{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T22:18:44Z","timestamp":1759961924589,"version":"3.40.5"},"reference-count":35,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2019,11,14]],"date-time":"2019-11-14T00:00:00Z","timestamp":1573689600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100004312","name":"Eli Lilly and Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004312","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int J of Rheum Dis"],"published-print":{"date-parts":[[2020,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>We evaluated the safety of baricitinib in an East Asian (EA) patient population with moderate\u2010to\u2010severely active rheumatoid arthritis (RA), through an integrated sub\u2010analysis of data from the overall baricitinib RA clinical program.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Data from EA patients who received any dose of baricitinib from five completed studies (1 Phase 2, 4 Phase 3) and an ongoing long\u2010term extension study were pooled up to 1 September, 2016. Exposure\u2010adjusted incidence rates (EAIR) and incidence rates (IRs), both per 100 patient\u2010years (PY), were calculated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>This analysis included 740 EA patients with 1294 PY of total baricitinib exposure (maximum 3.5\u00a0years). Overall, 109 patients discontinued baricitinib due to adverse events (AEs); EAIR: 8.4. No deaths were reported in this cohort. Serious AEs were reported by 125 patients (EAIR: 9.7). Serious infections were the most common serious AEs (n\u00a0=\u00a053, IR: 4.15). IR of herpes zoster infection was 6.2; the majority of events were of mild\u2010to\u2010moderate severity. Three cases (IR: 0.23) of tuberculosis were reported. The IRs of malignancy (excluding non\u2010melanoma skin cancer) was 0.99 and EAIR specifically of lymphoma was 0.1. The IR of major adverse cardiovascular events was 0.26, and deep vein thrombosis was reported in four patients (EAIR: 0.3). Two cases of gastrointestinal perforations (EAIR: 0.2) were reported.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Integrated data show that baricitinib is well\u2010tolerated in EA patients with moderate\u2010to\u2010severely active RA in the context of demonstrated efficacy, which is generally consistent with safety results of the overall study population.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1756-185x.13748","type":"journal-article","created":{"date-parts":[[2019,11,15]],"date-time":"2019-11-15T05:19:04Z","timestamp":1573795144000},"page":"65-73","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Safety of baricitinib in East Asian patients with moderate\u2010to\u2010severe active rheumatoid arthritis: An integrated analysis from clinical trials"],"prefix":"10.1111","volume":"23","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9404-2900","authenticated-orcid":false,"given":"Ying\u2010Chou","family":"Chen","sequence":"first","affiliation":[{"name":"Kaohsiung Chang Gung Memorial Hospital Chang Gung University College of Medicine Kaohsiung Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dae Hyun","family":"Yoo","sequence":"additional","affiliation":[{"name":"Hanyang University Hospital for Rheumatic Diseases Seoul Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chang Keun","family":"Lee","sequence":"additional","affiliation":[{"name":"Asan Medical Center College of Medicine University of Ulsan Seoul Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ko\u2010Jen","family":"Li","sequence":"additional","affiliation":[{"name":"National Taiwan University Hospital Taipei Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ji\u2010Eon","family":"Won","sequence":"additional","affiliation":[{"name":"Eli Lilly Korea Seoul Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6259-3409","authenticated-orcid":false,"given":"Wen\u2010Shuo","family":"Wu","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company (Taiwan) Inc. Taipei Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jinglin","family":"Zhong","sequence":"additional","affiliation":[{"name":"IQVIA, Inc. Durham NC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claudia","family":"Nicolay","sequence":"additional","affiliation":[{"name":"Lilly Deutschland GmbH Bad Homburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chad Daniel","family":"Walls","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company Indianapolis IN USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshiya","family":"Tanaka","sequence":"additional","affiliation":[{"name":"The First Department of Internal Medicine School of Medicine University of Occupational and Environmental Health, Japan Kitakyushu Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,11,14]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)30173-8"},{"issue":"1","key":"e_1_2_7_3_1","first-page":"010409","article-title":"Prevalence of rheumatoid arthritis in low\u2010 and middle\u2010income countries: a systematic review and analysis","volume":"5","author":"Rudan I","year":"2015","journal-title":"J Glob Health"},{"key":"e_1_2_7_4_1","article-title":"Burden of rheumatoid arthritis from a societal perspective: a prevalence\u2010based study on cost of illness for patients with rheumatoid arthritis in China","author":"Hu H","year":"2017","journal-title":"Int