Nabil El Hage Chehade, Sara Ghoneim, Sagar Shah, Darrell S Pardi, Francis A Farraye, Fadi F Francis, Jana G Hashash
{"title":"维多珠单抗和肿瘤坏死因子抑制剂治疗类固醇难治性微小结肠炎的有效性和安全性：系统回顾与元分析》。","authors":"Nabil El Hage Chehade, Sara Ghoneim, Sagar Shah, Darrell S Pardi, Francis A Farraye, Fadi F Francis, Jana G Hashash","doi":"10.1097/MCG.0000000000001914","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Tumor necrosis factor (TNF-α) inhibitors and the α4β7 integrin antagonist, vedolizumab, have been investigated as treatment options for patients with steroid-refractory microscopic colitis.</p><p><strong>Aims: </strong>To evaluate the benefit of vedolizumab and TNF-α inhibitors in patients with steroid-refractory microscopic colitis.</p><p><strong>Methods: </strong>Retrospective studies and case series involving patients with steroid-refractory MC who either received vedolizumab, adalimumab, or infliximab were eligible for inclusion. Pooled proportional meta-analyses were used to calculate the rate of clinical remission at induction, clinical response, maintenance of remission, histologic remission, and overall medication related adverse effects. Statistical analysis was performed in R using the metafor and meta packages.</p><p><strong>Results: </strong>A total of 14 studies involving 164 patients were included. Pooled analysis showed a clinical remission rate of 63.5% [95% CI (0.483; 0.776), I 2 =43% P =0.08], 57.8% [95% CI (0.3895; 0.7571), I 2 =0%, P =0.7541], and 39.3% [95% CI (0.0814; 0.7492), I 2 =66%, P =0.02] for vedolizumab, infliximab, and adalimumab, respectively. The maintenance of remission rates were 65.9% [95% CI (0.389; 0.889), I 2 =67%, P =0.02], 45.3% [95% CI (0.1479; 0.7747), I 2 =0%, P =0.36] and 32.5% [95% CI (0.000; 0.8508), I 2 =53%, P =0.14] in patients who received vedolizumab, infliximab, and adalimumab, respectively. Rate of biological-related adverse events warranting discontinuation of therapy was 12.2%, 32.9%, and 23.0% for the vedolizumab, infliximab, and adalimumab groups, respectively.</p><p><strong>Conclusion: </strong>Vedolizumab and anti-TNF-α agents demonstrated a clinical benefit in the treatment of steroid-refractory microscopic colitis and with a tolerable safety profile. Future randomized controlled trials are needed to compare vedolizumab with TNF-α inhibitors and examine treatment effect on patients' quality of life.</p>","PeriodicalId":15457,"journal":{"name":"Journal of clinical gastroenterology","volume":" ","pages":"789-799"},"PeriodicalIF":2.8000,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and Safety of Vedolizumab and Tumor Necrosis Factor Inhibitors in the Treatment of Steroid-refractory Microscopic Colitis: A Systematic Review and Meta-analysis.\",\"authors\":\"Nabil El Hage Chehade, Sara Ghoneim, Sagar Shah, Darrell S Pardi, Francis A Farraye, Fadi F Francis, Jana G Hashash\",\"doi\":\"10.1097/MCG.0000000000001914\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Tumor necrosis factor (TNF-α) inhibitors and the α4β7 integrin antagonist, vedolizumab, have been investigated as treatment options for patients with steroid-refractory microscopic colitis.</p><p><strong>Aims: </strong>To evaluate the benefit of vedolizumab and TNF-α inhibitors in patients with steroid-refractory microscopic colitis.</p><p><strong>Methods: </strong>Retrospective studies and case series involving patients with steroid-refractory MC who either received vedolizumab, adalimumab, or infliximab were eligible for inclusion. Pooled proportional meta-analyses were used to calculate the rate of clinical remission at induction, clinical response, maintenance of remission, histologic remission, and overall medication related adverse effects. Statistical analysis was performed in R using the metafor and meta packages.</p><p><strong>Results: </strong>A total of 14 studies involving 164 patients were included. Pooled analysis showed a clinical remission rate of 63.5% [95% CI (0.483; 0.776), I 2 =43% P =0.08], 57.8% [95% CI (0.3895; 0.7571), I 2 =0%, P =0.7541], and 39.3% [95% CI (0.0814; 0.7492), I 2 =66%, P =0.02] for vedolizumab, infliximab, and adalimumab, respectively. The maintenance of remission rates were 65.9% [95% CI (0.389; 0.889), I 2 =67%, P =0.02], 45.3% [95% CI (0.1479; 0.7747), I 2 =0%, P =0.36] and 32.5% [95% CI (0.000; 0.8508), I 2 =53%, P =0.14] in patients who received vedolizumab, infliximab, and adalimumab, respectively. Rate of biological-related adverse events warranting discontinuation of therapy was 12.2%, 32.9%, and 23.0% for the vedolizumab, infliximab, and adalimumab groups, respectively.