{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T18:29:23Z","timestamp":1793212163915,"version":"4.5.0"},"reference-count":22,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2019,4,12]],"date-time":"2019-04-12T00:00:00Z","timestamp":1555027200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003506","name":"Helse- og Omsorgsdepartementet","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003506","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Intern Med"],"published-print":{"date-parts":[[2019,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and objectives<\/jats:title>\n                    <jats:p>\n                      The 52\u2010week, randomized, double\u2010blind, noninferiority, government\u2010funded\n                      <jats:styled-content style=\"fixed-case\">NOR<\/jats:styled-content>\n                      \u2010\n                      <jats:styled-content style=\"fixed-case\">SWITCH<\/jats:styled-content>\n                      trial demonstrated that switching from infliximab originator to less expensive biosimilar\n                      <jats:styled-content style=\"fixed-case\">CT<\/jats:styled-content>\n                      \u2010P13 was not inferior to continued treatment with infliximab originator. The\n                      <jats:styled-content style=\"fixed-case\">NOR<\/jats:styled-content>\n                      \u2010\n                      <jats:styled-content style=\"fixed-case\">SWITCH<\/jats:styled-content>\n                      extension trial aimed to assess efficacy, safety and immunogenicity in patients on\n                      <jats:styled-content style=\"fixed-case\">CT<\/jats:styled-content>\n                      \u2010P13 throughout the 78\u2010week study period (maintenance group) versus patients switched to\n                      <jats:styled-content style=\"fixed-case\">CT<\/jats:styled-content>\n                      \u2010P13 at week 52 (switch group). The primary outcome was disease worsening during follow\u2010up based on disease\u2010specific composite measures.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients were recruited from 24 Norwegian hospitals, 380 of 438 patients who completed the main study: 197 in the maintenance group and 183 in the switch group. In the full analysis set, 127 (33%) had Crohn's disease, 80 (21%) ulcerative colitis, 67 (18%) spondyloarthritis, 55 (15%) rheumatoid arthritis, 20 (5%) psoriatic arthritis and 31 (8%) chronic plaque psoriasis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Baseline characteristics were similar in the two groups at the time of switching (week 52). Disease worsening occurred in 32 (16.8%) patients in the maintenance group vs. 20 (11.6%) in the switch group (per\u2010protocol set). Adjusted risk difference was 5.9% (95%\n                      <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>\n                      \u22121.1 to 12.9). Frequency of adverse events, anti\u2010drug antibodies, changes in generic disease variables and disease\u2010specific composite measures were comparable between arms. The study was inadequately powered to detect noninferiority within individual diseases.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>\n                      The\n                      <jats:styled-content style=\"fixed-case\">NOR<\/jats:styled-content>\n                      \u2010\n                      <jats:styled-content style=\"fixed-case\">SWITCH<\/jats:styled-content>\n                      extension showed no difference in safety and efficacy between patients who maintained\n                      <jats:styled-content style=\"fixed-case\">CT<\/jats:styled-content>\n                      \u2010P13 and patients who switched from originator infliximab to\n                      <jats:styled-content style=\"fixed-case\">CT<\/jats:styled-content>\n                      \u2010P13, supporting that switching from originator infliximab to\n                      <jats:styled-content style=\"fixed-case\">CT<\/jats:styled-content>\n                      \u2010P13 is safe and efficacious.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/joim.12880","type":"journal-article","created":{"date-parts":[[2019,2,14]],"date-time":"2019-02-14T06:30:46Z","timestamp":1550125846000},"page":"653-669","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":108,"title":["Long\u2010term efficacy and safety of biosimilar infliximab (CT\u2010P13) after switching from originator infliximab: open\u2010label extension of the NOR\u2010SWITCH trial"],"prefix":"10.1111","volume":"285","author":[{"given":"G. L.","family":"Goll","sequence":"first","affiliation":[{"name":"Department of Rheumatology Diakonhjemmet Hospital Oslo Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K. K.","family":"J\u00f8rgensen","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Akershus University Hospital L\u00f8renskog Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Sexton","sequence":"additional","affiliation":[{"name":"Department of Rheumatology Diakonhjemmet Hospital Oslo Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"I. 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