{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T21:43:30Z","timestamp":1790372610678,"version":"4.1.0"},"reference-count":29,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2026,4,3]],"date-time":"2026-04-03T00:00:00Z","timestamp":1775174400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,4,3]],"date-time":"2026-04-03T00:00:00Z","timestamp":1775174400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Pruritus and fatigue impose a significant burden on patient quality of life in primary biliary cholangitis (PBC). In the Phase 3 RESPONSE trial (NCT04620733), seladelpar, a potent and selective PPAR\u03b4 agonist, significantly improved markers of cholestasis and pruritus.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Here, we provide additional details on the effects of seladelpar on pruritus and quality of life.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In RESPONSE, patients with PBC and an inadequate response or intolerance to ursodeoxycholic acid were randomised 2:1 to seladelpar 10\u2009mg or placebo for 12\u2009months. Changes in severity of pruritus by the numeric rating scale (NRS) and changes in 5\u2010D Itch and PBC\u201040 in patients with moderate to severe itch (NRS \u2265\u20094), severe itch (NRS \u2265\u20097) and clinically significant itch (PBC\u201040 itch \u2265\u20097) at baseline were evaluated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      In patients with baseline\n                      <jats:styled-content style=\"fixed-case\">NRS<\/jats:styled-content>\n                      \u2265\u20094, mean\n                      <jats:styled-content style=\"fixed-case\">NRS<\/jats:styled-content>\n                      improved from the moderate to mild range with seladelpar, but not placebo. Bodily distribution of itch was reduced with seladelpar based on the 5\u2010D itch distribution domain. Itch\u2010related sleep disturbance was consistently improved with seladelpar across populations, and measures of fatigue were improved versus placebo in patients with severe itch at baseline. Patients without itching tended to remain free from itching with seladelpar, consistent with fewer adverse events of pruritus with seladelpar versus placebo.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>In addition to an established anticholestatic effect, seladelpar improved pruritus severity and distribution, itch\u2010related sleep disturbance and measures of fatigue in patients with PBC and pruritus, indicating clinically relevant improvements in itch and other quality of life benefits.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/apt.70630","type":"journal-article","created":{"date-parts":[[2026,4,4]],"date-time":"2026-04-04T03:21:00Z","timestamp":1775272860000},"page":"23-35","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Seladelpar Improved Itch, Itch\u2010Related Sleep Disturbance and Measures of Fatigue in Patients With Primary Biliary Cholangitis and Pruritus in the Phase 3\n                    <scp>RESPONSE<\/scp>\n                    Trial"],"prefix":"10.1111","volume":"64","author":[{"given":"Cynthia","family":"Levy","sequence":"first","affiliation":[{"name":"Schiff Center for Liver Diseases University of Miami Miller School of Medicine  Miami Florida USA"},{"name":"Division of Digestive Health and Liver Diseases University of Miami School of Medicine  Miami Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David E. J.","family":"Jones","sequence":"additional","affiliation":[{"name":"Department of Medical Sciences NIHR Newcastle Biomedical Research Centre  Newcastle UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marlyn J.","family":"Mayo","sequence":"additional","affiliation":[{"name":"Division of Digestive and Liver Diseases University of Texas SW Medical Center  Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher L.","family":"Bowlus","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology University of California Davis School of Medicine  Sacramento California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kris V.","family":"Kowdley","sequence":"additional","affiliation":[{"name":"Liver Institute Northwest  Seattle WA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gideon M.","family":"Hirschfield","sequence":"additional","affiliation":[{"name":"The Autoimmune and Rare Liver Disease Programme, Toronto General Hospital  Toronto Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jie","family":"Liu","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  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