Introduction: Ustekinumab (UST) is increasingly used in Crohn's disease patients with prior tumor necrosis factor-α inhibitor (TNFi) failure. However, whether to switch to another biologic or continue TNFi therapy at the time of surgery remains an important unresolved clinical question.
Methods: Among patients who underwent intestinal resection during TNFi therapy at our hospital from January 2008 to February 2022, 39 patients continued TNFi after surgery (TNFi continuation group) and 15 patients switched to UST after surgery (UST switch group) were included. Clinical and endoscopic recurrence rates were compared over long-term follow-up.
Results: This retrospective cohort study showed that the cumulative 2-year clinical recurrence-free rate was 82.6% in the TNFi continuation group and 60.0% in the UST switch group, with no statistical difference in the cumulative clinical recurrence-free rate between the two groups (log-rank test; p = 0.863). The follow-up endoscopy showed that postoperative endoscopic recurrence (PER) was observed in 14 of 34 patients (38.2%) in the TNFi group and 8 of 14 patients (57.1%) in the UST switch group, with no statistical difference between the two groups (p = 0.3384). Absence of PER at follow-up correlated with better long-term clinical outcomes. A medical claims database analysis confirmed no significant difference in the cumulative clinical recurrence-free rate (p = 0.232) or subsequent intestinal surgery-free rate (p = 0.554) between the TNFi continuation group and the UST switch group.
Conclusion: In patients undergoing surgery during TNFi treatment, there was no statistically significant difference between postoperative UST switching and TNFi continuation.
{"title":"A Retrospective Comparison of Postoperative Tumor Necrosis Factor-α Inhibitor Continuation versus Ustekinumab Switch in Crohn's Disease: Reset or Switch?","authors":"Shuhei Hosomi, Koji Fujimoto, Yumie Kobayashi, Rieko Nakata, Yu Nishida, Hirotsugu Maruyama, Masaki Ominami, Yuji Nadatani, Shusei Fukunaga, Koji Otani, Fumio Tanaka, Yasuhiro Fujiwara","doi":"10.1159/000549403","DOIUrl":"10.1159/000549403","url":null,"abstract":"<p><strong>Introduction: </strong>Ustekinumab (UST) is increasingly used in Crohn's disease patients with prior tumor necrosis factor-α inhibitor (TNFi) failure. However, whether to switch to another biologic or continue TNFi therapy at the time of surgery remains an important unresolved clinical question.</p><p><strong>Methods: </strong>Among patients who underwent intestinal resection during TNFi therapy at our hospital from January 2008 to February 2022, 39 patients continued TNFi after surgery (TNFi continuation group) and 15 patients switched to UST after surgery (UST switch group) were included. Clinical and endoscopic recurrence rates were compared over long-term follow-up.</p><p><strong>Results: </strong>This retrospective cohort study showed that the cumulative 2-year clinical recurrence-free rate was 82.6% in the TNFi continuation group and 60.0% in the UST switch group, with no statistical difference in the cumulative clinical recurrence-free rate between the two groups (log-rank test; <i>p</i> = 0.863). The follow-up endoscopy showed that postoperative endoscopic recurrence (PER) was observed in 14 of 34 patients (38.2%) in the TNFi group and 8 of 14 patients (57.1%) in the UST switch group, with no statistical difference between the two groups (<i>p</i> = 0.3384). Absence of PER at follow-up correlated with better long-term clinical outcomes. A medical claims database analysis confirmed no significant difference in the cumulative clinical recurrence-free rate (<i>p</i> = 0.232) or subsequent intestinal surgery-free rate (<i>p</i> = 0.554) between the TNFi continuation group and the UST switch group.</p><p><strong>Conclusion: </strong>In patients undergoing surgery during TNFi treatment, there was no statistically significant difference between postoperative UST switching and TNFi continuation.</p>","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"10 1","pages":"397-408"},"PeriodicalIF":0.0,"publicationDate":"2025-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12700595/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145756509","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: Vedolizumab (VDZ) is a gut-selective integrin antagonist approved for the treatment of ulcerative colitis. While its efficacy and safety have been demonstrated in clinical trials, real-world data on long-term treatment persistence and factors associated with loss of response are limited.
