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Real-world experience of vedolizumab use in Colombian patients with inflammatory bowel disease—EXVEDOCOL 哥伦比亚炎症性肠病患者使用韦多珠单抗的真实体验--EXVEDOCOL。
IF 2.2 4区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-10-01 DOI: 10.1016/j.gastrohep.2024.01.009

Background

Real-world studies about the effectiveness and safety of vedolizumab (VDZ) in the treatment of inflammatory bowel disease (IBD) in Latin America are scarce. Our study describes the effectiveness and safety of VDZ in Colombian patients with IBD.

Methods

EXVEDOCOL (EXperience of VEDOlizumab in COLombia) was a retrospective, multicenter, observational study. Adults with IBD receiving a first dose of VDZ between July 2016 and October 2018 were included. The co-primary outcomes clinical response, and remission, were determined at week 14 and last visit during the maintenance phase (LVMP). The secondary outcomes, deep remission and loss of response were recorded at LVMP.

Results

Thirty-one patients (25 ulcerative colitis (UC), 6 Crohn's disease (CD)) were included. At week 14, clinical response was achieved by 87.1% (27/31) of the patients treated with VDZ, while loss of response was reported in 6.7% (2/30). The remission rate at week 14 was 65.5% (19/29) and 75.9% (22/29) at LVMP. Prior anti-TNF exposure was reported in 61.3% (19 patients) of whom 84.2% (16/19) achieved clinical response at week 14 and 89.5% (17/19) at LVMP. For anti-TNF naïve patients, clinical response was recorded in 91.7% (11/12) at week 14 and 100% (12/12) at LVMP.