</p><p><strong>Conclusion: </strong>Vedolizumab and anti-TNF-α agents demonstrated a clinical benefit in the treatment of steroid-refractory microscopic colitis and with a tolerable safety profile. Future randomized controlled trials are needed to compare vedolizumab with TNF-α inhibitors and examine treatment effect on patients' quality of life.</p>\",\"PeriodicalId\":15457,\"journal\":{\"name\":\"Journal of clinical gastroenterology\",\"volume\":\" \",\"pages\":\"789-799\"},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2024-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of clinical gastroenterology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/MCG.0000000000001914\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of clinical gastroenterology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/MCG.0000000000001914","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景：肿瘤坏死因子（TNF-α）抑制剂和α4β7整合素拮抗剂维多珠单抗已被研究作为类固醇难治性显微镜下结肠炎患者的治疗选择。目的：评估维多珠单抗和TNF-α抑制剂对类固醇难治性显微镜下结肠炎患者的益处：纳入对象包括接受维多珠单抗、阿达木单抗或英夫利西单抗治疗的类固醇难治性MC患者的回顾性研究和系列病例。汇总比例荟萃分析用于计算诱导时的临床缓解率、临床反应、缓解维持率、组织学缓解率以及与药物相关的总体不良反应。统计分析在 R 中使用 metafor 和 meta 软件包进行：共纳入 14 项研究，涉及 164 名患者。汇总分析显示，维多单抗、英夫利昔单抗和阿达木单抗的临床缓解率分别为63.5% [95% CI (0.483; 0.776), I 2 =43% P =0.08]、57.8% [95% CI (0.3895; 0.7571), I 2 =0%, P =0.7541]和39.3% [95% CI (0.0814; 0.7492), I 2 =66%, P =0.02]。维多单抗、英夫利昔单抗和阿达木单抗患者的缓解维持率分别为65.9% [95% CI (0.389; 0.889)，I 2 =67%，P =0.02]、45.3% [95% CI (0.1479; 0.7747)，I 2 =0%，P =0.36]和32.5% [95% CI (0.000; 0.8508)，I 2 =53%，P =0.14]。韦多珠单抗组、英夫利昔单抗组和阿达木单抗组出现生物相关不良事件而需要终止治疗的比例分别为12.2%、32.9%和23.0%：韦多珠单抗和抗肿瘤坏死因子-α药物在治疗类固醇难治性微小结肠炎方面具有临床疗效，且安全性可耐受。未来需要进行随机对照试验，比较维多珠单抗和TNF-α抑制剂，并研究治疗对患者生活质量的影响。
Efficacy and Safety of Vedolizumab and Tumor Necrosis Factor Inhibitors in the Treatment of Steroid-refractory Microscopic Colitis: A Systematic Review and Meta-analysis.
Background: Tumor necrosis factor (TNF-α) inhibitors and the α4β7 integrin antagonist, vedolizumab, have been investigated as treatment options for patients with steroid-refractory microscopic colitis.
Aims: To evaluate the benefit of vedolizumab and TNF-α inhibitors in patients with steroid-refractory microscopic colitis.
Methods: Retrospective studies and case series involving patients with steroid-refractory MC who either received vedolizumab, adalimumab, or infliximab were eligible for inclusion. Pooled proportional meta-analyses were used to calculate the rate of clinical remission at induction, clinical response, maintenance of remission, histologic remission, and overall medication related adverse effects. Statistical analysis was performed in R using the metafor and meta packages.
Results: A total of 14 studies involving 164 patients were included. Pooled analysis showed a clinical remission rate of 63.5% [95% CI (0.483; 0.776), I 2 =43% P =0.08], 57.8% [95% CI (0.3895; 0.7571), I 2 =0%, P =0.7541], and 39.3% [95% CI (0.0814; 0.7492), I 2 =66%, P =0.02] for vedolizumab, infliximab, and adalimumab, respectively. The maintenance of remission rates were 65.9% [95% CI (0.389; 0.889), I 2 =67%, P =0.02], 45.3% [95% CI (0.1479; 0.7747), I 2 =0%, P =0.36] and 32.5% [95% CI (0.000; 0.8508), I 2 =53%, P =0.14] in patients who received vedolizumab, infliximab, and adalimumab, respectively. Rate of biological-related adverse events warranting discontinuation of therapy was 12.2%, 32.9%, and 23.0% for the vedolizumab, infliximab, and adalimumab groups, respectively.
Conclusion: Vedolizumab and anti-TNF-α agents demonstrated a clinical benefit in the treatment of steroid-refractory microscopic colitis and with a tolerable safety profile. Future randomized controlled trials are needed to compare vedolizumab with TNF-α inhibitors and examine treatment effect on patients' quality of life.
期刊介绍：
Journal of Clinical Gastroenterology gathers the world''s latest, most relevant clinical studies and reviews, case reports, and technical expertise in a single source. Regular features include cutting-edge, peer-reviewed articles and clinical reviews that put the latest research and development into the context of your practice. Also included are biographies, focused organ reviews, practice management, and therapeutic recommendations.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
