{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T17:41:17Z","timestamp":1791308477266,"version":"4.3.1"},"reference-count":35,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T00:00:00Z","timestamp":1789689600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T00:00:00Z","timestamp":1789689600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"abstract":"<jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Subcutaneous (SC) flat\u2010dose infliximab (IFX) biosimilar offers potential advantages over intravenous (IV) weight\u2010based dosing. Prospective pharmacokinetic data and clinical outcomes in inflammatory bowel disease (IBD) are scarce, since drug approval was primarily based on a rheumatoid\u2010arthritis study population concomitantly using methotrexate. We aim to compare IFX exposure during IV and SC therapy in IBD patients and address the effect of concomitant immunosuppressants.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this single\u2010centre, prospective study, adult IBD patients in clinical remission on a 6\u20138 weekly IFX IV\u2010dosing interval were switched to biweekly SC IFX and followed for 24\u2009weeks. Primary endpoint was the area under the concentration\u2010time curves (AUCs). Secondary endpoints included trough levels, time burden and quality\u2010of\u2010life (inflammatory bowel disease questionnaire [IBDQ\u2010NL]). As an additional follow\u2010up assessment, trough levels at \u226512\u2009months were compared across IFX mono\u2010, combination\u2010 and immunosuppressant discontinuation groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Thirty\u2010five patients were evaluated: 20 received IFX monotherapy and 15 IFX combination therapy. Mean AUCs\n                      <jats:sub>6\u20138 weeks<\/jats:sub>\n                      were comparable between IV and SC administration, independent of immune suppressive. IFX trough levels increased on SC IFX median 4.6\u00a0mg\/L\n                      <jats:italic>vs<\/jats:italic>\n                      .16.1\u00a0mg\/L (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.05), independent of concomitant immunosuppressants. These results were consistent at \u226512\u2009months, regardless of monotherapy, combination therapy or immunosuppressant discontinuation. Time burden decreased substantially (median \u22129.3\u00a0h\/6\u00a0months,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.05), and IBDQ\u2010NL score increased (189\u2013197,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.05). There were no exacerbations during follow\u2010up. After 24\u2009weeks, 97% were still being treated with IFX SC.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>SC IFX in IBD patients maintained equivalent drug exposure with higher trough levels, reduced time burden and stable quality\u2010of\u2010life, independent of concomitant immunosuppressants.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bcp.70832","type":"journal-article","created":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T07:26:20Z","timestamp":1789716380000},"source":"Crossref","is-referenced-by-count":1,"title":["Switching standard dosed intravenous to subcutaneous infliximab leads to similar drug exposure in inflammatory bowel disease patients independent of concomitant immunosuppressants (SHUFFLE study)"],"prefix":"10.1002","author":[{"ORCID":"https:\/\/orcid.org\/0009-0006-3946-8219","authenticated-orcid":false,"given":"Lieke M. 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L.","family":"Romberg\u2010Camps","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Geriatrics, Internal and Intensive Care Medicine (Co\u2010MIK) Zuyderland Medical Centre  Heerlen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dennis R.","family":"Wong","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, Pharmacology and Toxicology, Zuyderland Medical Centre  Heerlen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adriaan A.","family":"van Bodegraven","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Geriatrics, Internal and Intensive Care Medicine (Co\u2010MIK) Zuyderland Medical Centre  Heerlen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4236-2726","authenticated-orcid":false,"given":"Niels W.","family":"Boone","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, Pharmacology and Toxicology, Zuyderland Medical Centre  Heerlen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,18]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262\u2010018\u20100639\u20104"},{"key":"e_1_2_13_3_1","unstructured":"European Medicines Agency.Remsima: EPAR \u2013 product information. 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