Conclusions

High clinical remission rates and safety profile highlight VDZ as a valuable treatment option for IBD patients. Anti-TNF naïve patients may derive greater benefit from therapy. Studies with larger cohorts could confirm these findings.
背景:在拉丁美洲,有关韦多珠单抗(VDZ)治疗炎症性肠病(IBD)的有效性和安全性的实际研究很少。我们的研究描述了 VDZ 在哥伦比亚 IBD 患者中的有效性和安全性:EXVEDOCOL (EXperience of VEDOlizumab in COLombia) 是一项回顾性多中心观察研究。研究纳入了2016年7月至2018年10月期间接受首剂VDZ治疗的成人IBD患者。在第14周和维持阶段(LVMP)最后一次就诊时确定共同主要结果临床反应和缓解。次要结果、深度缓解和反应消失在LVMP时记录:共纳入 31 名患者(25 名溃疡性结肠炎(UC)患者,6 名克罗恩病(CD)患者)。在第14周,接受VDZ治疗的患者中有87.1%(27/31)获得了临床应答,6.7%(2/30)失去应答。第14周的缓解率为65.5%(19/29),LVMP为75.9%(22/29)。61.3%的患者(19例)曾接受过抗-TNF治疗,其中84.2%的患者(16/19例)在第14周时获得了临床应答,89.5%的患者(17/19例)在LVMP时获得了临床应答。对于抗肿瘤坏死因子(anti-TNF)治疗不成熟的患者,在第14周有91.7%(11/12)的患者出现临床应答,在LVMP时有100%(12/12)的患者出现临床应答:高临床缓解率和安全性突出表明,VDZ是IBD患者的重要治疗选择。抗肿瘤坏死因子(Anti-TNF)不成熟的患者可能从治疗中获益更多。更大规模的队列研究可以证实这些发现。
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引用次数: 0
Recomendaciones sobre el manejo de la obesidad grave en pacientes con enfermedad inflamatoria intestinal del Grupo Español de Trabajo en Enfermedad Inflamatoria Intestinal (GETECCU), Sociedad Española de Obesidad (SEEDO), Asociación Española de Cirugía (AEC) y Sociedad Española de Endoscopia Digestiva (SEED) 西班牙克罗恩病和溃疡性结肠炎小组 (GETECCU)、西班牙肥胖症协会 (SEEDO)、西班牙外科协会 (AEC) 和西班牙消化内镜协会 (SEED) 关于炎症性肠病患者严重肥胖症管理的建议。
IF 2.2 4区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-10-01 DOI: 10.1016/j.gastrohep.2023.12.008
Obesity is a multifactorial, chronic, progressive and recurrent disease considered a public health issue worldwide and an important determinant of disability and death. In Spain, its current prevalence in the adult population is about 24% and an estimated prevalence in 2035 of 37%. Obesity increases the probability of several diseases linked to higher mortality such as diabetes, cardiovascular disease, hyperlipidemia, arterial hypertension, non-alcoholic fatty liver disease, several types of cancer, or obstructive sleep apnea. On the other hand, although the incidence of inflammatory bowel disease (IBD) is stabilizing in Western countries, its prevalence already exceeds 0.3%. Paralleling to general population, the current prevalence of obesity in adult patients with IBD is estimated at 15-40%. Obesity in patients with IBD could entail, in addition to its already known impact on disability and mortality, a worse evolution of the IBD itself and a worse response to treatments. The aim of this document, performed in collaboration by four scientific societies involved in the clinical care of severe obesity and IBD, is to establish clear and concise recommendations on the therapeutic possibilities of severe or type III obesity in patients with IBD. The document establishes general recommendations on dietary, pharmacological, endoscopic, and surgical treatment of severe obesity in patients with IBD, as well as pre- and post-treatment evaluation.
肥胖症是一种多因素、慢性、进行性和复发性疾病,被认为是世界范围内的一个公共卫生问题,也是导致残疾和死亡的一个重要决定因素。在西班牙,肥胖症目前在成年人口中的发病率约为 24%,预计 2035 年的发病率为 37%。肥胖症会增加多种疾病的发病几率,如糖尿病、心血管疾病、高脂血症、动脉高血压、非酒精性脂肪肝、多种癌症或阻塞性睡眠呼吸暂停等,这些疾病都会导致死亡率升高。另一方面,虽然炎症性肠病(IBD)的发病率在西方国家趋于稳定,但其患病率已超过 0.3%。与普通人群相似,目前成年 IBD 患者的肥胖率估计为 15%-40%。IBD 患者肥胖除了会导致残疾和死亡之外,还可能导致 IBD 病情恶化和治疗效果不佳。本文件由参与严重肥胖症和 IBD 临床治疗的四个科学协会合作完成,旨在就 IBD 患者严重肥胖症或 III 型肥胖症的治疗可能性提出简明扼要的建议。该文件就 IBD 患者严重肥胖的饮食、药物、内窥镜和手术治疗以及治疗前后的评估提出了一般性建议。
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引用次数: 0
Alcohol-related liver disease: (Re)compensation of abstinence 与酒精有关的肝病:戒酒的(再)补偿。
IF 2.2 4区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-09-30 DOI: 10.1016/j.gastrohep.2024.502263
Joaquín Cabezas , José Ignacio Fortea , Ángela Puente Sánchez , Rocío Gallego-Durán , Andrés Conthe , David Martí-Aguado
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引用次数: 0
Peroral endoscopic myotomy (POEM) as a treatment for pediatric achalasia: multicenter study and first results. 以口腔内窥镜肌切开术(POEM)治疗小儿贲门失弛缓症:多中心研究及初步结果。
IF 2.2 4区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-09-27 DOI: 10.1016/j.gastrohep.2024.502262
Carlos Leganés Villanueva, Eduardo Albéniz Arbizu, Ilaria Goruppi, Nuria Brun Lozano, Federica Bianchi, Alberto Pérez Martínez, Sheyla Montori Pina, Ada Yessenia Molina Caballero, Marianette Murzi, Federico Betroletti, Fermin Estremera, Susana Boronat Guerrero, Carlos Guarner Argente

Introduction: Laparoscopic Heller miotomy of achalasia has been classically recognized as the gold standard management in children. There is increasing experience with the peroral endoscopic miotomy (POEM) approach in pediatrics, although the series published are scarce. The objective of this study was to present our experience in primary or secondary treatment of pediatric achalasia by POEM and its clinical success rate.

Methods: We performed a retrospective review of pediatric patients with achalasia who underwent POEM in some national centers from October 2016 to January 2023. We evaluated clinical efficacy (Eckardt score ≤3), demographic characteristics, intraoperative, preoperative and postoperative, complications, and follow-up.

