Results of WMR Raynauds and Digital Ulcer Study Reported

JAMA The Journal of the American Medical Association 315(18):1975-1988 · May 2016 

Abstract

Importance: 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. Objective: To evaluate the efficacy of macitentan in reducing the number of new digital ulcers in patients with systemic sclerosis. Conclusions and relevance: 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. Trial registration: clinicaltrials.gov Identifiers: NCT01474109, NCT01474122.

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