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Understanding Medication Nonadherence in Crohn's Disease Patients: A Qualitative Evaluation. 了解克罗恩病患者不遵医嘱用药的情况:定性评估。
IF 4.5 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-11-04 DOI: 10.1093/ibd/izad296
Robert E Brady, Jessica K Salwen-Deremer, Natalie C Tunnell, Michael W Winter

Background: Immune-modifying medications are widely available and recognized as valuable by most gastroenterologists. However, approximately 40% of patients with Crohn's disease (CD) do not comply with regimens using these medications, resulting in complications, hospitalization, and surgeries. We sought to identify factors that motivate adherence or nonadherence with medication recommendations for CD.

Methods: We conducted qualitative interviews with patients living with CD who were identified as adherent or nonadherent to immune-modifying medication recommendations by their treating gastroenterologist. Semistructured interview guides were developed based on an established framework for understanding health behaviors. We conducted content analysis of the resulting qualitative data using an inductive-deductive approach to identify emergent themes that influence medication decision-making.

Results: Twenty-five patients with CD completed interviews for this study. Interviews were independently coded and analyzed for thematic content. Two broad domains emerged comprising (1) themes reflected in the Theoretical Domains Framework and (2) novel themes specific to medication decision-making in CD. Adherent patients conveyed a sense of trust in science and healthcare provider expertise, while nonadherent patients were more likely to express beliefs in their ability to self-manage CD, concern about risks associated with medication, and a general ambivalence to treatment.

Conclusions: There are clear cognitive, behavioral, and relational factors that guide patients' medication-related decision-making. Several of the factors share features of other behavioral change and decision-making processes, while others are specific to the experience of patients with CD. A fuller understanding of these factors is essential to developing effective behavioral interventions to improve adherence to evidence-based treatment recommendations.

背景:免疫调节药物已被广泛使用,并被大多数胃肠病学家认为是有价值的药物。然而,约有 40% 的克罗恩病(CD)患者不遵守使用这些药物的治疗方案,导致并发症、住院和手术。我们试图找出促使克罗恩病患者遵守或不遵守用药建议的因素:我们对被消化内科医生认定为坚持或不坚持免疫调节药物治疗建议的 CD 患者进行了定性访谈。我们根据了解健康行为的既定框架制定了半结构化访谈指南。我们采用归纳-演绎法对所得定性数据进行了内容分析,以确定影响用药决策的新出现的主题:25 名 CD 患者完成了本研究的访谈。我们对访谈内容进行了独立编码和主题分析。访谈中出现了两大领域,包括:(1)理论领域框架中反映的主题;(2)CD 患者用药决策中特有的新主题。坚持用药的患者表达了对科学和医疗服务提供者专业知识的信任感,而不坚持用药的患者则更倾向于表达对自我管理 CD 能力的信念、对药物治疗相关风险的担忧以及对治疗的普遍矛盾心理:有明显的认知、行为和关系因素引导患者做出与用药相关的决策。其中一些因素与其他行为改变和决策过程有相同之处,而其他因素则是 CD 患者的特殊经历。更全面地了解这些因素对于制定有效的行为干预措施以提高循证治疗建议的依从性至关重要。
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引用次数: 0
Inflammatory Bowel Disease in Adults and Elderly: The Use of Selected Non-IBD Medication Examined in a Nationwide Cohort Study. 成人和老年人的炎症性肠病:在一项全国性队列研究中,选定的非ibd药物的使用
IF 4.5 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-11-04 DOI: 10.1093/ibd/izad244
Ken Lund, Floor Dijkstra Zegers, Jan Nielsen, Jacob Broder Brodersen, Torben Knudsen, Jens Kjeldsen, Michael Due Larsen, Bente Mertz Nørgård

Background: Real-world data on medications used for conditions other than inflammatory bowel disease (IBD) are sparse. We examined how the onset of IBD affects the prescription pattern of selected non-IBD medication and the risk of becoming an incident user.

Methods: This nationwide cohort study utilized data from Danish health registers. We included incident patients with young adult-onset IBD (18-39 years of age), adult-onset IBD (40-59 years of age), and elderly-onset IBD (60+ years of age), from 1998 to 2018 and followed all for 3 years. We examined redeemed prescriptions before and after the onset of IBD and estimated the risk of becoming a user of non-IBD medications using logistic regression models.

Results: We identified 36165 patients, 16 771 (46%) with young adult onset, 10615 (29%) with adult onset, and 8779 (24%) with elderly onset. The onset of IBD increased the use of antidepressants, antipsychotics, sedatives/hypnotics, opioids, nonopioid analgesics, antidiabetics, and proton pump inhibitors, even in patients with no other underlying comorbid diseases. The adjusted odds ratio for using antidepressants 1 year after the onset of IBD in elderly was 1.50 (95% confidence interval [CI], 1.14-1.82), in opioids 1.69 (95% CI, 1.45-1.95), in nonopioid analgesics 2.10 (95% CI, 1.77-2.48), in cardiovascular medication 2.20 (95% CI, 1.86-2.61), and in proton pump inhibitors 1.51 (95% CI, 1.31-1.74) compared with adults.

Conclusions: In all 3 age groups, the proportions of patients with redeemed prescriptions for several groups of non-IBD medication were significantly increased after the IBD diagnosis compared with before. The risk of becoming an incident user for several groups of non-IBD medication was increased in elderly patients.