Results: Fifteen POEM were performed in fourteen pediatric patients (aged 12 to 18 years) with achalasia. POEM was the first line treatment in 11 patients, but 4 (21.3%) had previous treatment: 1 (7,1%) pneumatic balloon dilation and 2 (14,2%) laparoscopic Heller myotomy and 1 (7,1%) previous POEM. The average age was 15 years (SD±1,9). The baseline Eckardt score was 7,5 (SD:±1,8), with the baseline GERD score being 6 (SD:±2,9). There was a Clavien-Dindo grade 2 postoperative adverse event corresponding to mild pneumonia (7,1%). The postoperative Eckardt and GERD score after 12 months of follow-up were 0.7 (SD±1,2) and 0,5 (SD±0,7). The study has a success rate greater than 93%.

Conclusions: POEM seems a safe and effective procedure, with a short postoperative period for treatment of pediatric achalasia.

简介腹腔镜海勒贲门失弛缓症切开术一直被认为是治疗儿童贲门失弛缓症的金标准。虽然口腔内镜下贲门失弛缓症切开术(POEM)在儿科的应用经验越来越丰富,但发表的系列文章却很少。本研究的目的是介绍我们通过口腔内镜下贲门失弛缓症切除术(POEM)对小儿贲门失弛缓症进行初次或二次治疗的经验及其临床成功率:我们对 2016 年 10 月至 2023 年 1 月期间在一些国家中心接受 POEM 治疗的小儿贲门失弛缓症患者进行了回顾性研究。我们评估了临床疗效(Eckardt评分≤3分)、人口统计学特征、术中、术前和术后、并发症以及随访情况:结果:14名患有贲门失弛缓症的儿童患者(12至18岁)接受了15例POEM手术。11名患者接受了POEM一线治疗,但有4名患者(21.3%)之前接受过治疗:1人(7.1%)接受过气动球囊扩张术,2人(14.2%)接受过腹腔镜海勒肌切开术,1人(7.1%)接受过 POEM。平均年龄为 15 岁(标清 ± 1.9)。基线 Eckardt 评分为 7.5(标准差:± 1.8)分,基线 GERD 评分为 6(标准差:± 2.9)分。术后发生了一起克拉维恩-丁度 2 级不良事件,即轻度肺炎(7.1%)。术后随访12个月后,Eckardt和胃食管反流评分分别为0.7(SD±1.2)和0.5(SD±0.7)。该研究的成功率超过 93%:POEM似乎是治疗小儿贲门失弛缓症的一种安全有效的手术,术后恢复期短。
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引用次数: 0
Chief cell-type fundic gland neoplasm, a new entity to consider. 首细胞型眼底腺瘤,一个值得考虑的新实体。
IF 2.2 4区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-09-27 DOI: 10.1016/j.gastrohep.2024.502261
Mariana Tavecchia Castro, Joaquin Fisac Vázquez, Laura Guerra Pastrián, Aurora Burgos García
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引用次数: 0
Antiphospholipid syndrome autoantibodies induction after treatment with anti-TNF alpha therapy in patients with IBD. IBD 患者接受抗肿瘤坏死因子α治疗后诱发抗磷脂综合征自身抗体。
IF 2.2 4区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-09-26 DOI: 10.1016/j.gastrohep.2024.502258
Virginia Robles-Alonso, Roser Solans, Ernesto Lastiri, Xavier Serra, Elena Céspedes-Martínez, Luís Mayorga, Claudia Herrera-deGuise, Francesc Casellas, Natalia Borruel

Introduction: Ant-iTNF treatment has been broadly linked with autoantibodies and autoimmune disorders development. After the clinical observation of aPTT (activated partial thromboplastin clotting time) prolongation in our cohort of IBD patients treated with anti-TNF, we sought to determine the presence of antiphospolipid antibodies in our population, along with antiphospholipid syndrome (APS) occurrence.

Methods: We included in the study 289 patients treated with anti-TNFα antibodies.

Results: Twenty four of 289 patients presented a prolonged aPPT (8.3%) after starting anti-TNF treatment. We found antiphospholipid antibodies in 70.8% (17/24) of patients with aPTT prolongation. No major thrombotic events were reported although one patient met criteria for APS because of persistent antiphospolipid antibodies and two miscarriages. Another patient was diagnosed with lupus-like syndrome.

Conclusion: Anti-TNF treatment is associated with the induction of various antibodies, among them, antiphospholipid antibodies. However, a very low number of patients develop APS. Testing for antiphospholipid antibodies patients with prolonged aPPT could identify those at risk and lead to individualized treatment. Additional prospective studies are necessary to acquire more information.

