{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,5]],"date-time":"2026-08-05T01:41:57Z","timestamp":1785894117946,"version":"3.56.0"},"reference-count":23,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2025,8,13]],"date-time":"2025-08-13T00:00:00Z","timestamp":1755043200000},"content-version":"vor","delay-in-days":12,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>Mirikizumab is a humanized anti\u2013interleukin\u201023\u2010p19 monoclonal antibody approved for both moderately\u2010to\u2010severely active ulcerative colitis and moderately\u2010to\u2010severely active Crohn's disease (CD). We characterized pharmacokinetics (PK) and exposure\u2010response (ER) of mirikizumab in relation to efficacy and safety in CD using data from randomized phase 2 SERENITY (NCT02891226) and phase 3 VIVID\u20101 (NCT03926130) trials. Patients received 12\u2010week mirikizumab induction (200, 600, or 1000\u2009mg [SERENITY] or 900\u2009mg [VIVID\u20101] intravenously [IV]) or placebo, every 4\u2009weeks (Q4W), then maintenance (200, 600, or 1000\u2009mg IV [SERENITY], 300\u2009mg subcutaneously (SC) [SERENITY and VIVID\u20101], or placebo, Q4W) to Week 52. PK and ER for efficacy were analyzed using population PK and logistic regression models for Weeks 12 and 52 endpoints, respectively, and included analyses of covariate effects. Mirikizumab PK was best described by a two\u2010compartment model, with first\u2010order absorption for SC maintenance doses. Body weight, body mass index, serum albumin concentration, C\u2010reactive protein, and disease severity had statistically significant effects on PK, while body weight and disease severity affected ER; these effects were not considered clinically relevant. Efficacy results of 900\u2009mg mirikizumab in VIVID\u20101 aligned with SERENITY, which observed near\u2010maximal efficacy at Week 12 with 600\u20131000\u2009mg mirikizumab IV. Efficacy at Week 52 did not vary markedly with exposure during maintenance. There was no significant association between exposure and adverse events. These results support the selection of 900\u2009mg mirikizumab IV Q4W for induction and 300\u2009mg SC Q4W for maintenance in patients with CD, with no dose adjustment for patient factors required.<\/jats:p>","DOI":"10.1111\/cts.70320","type":"journal-article","created":{"date-parts":[[2025,8,14]],"date-time":"2025-08-14T04:30:32Z","timestamp":1755145832000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Mirikizumab Pharmacokinetics and Exposure\u2010Response in Patients With Moderately\u2010To\u2010Severely Active Crohn's Disease: Results From Two Randomized Studies"],"prefix":"10.1111","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-5417-3062","authenticated-orcid":false,"given":"Laiyi","family":"Chua","sequence":"first","affiliation":[{"name":"Eli Lilly Singapore  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Cindy","family":"Zhang","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company  Indianapolis Indiana 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