Methods: We conducted a retrospective single-center observational study to evaluate the persistence of treatment and factors influencing loss of response in 59 patients with ulcerative colitis treated using VDZ. Clinical outcomes, endoscopic findings, and the impact of concomitant immunomodulator or 5-aminosalicylic acid use were analyzed.
Results: Thirty-two patients (54.2%) had achieved clinical remission at week 24 and 27 (45.8%) had not. The cumulative VDZ persistence rate at 3 years was 39.7%. Patients who had achieved endoscopic improvement at 24 weeks exhibited a significantly higher persistence rate. The incidence of adverse events was low (1.7%). The impact of immunomodulator and 5-aminosalicylic acid co-administration on treatment persistence was minimal.
Conclusion: Endoscopic improvement at week 24 was a key predictor of long-term VDZ persistence.
{"title":"Mayo Endoscopic Subscore at Week 24 Is a Predictor of Future Loss of Response to Vedolizumab in Patients with Ulcerative Colitis in Clinical Remission.","authors":"Daisuke Saito, Minoru Matsuura, Hiromu Morikubo, Noritaka Hibi, Haruka Komatsu, Noriaki Oguri, Takeshi Fujima, Haruka Wada, Ryota Ogihara, Tatsuya Mitsui, Mari Hayashida, Jun Miyoshi, Teppei Omori, Tadakazu Hisamatsu","doi":"10.1159/000549404","DOIUrl":"10.1159/000549404","url":null,"abstract":"<p><strong>Introduction: </strong>Vedolizumab (VDZ) is a gut-selective integrin antagonist approved for the treatment of ulcerative colitis. While its efficacy and safety have been demonstrated in clinical trials, real-world data on long-term treatment persistence and factors associated with loss of response are limited.</p><p><strong>Methods: </strong>We conducted a retrospective single-center observational study to evaluate the persistence of treatment and factors influencing loss of response in 59 patients with ulcerative colitis treated using VDZ. Clinical outcomes, endoscopic findings, and the impact of concomitant immunomodulator or 5-aminosalicylic acid use were analyzed.</p><p><strong>Results: </strong>Thirty-two patients (54.2%) had achieved clinical remission at week 24 and 27 (45.8%) had not. The cumulative VDZ persistence rate at 3 years was 39.7%. Patients who had achieved endoscopic improvement at 24 weeks exhibited a significantly higher persistence rate. The incidence of adverse events was low (1.7%). The impact of immunomodulator and 5-aminosalicylic acid co-administration on treatment persistence was minimal.</p><p><strong>Conclusion: </strong>Endoscopic improvement at week 24 was a key predictor of long-term VDZ persistence.</p>","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"10 1","pages":"387-396"},"PeriodicalIF":0.0,"publicationDate":"2025-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12685341/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145714372","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-31eCollection Date: 2025-01-01DOI: 10.1159/000548766
Raj Kirit Patel, Raechel Davis, Aurel Iuga, Lia Gass Rodriguez
Introduction: Inflammatory bowel disease (IBD) burdens patients and healthcare systems, often due to frequent emergency department (ED) visits. Comprehensive programs that connect members to providers with disease-specific expertise may improve IBD management and reduce emergency care needs.
Methods: This study evaluates the impact of a virtual condition management program on ED utilization among commercially insured members with IBD using claims data from 2017 to 2024. Propensity scores were estimated, with inverse probability of treatment weighting applied to balance baseline covariates (i.e., age, sex, prior healthcare utilization, and Charlson Comorbidity Index [CCI] scores). Weighted negative binomial regression estimated the association between program engagement and ED visit frequency, controlling for baseline characteristics. Sensitivity analyses using weighted logistic regressions evaluated the likelihood of any, gastrointestinal (GI)-related, and non-emergent ED visits post-eligibility.
Results: Engagement was significantly associated with reduced ED utilization. Members who chose to engage experienced a 45.7% reduction in ED visits, on average, compared to unengaged (p = 0.007). Males had significantly lower visits (p = 0.012), higher CCI scores were associated with fewer visits (p = 0.005), and prior ED use was strongly associated with visit frequency (p < 0.001). Sensitivity analyses reinforced these findings as engaged members had significantly lower odds of any (odds ratio [OR]: 0.50; p = 0.003), GI-related (OR: 0.46; p = 0.014), and non-emergent (OR: 0.41; p = 0.722) visits.