背景:关于用于炎症性肠病(IBD)以外疾病的药物的真实世界数据很少。我们研究了IBD的发作如何影响所选非IBD药物的处方模式以及成为意外使用者的风险。方法:这项全国性队列研究利用了丹麦健康登记处的数据。我们纳入了1998年至2018年的年轻成人发作性炎症性肠病(18-39岁)、成人发作性IBD(40-59岁)和老年人发作性IB病(60岁以上)的患者,并对所有患者进行了3年的随访。我们检查了IBD发作前后的赎回处方,并使用逻辑回归模型估计了成为非IBD药物使用者的风险。结果:我们确定了36165名患者,其中16名 771例(46%)为青年发病,10615例(29%)为成人发病,8779例(24%)为老年发病。IBD的发作增加了抗抑郁药、抗精神病药物、镇静剂/催眠药、阿片类药物、非阿片类止痛药、抗糖尿病药物和质子泵抑制剂的使用,即使在没有其他潜在合并症的患者中也是如此。与成人相比,老年人IBD发作1年后使用抗抑郁药的调整比值比为1.50(95%可信区间[CI],1.14-1.82),阿片类药物为1.69(95%置信区间,1.45-1.95),非阿片类镇痛药为2.10(95%置信度,1.77-2.48),心血管药物为2.20(95%置信指数,1.86-2.61),质子泵抑制剂为1.51(95%置信系数,1.31-1.74)。结论:在所有3个年龄组中,与诊断IBD前相比,诊断IBD后,几组非IBD药物的赎回处方患者比例显著增加。老年患者成为几组非IBD药物的意外使用者的风险增加。
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引用次数: 0
Total Proctocolectomy vs Subtotal/total Colectomy for Neoplasia in Patients With Inflammatory Bowel Disease and Primary Sclerosing Cholangitis. 针对炎症性肠病和原发性硬化性胆管炎患者的新生物全直肠切除术与小肠切除术/大肠切除术的比较
IF 4.5 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-11-04 DOI: 10.1093/ibd/izad278
Katie Ann Dunleavy, Priscila Santiago, Gerard Forde, W Scott Harmsen, Nicholas P McKenna, Nayantara Coelho-Prabhu, Sherief Shawki, Laura Raffals

Background: Patients with inflammatory bowel disease (IBD) and primary sclerosing cholangitis (PSC) frequently undergo restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) for medically refractory disease or colonic dysplasia/neoplasia. Subtotal colectomy with ileosigmoid or ileorectal anastomosis may have improved outcomes but is not well studied. Due to increased risk for colorectal cancer in PSC-IBD, there is hesitancy to perform subtotal colectomy. We aim to describe the frequency of colorectal dysplasia/neoplasia following IPAA vs subtotal colectomy in PSC-IBD patients.

Methods: We completed a retrospective study from 1972 to 2022 of patients with PSC-IBD who had undergone total proctocolectomy with IPAA or subtotal colectomy. We abstracted demographics, disease characteristics, and endoscopic surveillance data from the EMR.

Results: Of 125 patients (99 IPAA; 26 subtotal), the indication for surgery was rectal sparing medically refractory disease (51% vs 42%), dysplasia (37% vs 30%) and neoplasia (11% vs 26%) in IPAA vs subtotal colectomy patients, respectively. On endoscopic surveillance of IPAA patients, 2 (2%) had low-grade dysplasia (LGD) in the ileal pouch and 2 (2%) had LGD in the rectal cuff after an average of 8.4 years and 12.3 years of follow-up, respectively. One (1%) IPAA patient developed neoplasia of the rectal cuff after 17.8 years of surgical continuity. No subtotal colectomy patients had dysplasia/neoplasia in the residual colon or rectum.

Conclusions: In patients with PSC-IBD, there was no dysplasia or neoplasia in those who underwent subtotal colectomy as opposed to the IPAA group. Subtotal colectomy may be considered a viable surgical option in patients with rectal sparing PSC-IBD if adequate endoscopic surveillance is implemented.

背景:炎症性肠病(IBD)和原发性硬化性胆管炎(PSC)患者经常因药物难治性疾病或结肠发育不良/新生物而接受回肠袋-肛门吻合术(IPAA)的恢复性直肠结肠切除术。带回肠乙状结肠或回肠直肠吻合术的结肠次全切除术可能会改善疗效,但目前研究还不充分。由于 PSC-IBD 患者罹患结直肠癌的风险增加,人们对是否进行结肠次全切除术犹豫不决。我们的目的是描述 PSC-IBD 患者在接受 IPAA 与次全结肠切除术后出现结直肠发育不良/新生物的频率:我们完成了一项从 1972 年到 2022 年的回顾性研究,研究对象是接受了 IPAA 或次全结肠切除术的全直肠切除术的 PSC-IBD 患者。我们从 EMR 中抽取了人口统计学、疾病特征和内镜监测数据:在125名患者中(99名IPAA患者;26名次全结肠切除术患者),IPAA患者和次全结肠切除术患者的手术指征分别为直肠疏通难治性疾病(51% vs 42%)、发育不良(37% vs 30%)和肿瘤(11% vs 26%)。在对IPAA患者进行内镜监测时,有2例(2%)患者的回肠袋出现低度发育不良(LGD),2例(2%)患者的直肠袖带出现低度发育不良(LGD),平均随访时间分别为8.4年和12.3年。一名(1%)IPAA患者在手术持续 17.8 年后出现直肠袖带肿瘤。没有次全结肠切除术患者的残留结肠或直肠出现发育不良/肿瘤:结论:在PSC-IBD患者中,与IPAA组相比,接受结肠次全切除术的患者没有发育不良或肿瘤。如果实施了适当的内镜监测,对于直肠疏松型 PSC-IBD 患者来说,结肠次全切除术可能是一种可行的手术选择。
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引用次数: 0
Symptomatic and Sonographic Improvement of Immune Checkpoint Inhibitor Enterocolitis With Risankizumab. 利桑珠单抗改善免疫检查点抑制剂肠炎的症状和声像图
IF 4.5 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-11-04 DOI: 10.1093/ibd/izae259
Rena Mei, Emily Pepe, David Y Oh, Katy K Tsai, Rishika Chugh, Michael G Kattah
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引用次数: 0
The Effectiveness of Oral Vancomycin on Inflammatory Bowel Disease in Patients With Primary Sclerosing Cholangitis: A Systematic Review. 口服万古霉素对原发性硬化性胆管炎患者炎症性肠病的疗效:系统回顾
IF 4.5 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-11-04 DOI: 10.1093/ibd/izae257
Naik Arbabzada, Liz Dennett, Guanmin Meng, Farhad Peerani

