Laboratory analyses showed increases in aminotransferases in 10.5% of the bosentan patients, compared with 1.1% of the placebo patients, reinforcing "the need for continual monitoring of liver function with this treatment," the authors wrote.
The clinical utility of bosentan treatment for digital ulcer prevention in SSc "may be challenged," the authors wrote. "In a patient encountered with a single [digital ulcer], initiation of bosentan would not be expected to facilitate healing, and at least 66% of all bosentan-treated subjects would develop at least one additional [digital ulcer] over 6 months of follow-up." However, they noted, bosentan treatment offers greater potential benefit to patients who present with multiple digital ulcers. In this regard, the treatment "may be a useful adjunct in the management of patients with [SSc] and recurrent [digital ulcers]."
Disclosures: This study was funded by Actelion Pharmaceuticals. The authors disclosed financial relationships with Actelion, Pfizer, GlaxoSmithKline Beecham, Encysive, Genzyme, Aspreva, Biovitrum, DiGNA, Gilead, MediQuest, Centocor, FibroGen, Bristol-Myers Squibb, Lilly, and United Therapeutics.