Effects of Bosentan in the Treatment of Digital Ulcers in Korean Patients With Systemic Sclerosis: A Longitudinal, Multicenter, Uncontrolled Trial

Abstract

Digital ulcers (DUs) are one of the visible evidences of microangiopathy in systemic sclerosis (SSc).1 The randomized placebo-controlled investigation of digital ulcers in scleroderma (RAPIDS) 1 and 2 studies were randomized controlled trials (RCTs) evaluating the efficacy of bosentan on healing and preventing DUs. In both RCTs, there was no significant change in DU healing.2,3 However, some studies have suggested bosentan as a treatment option for DUs. In a multicenter retrospective study, the use of bosentan resulted in a decrease in the median number of DUs by 3.6 and 5.0 at 12 and 24 months, respectively.4 A prospective 3-year study also reported that DUs in 65% of SSc patients healed after a median period of 25 weeks of bosentan treatment.5 This longitudinal, multicenter, uncontrolled study involving 4 centers in South Korea aimed to evaluate the clinical outcomes and tolerability of bosentan in treating DUs secondary to SSc or mixed connective tissue disease (MCTD) in a real-world clinical setting.