Conclusions: Engagement with a care management program was associated with reduced ED visitation and lower likelihoods of any, non-emergent, and GI-related visits. Virtual programs offering condition-specific expertise may improve disease management and decrease reliance on ED services for patients with chronic GI diseases.
简介:炎症性肠病(IBD)给患者和医疗保健系统带来负担,通常是由于频繁的急诊(ED)就诊。将成员与具有特定疾病专业知识的提供者联系起来的综合计划可能会改善IBD管理并减少紧急护理需求。方法:本研究使用2017年至2024年的索赔数据,评估虚拟状态管理程序对IBD商业保险会员ED利用的影响。估计倾向得分,用治疗加权的逆概率来平衡基线协变量(即年龄、性别、既往医疗保健利用和Charlson合并症指数[CCI]得分)。加权负二项回归估计了项目参与和ED访问频率之间的关系,控制了基线特征。敏感性分析使用加权逻辑回归评估任何可能性,胃肠道(GI)相关,非紧急急诊科就诊后的资格。结果:参与与ED使用率降低显著相关。与不参与的会员相比,选择参与的会员平均减少了45.7%的ED就诊次数(p = 0.007)。男性患者的就诊次数显著减少(p = 0.012), CCI评分越高,就诊次数越少(p = 0.005),既往ED使用与就诊频率密切相关(p < 0.001)。敏感性分析强化了这些发现,因为参与的成员在任何(比值比[OR]: 0.50; p = 0.003)、地理信息系统相关(OR: 0.46; p = 0.014)和非紧急(OR: 0.41; p = 0.722)就诊方面的几率都显著降低。结论:参与护理管理计划与急诊科就诊减少以及任何非紧急和gi相关就诊的可能性降低有关。提供特定疾病专业知识的虚拟程序可以改善疾病管理,减少慢性胃肠道疾病患者对急诊科服务的依赖。
{"title":"The Impact of a Specialized Condition Management Program on Emergency Department Visits in Patients with Inflammatory Bowel Disease.","authors":"Raj Kirit Patel, Raechel Davis, Aurel Iuga, Lia Gass Rodriguez","doi":"10.1159/000548766","DOIUrl":"10.1159/000548766","url":null,"abstract":"<p><strong>Introduction: </strong>Inflammatory bowel disease (IBD) burdens patients and healthcare systems, often due to frequent emergency department (ED) visits. Comprehensive programs that connect members to providers with disease-specific expertise may improve IBD management and reduce emergency care needs.</p><p><strong>Methods: </strong>This study evaluates the impact of a virtual condition management program on ED utilization among commercially insured members with IBD using claims data from 2017 to 2024. Propensity scores were estimated, with inverse probability of treatment weighting applied to balance baseline covariates (i.e., age, sex, prior healthcare utilization, and Charlson Comorbidity Index [CCI] scores). Weighted negative binomial regression estimated the association between program engagement and ED visit frequency, controlling for baseline characteristics. Sensitivity analyses using weighted logistic regressions evaluated the likelihood of any, gastrointestinal (GI)-related, and non-emergent ED visits post-eligibility.</p><p><strong>Results: </strong>Engagement was significantly associated with reduced ED utilization. Members who chose to engage experienced a 45.7% reduction in ED visits, on average, compared to unengaged (<i>p</i> = 0.007). Males had significantly lower visits (<i>p</i> = 0.012), higher CCI scores were associated with fewer visits (<i>p</i> = 0.005), and prior ED use was strongly associated with visit frequency (<i>p</i> < 0.001). Sensitivity analyses reinforced these findings as engaged members had significantly lower odds of any (odds ratio [OR]: 0.50; <i>p</i> = 0.003), GI-related (OR: 0.46; <i>p</i> = 0.014), and non-emergent (OR: 0.41; <i>p</i> = 0.722) visits.</p><p><strong>Conclusions: </strong>Engagement with a care management program was associated with reduced ED visitation and lower likelihoods of any, non-emergent, and GI-related visits. Virtual programs offering condition-specific expertise may improve disease management and decrease reliance on ED services for patients with chronic GI diseases.</p>","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"10 1","pages":"359-370"},"PeriodicalIF":0.0,"publicationDate":"2025-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12659676/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145647646","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-28eCollection Date: 2025-01-01DOI: 10.1159/000549227
Dai Ishikawa, Xiaochen Zhang, Kei Nomura, Akihito Nagahara
Background: Fecal microbiota transplantation (FMT) is an emerging therapeutic strategy for inflammatory bowel disease (IBD). Every step of the FMT process, from donor recruitment and patient selection to pretreatment protocols, administration techniques, and post-FMT interventions, can significantly influence treatment outcomes. These components are interrelated, and even subtle differences in methodology may affect the overall efficacy of FMT for IBD. This review aimed to outline the current clinical experience and findings regarding FMT for IBD during the application process.
