Geert D'Haens, Maria Rosario, Daniel Polhamus, Nathanael L Dirks, Chunlin Chen, Krisztina Kisfalvi, Christian Agboton, Séverine Vermeire, Brian G Feagan, William J Sandborn
{"title":"维多珠单抗皮下注射和静脉注射制剂在克罗恩病和溃疡性结肠炎中的暴露-疗效关系。","authors":"Geert D'Haens, Maria Rosario, Daniel Polhamus, Nathanael L Dirks, Chunlin Chen, Krisztina Kisfalvi, Christian Agboton, Séverine Vermeire, Brian G Feagan, William J Sandborn","doi":"10.1080/17512433.2024.2318465","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and aims: </strong>This posthoc analysis of the GEMINI and VISIBLE studies in ulcerative colitis (UC) and Crohn's Disease (CD) assessed exposure-efficacy of vedolizumab intravenous (IV) and subcutaneous (SC).</p><p><strong>Methods: </strong>A previously described population pharmacokinetic model was used to predict average serum and trough concentrations at steady state (C<sub>av,ss</sub>, C<sub>trough,ss</sub>) and simulate the transition from vedolizumab IV to SC. Efficacy was defined as clinical remission at week 52: complete Mayo score ≤ 2 points and no individual subscore > 1 point (UC), and CD activity index score ≤ 150 points (CD).</p><p><strong>Results: </strong>Data were from 1968 patients (GEMINI 1 [<i>n</i> = 334], VISIBLE 1 [<i>n</i> = 216], GEMINI 2 [<i>n</i> = 1009], VISIBLE 2 [<i>n</i> = 409]) who received maintenance treatment with vedolizumab IV-Q8W, IV-Q4W, SC-Q2W, or placebo. Model-predicted C<sub>av,ss</sub> for IV-Q8W and SC-Q2W was similar in UC and CD. C<sub>av,ss</sub> was higher for IV-Q4W than IV-Q8W and SC-Q2W. C<sub>trough,ss</sub> values from IV and SC aligned well with pooled observed C<sub>trough</sub> by treatment group in UC and CD. C<sub>av,ss</sub> was equivalent for SC and IV. For UC and CD, efficacy rates were greater in patients in the highest quartiles of vedolizumab exposure for both formulations.</p><p><strong>Conclusion: </strong>Exposure-efficacy relationships for IV and SC vedolizumab administration were comparable, confirming that both are equally effective during maintenance treatment.</p>","PeriodicalId":3,"journal":{"name":"ACS Applied Electronic Materials","volume":null,"pages":null},"PeriodicalIF":4.3000,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Exposure-efficacy relationship of vedolizumab subcutaneous and intravenous formulations in Crohn's disease and ulcerative colitis.\",\"authors\":\"Geert D'Haens, Maria Rosario, Daniel Polhamus, Nathanael L Dirks, Chunlin Chen, Krisztina Kisfalvi, Christian Agboton, Séverine Vermeire, Brian G Feagan, William J Sandborn\",\"doi\":\"10.1080/17512433.2024.2318465\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background and aims: </strong>This posthoc analysis of the GEMINI and VISIBLE studies in ulcerative colitis (UC) and Crohn's Disease (CD) assessed exposure-efficacy of vedolizumab intravenous (IV) and subcutaneous (SC).</p><p><strong>Methods: </strong>A previously described population pharmacokinetic model was used to predict average serum and trough concentrations at steady state (C<sub>av,ss</sub>, C<sub>trough,ss</sub>) and simulate the transition from vedolizumab IV to SC. Efficacy was defined as clinical remission at week 52: complete Mayo score ≤ 2 points and no individual subscore > 1 point (UC), and CD activity index score ≤ 150 points (CD).</p><p><strong>Results: </strong>Data were from 1968 patients (GEMINI 1 [<i>n</i> = 334], VISIBLE 1 [<i>n</i> = 216], GEMINI 2 [<i>n</i> = 1009], VISIBLE 2 [<i>n</i> = 409]) who received maintenance treatment with vedolizumab IV-Q8W, IV-Q4W, SC-Q2W, or placebo. Model-predicted C<sub>av,ss</sub> for IV-Q8W and SC-Q2W was similar in UC and CD. C<sub>av,ss</sub> was higher for IV-Q4W than IV-Q8W and SC-Q2W. C<sub>trough,ss</sub> values from IV and SC aligned well with pooled observed C<sub>trough</sub> by treatment group in UC and CD. C<sub>av,ss</sub> was equivalent for SC and IV. For UC and CD, efficacy rates were greater in patients in the highest quartiles of vedolizumab exposure for both formulations.</p><p><strong>Conclusion: </strong>Exposure-efficacy relationships for IV and SC vedolizumab administration were comparable, confirming that both are equally effective during maintenance treatment.</p>\",\"PeriodicalId\":3,\"journal\":{\"name\":\"ACS Applied Electronic Materials\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":4.3000,\"publicationDate\":\"2024-04-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"ACS Applied Electronic Materials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/17512433.2024.2318465\",\"RegionNum\":3,\"RegionCategory\":\"材料科学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/3/5 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"ENGINEERING, ELECTRICAL & ELECTRONIC\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"ACS Applied Electronic Materials","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/17512433.2024.2318465","RegionNum":3,"RegionCategory":"材料科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/3/5 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"ENGINEERING, ELECTRICAL & ELECTRONIC","Score":null,"Total":0}
Exposure-efficacy relationship of vedolizumab subcutaneous and intravenous formulations in Crohn's disease and ulcerative colitis.
Background and aims: This posthoc analysis of the GEMINI and VISIBLE studies in ulcerative colitis (UC) and Crohn's Disease (CD) assessed exposure-efficacy of vedolizumab intravenous (IV) and subcutaneous (SC).
Methods: A previously described population pharmacokinetic model was used to predict average serum and trough concentrations at steady state (Cav,ss, Ctrough,ss) and simulate the transition from vedolizumab IV to SC. Efficacy was defined as clinical remission at week 52: complete Mayo score ≤ 2 points and no individual subscore > 1 point (UC), and CD activity index score ≤ 150 points (CD).
Results: Data were from 1968 patients (GEMINI 1 [n = 334], VISIBLE 1 [n = 216], GEMINI 2 [n = 1009], VISIBLE 2 [n = 409]) who received maintenance treatment with vedolizumab IV-Q8W, IV-Q4W, SC-Q2W, or placebo. Model-predicted Cav,ss for IV-Q8W and SC-Q2W was similar in UC and CD. Cav,ss was higher for IV-Q4W than IV-Q8W and SC-Q2W. Ctrough,ss values from IV and SC aligned well with pooled observed Ctrough by treatment group in UC and CD. Cav,ss was equivalent for SC and IV. For UC and CD, efficacy rates were greater in patients in the highest quartiles of vedolizumab exposure for both formulations.
Conclusion: Exposure-efficacy relationships for IV and SC vedolizumab administration were comparable, confirming that both are equally effective during maintenance treatment.
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