简介抗肿瘤坏死因子(AntiTNF)治疗与自身抗体和自身免疫性疾病的发展有着广泛的联系。在临床观察到接受抗肿瘤坏死因子治疗的 IBD 患者的 aPTT(活化部分凝血酶原凝集时间)延长后,我们试图确定人群中是否存在抗磷脂抗体以及抗磷脂综合征(APS)的发生情况:结果:289 名患者中有 24 人(8.3%)在开始接受抗肿瘤坏死因子治疗后出现 aPPT 延长。我们在70.8%(17/24)的aPTT延长患者中发现了抗磷脂抗体。尽管有一名患者因持续存在抗磷脂抗体和两次流产而符合 APS 标准,但未报告发生重大血栓事件。另一名患者被诊断为狼疮样综合征:结论:抗肿瘤坏死因子治疗与诱导各种抗体有关,其中包括抗磷脂抗体。结论:抗肿瘤坏死因子治疗会诱发多种抗体,其中包括抗磷脂抗体。对长期接受 aPPT 的患者进行抗磷脂抗体检测,可以识别高危人群,并进行个体化治疗。有必要进行更多的前瞻性研究,以获取更多信息。
{"title":"Antiphospholipid syndrome autoantibodies induction after treatment with anti-TNF alpha therapy in patients with IBD.","authors":"Virginia Robles-Alonso, Roser Solans, Ernesto Lastiri, Xavier Serra, Elena Céspedes-Martínez, Luís Mayorga, Claudia Herrera-deGuise, Francesc Casellas, Natalia Borruel","doi":"10.1016/j.gastrohep.2024.502258","DOIUrl":"10.1016/j.gastrohep.2024.502258","url":null,"abstract":"<p><strong>Introduction: </strong>Ant-iTNF treatment has been broadly linked with autoantibodies and autoimmune disorders development. After the clinical observation of aPTT (activated partial thromboplastin clotting time) prolongation in our cohort of IBD patients treated with anti-TNF, we sought to determine the presence of antiphospolipid antibodies in our population, along with antiphospholipid syndrome (APS) occurrence.</p><p><strong>Methods: </strong>We included in the study 289 patients treated with anti-TNFα antibodies.</p><p><strong>Results: </strong>Twenty four of 289 patients presented a prolonged aPPT (8.3%) after starting anti-TNF treatment. We found antiphospholipid antibodies in 70.8% (17/24) of patients with aPTT prolongation. No major thrombotic events were reported although one patient met criteria for APS because of persistent antiphospolipid antibodies and two miscarriages. Another patient was diagnosed with lupus-like syndrome.</p><p><strong>Conclusion: </strong>Anti-TNF treatment is associated with the induction of various antibodies, among them, antiphospholipid antibodies. However, a very low number of patients develop APS. Testing for antiphospholipid antibodies patients with prolonged aPPT could identify those at risk and lead to individualized treatment. Additional prospective studies are necessary to acquire more information.</p>","PeriodicalId":12802,"journal":{"name":"Gastroenterologia y hepatologia","volume":" ","pages":"502258"},"PeriodicalIF":2.2,"publicationDate":"2024-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142345150","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Uncommon cause of upper gastrointestinal bleeding: Spontaneous large gastric intramural hematoma. 上消化道出血的罕见病因:自发性大胃壁内血肿。
IF 2.2 4区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-09-23 DOI: 10.1016/j.gastrohep.2024.502259
Tiago Lima Capela, Tiago Cúrdia Gonçalves, Joana Magalhães, José Cotter
{"title":"Uncommon cause of upper gastrointestinal bleeding: Spontaneous large gastric intramural hematoma.","authors":"Tiago Lima Capela, Tiago Cúrdia Gonçalves, Joana Magalhães, José Cotter","doi":"10.1016/j.gastrohep.2024.502259","DOIUrl":"10.1016/j.gastrohep.2024.502259","url":null,"abstract":"","PeriodicalId":12802,"journal":{"name":"Gastroenterologia y hepatologia","volume":" ","pages":"502259"},"PeriodicalIF":2.2,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142345155","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The figure of the Advanced Practice Nursing professional in Digestive Endoscopy Units. 消化内窥镜检查室高级实践护理专业人员的形象。
IF 2.2 4区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-09-23 DOI: 10.1016/j.gastrohep.2024.502260
Gema Cámara Viudez
{"title":"The figure of the Advanced Practice Nursing professional in Digestive Endoscopy Units.","authors":"Gema Cámara Viudez","doi":"10.1016/j.gastrohep.2024.502260","DOIUrl":"10.1016/j.gastrohep.2024.502260","url":null,"abstract":"","PeriodicalId":12802,"journal":{"name":"Gastroenterologia y hepatologia","volume":" ","pages":"502260"},"PeriodicalIF":2.2,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142345154","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Leishmania colitis: An uncommon cause of gastrointestinal bleeding in an immunosuppressed patient. 利什曼原虫结肠炎:免疫抑制患者消化道出血的罕见病因。
IF 2.2 4区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-09-11 DOI: 10.1016/j.gastrohep.2024.502254
Francisco Vara-Luiz, Helena Pires, Ivo Mendes, Carolina Palma, Eduardo Fernandes, Ana Elisa Teles, Francisco Martins do Vale, Marta Patita, Jorge Fonseca, Pedro Pinto-Marques
{"title":"Leishmania colitis: An uncommon cause of gastrointestinal bleeding in an immunosuppressed patient.","authors":"Francisco Vara-Luiz, Helena Pires, Ivo Mendes, Carolina Palma, Eduardo Fernandes, Ana Elisa Teles, Francisco Martins do Vale, Marta Patita, Jorge Fonseca, Pedro Pinto-Marques","doi":"10.1016/j.gastrohep.2024.502254","DOIUrl":"10.1016/j.gastrohep.2024.502254","url":null,"abstract":"","PeriodicalId":12802,"journal":{"name":"Gastroenterologia y hepatologia","volume":" ","pages":"502254"},"PeriodicalIF":2.2,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142284424","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Optimizing outcomes with maintenance IV UST in highly bio-exposed patients with IBD. Efficacy and adjusted regimen in real world. 优化高度生物暴露的 IBD 患者静脉滴注 UST 的疗效。真实世界中的疗效和调整方案。
IF 2.2 4区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-09-11 DOI: 10.1016/j.gastrohep.2024.502253
Alejandro Mínguez, Elena Coello, Alejandro Garrido, Paula Ripoll, María Gomez, Mariam Aguas, Marisa Iborra, Elena Cerrillo, Lluis Tortosa, Virginia Bayarri, Noemí Bueno, Maria José Fernández, Remedios Marqués, Pilar Nos, Guillermo Bastida