Summary: Donor screening has traditionally focused on safety. In recent years, although safety remains essential, increasing attention has been paid to the donor selection efficacy. Particularly, identifying patients who are most likely to benefit from FMT is crucial because timely and appropriate patient selection can prevent delays in effective treatment. Pretreatment strategies and FMT procedures remain hot topics of current research. Approaches, such as antibiotic pretreatment, may enhance microbial engraftment; however, the optimal antibiotic combination remains unclear. Bowel lavage is commonly used to reduce the microbial burden and facilitate donor microbiota colonization, whereas corticosteroid pretreatment has shown conflicting results. There are various routes of administration, and oral capsules are gaining popularity owing to their safety and patient acceptability. Stool preparation factors, including the use of single versus pooled donors, anaerobic processing, and storage form (fresh, frozen, or freeze-dried), can significantly influence microbial viability and clinical outcomes. Repeated FMTs tend to be more effective than single infusions; nonetheless, the optimal frequency remains unclear. Post-FMT interventions, such as dietary modifications and supplementation with prebiotics, such as pectin and alginic acid, are also promising strategies.
Key messages: Despite encouraging results, variations in treatment protocols, donor characteristics, and host factors continue to obscure the definitive predictors of FMT success. Further randomized controlled trials and mechanistic studies are required to standardize these procedures and optimize their long-term efficacy.
{"title":"Fecal Microbiota Transplantation for Inflammatory Bowel Disease: Where We Stand and What Is Next.","authors":"Dai Ishikawa, Xiaochen Zhang, Kei Nomura, Akihito Nagahara","doi":"10.1159/000549227","DOIUrl":"10.1159/000549227","url":null,"abstract":"<p><strong>Background: </strong>Fecal microbiota transplantation (FMT) is an emerging therapeutic strategy for inflammatory bowel disease (IBD). Every step of the FMT process, from donor recruitment and patient selection to pretreatment protocols, administration techniques, and post-FMT interventions, can significantly influence treatment outcomes. These components are interrelated, and even subtle differences in methodology may affect the overall efficacy of FMT for IBD. This review aimed to outline the current clinical experience and findings regarding FMT for IBD during the application process.</p><p><strong>Summary: </strong>Donor screening has traditionally focused on safety. In recent years, although safety remains essential, increasing attention has been paid to the donor selection efficacy. Particularly, identifying patients who are most likely to benefit from FMT is crucial because timely and appropriate patient selection can prevent delays in effective treatment. Pretreatment strategies and FMT procedures remain hot topics of current research. Approaches, such as antibiotic pretreatment, may enhance microbial engraftment; however, the optimal antibiotic combination remains unclear. Bowel lavage is commonly used to reduce the microbial burden and facilitate donor microbiota colonization, whereas corticosteroid pretreatment has shown conflicting results. There are various routes of administration, and oral capsules are gaining popularity owing to their safety and patient acceptability. Stool preparation factors, including the use of single versus pooled donors, anaerobic processing, and storage form (fresh, frozen, or freeze-dried), can significantly influence microbial viability and clinical outcomes. Repeated FMTs tend to be more effective than single infusions; nonetheless, the optimal frequency remains unclear. Post-FMT interventions, such as dietary modifications and supplementation with prebiotics, such as pectin and alginic acid, are also promising strategies.</p><p><strong>Key messages: </strong>Despite encouraging results, variations in treatment protocols, donor characteristics, and host factors continue to obscure the definitive predictors of FMT success. Further randomized controlled trials and mechanistic studies are required to standardize these procedures and optimize their long-term efficacy.</p>","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"10 1","pages":"371-386"},"PeriodicalIF":0.0,"publicationDate":"2025-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12674670/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145677630","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-02eCollection Date: 2025-01-01DOI: 10.1159/000548730
Cléa Kunz, Alain Schoepfer, Christiane Sokollik, Mathilde Crédeville, Vasikili Spyropoulou, Franziska Righini Grunder, Michela G Schaeppi Tempia, Henrik Köhler, Andreas Nydegger
Introduction: Up to 85% of pediatric patients affected by Crohn's disease experience growth failure. This study aims to elucidate the effects of anti-tumor necrosis factor (TNF) biologics on patient growth.