Background: Approximately 70% of primary sclerosing cholangitis (PSC) patients have inflammatory bowel disease (IBD). The IBD therapies currently used to treat PSC-IBD patients have side effects and can be costly. Oral vancomycin (OV)-a safe, economical, and convenient therapy-has been reported to be a salvage therapy in refractory PSC-IBD patients. This systematic review aims to summarize the current literature regarding the effectiveness and safety of OV to treat IBD in PSC patients.

Methods: A systematic literature review of Scopus, Embase, Web of Science, MEDLINE, and CINAHL was performed until March 2024. The Murad scale, Newcastle-Ottawa scale, and Cochrane Collaboration Risk of Bias Tool were used to determine the quality of the case reports and case series, cohort studies, and randomized controlled trial (RCT), respectively. The outcomes sought were response or remission across clinical, biochemical, endoscopic, and histological parameters.

Results: Of the 1725 published studies, we identified 9 case reports, 7 case series, 3 cohort studies, and 1 RCT. Most studies reported an improvement in clinical IBD symptoms such as diarrhea and hematochezia. Fewer publications provided supporting objective data in the form of fecal calprotectin, endoscopic Mayo scores, and histology. There were no reports of vancomycin-resistant enterococci infections.

Conclusions: Oral vancomycin appears safe and effective to treat IBD in a subset of PSC patients. Future studies would benefit from prospective data collection incorporating standardized symptomatic, endoscopic, and histologic indices. Ultimately, a well-powered RCT is needed to better assess the effectiveness, safety, and durability of OV therapy.

背景:约 70% 的原发性硬化性胆管炎(PSC)患者患有炎症性肠病(IBD)。目前用于治疗原发性硬化性胆管炎(PSC-IBD)患者的 IBD 疗法有副作用且费用昂贵。据报道,万古霉素口服液(OV)是一种安全、经济、方便的疗法,可作为难治性 PSC-IBD 患者的挽救疗法。本系统性综述旨在总结目前有关 OV 治疗 PSC 患者 IBD 的有效性和安全性的文献:截至 2024 年 3 月,对 Scopus、Embase、Web of Science、MEDLINE 和 CINAHL 进行了系统性文献综述。采用穆拉德量表、纽卡斯尔-渥太华量表和 Cochrane 协作偏倚风险工具分别确定病例报告和系列病例、队列研究和随机对照试验(RCT)的质量。研究结果为临床、生化、内镜和组织学参数的反应或缓解:在已发表的 1725 项研究中,我们发现了 9 项病例报告、7 项病例系列研究、3 项队列研究和 1 项随机对照试验。大多数研究报告称腹泻和血尿等 IBD 临床症状有所改善。较少文献提供了粪便钙蛋白、内镜下梅奥评分和组织学方面的客观数据支持。没有关于耐万古霉素肠球菌感染的报道:结论:口服万古霉素治疗部分PSC患者的IBD似乎安全有效。未来的研究将受益于纳入标准化症状、内镜和组织学指标的前瞻性数据收集。最终,还需要进行有充分证据支持的 RCT 研究,以更好地评估口服万古霉素治疗的有效性、安全性和持久性。
{"title":"The Effectiveness of Oral Vancomycin on Inflammatory Bowel Disease in Patients With Primary Sclerosing Cholangitis: A Systematic Review.","authors":"Naik Arbabzada, Liz Dennett, Guanmin Meng, Farhad Peerani","doi":"10.1093/ibd/izae257","DOIUrl":"https://doi.org/10.1093/ibd/izae257","url":null,"abstract":"<p><strong>Background: </strong>Approximately 70% of primary sclerosing cholangitis (PSC) patients have inflammatory bowel disease (IBD). The IBD therapies currently used to treat PSC-IBD patients have side effects and can be costly. Oral vancomycin (OV)-a safe, economical, and convenient therapy-has been reported to be a salvage therapy in refractory PSC-IBD patients. This systematic review aims to summarize the current literature regarding the effectiveness and safety of OV to treat IBD in PSC patients.</p><p><strong>Methods: </strong>A systematic literature review of Scopus, Embase, Web of Science, MEDLINE, and CINAHL was performed until March 2024. The Murad scale, Newcastle-Ottawa scale, and Cochrane Collaboration Risk of Bias Tool were used to determine the quality of the case reports and case series, cohort studies, and randomized controlled trial (RCT), respectively. The outcomes sought were response or remission across clinical, biochemical, endoscopic, and histological parameters.</p><p><strong>Results: </strong>Of the 1725 published studies, we identified 9 case reports, 7 case series, 3 cohort studies, and 1 RCT. Most studies reported an improvement in clinical IBD symptoms such as diarrhea and hematochezia. Fewer publications provided supporting objective data in the form of fecal calprotectin, endoscopic Mayo scores, and histology. There were no reports of vancomycin-resistant enterococci infections.</p><p><strong>Conclusions: </strong>Oral vancomycin appears safe and effective to treat IBD in a subset of PSC patients. Future studies would benefit from prospective data collection incorporating standardized symptomatic, endoscopic, and histologic indices. Ultimately, a well-powered RCT is needed to better assess the effectiveness, safety, and durability of OV therapy.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":""},"PeriodicalIF":4.5,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142568357","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Early Intestinal Ultrasound Predicts Clinical and Endoscopic Treatment Response and Demonstrates Drug-Specific Kinetics in Moderate-to-Severe Ulcerative Colitis. 早期肠道超声预测临床和内镜治疗反应,并证明中重度溃疡性结肠炎的药物特异性动力学。
IF 4.5 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-11-04 DOI: 10.1093/ibd/izad274
Floris A de Voogd, Steven J Bots, Elsa A van Wassenaer, Maria de Jong, Maarten J Pruijt, Geert R D'Haens, Krisztina B Gecse

