{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T19:45:44Z","timestamp":1787946344341,"version":"build-2784847793"},"reference-count":90,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2023,7,5]],"date-time":"2023-07-05T00:00:00Z","timestamp":1688515200000},"content-version":"vor","delay-in-days":2,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,2,26]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>We evaluated the real-world safety\/effectiveness of tofacitinib, an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA), in patients with RA in Japan registered in a post-marketing surveillance study.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This interim analysis included data from July 2013 to December 2018. Adverse events (AEs), serious AEs (SAEs), Simplified Disease Activity Index (SDAI)\/Clinical Disease Activity Index (CDAI)\/Disease Activity Score in 28 joints, erythrocyte sedimentation rate [DAS28-4(ESR)] scores, and rates of SDAI\/CDAI\/DAS28-4(ESR)-defined remission and low disease activity were analysed using 6\u2009months of data. Risk factors for serious infections were assessed by multivariable analyses.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Safety and disease activity were evaluated in 6866 and 6649 patients, respectively. Overall, 32.73%\/7.37% of patients reported AEs\/SAEs. Clinically important AEs with tofacitinib included serious infections\/infestations [3.13% of patients; incidence rate (IR; patients with events) 6.91\/100 patient-years (PY)], herpes zoster (3.63%; IR 8.02\/100 PY), and malignancies (0.68%; IR 1.45\/100 PY). SDAI\/CDAI\/DAS28-4(ESR) scores and remission\/low disease activity rates improved over 6\u2009months. Male sex, older age, Steinbrocker\u2019s stage IV, history of infection, and diabetes mellitus at baseline were independent risk factors for serious infection.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>In patients with RA receiving tofacitinib in Japan, safety was consistent with the reported profile, and disease activity improved over 6\u2009months.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Study identifier<\/jats:title>\n                  <jats:p>NCT01932372.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/mr\/road063","type":"journal-article","created":{"date-parts":[[2023,7,5]],"date-time":"2023-07-05T19:31:12Z","timestamp":1688585472000},"page":"272-286","source":"Crossref","is-referenced-by-count":11,"title":["Six-month safety and\u00a0effectiveness of\u00a0tofacitinib in\u00a0patients with rheumatoid arthritis in\u00a0Japan: Interim analysis of\u00a0post-marketing surveillance"],"prefix":"10.1093","volume":"34","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8352-6136","authenticated-orcid":false,"given":"Masataka","family":"Kuwana","sequence":"first","affiliation":[{"name":"Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naonobu","family":"Sugiyama","sequence":"additional","affiliation":[{"name":"Inflammation and Immunology Medical Affairs, Pfizer Japan Inc. , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shigeki","family":"Momohara","sequence":"additional","affiliation":[{"name":"Kusanagi Orthopedic Rheumatology Clinic , Shizuoka, Japan"},{"name":"Department of Orthopaedic Surgery, School of Medicine, Keio University , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatsuya","family":"Atsumi","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University , Sapporo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Syuji","family":"Takei","sequence":"additional","affiliation":[{"name":"Pediatric Rheumatology, Medical Center for Children, Kagoshima University Hospital , Kagoshima, 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 School of Medicine , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6418-2603","authenticated-orcid":false,"given":"Masayoshi","family":"Harigai","sequence":"additional","affiliation":[{"name":"Division of Rheumatology, Department of Internal Medicine, Tokyo Women\u2019s Medical University School 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":"Hiroaki","family":"Matsuno","sequence":"additional","affiliation":[{"name":"Matsuno Clinic for Rheumatic Diseases , Toyama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tsutomu","family":"Takeuchi","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Keio University School of Medicine , Tokyo, Japan"},{"name":"Saitama Medical University , Saitama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuhiko","family":"Yamamoto","sequence":"additional","affiliation":[{"name":"The