J Rheum Dis"},{"issue":"3","key":"e_1_2_7_5_1","first-page":"347","article-title":"One year in review 2018: novelties in the treatment of rheumatoid arthritis","volume":"36","author":"Bortoluzzi A","year":"2018","journal-title":"Clin Exp Rheumatol"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1080\/14656566.2017.1359256"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2014-206478"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.150613"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1507247"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-210094"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.39953"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1608345"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00393-016-0254-4"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.171361"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/1756-185X.12754"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.40189"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1080\/14397595.2017.1392057"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.1994.tb05705.x"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/acr.21764"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1080\/14397595.2019.1583711"},{"issue":"2","key":"e_1_2_7_21_1","first-page":"969","article-title":"SAT0218 Efficacy and safety of baricitinib in mtx\u2010ir patients with rheumatoid arthritis: 52 week results from a phase 3 study (RA\u2010BALANCE)","volume":"77","author":"Li Z","year":"2018","journal-title":"Ann Rheum Dis"},{"key":"e_1_2_7_22_1","unstructured":"WonJ\u2010E WuW\u2010S ZhongJ NicolayC SatoM WallsCD et al.Long\u2010term Safety of Baricitinib an Oral JAK1\/JAK2 Inhibitor in an East Asian Patient Population With Moderate\u2010to\u2010Severe Active Rheumatoid Arthritis: An Integrated Analysis. Poster presented at: 38th KCR Annual Scientific Meeting and 12th International Symposium; 18\u201319. Korea: Seoul; 2018 May."},{"key":"e_1_2_7_23_1","article-title":"Safety profile of baricitinib for the treatment of rheumatoid arthritis up to 5.5 years: an updated integrated safety analysis [abstract]","volume":"69","author":"Genovese MC","year":"2017","journal-title":"Am Coll Rheumatol"},{"issue":"3","key":"e_1_2_7_24_1","first-page":"1","article-title":"Serious infections in rheumatoid arthritis and strategies for their prevention \u2010 a review and discussion of implications for clinical practice","volume":"2","author":"Ravanbod HR","year":"2017","journal-title":"J Immunol Infect Inflam Dis"},{"key":"e_1_2_7_25_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-210457"},{"issue":"2","key":"e_1_2_7_26_1","first-page":"755","article-title":"FRI0164|Incidence rate and characterization of herpes zoster in patients with moderate\u2010to\u2010severe rheumatoid arthritis: an update from baricitinib clinical studies","volume":"78","author":"Chen Y\u2010H","year":"2019","journal-title":"Ann Rheum Dis"},{"key":"e_1_2_7_27_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.38745"},{"key":"e_1_2_7_28_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrrheum.2017.153"},{"key":"e_1_2_7_29_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0166339"},{"issue":"4","key":"e_1_2_7_30_1","first-page":"706","article-title":"Incidence of tuberculosis in Korean patients with rheumatoid arthritis (RA): effects of RA itself and of tumor necrosis factor blockers","volume":"34","author":"Seong SS","year":"2007","journal-title":"J Rheumatol"},{"key":"e_1_2_7_31_1","first-page":"1","article-title":"Tuberculosis and viral hepatitis infection in Eastern Europe, Asia, and Latin America: impact of tumor necrosis factor\u2010alpha inhibitors in clinical practice","volume":"12","author":"Chen YH","year":"2018","journal-title":"Biologics"},{"key":"e_1_2_7_32_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2013-203380"},{"key":"e_1_2_7_33_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12959-017-0155-z"},{"key":"e_1_2_7_34_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2013.122"},{"key":"e_1_2_7_35_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrrheum.2017.51"},{"key":"e_1_2_7_36_1","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.130683"}],"container-title":["International Journal of Rheumatic Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1756-185X.13748","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/1756-185X.13748","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1756-185X.13748","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,7]],"date-time":"2023-09-07T11:36:24Z","timestamp":1694086584000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/1756-185X.13748"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,11,14]]},"references-count":35,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2020,1]]}},"alternative-id":["10.1111\/1756-185X.13748"],"URL":"https:\/\/doi.org\/10.1111\/1756-185x.13748","archive":["Portico"],"relation":{},"ISSN":["1756-1841","1756-185X"],"issn-type":[{"type":"print","value":"1756-1841"},{"type":"electronic","value":"1756-185X"}],"subject":[],"published":{"date-parts":[[2019,11,14]]},"assertion":[{"value":"2019-07-09","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-10-23","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-11-14","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}