{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T11:11:24Z","timestamp":1793272284920,"version":"4.5.0"},"reference-count":28,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2020,11,22]],"date-time":"2020-11-22T00:00:00Z","timestamp":1606003200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2021,1]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To assess the safety and efficacy of RSLV\u2010132, an RNase Fc fusion protein, in a phase II randomized, double\u2010blind, placebo\u2010controlled clinical trial in patients with primary Sj\u00f6gren\u2019s syndrome (SS).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Thirty patients with primary SS were randomized to receive treatment with RSLV\u2010132 or placebo intravenously once per week for 2 weeks, and then every 2 weeks for 12 weeks. Eight patients received placebo and 20 patients received RSLV\u2010132 at a dose of 10 mg\/kg. Clinical efficacy measures included the European League Against Rheumatism (EULAR) Sj\u00f6gren\u2019s Syndrome Disease Activity Index, EULAR Sj\u00f6gren\u2019s Syndrome Patient Reported Index (ESSPRI), Functional Assessment of Chronic Illness Therapy\u2013Fatigue (FACIT\u2010F), Profile of Fatigue (ProF), and the Digit Symbol Substitution Test (DSST).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Patients randomized to receive RSLV\u2010132 experienced clinically meaningful improvements in the ESSPRI score (<jats:italic>P<\/jats:italic> = 0.27), FACIT\u2010F score (<jats:italic>P<\/jats:italic> = 0.05), ProF score (<jats:italic>P<\/jats:italic> = 0.07), and DSST (<jats:italic>P<\/jats:italic> = 0.02) from baseline to day 99, whereas patients who received placebo showed no changes in any of these clinical efficacy measures. This improvement was significantly correlated with increased expression of selected interferon\u2010inducible genes (Pearson\u2019s correlations, each <jats:italic>P<\/jats:italic> &lt; 0.05).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Administration of RSLV\u2010132 improved severe fatigue, as determined by 4 independent patient\u2010reported measures of fatigue, in patients with primary SS.<\/jats:p><\/jats:sec>","DOI":"10.1002\/art.41489","type":"journal-article","created":{"date-parts":[[2020,8,15]],"date-time":"2020-08-15T03:58:44Z","timestamp":1597463924000},"page":"143-150","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":64,"title":["Improvement of Severe Fatigue Following Nuclease Therapy in Patients With Primary Sj\u00f6gren\u2019s Syndrome: A Randomized Clinical 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UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Casement","sequence":"additional","affiliation":[{"name":"Newcastle University  Newcastle upon Tyne UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kerry","family":"Jobling","sequence":"additional","affiliation":[{"name":"Newcastle Biomedical Research Centre and Newcastle upon Tyne Hospital NHS Foundation Trust  Newcastle upon Tyne UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Gallagher","sequence":"additional","affiliation":[{"name":"Newcastle University  Newcastle upon Tyne UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Douglas","family":"Wilson","sequence":"additional","affiliation":[{"name":"Q2 Solutions  Morrisville North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Barone","sequence":"additional","affiliation":[{"name":"University of Birmingham  Birmingham 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