Background: Intestinal ultrasound (IUS) is an emerging modality in monitoring disease activity in ulcerative colitis (UC). Here, we aimed to identify early IUS predictors of treatment response as evaluated by endoscopy and assessed the kinetics of IUS changes.

Methods: This prospective, longitudinal study included UC patients with endoscopic disease activity (endoscopic Mayo score [EMS] ≥2) starting anti-inflammatory treatment. Clinical scores, biochemical parameters and IUS were assessed at baseline (W0), at week 2 (W2), at W6(W6), and at the time of second endoscopy (W8-W26). Per colonic segment, endoscopic remission (EMS = 0), improvement (EMS ≤1), response (decrease in EMS ≥1), and clinical remission (Lichtiger score ≤3) were assessed and correlated with common IUS parameters. Additionally, drug-specific responsiveness of bowel wall thickness (BWT) was assessed.

Results: A total of 51 patients were included and followed, and 33 patients underwent second endoscopy. BWT was lower from W6 onward for patients reaching endoscopic improvement (3.0 ± 1.2 mm vs 4.1 ± 1.3 mm; P = .026), remission (2.5 ± 1.2 mm vs 4.1 ± 1.1 mm; P = .002), and clinical remission (3.01 ± 1.34 mm vs 3.85 ± 1.20 mm; P = .035). Decrease in BWT was more pronounced in endoscopic responders (-40 ± 25% vs -4 ± 28%; P = .001) at W8 to W26. At W6, BWT ≤3.0 mm (odds ratio [OR], 25.13; 95% confidence interval, 2.01-3.14; P = .012) and color Doppler signal (OR, 0.35; 95% confidence interval, 0.14-0.88; P = .026) predicted endoscopic remission and improvement, respectively. Submucosal layer thickness at W6 predicted endoscopic remission (OR, 0.09; P = .018) and improvement (OR, 0.14; P = .02). Furthermore, BWT decreased significantly at W2 for infliximab and tofacitinib and at W6 for vedolizumab.

Conclusions: BWT and color Doppler signal predicted endoscopic targets already after 6 weeks of treatment and response was drug specific. IUS allows close monitoring of treatment in UC and is a surrogate marker of endoscopy.