Background and aims: Ustekinumab is an effective treatment for inflammatory bowel diseases. However, some patients do not respond to conventional doses. The aim of the study was to evaluate the effectiveness of intravenous maintenance ustekinumab in patients with secondary failure.

Methods: Single-center, retrospective study in adult patients with intravenous maintenance ustekinumab. The reduction of biochemical activity markers, ustekinumab trough levels and clinical indices of activity were evaluated. Biological remission was defined as the percentage decrease fecal calprotectin ≥80% and/or final fecal calprotectin ≤250 and C reactive protein <5mg/L.

Results: Thirty-one patients were included: Crohn's disease 77.4%. All included patients were bio-exposed and 61.3% had carried ≥2 biologics. Pre-intravenous maintenance mean Harvey-Bradshaw Index was 6.5±4.38 vs 5±3.1 at week 8 (p=0.024) vs 4.1±3.1 at week 24 (p=0.019). The median ustekinumab trough level pre-intravenous maintenance was 1.40μg/ml [IQR 2.3] vs 5.35μg/ml [IQR 4.1] at week 8 (p<0.001) vs 4.8μg/ml [IQR 3.9] at week 24 (p<0.001). The pre-intravenous maintenance median fecal calprotectin was 809μg/g [IQR: 2256] vs 423μg/g [IQR: 999] at week 8 (p=0.025) vs 333μg/g [508] (p=0.001) at week 24. At the end of follow-up 48% went into biological remission. The presence of perianal disease was associated with lower biological remission (70.6% vs 27.3%, p=0.025). Median intravenous ustekinumab maintenance time was 8.55 [IQR 23.9] months. In 83.9% of patients no serious infections or malignancy were documented.

