engleski

. Effect of Macitentan on the Development of New Ischemic Digital Ulcers in Patients With Systemic Sclerosis DUAL – 1 and DUAL – 2 Randomized Clinical Trials

Digital ulcers in patients with systemic sclerosis are associated with pain and poor quality of life. Endothelin-1 promotes vasculopathy in systemic sclerosis after macitentan, an endothelin-1 blocker.To evaluate the efficacy of macitentan in reducing the number of new digital ulcers in patients with systemic sclerosis. In DUAL-1, among 289 randomized patients (mean age 51.2 years ; 85.8% women), 226 completed the study. The adjusted mean number of new digital ulcers per patient over 16 weeks was 0.94 in the 3-mg macitentan group (n = 95) and 1.08 in the 10-mg macitentan group (n = 97) compared with 0.85 in the placebo group (n = 97) (absolute difference, 0.09 [95%CI, −0.37 to 0.54] for 3mg of macitentan vs placebo and 0.23 [−0.27 to 0.72] for 10mg of macitentan vs placebo). Among 265 patients randomized in DUAL-2 (mean age 49.6 years ; 81.9% women), 216 completed the study. In DUAL- 2, the adjusted mean number of new digital ulcers was 1.44 in the 3-mg macitentan group (n = 88) and 1.46 in the 10-mg macitentan group (n = 88) compared with 1.21 in the placebo group (n = 89) (absolute difference, 0.23 [95%CI, −0.35 to 0.82] for 3mg of macitentan vs placebo and 0.25 [95%CI, −0.34 to 0.84] for 10mg of macitentan vs placebo). Adverse events more frequently associated with macitentan than with placebo were headache, peripheral edema, skin ulcer, anemia, upper respiratory tract infection, diarrhea, and nasopharyngitis. Among patients with systemic sclerosis and active ischemic digital ulcers, treatment with macitentan did not reduce new digital ulcers over 16 weeks. These results do not support the use of macitentan for the treatment of digital ulcers in this patient population.

Digital Ulcers, Patients With Systemic Sclerosis, Effect of Macitentan

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