{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,9]],"date-time":"2026-04-09T18:14:20Z","timestamp":1775758460267,"version":"3.50.1"},"reference-count":10,"publisher":"The Journal of Rheumatology","issue":"9","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Rheumatol"],"published-print":{"date-parts":[[2016,9]]},"abstract":"<jats:sec><jats:title>Objective.<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods.<\/jats:title><jats:p>A multicenter, retrospective study was conducted to determine DU burden in the year after withdrawal from oral treprostinil. DU burden 3\u20136 months (Time A) and &gt; 6\u201312 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results.<\/jats:title><jats:p>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 \u22120.6) 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion.<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec>","DOI":"10.3899\/jrheum.151437","type":"journal-article","created":{"date-parts":[[2016,6,16]],"date-time":"2016-06-16T00:57:22Z","timestamp":1466038642000},"page":"1665-1671","source":"Crossref","is-referenced-by-count":23,"title":["The Recurrence of Digital Ulcers in Patients with Systemic Sclerosis after Discontinuation of Oral Treprostinil"],"prefix":"10.3899","volume":"43","author":[{"given":"Ami A.","family":"Shah","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elena","family":"Schiopu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Soumya","family":"Chatterjee","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mary Ellen","family":"Csuka","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tracy","family":"Frech","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Avram","family":"Goldberg","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Spiera","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stanford L.","family":"Peng","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ryan J.","family":"McBride","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jody M.","family":"Cleveland","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Virginia","family":"Steen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2262","published-online":{"date-parts":[[2016,6,15]]},"reference":[{"key":"2018112909361032000_43.9.1665.1","doi-asserted-by":"publisher","DOI":"10.1002\/acr.20336"},{"key":"2018112909361032000_43.9.1665.2","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2008.096677"},{"key":"2018112909361032000_43.9.1665.3","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.298.6673.561"},{"key":"2018112909361032000_43.9.1665.4","doi-asserted-by":"publisher","DOI":"10.1136\/ard.50.11.800"},{"key":"2018112909361032000_43.9.1665.5","first-page":"1407","article-title":"Intravenous iloprost treatment of Raynaud\u2019s phenomenon and ischemic ulcers secondary to systemic sclerosis","volume":"19","author":"Wigley","year":"1992","journal-title":"J Rheumatol"},{"key":"2018112909361032000_43.9.1665.6","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-120-3-199402010-00004"},{"key":"2018112909361032000_43.9.1665.7","doi-asserted-by":"publisher","DOI":"10.1186\/ar4216"},{"issue":"Suppl 10","key":"2018112909361032000_43.9.1665.8","first-page":"2483","article-title":"Digital ischemic ulcers in scleroderma treated with oral treprostinil diethanolamine: a randomized, double-blind, placebo-controlled, multicenter study","volume":"63","author":"Seibold","year":"2011","journal-title":"Arthritis Rheum"},{"key":"2018112909361032000_43.9.1665.9","unstructured":"ClinicalTrials.gov . Digital ischemic lesions in scleroderma treated with oral treprostinil diethanolamine (DISTOL-1). [Internet. Accessed May 25, 2016.] Available from: ClinicalTrials.gov\/ct2\/show\/NCT00775463"},{"key":"2018112909361032000_43.9.1665.10","doi-asserted-by":"publisher","DOI":"10.1007\/s10067-013-2460-7"}],"container-title":["The Journal of Rheumatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.3899\/jrheum.151437","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2018,11,29]],"date-time":"2018-11-29T14:08:53Z","timestamp":1543500533000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.jrheum.org\/lookup\/doi\/10.3899\/jrheum.151437"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,6,15]]},"references-count":10,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2016,9,1]]},"published-print":{"date-parts":[[2016,9]]}},"alternative-id":["10.3899\/jrheum.151437"],"URL":"https:\/\/doi.org\/10.3899\/jrheum.151437","relation":{},"ISSN":["0315-162X","1499-2752"],"issn-type":[{"value":"0315-162X","type":"print"},{"value":"1499-2752","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,6,15]]}}}