Conclusions: The use of maintenance intravenous ustekinumab appears to be an effective and safe strategy that can be evaluated as a salvage treatment especially in highly bio-exposed patients.

背景和目的优昔单抗是治疗炎症性肠病的有效药物。然而,一些患者对常规剂量无效。本研究旨在评估静脉维持乌司替库单抗治疗继发性失败患者的有效性:单中心回顾性研究:成年患者静脉注射乌司替库单抗。评估生化活性指标、乌斯特库单抗谷值水平和临床活性指标的降低情况。生物缓解定义为粪便钙蛋白下降百分比≥80%和/或最终粪便钙蛋白≤250和C反应蛋白<5mg/L:共纳入31例患者:克罗恩病占77.4%。所有纳入的患者均有生物暴露,61.3%的患者携带≥2种生物制剂。静脉维持治疗前的平均哈维-布拉肖指数(Harvey-Bradshaw Index)为(6.5±4.38),第8周为(5±3.1)(P=0.024),第24周为(4.1±3.1)(P=0.019)。静脉维持治疗前的乌司替库单抗谷值中位数为1.40µg/ml [IQR 2.3] vs 第8周时为5.35µg/ml [IQR 4.1] (p结论:静脉注射乌斯特库单抗似乎是一种有效而安全的治疗策略,可作为一种挽救性治疗方法进行评估,尤其是对于生物暴露程度较高的患者。
{"title":"Optimizing outcomes with maintenance IV UST in highly bio-exposed patients with IBD. Efficacy and adjusted regimen in real world.","authors":"Alejandro Mínguez, Elena Coello, Alejandro Garrido, Paula Ripoll, María Gomez, Mariam Aguas, Marisa Iborra, Elena Cerrillo, Lluis Tortosa, Virginia Bayarri, Noemí Bueno, Maria José Fernández, Remedios Marqués, Pilar Nos, Guillermo Bastida","doi":"10.1016/j.gastrohep.2024.502253","DOIUrl":"10.1016/j.gastrohep.2024.502253","url":null,"abstract":"<p><strong>Background and aims: </strong>Ustekinumab is an effective treatment for inflammatory bowel diseases. However, some patients do not respond to conventional doses. The aim of the study was to evaluate the effectiveness of intravenous maintenance ustekinumab in patients with secondary failure.</p><p><strong>Methods: </strong>Single-center, retrospective study in adult patients with intravenous maintenance ustekinumab. The reduction of biochemical activity markers, ustekinumab trough levels and clinical indices of activity were evaluated. Biological remission was defined as the percentage decrease fecal calprotectin ≥80% and/or final fecal calprotectin ≤250 and C reactive protein <5mg/L.</p><p><strong>Results: </strong>Thirty-one patients were included: Crohn's disease 77.4%. All included patients were bio-exposed and 61.3% had carried ≥2 biologics. Pre-intravenous maintenance mean Harvey-Bradshaw Index was 6.5±4.38 vs 5±3.1 at week 8 (p=0.024) vs 4.1±3.1 at week 24 (p=0.019). The median ustekinumab trough level pre-intravenous maintenance was 1.40μg/ml [IQR 2.3] vs 5.35μg/ml [IQR 4.1] at week 8 (p<0.001) vs 4.8μg/ml [IQR 3.9] at week 24 (p<0.001). The pre-intravenous maintenance median fecal calprotectin was 809μg/g [IQR: 2256] vs 423μg/g [IQR: 999] at week 8 (p=0.025) vs 333μg/g [508] (p=0.001) at week 24. At the end of follow-up 48% went into biological remission. The presence of perianal disease was associated with lower biological remission (70.6% vs 27.3%, p=0.025). Median intravenous ustekinumab maintenance time was 8.55 [IQR 23.9] months. In 83.9% of patients no serious infections or malignancy were documented.</p><p><strong>Conclusions: </strong>The use of maintenance intravenous ustekinumab appears to be an effective and safe strategy that can be evaluated as a salvage treatment especially in highly bio-exposed patients.</p>","PeriodicalId":12802,"journal":{"name":"Gastroenterologia y hepatologia","volume":" ","pages":"502253"},"PeriodicalIF":2.2,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142284425","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
Gastroenterologia y hepatologia
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