{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T19:22:29Z","timestamp":1792610549429,"version":"4.5.0"},"reference-count":40,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"3","license":[{"start":{"date-parts":[[2023,2,20]],"date-time":"2023-02-20T00:00:00Z","timestamp":1676851200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/ http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>\n                      There is a real unmet need for primary biliary cholangitis (PBC) treatments that can improve quality of life impacting symptoms. In this\n                      <jats:italic toggle=\"yes\">post hoc<\/jats:italic>\n                      analysis, we evaluated potential effects of the NADP oxidase 1\/4 inhibitor, setanaxib, on patient-reported quality of life from a phase 2 trial in PBC.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients and Methods:<\/jats:title>\n                    <jats:p>\n                      The underpinning double-blind, randomized, placebo-controlled trial (NCT03226067) recruited 111 patients with PBC and inadequate response\/intolerance to ursodeoxycholic acid. Patients self-administered oral placebo (n=37), setanaxib 400\u00a0mg once daily (OD; n=38), or setanaxib 400\u00a0mg twice daily (BID; n=36), in addition to ursodeoxycholic acid for 24 weeks. Quality of life outcomes were assessed using the validated PBC-40 questionnaire. Patients were stratified\n                      <jats:italic toggle=\"yes\">post hoc<\/jats:italic>\n                      by baseline fatigue severity.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>At week 24, patients treated with setanaxib 400\u00a0mg BID reported greater mean (SE) absolute reductions from baseline in PBC-40 fatigue domain score [\u20133.6 (1.3)] versus those receiving setanaxib 400\u00a0mg OD [\u20130.8 (1.0)]) or placebo [0.6 (0.9)]. Similar observations were made across all PBC-40 domains except itch. In the setanaxib 400\u00a0mg BID arm, patients with moderate-to-severe fatigue at baseline had a greater reduction in mean fatigue score at week 24 [\u20135.8 (2.1)] versus those with mild fatigue [\u20130.6 (0.9)]; results were similar across all domains. Reduced fatigue was correlated with emotional, social, symptom, and cognitive improvements.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>These results support further investigation of setanaxib as a treatment for patients with PBC, particularly for those with clinically significant fatigue.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1097\/hc9.0000000000000057","type":"journal-article","created":{"date-parts":[[2023,2,21]],"date-time":"2023-02-21T13:20:15Z","timestamp":1676985615000},"page":"e0057-e0057","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":40,"title":["Impact of setanaxib on quality of life outcomes in primary biliary cholangitis in a phase 2 randomized controlled trial"],"prefix":"10.1097","volume":"7","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0083-5564","authenticated-orcid":false,"given":"David","family":"Jones","sequence":"first","affiliation":[{"name":"Newcastle University Medical School, Newcastle Upon Tyne, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1445-0443","authenticated-orcid":false,"given":"Marco","family":"Carbone","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Department of Medicine and Surgery, Centre for Autoimmune Liver Diseases, University of Milano-Bicocca, Monza, Italy"},{"name":"European Reference Network on Hepatological Diseases (ERN RARE-LIVER), San Gerardo Hospital, Monza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3262-1998","authenticated-orcid":false,"given":"Pietro","family":"Invernizzi","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Department of Medicine and Surgery, Centre for Autoimmune Liver Diseases, University of Milano-Bicocca, Monza, Italy"},{"name":"European Reference Network on Hepatological Diseases (ERN RARE-LIVER), San Gerardo Hospital, Monza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7007-3008","authenticated-orcid":false,"given":"Nicola","family":"Little","sequence":"additional","affiliation":[{"name":"Calliditas Therapeutics AB, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2905-5112","authenticated-orcid":false,"given":"Frederik","family":"Nevens","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, University Hospital KU Leuven, Health Care Provider of the ERN RARE-LIVER, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0919-4468","authenticated-orcid":false,"given":"Mark G.","family":"Swain","sequence":"additional","affiliation":[{"name":"University of Calgary Liver Unit, Calgary, Alberta, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7287-2703","authenticated-orcid":false,"given":"Philippe","family":"Wiesel","sequence":"additional","affiliation":[{"name":"Genkyotex, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5498-6037","authenticated-orcid":false,"given":"Cynthia","family":"Levy","sequence":"additional","affiliation":[{"name":"Schiff Center for Liver Diseases, University of Miami, Florida, 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