Suzanne I Anjie, Krisztina B Gecse, Chiara M Meloni, Andrés Vidal-Itriago, Mark Löwenberg, Geert R D'Haens
{"title":"皮下英夫利昔单抗单药治疗与联合治疗对IBD的免疫原性和疗效：一项系统综述和荟萃分析。","authors":"Suzanne I Anjie, Krisztina B Gecse, Chiara M Meloni, Andrés Vidal-Itriago, Mark Löwenberg, Geert R D'Haens","doi":"10.1016/j.cgh.2025.03.021","DOIUrl":null,"url":null,"abstract":"<p><strong>Background & aims: </strong>Intravenous (IV) infliximab (IFX) combined with an immunomodulator (combination therapy) outperforms IV IFX monotherapy in terms of clinical, endoscopic, and immunogenicity outcomes in patients with inflammatory bowel disease (IBD). With the advent of subcutaneous (SC) IFX, which is associated with higher serum drug concentrations, it is essential to assess whether SC IFX monotherapy provides similar pharmacokinetic and clinical benefits as combination therapy.</p><p><strong>Methods: </strong>We conducted a systematic review and meta-analysis (until August 2024), of studies on patients with IBD treated with SC IFX. The primary outcome was anti-drug antibodies (ADAs) formation within 12 months (M) after starting SC IFX or after switching from IV to SC IFX. Secondary outcomes included treatment persistence, clinical efficacy, and biochemical parameters.</p><p><strong>Results: </strong>Twenty-four studies (n = 3172) were included. Among patients transitioning from IV IFX induction to SC IFX, immunogenicity was more prevalent with monotherapy than combination treatment (median, 68% vs 48%; odds ratio [OR], 3.29; 95% confidence interval [CI], 1.71-6.31; P < .001). Clinical response rates at 12M were comparable, with a trend favoring combination therapy (OR, 0.73; 95% CI, 0.50-1.06; P = .10). In patients switching from IV maintenance to SC IFX, relapse rates were low (median, 12% at 6M, 11% at week 50), with stable biochemical markers. Treatment persistence was high (93% at 6M, 92% at 12M). Among patients with quiescent disease at the time of switching, 1-year relapse rates were 9% to 11%, with baseline immunogenicity predicting treatment failure.</p><p><strong>Conclusion: </strong>SC IFX monotherapy is associated with higher immunogenicity rates compared with combination therapy, particularly in new IFX starters. Although clinical response was comparable, a trend favoring combination therapy warrants further investigation.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6000,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Immunogenicity and Efficacy of Subcutaneous Infliximab Monotherapy vs Combination Therapy in Inflammatory Bowel Disease: A Systematic Review and Meta-analysis.\",\"authors\":\"Suzanne I Anjie, Krisztina B Gecse, Chiara M Meloni, Andrés Vidal-Itriago, Mark Löwenberg, Geert R D'Haens\",\"doi\":\"10.1016/j.cgh.2025.03.021\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background & aims: </strong>Intravenous (IV) infliximab (IFX) combined with an immunomodulator (combination therapy) outperforms IV IFX monotherapy in terms of clinical, endoscopic, and immunogenicity outcomes in patients with inflammatory bowel disease (IBD). With the advent of subcutaneous (SC) IFX, which is associated with higher serum drug concentrations, it is essential to assess whether SC IFX monotherapy provides similar pharmacokinetic and clinical benefits as combination therapy.</p><p><strong>Methods: </strong>We conducted a systematic review and meta-analysis (until August 2024), of studies on patients with IBD treated with SC IFX. The primary outcome was anti-drug antibodies (ADAs) formation within 12 months (M) after starting SC IFX or after switching from IV to SC IFX. Secondary outcomes included treatment persistence, clinical efficacy, and biochemical parameters.</p><p><strong>Results: </strong>Twenty-four studies (n = 3172) were included. Among patients transitioning from IV IFX induction to SC IFX, immunogenicity was more prevalent with monotherapy than combination treatment (median, 68% vs 48%; odds ratio [OR], 3.29; 95% confidence interval [CI], 1.71-6.31; P < .001). Clinical response rates at 12M were comparable, with a trend favoring combination therapy (OR, 0.73; 95% CI, 0.50-1.06; P = .10). In patients switching from IV maintenance to SC IFX, relapse rates were low (median, 12% at 6M, 11% at week 50), with stable biochemical markers. Treatment persistence was high (93% at 6M, 92% at 12M). Among patients with quiescent disease at the time of switching, 1-year relapse rates were 9% to 11%, with baseline immunogenicity predicting treatment failure.