{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T09:14:39Z","timestamp":1790673279654,"version":"4.1.0"},"reference-count":45,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2017,11,28]],"date-time":"2017-11-28T00:00:00Z","timestamp":1511827200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005646","name":"Actelion Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005646","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2017,12]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To determine the effect of selexipag, an oral, selective <jats:styled-content style=\"fixed-case\">IP<\/jats:styled-content> prostacyclin receptor agonist, on the frequency of attacks of Raynaud's phenomenon (<jats:styled-content style=\"fixed-case\">RP<\/jats:styled-content>) in patients with systemic sclerosis (<jats:styled-content style=\"fixed-case\">SS<\/jats:styled-content>c).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients with <jats:styled-content style=\"fixed-case\">SS<\/jats:styled-content>c\u2010related <jats:styled-content style=\"fixed-case\">RP<\/jats:styled-content> were randomized 1:1 to placebo (n = 38) or selexipag (n = 36) in individualized doses (maximum of 1,600 \u03bcg twice daily) during a 3\u2010week titration period. The primary end point was the weekly average number of <jats:styled-content style=\"fixed-case\">RP<\/jats:styled-content> attacks during the study maintenance period, analyzed using a Bayesian approach with a negative binomial model adjusted for baseline number of <jats:styled-content style=\"fixed-case\">RP<\/jats:styled-content> attacks. Other outcome measures included Raynaud's Condition Score (<jats:styled-content style=\"fixed-case\">RCS<\/jats:styled-content>), <jats:styled-content style=\"fixed-case\">RP<\/jats:styled-content> attack duration, and treatment\u2010emergent adverse events (<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Baseline characteristics were comparable between treatment groups. For 83.3% of patients, the individualized maintenance dosage of selexipag was \u2264800 \u03bcg twice daily. No significant difference was observed between placebo and selexipag in weekly average number of electronic diary (<jats:styled-content style=\"fixed-case\">eD<\/jats:styled-content>iary)\u2013recorded <jats:styled-content style=\"fixed-case\">RP<\/jats:styled-content> attacks during the maintenance period (14.2 attacks during the maintenance period and 21.5 attacks during the baseline week in the placebo group [n = 32] versus 18.0 attacks during the maintenance period and 22.4 attacks during the baseline week in the selexipag group [n = 27]; adjusted mean treatment difference of 3.4 in favor of placebo). No significant treatment effect was observed on <jats:styled-content style=\"fixed-case\">RCS<\/jats:styled-content> or <jats:styled-content style=\"fixed-case\">RP<\/jats:styled-content> attack duration. In the double\u2010blind period, 86.8% of placebo\u2010treated patients and 100% of selexipag\u2010treated patients reported \u22651 <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>; 55.3% and 91.7%, respectively, reported \u22651 prostacyclin\u2010associated <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Treatment with selexipag did not reduce the number of <jats:styled-content style=\"fixed-case\">RP<\/jats:styled-content> attacks compared with placebo. The safety profile of selexipag was similar to that previously reported. This study provides important information about the feasibility of <jats:styled-content style=\"fixed-case\">eD<\/jats:styled-content>iary reporting of <jats:styled-content style=\"fixed-case\">RP<\/jats:styled-content> attacks in clinical trials.<\/jats:p><\/jats:sec>","DOI":"10.1002\/art.40242","type":"journal-article","created":{"date-parts":[[2017,12,1]],"date-time":"2017-12-01T13:39:59Z","timestamp":1512135599000},"page":"2370-2379","source":"Crossref","is-referenced-by-count":71,"title":["Efficacy and Safety of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis"],"prefix":"10.1002","volume":"69","author":[{"given":"Christopher P.","family":"Denton","sequence":"first","affiliation":[{"name":"Royal Free Hospital London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"\u00c9ric","family":"Hachulla","sequence":"additional","affiliation":[{"name":"National Referral Centre for Rare Systemic Auto\u2010immune Diseases Department of Internal Medicine H\u00f4pital Huriez University of Lille Lille France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriela","family":"Riemekasten","sequence":"additional","affiliation":[{"name":"Charit\u00e9 University of Medicine Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Schwarting","sequence":"additional","affiliation":[{"name":"Johannes Gutenberg University Mainz, and ACURA Rheumatology Centre RLP Bad Kreuznach Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean\u2010Marie","family":"Frenoux","sequence":"additional","affiliation":[{"name":"Actelion Pharmaceuticals Ltd. 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