STUDY SHOWS REDUCTION OF ULCERS IN PATIENTS WITH SYSTEMIC SCLEROSIS

Actelion has announced the preliminary result of a double-blind, placebo-controlled, randomized, multicenter, 190-patient Phase III study, RAPIDS-2, with the dual endothelin receptor antagonist bosentan (Tracleer) in systemic sclerosis patients suffering from digital ulceration.

Preliminary analysis indicates that the primary endpoint of reduction in the occurrence of new digital ulcers during the 6-month treatment period was statistically significant. This result confirms the positive findings from an earlier trial, RAPIDS-1.

The study RAPIDS-2 also evaluated the effect on time to healing of existing digital ulceration in this patient population. There was no difference in time to healing between patients receiving placebo and those receiving bosentan. The safety profile of bosentan in this study was comparable to that observed in previous clinical trials and postmarketing experience with Tracleer.