</p><p><strong>Conclusion: </strong>SC IFX monotherapy is associated with higher immunogenicity rates compared with combination therapy, particularly in new IFX starters. Although clinical response was comparable, a trend favoring combination therapy warrants further investigation.</p>\",\"PeriodicalId\":10347,\"journal\":{\"name\":\"Clinical Gastroenterology and Hepatology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":11.6000,\"publicationDate\":\"2025-05-14\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Gastroenterology and Hepatology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.cgh.2025.03.021\",\"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":"Clinical Gastroenterology and Hepatology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.cgh.2025.03.021","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景和目的：在炎症性肠病（IBD）患者的临床、内镜和免疫原性结果方面，静脉（IV）英夫利昔单抗（IFX）联合免疫调节剂（联合治疗）优于静脉（IV） IFX单药治疗。随着皮下（SC） IFX的出现，它与较高的血清药物浓度相关，评估SC IFX单药治疗是否提供与联合治疗相似的药代动力学和临床益处是至关重要的。方法：我们对IBD患者接受SC IFX治疗的研究进行了系统回顾和荟萃分析（截止到2024年8月）。主要终点是在开始注射SC IFX或从静脉注射转为SC IFX后12个月内的抗药物抗体（ADA）形成。次要结局包括治疗持续性、临床疗效和生化指标。结果：纳入24项研究（n=3172）。在从IV IFX诱导过渡到SC IFX的患者中，单药治疗的免疫原性比联合治疗更普遍（中位数68% vs. 48%, OR 3.29, 95% CI 1.71-6.31）。结论：与联合治疗相比，SC IFX单药治疗具有更高的免疫原性，特别是在新的IFX起始者中。虽然临床反应具有可比性，但有利于联合治疗的趋势值得进一步调查。
Immunogenicity and Efficacy of Subcutaneous Infliximab Monotherapy vs Combination Therapy in Inflammatory Bowel Disease: A Systematic Review and Meta-analysis.
Background & aims: Intravenous (IV) infliximab (IFX) combined with an immunomodulator (combination therapy) outperforms IV IFX monotherapy in terms of clinical, endoscopic, and immunogenicity outcomes in patients with inflammatory bowel disease (IBD). With the advent of subcutaneous (SC) IFX, which is associated with higher serum drug concentrations, it is essential to assess whether SC IFX monotherapy provides similar pharmacokinetic and clinical benefits as combination therapy.
Methods: We conducted a systematic review and meta-analysis (until August 2024), of studies on patients with IBD treated with SC IFX. The primary outcome was anti-drug antibodies (ADAs) formation within 12 months (M) after starting SC IFX or after switching from IV to SC IFX. Secondary outcomes included treatment persistence, clinical efficacy, and biochemical parameters.
Results: Twenty-four studies (n = 3172) were included. Among patients transitioning from IV IFX induction to SC IFX, immunogenicity was more prevalent with monotherapy than combination treatment (median, 68% vs 48%; odds ratio [OR], 3.29; 95% confidence interval [CI], 1.71-6.31; P < .001). Clinical response rates at 12M were comparable, with a trend favoring combination therapy (OR, 0.73; 95% CI, 0.50-1.06; P = .10). In patients switching from IV maintenance to SC IFX, relapse rates were low (median, 12% at 6M, 11% at week 50), with stable biochemical markers. Treatment persistence was high (93% at 6M, 92% at 12M). Among patients with quiescent disease at the time of switching, 1-year relapse rates were 9% to 11%, with baseline immunogenicity predicting treatment failure.
Conclusion: SC IFX monotherapy is associated with higher immunogenicity rates compared with combination therapy, particularly in new IFX starters. Although clinical response was comparable, a trend favoring combination therapy warrants further investigation.
期刊介绍：
Clinical Gastroenterology and Hepatology (CGH) is dedicated to offering readers a comprehensive exploration of themes in clinical gastroenterology and hepatology. Encompassing diagnostic, endoscopic, interventional, and therapeutic advances, the journal covers areas such as cancer, inflammatory diseases, functional gastrointestinal disorders, nutrition, absorption, and secretion.
As a peer-reviewed publication, CGH features original articles and scholarly reviews, ensuring immediate relevance to the practice of gastroenterology and hepatology. Beyond peer-reviewed content, the journal includes invited key reviews and articles on endoscopy/practice-based technology, health-care policy, and practice management. Multimedia elements, including images, video abstracts, and podcasts, enhance the reader's experience. CGH remains actively engaged with its audience through updates and commentary shared via platforms such as Facebook and Twitter.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