University of Tokyo , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshinari","family":"Takasaki","sequence":"additional","affiliation":[{"name":"Juntendo Koshigaya Hospital, Juntendo University Faculty of Medicine , Saitama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miki","family":"Tanigawa","sequence":"additional","affiliation":[{"name":"Pfizer R&D Japan G.K. , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yutaka","family":"Endo","sequence":"additional","affiliation":[{"name":"Pfizer R&D Japan G.K. , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomohiro","family":"Hirose","sequence":"additional","affiliation":[{"name":"Inflammation and Immunology Medical Affairs, Pfizer Japan Inc. , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yosuke","family":"Morishima","sequence":"additional","affiliation":[{"name":"Inflammation and Immunology Medical Affairs, Pfizer Japan Inc. , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noritoshi","family":"Yoshii","sequence":"additional","affiliation":[{"name":"Inflammation and Immunology Medical Affairs, Pfizer Japan Inc. , Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tsuneyo","family":"Mimori","sequence":"additional","affiliation":[{"name":"Ijinkai Takeda General Hospital , Kyoto, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3052-787X","authenticated-orcid":false,"given":"Michiaki","family":"Takagi","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, Yamagata University Faculty of Medicine , Yamagata, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2023,7,3]]},"reference":[{"key":"2024022623084627100_R1","doi-asserted-by":"crossref","first-page":"1108","DOI":"10.1002\/art.41752","article-title":"2021 American College of\u00a0Rheumatology guideline for\u00a0the treatment of\u00a0rheumatoid arthritis","volume":"73","author":"Fraenkel","year":"2021","journal-title":"Arthritis Rheumatol"},{"key":"2024022623084627100_R2","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1080\/14397595.2019.1660028","article-title":"A large observational cohort study of\u00a0rheumatoid arthritis, IORRA: providing context for\u00a0today\u2019s treatment options","volume":"30","author":"Yamanaka","year":"2020","journal-title":"Mod Rheumatol"},{"key":"2024022623084627100_R3","doi-asserted-by":"crossref","first-page":"1431","DOI":"10.1002\/art.23112","article-title":"The risk of\u00a0herpes zoster in\u00a0patients with rheumatoid arthritis in\u00a0the United States and\u00a0the United Kingdom","volume":"57","author":"Smitten","year":"2007","journal-title":"Arthritis Rheum"},{"key":"2024022623084627100_R4","doi-asserted-by":"crossref","first-page":"2328","DOI":"10.1002\/art.39670","article-title":"Risk of\u00a0herpes zoster in\u00a0autoimmune and\u00a0inflammatory diseases: implications for\u00a0vaccination","volume":"68","author":"Yun","year":"2016","journal-title":"Arthritis Rheumatol"},{"key":"2024022623084627100_R5","doi-asserted-by":"crossref","first-page":"788","DOI":"10.1080\/14397595.2018.1519889","article-title":"Higher risk of\u00a0hospitalized infection, cardiovascular disease, and\u00a0fracture in\u00a0patients with rheumatoid arthritis determined using the Japanese health insurance database","volume":"29","author":"Kasai","year":"2019","journal-title":"Mod Rheumatol"},{"key":"2024022623084627100_R6","doi-asserted-by":"crossref","first-page":"1212","DOI":"10.1136\/annrheumdis-2013-204960","article-title":"Are 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evidence of\u00a0the safety of\u00a0JAK inhibitors in\u00a0patients with rheumatoid arthritis","volume":"58","author":"Harigai","year":"2019","journal-title":"Rheumatology (Oxford)"},{"key":"2024022623084627100_R10","doi-asserted-by":"crossref","first-page":"1183","DOI":"10.1007\/s40265-020-01349-1","article-title":"Selectivity of\u00a0Janus kinase inhibitors in\u00a0rheumatoid arthritis and\u00a0other immune-mediated inflammatory diseases: is expectation the root of\u00a0all headache?","volume":"80","author":"Harigai","year":"2020","journal-title":"Drugs"},{"key":"2024022623084627100_R11","doi-asserted-by":"crossref","first-page":"760","DOI":"10.1136\/annrheumdis-2019-216653","article-title":"Safety of\u00a0synthetic and\u00a0biological DMARDs: a systematic literature review informing the 2019 update of\u00a0the EULAR recommendations for\u00a0the management of\u00a0rheumatoid arthritis","volume":"79","author":"Sepriano","year":"2020","journal-title":"Ann Rheum 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