Maria Jesús, LLORIA, Xavier, FONOLLOSA, Vicent
• Format: Journal Article
• Language: English
• Published: Toronto, ON Journal of Rheumatology Publishing 01-08-2011
• Subjects: Antihypertensive Agents - therapeutic use; Biological and medical sciences; Cohort Studies; Diseases of the osteoarticular system; Humans; Hypertension - drug therapy; Ischemia - pathology; Medical sciences; Randomized Controlled Trials as Topic; Retrospective Studies; Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis; Scleroderma, Systemic - complications; Scleroderma, Systemic - drug therapy; Scleroderma, Systemic - pathology; Skin Ulcer - drug therapy; Skin Ulcer - etiology; Skin Ulcer - pathology; Spain; Sulfonamides - therapeutic use; Treatment Outcome; Spain; Human; Immunopathology; Connective tissue disease; OBSERVATIONAL STUDY; Skin disease; Endothelin; SYSTEMIC SCLEROSIS; Rheumatology; Autoimmune disease; Cardiovascular disease; Bosentan; Treatment; Ischemia; DIGITAL ULCERS; Cohort study; Systemic disease; Peptidergic receptor; Ulcer; Antagonist; Scleroderma; Endothelin receptor
• ISSN: 0315-162X; 1499-2752
• DOI: 10.3899/jrheum.101266

To describe treatment outcomes and safety experience with bosentan in patients with systemic sclerosis (SSc) and digital ulcers (DU), in a clinical setting in Spain.
This was a multicenter, noninterventional retrospective cohort study. Data were collected retrospectively from patients with DU, with or without pulmonary arterial hypertension (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 adverse events.
Sixty-seven patients with SSc and DU or other ulcers were included. PAH was also present in 12 patients (18%). At the start of bosentan treatment, the median number of DU per patient was 3.0. The median change in number of DU was -3.6 and -5.0 at 12 and 24 months, respectively. Sixty-eight percent of the patients did not develop any new DU at 12 months. DU clinical status was reported at 12 months for 22 patients: 18 patients (81.8%) improved and 4 (18.2%) stabilized. The median treatment duration was 13.0 months. The main adverse event was increase of aminotransferase, observed in 5 patients (7%), leading to discontinuation of treatment in 3 patients (4.4%).
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.