背景:肠道超声(IUS)是监测溃疡性结肠炎(UC)疾病活动的一种新兴方式。在这里,我们旨在通过内窥镜评估确定治疗反应的早期IUS预测因子,并评估IUS变化的动力学。方法:这项前瞻性、纵向研究纳入内镜下疾病活动性(内镜下Mayo评分[EMS]≥2)的UC患者,开始抗炎治疗。在基线(W0)、第2周(W2)、第6周(W6)和第二次内镜检查(W8-W26)时评估临床评分、生化参数和IUS。评估每个结肠段的内镜下缓解(EMS = 0)、改善(EMS≤1)、缓解(EMS≥1下降)和临床缓解(Lichtiger评分≤3),并与常见IUS参数相关。此外,还评估了肠壁厚度(BWT)的药物特异性反应性。结果:51例患者纳入随访,33例患者行二次内镜检查。达到内镜改善的患者BWT从W6开始降低(3.0±1.2 mm vs 4.1±1.3 mm;P = .026),缓解(2.5±1.2毫米和4.1±1.1毫米;P = .002),临床缓解(3.01±1.34 mm vs 3.85±1.20 mm;p = .035)。内窥镜应答者BWT下降更为明显(-40±25% vs -4±28%;P = .001)。W6时,BWT≤3.0 mm(优势比[OR], 25.13;95%置信区间为2.01-3.14;P = 0.012)和彩色多普勒信号(OR, 0.35;95%置信区间为0.14-0.88;P = 0.026)分别预测内镜下缓解和改善。W6时粘膜下层厚度预测内镜缓解(OR, 0.09;P = 0.018)和改善(OR, 0.14;p = .02)。此外,英夫利昔单抗和托法替尼的BWT在W2和维多单抗的W6时显著下降。结论:BWT和彩色多普勒信号在治疗6周后已经预测了内镜下的靶标,并且反应是药物特异性的。IUS允许密切监测UC的治疗,是内窥镜检查的替代标志。
{"title":"Early Intestinal Ultrasound Predicts Clinical and Endoscopic Treatment Response and Demonstrates Drug-Specific Kinetics in Moderate-to-Severe Ulcerative Colitis.","authors":"Floris A de Voogd, Steven J Bots, Elsa A van Wassenaer, Maria de Jong, Maarten J Pruijt, Geert R D'Haens, Krisztina B Gecse","doi":"10.1093/ibd/izad274","DOIUrl":"10.1093/ibd/izad274","url":null,"abstract":"<p><strong>Background: </strong>Intestinal ultrasound (IUS) is an emerging modality in monitoring disease activity in ulcerative colitis (UC). Here, we aimed to identify early IUS predictors of treatment response as evaluated by endoscopy and assessed the kinetics of IUS changes.</p><p><strong>Methods: </strong>This prospective, longitudinal study included UC patients with endoscopic disease activity (endoscopic Mayo score [EMS] ≥2) starting anti-inflammatory treatment. Clinical scores, biochemical parameters and IUS were assessed at baseline (W0), at week 2 (W2), at W6(W6), and at the time of second endoscopy (W8-W26). Per colonic segment, endoscopic remission (EMS = 0), improvement (EMS ≤1), response (decrease in EMS ≥1), and clinical remission (Lichtiger score ≤3) were assessed and correlated with common IUS parameters. Additionally, drug-specific responsiveness of bowel wall thickness (BWT) was assessed.</p><p><strong>Results: </strong>A total of 51 patients were included and followed, and 33 patients underwent second endoscopy. BWT was lower from W6 onward for patients reaching endoscopic improvement (3.0 ± 1.2 mm vs 4.1 ± 1.3 mm; P = .026), remission (2.5 ± 1.2 mm vs 4.1 ± 1.1 mm; P = .002), and clinical remission (3.01 ± 1.34 mm vs 3.85 ± 1.20 mm; P = .035). Decrease in BWT was more pronounced in endoscopic responders (-40 ± 25% vs -4 ± 28%; P = .001) at W8 to W26. At W6, BWT ≤3.0 mm (odds ratio [OR], 25.13; 95% confidence interval, 2.01-3.14; P = .012) and color Doppler signal (OR, 0.35; 95% confidence interval, 0.14-0.88; P = .026) predicted endoscopic remission and improvement, respectively. Submucosal layer thickness at W6 predicted endoscopic remission (OR, 0.09; P = .018) and improvement (OR, 0.14; P = .02). Furthermore, BWT decreased significantly at W2 for infliximab and tofacitinib and at W6 for vedolizumab.</p><p><strong>Conclusions: </strong>BWT and color Doppler signal predicted endoscopic targets already after 6 weeks of treatment and response was drug specific. IUS allows close monitoring of treatment in UC and is a surrogate marker of endoscopy.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"1992-2003"},"PeriodicalIF":4.5,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11532594/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138444570","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Single-center Experience With Upadacitinib for Adolescents With Refractory Inflammatory Bowel Disease. 奥帕他替尼治疗青少年难治性炎症性肠病的单中心经验
IF 4.5 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-11-04 DOI: 10.1093/ibd/izad300
Elizabeth A Spencer, Suzannah Bergstein, Michael Dolinger, Nanci Pittman, Amelia Kellar, David Dunkin, Marla C Dubinsky

Background: Upadacitinib (UPA) is a novel selective JAK inhibitor approved for adults with ulcerative colitis (UC) and with positive phase 3 data for Crohn's disease (CD). Pediatric off-label use is common due to delays in pediatric approvals; real-world data on UPA are needed to understand the safety and effectiveness in pediatric IBD.

Methods: This is a single-center retrospective case series study of adolescents (12-17 years) with inflammatory bowel disease IBD on UPA. The primary outcome was postinduction steroid-free clinical remission (SF-CR) defined as Pediatric UC Activity Index (PUCAI) or Pediatric CD Activity Index (PCDAI) ≤10. Secondary outcomes include postinduction clinical response (decrease ≥12.5 in PUCAI/PCDAI), postinduction C-reactive protein (CRP) normalization, 6-month SF-CR, and intestinal ultrasound response and remission. Adverse events were recorded through last follow-up.

Results: Twenty patients (9 CD, 10 UC, 1 IBD-U; 55% female; median age 15 years, 90% ≥2 biologics) were treated with UPA for ≥12 weeks (median 51 [43-63] weeks). Upadacitinib was used as monotherapy in 55% and as combination with ustekinumab and vedolizumab in 35% and 10%, respectively. Week 12 SF-CR was achieved in 75% (15/20) and 80% (16/20) with CRP normalization. About 3/4 (14/19) achieved SF-CR at 6 months. Adverse event occurred in 2 patients (10%): Cytomegalovirus colitis requiring hospitalization and hyperlipidemia requiring no treatment. In the 75% with ultrasound monitoring, response and remission were achieved in 77% and 60%, respectively.

Conclusion: While awaiting pediatric registration trials, our data suggest that UPA is effective in inducing and maintaining SF-CR in adolescents with highly-refractory IBD with an acceptable safety profile.

