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This approach was suggested by the US Food and Drug Administration (FDA) following review of the primary endpoint analysis results of secukinumab 3\u2009mg\/kg q4w IV in patients with PsA (INVIGORATE\u20102 study). Noting the higher exposure of the investigated IV regimen compared to the approved SC regimens, the FDA considered that the INVIGORATE\u20102 data available through Week 16 only may not convey sufficient safety information to support the benefit\u2013risk assessment of this IV regimen. A population pharmacokinetic (popPK) analysis was conducted on a pool of 15 PsA or axSpA clinical trials to identify 1.75\u2009mg\/kg IV secukinumab q4w (with or without a 6\u2009mg\/kg IV loading dose at Week 0) as a regimen with steady\u2010state exposure within the ranges of the approved SC regimens. This entitled its efficacy and safety to be assessed by full extrapolation from those of the approved SC regimens. This extrapolation was substantiated by the use of exposure\u2010response analyses to predict the efficacy and safety of the IV regimen. Based on those analyses, this IV secukinumab regimen, not tested in clinical trials, was approved by the FDA for the treatment of patients with PsA and axSpA.<\/jats:p>","DOI":"10.1002\/cpt.3716","type":"journal-article","created":{"date-parts":[[2025,6,2]],"date-time":"2025-06-02T06:14:32Z","timestamp":1748844872000},"page":"480-488","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Model\u2010Informed Drug Development\u2010Based Bridging from Subcutaneous to Intravenous Secukinumab Dosing: Approval in Psoriatic Arthritis and Axial Spondyloarthritis"],"prefix":"10.1002","volume":"118","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4645-4908","authenticated-orcid":false,"given":"Thomas","family":"Dumortier","sequence":"first","affiliation":[{"name":"Novartis Pharma AG  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guillermo","family":"Valenzuela","sequence":"additional","affiliation":[{"name":"Integral Rheumatology &amp; Immunology Specialists  Plantation Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melvin","family":"Churchill","sequence":"additional","affiliation":[{"name":"Arthritis Center of Nebraska  Lincoln Nebraska USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jelena","family":"Mijatovic","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8773-0705","authenticated-orcid":false,"given":"Gerard","family":"Bruin","sequence":"additional","affiliation":[{"name":"Novartis Biomedical Research  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luminita","family":"Pricop","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals Corporation  East Hanover New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hanno","family":"Richards","sequence":"additional","affiliation":[{"name":"Novartis Biomedical Research  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-9663-0230","authenticated-orcid":false,"given":"Didier","family":"Renard","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atul","family":"Singhal","sequence":"additional","affiliation":[{"name":"Southwest Rheumatology  Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anshu","family":"Marathe","sequence":"additional","affiliation":[{"name":"Novartis Biomedical Research  East Hanover New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,6,2]]},"reference":[{"key":"e_1_2_11_1_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12016-018-8702-3"},{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.5152\/eurjrheum.2017.17037"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2019-215356"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1505066"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13075-017-1490-y"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40744-018-0123-5"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1412679"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)61134-5"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13075-018-1551-x"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40744-019-0163-5"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2017-212687"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1097\/CM9.0000000000001099"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.41477"},{"key":"e_1_2_11_14_1","volume-title":"Prescribing Information","author":"Cosentyx\u00ae (secukinumab)","year":"2024"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.42993"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.42997"},{"key":"e_1_2_11_17_1","unstructured":"US Food and Drug Administration Center for Drug Evaluation and Research.Memorandum of Meeting Minutes<https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2024\/761349Orig1s000AdminCorres.pdf>. 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