Faculty Collaboration Database

The Recurrence of Digital Ulcers in Patients with Systemic Sclerosis after Discontinuation of Oral Treprostinil. J Rheumatol 2016 Sep;43(9):1665-71

Date

06/17/2016

Pubmed ID

27307535

DOI

10.3899/jrheum.151437

Scopus ID

2-s2.0-84984984880 (requires institutional sign-in at Scopus site)   15 Citations

Abstract

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.

Author List

Shah AA, Schiopu E, Chatterjee S, Csuka ME, Frech T, Goldberg A, Spiera R, Peng SL, McBride RJ, Cleveland JM, Steen V

Author

Mary Ellen Csuka MD Professor in the Medicine department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adult
Aged
Antihypertensive Agents
Epoprostenol
Female
Fingers
Humans
Male
Middle Aged
Raynaud Disease
Recurrence
Retrospective Studies
Scleroderma, Systemic
Skin Ulcer