背景:乌达帕替尼(UPA)是一种新型选择性JAK抑制剂,已被批准用于成人溃疡性结肠炎(UC)患者,其治疗克罗恩病(CD)的3期临床数据良好。由于儿科用药审批的延迟,儿科标签外用药很常见;需要UPA的真实世界数据来了解其在儿科IBD中的安全性和有效性:这是一项单中心回顾性病例系列研究,研究对象为服用 UPA 的炎症性肠病 IBD 青少年(12-17 岁)。主要结果是诱导后无类固醇临床缓解(SF-CR),定义为小儿UC活动指数(PUCAI)或小儿CD活动指数(PCDAI)≤10。次要结果包括诱导后临床反应(PUCAI/PCDAI 下降≥12.5)、诱导后 C 反应蛋白(CRP)正常化、6 个月 SF-CR、肠道超声反应和缓解。最后一次随访记录了不良事件:20例患者(9例CD,10例UC,1例IBD-U;55%为女性;中位年龄15岁,90%≥2种生物制剂)接受UPA治疗≥12周(中位51 [43-63]周)。55%的患者接受了乌达替尼单药治疗,35%和10%的患者分别接受了乌斯特库单抗和维多珠单抗联合治疗。75%(15/20)和 80%(16/20)的患者在第 12 周达到 SF-CR,CRP 恢复正常。约3/4(14/19)的患者在6个月时实现了SF-CR。2名患者(10%)出现了不良反应:巨细胞病毒结肠炎需要住院治疗,高脂血症无需治疗。在75%接受超声监测的患者中,分别有77%和60%达到了应答和缓解:我们的数据表明,UPA 能有效诱导和维持高度难治性 IBD 青少年患者的 SF-CR,且安全性可接受。
{"title":"Single-center Experience With Upadacitinib for Adolescents With Refractory Inflammatory Bowel Disease.","authors":"Elizabeth A Spencer, Suzannah Bergstein, Michael Dolinger, Nanci Pittman, Amelia Kellar, David Dunkin, Marla C Dubinsky","doi":"10.1093/ibd/izad300","DOIUrl":"10.1093/ibd/izad300","url":null,"abstract":"<p><strong>Background: </strong>Upadacitinib (UPA) is a novel selective JAK inhibitor approved for adults with ulcerative colitis (UC) and with positive phase 3 data for Crohn's disease (CD). Pediatric off-label use is common due to delays in pediatric approvals; real-world data on UPA are needed to understand the safety and effectiveness in pediatric IBD.</p><p><strong>Methods: </strong>This is a single-center retrospective case series study of adolescents (12-17 years) with inflammatory bowel disease IBD on UPA. The primary outcome was postinduction steroid-free clinical remission (SF-CR) defined as Pediatric UC Activity Index (PUCAI) or Pediatric CD Activity Index (PCDAI) ≤10. Secondary outcomes include postinduction clinical response (decrease ≥12.5 in PUCAI/PCDAI), postinduction C-reactive protein (CRP) normalization, 6-month SF-CR, and intestinal ultrasound response and remission. Adverse events were recorded through last follow-up.</p><p><strong>Results: </strong>Twenty patients (9 CD, 10 UC, 1 IBD-U; 55% female; median age 15 years, 90% ≥2 biologics) were treated with UPA for ≥12 weeks (median 51 [43-63] weeks). Upadacitinib was used as monotherapy in 55% and as combination with ustekinumab and vedolizumab in 35% and 10%, respectively. Week 12 SF-CR was achieved in 75% (15/20) and 80% (16/20) with CRP normalization. About 3/4 (14/19) achieved SF-CR at 6 months. Adverse event occurred in 2 patients (10%): Cytomegalovirus colitis requiring hospitalization and hyperlipidemia requiring no treatment. In the 75% with ultrasound monitoring, response and remission were achieved in 77% and 60%, respectively.</p><p><strong>Conclusion: </strong>While awaiting pediatric registration trials, our data suggest that UPA is effective in inducing and maintaining SF-CR in adolescents with highly-refractory IBD with an acceptable safety profile.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"2057-2063"},"PeriodicalIF":4.5,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138884896","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Automatic Segmentation and Radiomics for Identification and Activity Assessment of CTE Lesions in Crohn's Disease. 自动分割和放射组学用于克罗恩病CTE病变的识别和活性评估。
IF 4.5 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-11-04 DOI: 10.1093/ibd/izad285
Yankun Gao, Bo Zhang, Dehan Zhao, Shuai Li, Chang Rong, Mingzhai Sun, Xingwang Wu

Background: The purpose of this article is to develop a deep learning automatic segmentation model for the segmentation of Crohn's disease (CD) lesions in computed tomography enterography (CTE) images. Additionally, the radiomics features extracted from the segmented CD lesions will be analyzed and multiple machine learning classifiers will be built to distinguish CD activity.

Methods: This was a retrospective study with 2 sets of CTE image data. Segmentation datasets were used to establish nnU-Net neural network's automatic segmentation model. The classification dataset was processed using the automatic segmentation model to obtain segmentation results and extract radiomics features. The most optimal features were then selected to build 5 machine learning classifiers to distinguish CD activity. The performance of the automatic segmentation model was evaluated using the Dice similarity coefficient, while the performance of the machine learning classifier was evaluated using the area under the curve, sensitivity, specificity, and accuracy.

Results: The segmentation dataset had 84 CTE examinations of CD patients (mean age 31 ± 13 years, 60 males), and the classification dataset had 193 (mean age 31 ± 12 years, 136 males). The deep learning segmentation model achieved a Dice similarity coefficient of 0.824 on the testing set. The logistic regression model showed the best performance among the 5 classifiers in the testing set, with an area under the curve, sensitivity, specificity, and accuracy of 0.862, 0.697, 0.840, and 0.759, respectively.

Conclusion: The automated segmentation model accurately segments CD lesions, and machine learning classifier distinguishes CD activity well. This method can assist radiologists in promptly and precisely evaluating CD activity.

