Sung Noh Hong, Joo Hye Song, Sung Jin Kim, Yoon Ha Park, Chang Wan Choi, Ji Eun Kim, Eun Ran Kim, Dong Kyung Chang, Young-Ho Kim
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A subcutaneous formulation of infliximab (SC-IFX) has shown high C<sub>trough</sub> values due to its favourable pharmacokinetics.</p>\n </section>\n \n <section>\n \n <h3> Aims</h3>\n \n <p>To evaluate the association of C<sub>trough</sub> of SC-IFX with therapeutic outcomes and the threshold of SC-IFX C<sub>trough</sub> for achieving mucosal healing (MH) and transmural healing (TH) in patients with CD.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>We performed this cross-sectional study in patients with CD who had received SC-IFX maintenance therapy for ≥ 6 months. We measured SC-IFX C<sub>trough</sub> immediately before SC-IFX injection. We performed ileocolonoscopy/single-balloon enteroscopy and/or magnetic resonance enterography within 3 months of SC-IFX C<sub>trough</sub> measurement. MH was defined as SES-CD–ulcerated surface subscore of 0. TH was defined as simplified MaRIA score of 0.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>We enrolled 124 patients with MH in 77.9% (74/95) and TH in 36.3% (37/102). SC-IFX C<sub>trough</sub> was significantly higher in patients with MH (24.1 vs.16.9 μg/mL; <i>p</i> = 0.001) and TH (26.0 vs. 20.5 μg/mL; <i>p</i> = 0.007) than in those without. ROC analysis identified that the threshold of SC-IFX C<sub>trough</sub> for MH and TH were 17.5 and 30.3 μg/mL, respectively. Multivariate logistic regression showed that SC-IFX C<sub>trough</sub> was significantly associated with MH (OR 1.16; 95% CI 1.05–1.27; <i>p</i> = 0.002) and TH (OR 1.08; 95% CI 1.02–1.14; <i>p</i> = 0.005).</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>SC-IFX C<sub>trough</sub> was positively associated with MH (≥ 18 μg/mL) and TH (≥ 30 μg/mL) in patients with CD, which may guide treatment decisions to optimise therapeutic response in the era of treat-to-target.</p>\n </section>\n </div>","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"61 2","pages":"313-322"},"PeriodicalIF":6.8000,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Subcutaneous Infliximab Concentration Thresholds for Mucosal and Transmural Healing in Patients With Crohn's Disease\",\"authors\":\"Sung Noh Hong, Joo Hye Song, Sung Jin Kim, Yoon Ha Park, Chang Wan Choi, Ji Eun Kim, Eun Ran Kim, Dong Kyung Chang, Young-Ho Kim\",\"doi\":\"10.1111/apt.18354\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>Predose trough concentrations (C<sub>trough</sub>) of intravenous infliximab (IV-IFX) during maintenance therapy are associated with therapeutic outcomes in patients with Crohn's disease (CD). A subcutaneous formulation of infliximab (SC-IFX) has shown high C<sub>trough</sub> values due to its favourable pharmacokinetics.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Aims</h3>\\n \\n <p>To evaluate the association of C<sub>trough</sub> of SC-IFX with therapeutic outcomes and the threshold of SC-IFX C<sub>trough</sub> for achieving mucosal healing (MH) and transmural healing (TH) in patients with CD.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>We performed this cross-sectional study in patients with CD who had received SC-IFX maintenance therapy for ≥ 6 months. We measured SC-IFX C<sub>trough</sub> immediately before SC-IFX injection. We performed ileocolonoscopy/single-balloon enteroscopy and/or magnetic resonance enterography within 3 months of SC-IFX C<sub>trough</sub> measurement. MH was defined as SES-CD–ulcerated surface subscore of 0. TH was defined as simplified MaRIA score of 0.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>We enrolled 124 patients with MH in 77.9% (74/95) and TH in 36.3% (37/102). SC-IFX C<sub>trough</sub> was significantly higher in patients with MH (24.1 vs.16.9 μg/mL; <i>p</i> = 0.001) and TH (26.0 vs. 20.5 μg/mL; <i>p</i> = 0.007) than in those without. ROC analysis identified that the threshold of SC-IFX C<sub>trough</sub> for MH and TH were 17.5 and 30.3 μg/mL, respectively. Multivariate logistic regression showed that SC-IFX C<sub>trough</sub> was significantly associated with MH (OR 1.16; 95% CI 1.05–1.27; <i>p</i> = 0.002) and TH (OR 1.08; 95% CI 1.02–1.14; <i>p</i> = 0.005).</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>SC-IFX C<sub>trough</sub> was positively associated with MH (≥ 18 μg/mL) and TH (≥ 30 μg/mL) in patients with CD, which may guide treatment decisions to optimise therapeutic response in the era of treat-to-target.</p>\\n </section>\\n </div>\",\"PeriodicalId\":121,\"journal\":{\"name\":\"Alimentary Pharmacology & Therapeutics\",\"volume\":\"61 2\",\"pages\":\"313-322\"},\"PeriodicalIF\":6.8000,\"publicationDate\":\"2024-11-18\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Alimentary Pharmacology & Therapeutics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1111/apt.18354\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Alimentary Pharmacology & Therapeutics","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/apt.18354","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
Subcutaneous Infliximab Concentration Thresholds for Mucosal and Transmural Healing in Patients With Crohn's Disease
Background
Predose trough concentrations (Ctrough) of intravenous infliximab (IV-IFX) during maintenance therapy are associated with therapeutic outcomes in patients with Crohn's disease (CD). A subcutaneous formulation of infliximab (SC-IFX) has shown high Ctrough values due to its favourable pharmacokinetics.
Aims
To evaluate the association of Ctrough of SC-IFX with therapeutic outcomes and the threshold of SC-IFX Ctrough for achieving mucosal healing (MH) and transmural healing (TH) in patients with CD.
Methods
We performed this cross-sectional study in patients with CD who had received SC-IFX maintenance therapy for ≥ 6 months. We measured SC-IFX Ctrough immediately before SC-IFX injection. We performed ileocolonoscopy/single-balloon enteroscopy and/or magnetic resonance enterography within 3 months of SC-IFX Ctrough measurement. MH was defined as SES-CD–ulcerated surface subscore of 0. TH was defined as simplified MaRIA score of 0.
Results
We enrolled 124 patients with MH in 77.9% (74/95) and TH in 36.3% (37/102). SC-IFX Ctrough was significantly higher in patients with MH (24.1 vs.16.9 μg/mL; p = 0.001) and TH (26.0 vs. 20.5 μg/mL; p = 0.007) than in those without. ROC analysis identified that the threshold of SC-IFX Ctrough for MH and TH were 17.5 and 30.3 μg/mL, respectively. Multivariate logistic regression showed that SC-IFX Ctrough was significantly associated with MH (OR 1.16; 95% CI 1.05–1.27; p = 0.002) and TH (OR 1.08; 95% CI 1.02–1.14; p = 0.005).
Conclusions
SC-IFX Ctrough was positively associated with MH (≥ 18 μg/mL) and TH (≥ 30 μg/mL) in patients with CD, which may guide treatment decisions to optimise therapeutic response in the era of treat-to-target.
期刊介绍：
Alimentary Pharmacology & Therapeutics is a global pharmacology journal focused on the impact of drugs on the human gastrointestinal and hepato-biliary systems. It covers a diverse range of topics, often with immediate clinical relevance to its readership.
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