PT  - JOURNAL ARTICLE
AU  - Ami A. Shah
AU  - Elena Schiopu
AU  - Soumya Chatterjee
AU  - Mary Ellen Csuka
AU  - Tracy Frech
AU  - Avram Goldberg
AU  - Robert Spiera
AU  - Stanford L. Peng
AU  - Ryan J. McBride
AU  - Jody M. Cleveland
AU  - Virginia Steen
TI  - The Recurrence of Digital Ulcers in Patients with Systemic Sclerosis after Discontinuation of Oral Treprostinil
AID  - 10.3899/jrheum.151437
DP  - 2016 Sep 01
TA  - The Journal of Rheumatology
PG  - 1665--1671
VI  - 43
IP  - 9
4099  - http://www.jrheum.org/content/43/9/1665.short
4100  - http://www.jrheum.org/content/43/9/1665.full
SO  - J Rheumatol2016 Sep 01; 43
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.