Karin Cerna, Dana Duricova, Martin Lukas, Martin Kolar, Nadezda Machkova, Veronika Hruba, Katarina Mitrova, Kristyna Kubickova, Marta Kostrejova, Jakub Jirsa, Kristyna Kastylova, Stepan Peterka, Gabriela Vojtechova, Milan Lukas
{"title":"皮下英夫利昔单抗治疗难治性克罗恩病患者:一种可能的生物better?","authors":"Karin Cerna, Dana Duricova, Martin Lukas, Martin Kolar, Nadezda Machkova, Veronika Hruba, Katarina Mitrova, Kristyna Kubickova, Marta Kostrejova, Jakub Jirsa, Kristyna Kastylova, Stepan Peterka, Gabriela Vojtechova, Milan Lukas","doi":"10.1093/crocol/otad040","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>A subcutaneous formulation of infliximab (IFX-SC) approved to treat patients with inflammatory bowel disease may offer improved efficacy versus intravenous infliximab.</p><p><strong>Methods: </strong>Patients with refractory Crohn's disease (CD, <i>n</i> = 32) previously treated unsuccessfully with at least 2 biologics were treated with IFX-SC and followed from baseline at Week 0 (W0) to Week 30 (W30). The study's primary endpoint was the treatment's persistence at W30, while secondary goals included the analysis of serum infliximab trough levels (TL IFX), dynamics of anti-IFX antibodies (ATIs), and clinical, serum and fecal markers of CD activity during IFX-SC treatment.</p><p><strong>Results: </strong>Midterm treatment persistence with the continuation of treatment after W30 was 53%. TL IFX median values showed rapid, significant upward dynamics and exceeded 15.5 μg/mL at W30, whereas median ATI levels significantly declined. Among ATI-negative patients at W0 (<i>n</i> = 15), only one showed IFX immunogenicity with newly developed ATIs at W30. Among ATI-positive patients at W0, ATI seroconversion from ATI-positive to ATI-negative status was observed in 10 of 17 patients (58.8%). Patients who had continued IFX-SC treatment at W30 showed significant decreases in C-reactive protein (<i>P</i> = .0341), fecal calprotectin (<i>P</i> = .0002), and Harvey-Bradshaw index (<i>P =</i> .0029) since W0.</p><p><strong>Conclusions: </strong>Patients with refractory CD previously treated with at least 2 biologics exhibited clinically relevant improvement with IFX-SC, which showed less immunogenic potential than IFX-IV and highly stable TL IFX.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":null,"pages":null},"PeriodicalIF":1.8000,"publicationDate":"2023-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10640858/pdf/","citationCount":"0","resultStr":"{\"title\":\"Subcutaneous Infliximab in Refractory Crohn's Disease Patients: A Possible Biobetter?\",\"authors\":\"Karin Cerna, Dana Duricova, Martin Lukas, Martin Kolar, Nadezda Machkova, Veronika Hruba, Katarina Mitrova, Kristyna Kubickova, Marta Kostrejova, Jakub Jirsa, Kristyna Kastylova, Stepan Peterka, Gabriela Vojtechova, Milan Lukas\",\"doi\":\"10.1093/crocol/otad040\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>A subcutaneous formulation of infliximab (IFX-SC) approved to treat patients with inflammatory bowel disease may offer improved efficacy versus intravenous infliximab.</p><p><strong>Methods: </strong>Patients with refractory Crohn's disease (CD, <i>n</i> = 32) previously treated unsuccessfully with at least 2 biologics were treated with IFX-SC and followed from baseline at Week 0 (W0) to Week 30 (W30). The study's primary endpoint was the treatment's persistence at W30, while secondary goals included the analysis of serum infliximab trough levels (TL IFX), dynamics of anti-IFX antibodies (ATIs), and clinical, serum and fecal markers of CD activity during IFX-SC treatment.</p><p><strong>Results: </strong>Midterm treatment persistence with the continuation of treatment after W30 was 53%. TL IFX median values showed rapid, significant upward dynamics and exceeded 15.5 μg/mL at W30, whereas median ATI levels significantly declined. Among ATI-negative patients at W0 (<i>n</i> = 15), only one showed IFX immunogenicity with newly developed ATIs at W30. Among ATI-positive patients at W0, ATI seroconversion from ATI-positive to ATI-negative status was observed in 10 of 17 patients (58.8%). Patients who had continued IFX-SC treatment at W30 showed significant decreases in C-reactive protein (<i>P</i> = .0341), fecal calprotectin (<i>P</i> = .0002), and Harvey-Bradshaw index (<i>P =</i> .0029) since W0.</p><p><strong>Conclusions: </strong>Patients with refractory CD previously treated with at least 2 biologics exhibited clinically relevant improvement with IFX-SC, which showed less immunogenic potential than IFX-IV and highly stable TL IFX.</p>\",\"PeriodicalId\":10847,\"journal\":{\"name\":\"Crohn's & Colitis 360\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.8000,\"publicationDate\":\"2023-07-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10640858/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Crohn's & Colitis 360\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1093/crocol/otad040\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/10/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q3\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Crohn's & Colitis 360","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1093/crocol/otad040","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/10/1 0:00:00","PubModel":"eCollection","JCR":"Q3","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
Subcutaneous Infliximab in Refractory Crohn's Disease Patients: A Possible Biobetter?
Background: A subcutaneous formulation of infliximab (IFX-SC) approved to treat patients with inflammatory bowel disease may offer improved efficacy versus intravenous infliximab.
Methods: Patients with refractory Crohn's disease (CD, n = 32) previously treated unsuccessfully with at least 2 biologics were treated with IFX-SC and followed from baseline at Week 0 (W0) to Week 30 (W30). The study's primary endpoint was the treatment's persistence at W30, while secondary goals included the analysis of serum infliximab trough levels (TL IFX), dynamics of anti-IFX antibodies (ATIs), and clinical, serum and fecal markers of CD activity during IFX-SC treatment.
Results: Midterm treatment persistence with the continuation of treatment after W30 was 53%. TL IFX median values showed rapid, significant upward dynamics and exceeded 15.5 μg/mL at W30, whereas median ATI levels significantly declined. Among ATI-negative patients at W0 (n = 15), only one showed IFX immunogenicity with newly developed ATIs at W30. Among ATI-positive patients at W0, ATI seroconversion from ATI-positive to ATI-negative status was observed in 10 of 17 patients (58.8%). Patients who had continued IFX-SC treatment at W30 showed significant decreases in C-reactive protein (P = .0341), fecal calprotectin (P = .0002), and Harvey-Bradshaw index (P = .0029) since W0.
Conclusions: Patients with refractory CD previously treated with at least 2 biologics exhibited clinically relevant improvement with IFX-SC, which showed less immunogenic potential than IFX-IV and highly stable TL IFX.