背景:本文的目的是开发一种用于克罗恩病(CD) ct肠摄影(CTE)图像中病变分割的深度学习自动分割模型。此外,将分析从分割的CD病变中提取的放射组学特征,并构建多个机器学习分类器来区分CD活动。方法:采用2组CTE影像资料进行回顾性研究。利用分割数据集建立nnU-Net神经网络的自动分割模型。利用自动分割模型对分类数据集进行处理,得到分割结果并提取放射组学特征。然后选择最优特征构建5个机器学习分类器来区分CD活动。使用Dice相似系数评估自动分割模型的性能,而使用曲线下面积,灵敏度,特异性和准确性评估机器学习分类器的性能。结果:分割数据集有84例CD患者的CTE检查(平均年龄31±13岁,男性60例),分类数据集有193例(平均年龄31±12岁,男性136例)。深度学习分割模型在测试集上的Dice相似系数为0.824。logistic回归模型在测试集中5个分类器中表现最好,曲线下面积为0.862,灵敏度为0.697,特异性为0.840,准确率为0.759。结论:自动分割模型能准确分割CD病灶,机器学习分类器能很好地区分CD活动。该方法可帮助放射科医师及时准确地评估CD活动性。
{"title":"Automatic Segmentation and Radiomics for Identification and Activity Assessment of CTE Lesions in Crohn's Disease.","authors":"Yankun Gao, Bo Zhang, Dehan Zhao, Shuai Li, Chang Rong, Mingzhai Sun, Xingwang Wu","doi":"10.1093/ibd/izad285","DOIUrl":"10.1093/ibd/izad285","url":null,"abstract":"<p><strong>Background: </strong>The purpose of this article is to develop a deep learning automatic segmentation model for the segmentation of Crohn's disease (CD) lesions in computed tomography enterography (CTE) images. Additionally, the radiomics features extracted from the segmented CD lesions will be analyzed and multiple machine learning classifiers will be built to distinguish CD activity.</p><p><strong>Methods: </strong>This was a retrospective study with 2 sets of CTE image data. Segmentation datasets were used to establish nnU-Net neural network's automatic segmentation model. The classification dataset was processed using the automatic segmentation model to obtain segmentation results and extract radiomics features. The most optimal features were then selected to build 5 machine learning classifiers to distinguish CD activity. The performance of the automatic segmentation model was evaluated using the Dice similarity coefficient, while the performance of the machine learning classifier was evaluated using the area under the curve, sensitivity, specificity, and accuracy.</p><p><strong>Results: </strong>The segmentation dataset had 84 CTE examinations of CD patients (mean age 31 ± 13 years, 60 males), and the classification dataset had 193 (mean age 31 ± 12 years, 136 males). The deep learning segmentation model achieved a Dice similarity coefficient of 0.824 on the testing set. The logistic regression model showed the best performance among the 5 classifiers in the testing set, with an area under the curve, sensitivity, specificity, and accuracy of 0.862, 0.697, 0.840, and 0.759, respectively.</p><p><strong>Conclusion: </strong>The automated segmentation model accurately segments CD lesions, and machine learning classifier distinguishes CD activity well. This method can assist radiologists in promptly and precisely evaluating CD activity.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"1957-1964"},"PeriodicalIF":4.5,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138444569","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Pediatric IBD Patients Treated With Infliximab and Proactive Drug Monitoring Benefit From Early Concomitant Immunomodulatory Therapy: A Retrospective Analysis of a 10-Year Real-Life Cohort. 儿童IBD患者接受英夫利昔单抗和主动药物监测从早期伴随免疫调节治疗中获益:一项10年真实队列的回顾性分析
IF 4.5 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-11-04 DOI: 10.1093/ibd/izad277
Hannes Hoelz, Lena Bragagna, Anna Litwin, Sibylle Koletzko, Thu Giang Le Thi, Tobias Schwerd

Background: Limited approval of second-line treatments in pediatric inflammatory bowel disease (pIBD) necessitates optimized use of infliximab (IFX) with proactive therapeutic drug monitoring (TDM). We investigated whether early combo-therapy with an immunomodulator (IMM) provides additional benefit.

Methods: In the retrospectively reviewed medical records of all children treated with IFX and proactive TDM between 2013 and 2022, IMMearly (IMM ≤3 months since IFX start) was evaluated against IMMother/no (late/short or no IMM) over follow-up of 3 to 60 months. Kaplan-Meier analysis was used to analyze time to loss of response (LOR) with IFX discontinuation or time to antibodies-to-IFX (ATI) development.

Results: Three hundred fifteen patients with pIBD were reviewed; of those, 127 with 2855 visits were included (77 CD, 50 UC/IBD-unclassified). Sixty patients received IMMearly, 20 patients IMMother, and 47 had IFX monotherapy. Median follow-up time was 30 and 26 months for IMMearly and IMMother/no, respectively, with comparable proactive TDM. Infliximab treatment persistence was 68% after 60 months. Loss of response was observed in 7 IMMearly and 15 IMMother/no patients (P = .16). Early combo-therapy significantly delayed LOR with IFX discontinuation (median LOR free interval IMMearly 30 months vs IMMother/no 9 months, P = .01). Patients with IMMother/no were 10-, 3- and 2-times more likely to experience LOR with IFX discontinuation after 1, 3, and 5 years, respectively. There were no significant group differences regarding the presence of any positive (>10 arbitrary units per milliliter [AU/mL]) or high (>100 AU/mL) ATI, median ATI concentrations, and ATI-free interval.

Conclusions: Early IMM combo-therapy in proactively monitored patients with pIBD significantly prolonged the median LOR free interval compared with late/short or no IMM treatment.

