{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T19:45:46Z","timestamp":1787946346604,"version":"build-2784847793"},"reference-count":49,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2025,3,7]],"date-time":"2025-03-07T00:00:00Z","timestamp":1741305600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,7,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate tofacitinib real-world safety\/effectiveness in patients with rheumatoid arthritis (RA) in Japan in a 3-year all-case postmarketing surveillance study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>All patients with RA who initiated tofacitinib (30 July 2013\u201303 December 2017) were registered in Japan. Serious infections\/malignancy\/mortality incidences were compared in patients with active RA after &amp;gt;8\u2009mg methotrexate\/week for \u22653\u2009months who received tofacitinib or other drugs (control: methotrexate\/other disease-modifying antirheumatic drugs\/immunosuppressants). Disease activity was assessed over 3\u2009years.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The adherent comparative safety analysis set included 3731\/2419 (tofacitinib\/control) patients. Baseline (tofacitinib\/control) biologic disease-modifying antirheumatic drug history (53.3%\/12.2%), methotrexate history (81.4%\/98.6%), and RA stage (I\u2013II: 45.3%\/67.1%) and class (1\u20132: 76.5%\/90.8%) varied between groups. For tofacitinib vs control, incidence rates [patients with event\/100 patient-years (95% confidence interval)] were 6.86 (5.96\u20137.86) vs 1.42 (0.97\u20132.00) for serious infections (adjusted hazard ratios 3.25\u20133.80); 1.40 (1.18\u20131.66) vs 0.88 (0.66\u20131.15) for malignancies (adjusted hazard ratios 1.37\u20131.53); 0.89 (0.72\u20131.10) vs 0.26 (0.15\u20130.43) for mortality (unadjusted hazard ratio 3.29). Remission\/low disease activity rates with tofacitinib increased over 3\u2009years.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Serious infection rates were higher, and malignancy rates were numerically higher with tofacitinib vs control. Results should be interpreted cautiously due to imbalanced groups and unmeasured confounders.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/mr\/roaf017","type":"journal-article","created":{"date-parts":[[2025,3,6]],"date-time":"2025-03-06T15:22:27Z","timestamp":1741274547000},"page":"637-649","source":"Crossref","is-referenced-by-count":8,"title":["Three-year safety and effectiveness of tofacitinib in patients with rheumatoid arthritis in Japan: Final analysis of an all-case postmarketing surveillance study"],"prefix":"10.1093","volume":"35","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 , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naonobu","family":"Sugiyama","sequence":"additional","affiliation":[{"name":"Inflammation and Immunology, Medical 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Kagoshima,","place":["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,","place":["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,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takao","family":"Fujii","sequence":"additional","affiliation":[{"name":"Department of Rheumatology and Clinical Immunology, Wakayama Medical University , Wakayama,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroaki","family":"Matsuno","sequence":"additional","affiliation":[{"name":"Matsuno Clinic for Rheumatic Diseases , Toyama City,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuhiko","family":"Yamamoto","sequence":"additional","affiliation":[{"name":"School of Medicine, University of Tokyo , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshinari","family":"Takasaki","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Rheumatology, Juntendo University Faculty of Medicine , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9085-5250","authenticated-orcid":false,"given":"Nami","family":"Okamoto","sequence":"additional","affiliation":[{"name":"Department of Paediatrics, Osaka Rosai Hospital , Osaka,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nobunori","family":"Takahashi","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, Aichi Medical University , Nagakute,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atsuo","family":"Nakajima","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Ueno Dialysis Clinic , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6789-1739","authenticated-orcid":false,"given":"Ayako","family":"Nakajima","sequence":"additional","affiliation":[{"name":"Center for Rheumatic Diseases, Mie University Hospital , Mie,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miki","family":"Tanigawa","sequence":"additional","affiliation":[{"name":"Pfizer R&D Japan G.K. , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yutaka","family":"Endo","sequence":"additional","affiliation":[{"name":"Pfizer R&D Japan G.K. , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshitaka","family":"Hirano","sequence":"additional","affiliation":[{"name":"Inflammation and Immunology, Medical Affairs, Pfizer Japan Inc , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2874-1807","authenticated-orcid":false,"given":"Masato","family":"Hoshi","sequence":"additional","affiliation":[{"name":"Inflammation and Immunology, Medical Affairs, Pfizer Japan Inc , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tsuneyo","family":"Mimori","sequence":"additional","affiliation":[{"name":"Department of Rheumatology and Clinical Immunology, Graduate School of Medicine, Kyoto University , Kyoto,","place":["Japan"]},{"name":"Takeda Clinic for Rheumatic Diseases , Kyoto,","place":["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,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9210-9414","authenticated-orcid":false,"given":"Sakae","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, Faculty of Medicine, University of Tokyo , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0807-7139","authenticated-orcid":false,"given":"Yoshiya","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, 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