Ana Isabel Ferreira, Tiago Lima Capela, Cátia Arieira, Sofia Xavier, José Cotter
{"title":"皮下注射与静脉注射英夫利西单抗疗法--一项真实世界研究:提高药物浓度。","authors":"Ana Isabel Ferreira, Tiago Lima Capela, Cátia Arieira, Sofia Xavier, José Cotter","doi":"10.1097/MEG.0000000000002835","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Recently, a formula of subcutaneous infliximab (SC-IFX) has been approved for inflammatory bowel disease (IBD), demonstrating a better pharmacokinetic and immunogenic profiles, compared to intravenous infliximab (IV-IFX), with similar efficacy and safety.</p><p><strong>Aim: </strong>The aim of this study is to evaluate the clinical, biochemical, and pharmacological outcomes of IBD patients in clinical remission, who switched from IV-IFX to SC-IFX, with a follow-up period of 6 months.</p><p><strong>Methods: </strong>Retrospective cohort study, including IBD patients in clinical remission, previously medicated with IV-IFX, who switched to SC-IFX 120 mg every other week. Biochemical parameters were evaluated before the switch and 6 months after, namely infliximab serum concentrations, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and fecal calprotectin.</p><p><strong>Results: </strong>Included 41 patients in clinical remission, 32 with Crohn's disease (78.0%) and 9 with ulcerative colitis (22.0%). All patients maintained clinical remission during the 6 months after the switch, with a treatment persistence rate of 100%, and no patients requiring corticosteroid therapy, switching back to IV-IFX, or IBD-related hospitalization. The mean infliximab serum concentrations were significantly higher after 6 months of SC-IFX (17.3 ± 6.6 vs. 9.1 ± 5.5 µg/ml, P < 0.001). However, there were no differences between values of ESR, CRP, and fecal calprotectin, before and after the switch ( P = 0.791, P = 0.246, and P = 0.639). Additionally, none of the patients developed antibodies to infliximab.</p><p><strong>Conclusion: </strong>Switching from IV-IFX to SC-IFX in IBD patients in clinical remission is effective and leads to higher infliximab serum concentrations, regardless of the combination with immunomodulatory therapy.</p>","PeriodicalId":11999,"journal":{"name":"European Journal of Gastroenterology & Hepatology","volume":" ","pages":"1314-1318"},"PeriodicalIF":2.3000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Subcutaneous versus intravenous infliximab therapy - a real-world study: toward higher drug concentrations.\",\"authors\":\"Ana Isabel Ferreira, Tiago Lima Capela, Cátia Arieira, Sofia Xavier, José Cotter\",\"doi\":\"10.1097/MEG.0000000000002835\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Recently, a formula of subcutaneous infliximab (SC-IFX) has been approved for inflammatory bowel disease (IBD), demonstrating a better pharmacokinetic and immunogenic profiles, compared to intravenous infliximab (IV-IFX), with similar efficacy and safety.</p><p><strong>Aim: </strong>The aim of this study is to evaluate the clinical, biochemical, and pharmacological outcomes of IBD patients in clinical remission, who switched from IV-IFX to SC-IFX, with a follow-up period of 6 months.</p><p><strong>Methods: </strong>Retrospective cohort study, including IBD patients in clinical remission, previously medicated with IV-IFX, who switched to SC-IFX 120 mg every other week. Biochemical parameters were evaluated before the switch and 6 months after, namely infliximab serum concentrations, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and fecal calprotectin.</p><p><strong>Results: </strong>Included 41 patients in clinical remission, 32 with Crohn's disease (78.0%) and 9 with ulcerative colitis (22.0%). All patients maintained clinical remission during the 6 months after the switch, with a treatment persistence rate of 100%, and no patients requiring corticosteroid therapy, switching back to IV-IFX, or IBD-related hospitalization. The mean infliximab serum concentrations were significantly higher after 6 months of SC-IFX (17.3 ± 6.6 vs. 9.1 ± 5.5 µg/ml, P < 0.001). However, there were no differences between values of ESR, CRP, and fecal calprotectin, before and after the switch ( P = 0.791, P = 0.246, and P = 0.639). Additionally, none of the patients developed antibodies to infliximab.</p><p><strong>Conclusion: </strong>Switching from IV-IFX to SC-IFX in IBD patients in clinical remission is effective and leads to higher infliximab serum concentrations, regardless of the combination with immunomodulatory therapy.</p>\",\"PeriodicalId\":11999,\"journal\":{\"name\":\"European Journal of Gastroenterology & Hepatology\",\"volume\":\" \",\"pages\":\"1314-1318\"},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2024-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European Journal of Gastroenterology & Hepatology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/MEG.0000000000002835\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/8/19 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Journal of Gastroenterology & Hepatology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/MEG.0000000000002835","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/8/19 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
Subcutaneous versus intravenous infliximab therapy - a real-world study: toward higher drug concentrations.
Background: Recently, a formula of subcutaneous infliximab (SC-IFX) has been approved for inflammatory bowel disease (IBD), demonstrating a better pharmacokinetic and immunogenic profiles, compared to intravenous infliximab (IV-IFX), with similar efficacy and safety.
Aim: The aim of this study is to evaluate the clinical, biochemical, and pharmacological outcomes of IBD patients in clinical remission, who switched from IV-IFX to SC-IFX, with a follow-up period of 6 months.
Methods: Retrospective cohort study, including IBD patients in clinical remission, previously medicated with IV-IFX, who switched to SC-IFX 120 mg every other week. Biochemical parameters were evaluated before the switch and 6 months after, namely infliximab serum concentrations, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and fecal calprotectin.
Results: Included 41 patients in clinical remission, 32 with Crohn's disease (78.0%) and 9 with ulcerative colitis (22.0%). All patients maintained clinical remission during the 6 months after the switch, with a treatment persistence rate of 100%, and no patients requiring corticosteroid therapy, switching back to IV-IFX, or IBD-related hospitalization. The mean infliximab serum concentrations were significantly higher after 6 months of SC-IFX (17.3 ± 6.6 vs. 9.1 ± 5.5 µg/ml, P < 0.001). However, there were no differences between values of ESR, CRP, and fecal calprotectin, before and after the switch ( P = 0.791, P = 0.246, and P = 0.639). Additionally, none of the patients developed antibodies to infliximab.
Conclusion: Switching from IV-IFX to SC-IFX in IBD patients in clinical remission is effective and leads to higher infliximab serum concentrations, regardless of the combination with immunomodulatory therapy.
期刊介绍:
European Journal of Gastroenterology & Hepatology publishes papers reporting original clinical and scientific research which are of a high standard and which contribute to the advancement of knowledge in the field of gastroenterology and hepatology.
The journal publishes three types of manuscript: in-depth reviews (by invitation only), full papers and case reports. Manuscripts submitted to the journal will be accepted on the understanding that the author has not previously submitted the paper to another journal or had the material published elsewhere. Authors are asked to disclose any affiliations, including financial, consultant, or institutional associations, that might lead to bias or a conflict of interest.