背景:儿童炎症性肠病(pIBD)二线治疗的有限批准需要优化英夫利昔单抗(IFX)与主动治疗药物监测(TDM)的使用。我们研究了早期联合免疫调节剂(IMM)治疗是否能提供额外的益处。方法:回顾性回顾2013年至2022年期间所有接受IFX和主动TDM治疗的儿童的医疗记录,在3至60个月的随访中,对imearly (IFX开始后IMM≤3个月)与IMMother/no(晚/短或无IMM)进行评估。Kaplan-Meier分析用于分析IFX停药至反应丧失(LOR)的时间或IFX抗体(ATI)产生的时间。结果:回顾了315例pIBD患者;其中127例2855次就诊(77例CD, 50例UC/ ibd未分类)。60例患者接受imnearly治疗,20例患者接受IMMother治疗,47例患者接受IFX单药治疗。IMMearly和IMMother/no的中位随访时间分别为30个月和26个月,具有可比性的主动TDM。英夫利昔单抗治疗60个月后的持续性为68%。7例imnear患者和15例IMMother/no患者出现反应丧失(P = 0.16)。早期联合治疗可显著延迟肺活度与IFX停药(中位肺活度无间隔为近30个月vs IMMother/no 9个月,P = 0.01)。IMMother/no患者分别在1年、3年和5年后停用IFX时发生LOR的可能性增加10倍、3倍和2倍。在ATI阳性(>10任意单位/毫升[AU/mL])或高(>100 AU/mL)、ATI中位数浓度和ATI无间隔方面,组间无显著差异。结论:与晚期/短期或无IMM治疗相比,主动监测的pIBD患者早期IMM联合治疗显着延长了中位LOR空闲时间。
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引用次数: 0
Assessment of Treatment Response in Known Crohn's Disease-A Prospective Blinded Study Comparing the Diagnostic Accuracy of Intestinal Ultrasound, Magnetic Resonance Enterocolonography, Panenteric Capsule Endoscopy, and Fecal Calprotectin. 已知克罗恩病治疗反应的评估--比较肠道超声波、磁共振肠结肠成像、泛肠胶囊内窥镜和粪便钙蛋白诊断准确性的前瞻性盲法研究。
IF 4.5 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-11-04 DOI: 10.1093/ibd/izae254
Jacob Broder Brodersen, Søren Rafael Rafaelsen, Mie Agerbæk Juel, Torben Knudsen, Jens Kjeldsen, Michael Dam Jensen

Background: Minimally invasive modalities may replace ileocolonoscopy (IC) in the follow-up of Crohn's disease (CD). The aim of this study was to evaluate intestinal ultrasound (IUS), magnetic resonance enterocolonography (MREC), panenteric capsule endoscopy (PCE), and fecal calprotectin (FC) for determining response to medical treatment in patients with ileocolonic CD.

Methods: This prospective, blinded, multicenter study included patients with endoscopically active CD. Patients were scheduled for IC, MREC, IUS, PCE, and FC before and 12 weeks after treatment with corticosteroids or biological therapy. A ≥50% reduction of the Simple Endoscopic Score for Crohn's Disease (SES-CD) with IC defined treatment response.

Results: Fifty patients completed the pre- and posttreatment evaluation with IC, and endoscopic response was achieved in 25 (50.0%). PCE was omitted in 12 (24.0%) patients because of stricturing CD. All activity scores decreased in patients achieving endoscopic response: The Simple Ultrasound Score for Crohn's Disease 2.2 vs 6.1 (P < .001), Magnetic Resonance Index of Activity 29.0 vs 37.1 (P = .05), SES-CD with PCE 3.1 vs 12.8 (P < .001), and FC 115.3 vs 1339.9 mg/kg (P < .001). The sensitivity and specificity of IUS, MREC, PCE, and FC were 80.0% (95% CI, 56.3-94.3)/77.8% (95% CI, 52.4-93.6), 65.2% (95% CI, 42.7-83.6)/87.0% (95% CI, 66.4-97.2), 87.5% (95% CI, 61.7-98.4)/86.7% (95% CI, 59.5-98.3), and 90.0% (95% CI, 68.3-98.8)/86.4% (95% CI, 65.1-97.1), respectively.

Conclusions: IUS and FC are equally effective for determining treatment response in patients with active CD. PCE is limited by the occurrence of strictures in this group of patients.

背景:在克罗恩病(CD)的随访中,微创方式可能会取代回肠结肠镜检查(IC)。本研究旨在评估肠道超声(IUS)、磁共振肠结肠造影(MREC)、肠道胶囊内镜(PCE)和粪便钙蛋白(FC)在确定回结肠 CD 患者对药物治疗的反应方面的作用:这项前瞻性、盲法、多中心研究纳入了内镜下活动性 CD 患者。患者在皮质类固醇或生物疗法治疗前和治疗后12周接受IC、MREC、IUS、PCE和FC检查。内镜下克罗恩病简易评分(SES-CD)与IC评分下降≥50%即为治疗反应:结果:50 名患者完成了 IC 治疗前后的评估,其中 25 人(50.0%)获得了内镜反应。有 12 例(24.0%)患者因内镜下 CD 治疗严格而省略了 PCE。在获得内镜反应的患者中,所有活动评分均有所下降:克罗恩病简易超声评分 2.2 vs 6.1(P 结论:IUS 和 FC 对克罗恩病同样有效:IUS 和 FC 对于确定活动性 CD 患者的治疗反应同样有效。PCE 受限于这类患者的狭窄发生率。
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引用次数: 0
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Inflammatory Bowel Diseases
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