{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,19]],"date-time":"2026-02-19T22:16:02Z","timestamp":1771539362701,"version":"3.50.1"},"reference-count":32,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2021,9,10]],"date-time":"2021-09-10T00:00:00Z","timestamp":1631232000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Nippon Kayaku Co., Ltd"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,7,1]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>The aim of this post-marketing surveillance (PMS) study is to evaluate the real-world safety and efficacy of CT-P13, the first biosimilar of infliximab (IFX).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Japanese patients with rheumatoid arthritis were prospectively registered from November 2014 and followed up for 1 year.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Of 794 patients in the analysis set, 318 patients na\u00efve to biological disease-modifying antirheumatic drugs (bDMARDs) showed an immediate decrease in Disease Activity Score in 28 joints with C-reactive protein (DAS28-CRP) and increased remission rate (DAS28-CRP &amp;lt;\u20092.6). In patients who switched from IFX to CT-P13 for non-medical reasons (n\u2009=\u2009374), the low DAS28-CRP due to previous IFX treatment decreased further with continued CT-P13 therapy. As in na\u00efve patients, patients who switched from other bDMARDs, mainly for medical reasons (n\u2009=\u2009102), responded similarly to CT-P13. CT-P13 in this PMS and IFX in a previous PMS had similar adverse reaction profiles, although the incidence rate in na\u00efve patients in this current PMS was lower due to earlier initiation of CT-P13 therapy.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>CT-P13 showed excellent effectiveness as first-line therapy, no clinical difficulties in switching from IFX, and clinical improvement in patients who failed other bDMARDs. CT-P13 could be a cost-effective alternative to IFX in the treatment of rheumatoid arthritis.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/mr\/roab068","type":"journal-article","created":{"date-parts":[[2021,10,18]],"date-time":"2021-10-18T03:23:26Z","timestamp":1634527406000},"page":"718-727","source":"Crossref","is-referenced-by-count":12,"title":["Real-world safety and efficacy of CT-P13, an infliximab biosimilar, in Japanese rheumatoid arthritis patients na\u00efve to or switched from biologics"],"prefix":"10.1093","volume":"32","author":[{"given":"Tsutomu","family":"Takeuchi","sequence":"first","affiliation":[{"name":"Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine , Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2350-6189","authenticated-orcid":false,"given":"Kiyohiro","family":"Nishikawa","sequence":"additional","affiliation":[{"name":"Quality & Pharmacovigilance Division, Pharmaceuticals Group, Nippon Kayaku Co., Ltd. , Tokyo, Japan"},{"name":"Asajes Ventures, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fumika","family":"Yamada","sequence":"additional","affiliation":[{"name":"Quality & Pharmacovigilance Division, Pharmaceuticals Group, Nippon Kayaku Co., Ltd. , Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shiro","family":"Ohshima","sequence":"additional","affiliation":[{"name":"Department of Rheumatology and Allergology, National Hospital Organization, Osaka Minami Medical Center , Osaka, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Makoto","family":"Inoue","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Inoue Hospital , Takasaki, Gunma, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yutaka","family":"Yoshioka","sequence":"additional","affiliation":[{"name":"Department of 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