RT Journal Article
SR Electronic
T1 The Recurrence of Digital Ulcers in Patients with Systemic Sclerosis after Discontinuation of Oral Treprostinil
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 1665
OP 1671
DO 10.3899/jrheum.151437
VO 43
IS 9
A1 Ami A. Shah
A1 Elena Schiopu
A1 Soumya Chatterjee
A1 Mary Ellen Csuka
A1 Tracy Frech
A1 Avram Goldberg
A1 Robert Spiera
A1 Stanford L. Peng
A1 Ryan J. McBride
A1 Jody M. Cleveland
A1 Virginia Steen
YR 2016
UL http://www.jrheum.org/content/43/9/1665.abstract
AB Objective. Prior studies investigating the efficacy of oral treprostinil to treat digital ulcers (DU) in systemic sclerosis (SSc)-associated Raynaud phenomenon have yielded conflicting results. In this investigation, we examined whether DU burden increased after patients withdrew from oral treprostinil that was administered during an open-label extension study.Methods. A multicenter, retrospective study was conducted to determine DU burden in the year after withdrawal from oral treprostinil. DU burden 3–6 months (Time A) and > 6–12 months (Time B) after drug withdrawal was compared with DU burden at baseline, defined as the last day receiving drug in the open-label extension study, by a paired Student t test. Changes in DU burden while receiving drug in the open-label study were compared with changes in DU burden at Time B by a paired Student t test.Results. Fifty-one patients from 9 clinical sites were included for analysis. DU burden increased significantly from baseline (mean 0.47) to Time A (mean 2.1, p = 0.002, n = 23) and Time B (mean 1.45, p = 0.013, n = 30). Total DU burden decreased during oral treprostinil exposure (mean change −0.6) and then increased by Time B (mean change 1.05, p = 0.0027 for comparison, n = 30). In the year after drug withdrawal, many patients required vasodilator therapy and pain medications. Three patients were hospitalized for complications from DU, and 4 patients required surgery for DU.Conclusion. Total DU burden increased significantly after discontinuation of oral treprostinil. These data provide supportive evidence of a beneficial effect of oral treprostinil for the vascular complications of SSc and suggest that further study is warranted.