{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T22:26:53Z","timestamp":1790029613204,"version":"4.0.1"},"reference-count":45,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2022,8,6]],"date-time":"2022-08-06T00:00:00Z","timestamp":1659744000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Baricitinib is devel-oped by Eli Lilly and Company"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,7,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To assess the safety and effectiveness of baricitinib treatment for rheumatoid arthritis (RA) in real-world clinical practice.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This ongoing all-case post-marketing surveillance study (starting September 2017) includes all patients with RA treated with baricitinib in Japan. Safety and effectiveness (disease activity) were assessed for 24\u2009weeks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Safety analyses to February 2021 included 4731 patients (initial baricitinib dose: 4\u2009mg\/day, n\u2009=\u20093058; 2\u2009mg\/day, n\u2009=\u20091661; other, n\u2009=\u200912); 1059 (22.38%) were \u226575\u2009years and 3362 (71.06%) previously received biologic therapy. The overall observational period was 1863.14 patient-years; 1174 (24.82%) patients discontinued baricitinib before Week 24, mostly for lack of effectiveness (n\u2009=\u2009478; 10.10%). Adverse events occurred in 1271 (26.87%) patients [serious: 203 (4.29%); death: 18 (0.38%)]. The incidence of herpes zoster, hepatic function disorder, and serious infection was 3.09%, 2.77%, and 1.90%, respectively. Malignancy occurred in 17 patients (0.36%) and major adverse cardiovascular events in seven patients (0.15%). Among patients with effectiveness data, at least 26.57% (Boolean) achieved remission at Week 24.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This large nationwide surveillance study evaluated the safety and effectiveness of 24\u2009weeks of baricitinib for RA in real-world clinical practice. Continued surveillance of long-term safety is ongoing.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/mr\/roac089","type":"journal-article","created":{"date-parts":[[2022,8,6]],"date-time":"2022-08-06T07:59:47Z","timestamp":1659772787000},"page":"647-656","source":"Crossref","is-referenced-by-count":26,"title":["Safety and effectiveness of baricitinib for rheumatoid arthritis in Japanese clinical practice: 24-week results of all-case post-marketing surveillance"],"prefix":"10.1093","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3052-787X","authenticated-orcid":false,"given":"Michiaki","family":"Takagi","sequence":"first","affiliation":[{"name":"Department of Orthopaedic Surgery, Yamagata University Faculty of Medicine , Yamagata, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatsuya","family":"Atsumi","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine, Hokkaido University , Sapporo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroaki","family":"Matsuno","sequence":"additional","affiliation":[{"name":"Matsuno Clinic for Rheumatic Diseases , Toyama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1729-2954","authenticated-orcid":false,"given":"Naoto","family":"Tamura","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Rheumatology, Juntendo University Faculty of Medicine , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takao","family":"Fujii","sequence":"additional","affiliation":[{"name":"Department of Rheumatology and Clinical Immunology, Wakayama Medical University , Wakayama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nami","family":"Okamoto","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, School of Medicine, Osaka Medical and 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Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atsushi","family":"Nishikawa","sequence":"additional","affiliation":[{"name":"Japan Drug Development & Medical Affairs, Eli Lilly Japan K.K. , Kobe, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taeko","family":"Ishii","sequence":"additional","affiliation":[{"name":"Japan Drug Development & Medical Affairs, Eli Lilly Japan K.K. , Kobe, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tsutomu","family":"Takeuchi","sequence":"additional","affiliation":[{"name":"Keio University School of Medicine , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8352-6136","authenticated-orcid":false,"given":"Masataka","family":"Kuwana","sequence":"additional","affiliation":[{"name":"Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine , Tokyo, 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