Methods: This retrospective analysis examined height, height velocity and weight in pediatric patients with Crohn's disease from the Swiss Inflammatory Bowel Disease Cohort Study between 2007 and 2020 (n = 97). Z-scores were determined according to age and gender of a healthy pediatric population. Growth of patients treated with anti-TNF biologics and immunomodulators was analyzed by linear regression over 5 years and compared within each subgroup by paired Student t tests 1 year (T1), 2 years (T2), and 5 years (T5) after treatment initiation.
Results: Mean height and weight z-scores at diagnosis were -0.3 ± 1.3 and -1.0 ± 1.6, respectively (age at diagnosis 11.1 ± 2.7 years, 52.0% male). Initial treatment was led by azathioprine (58.3%) and infliximab (19.8%). Patients treated with biologics exhibited significant height increase at T1 (p = 0.022), with an overall flat height evolution (y = 0.00x - 0.31), whereas significant weight increase was maintained at T5 (p = 0.0005, y = 0.13x - 0.50). Patients on immunomodulators showed a height increase (y = 0.15x - 0.20) and a significant weight increase at T2 (p = 0.0047, y = 0.10x - 0.41). Height velocity z-scores showed a significant increase across both genders. Factors contributing to a decreased height z-score included male sex, age 10 and below at diagnosis, a concomitant corticosteroid treatment and a top-down treatment strategy.
Conclusion: Our findings indicate that anti-TNF biologics are associated with significant short-term height and long-term weight gains in pediatric patients with Crohn's disease, similar to those observed with immunomodulators.
{"title":"Evolution of Growth following Anti-Tumor Necrosis Factor-α Therapy in Paediatric Crohn's Disease: Data from the Swiss IBD Cohort Study.","authors":"Cléa Kunz, Alain Schoepfer, Christiane Sokollik, Mathilde Crédeville, Vasikili Spyropoulou, Franziska Righini Grunder, Michela G Schaeppi Tempia, Henrik Köhler, Andreas Nydegger","doi":"10.1159/000548730","DOIUrl":"10.1159/000548730","url":null,"abstract":"<p><strong>Introduction: </strong>Up to 85% of pediatric patients affected by Crohn's disease experience growth failure. This study aims to elucidate the effects of anti-tumor necrosis factor (TNF) biologics on patient growth.</p><p><strong>Methods: </strong>This retrospective analysis examined height, height velocity and weight in pediatric patients with Crohn's disease from the Swiss Inflammatory Bowel Disease Cohort Study between 2007 and 2020 (<i>n</i> = 97)<i>.</i> Z-scores were determined according to age and gender of a healthy pediatric population. Growth of patients treated with anti-TNF biologics and immunomodulators was analyzed by linear regression over 5 years and compared within each subgroup by paired Student <i>t</i> tests 1 year (T1), 2 years (T2), and 5 years (T5) after treatment initiation.</p><p><strong>Results: </strong>Mean height and weight z-scores at diagnosis were -0.3 ± 1.3 and -1.0 ± 1.6, respectively (age at diagnosis 11.1 ± 2.7 years, 52.0% male). Initial treatment was led by azathioprine (58.3%) and infliximab (19.8%). Patients treated with biologics exhibited significant height increase at T1 (<i>p</i> = 0.022), with an overall flat height evolution (<i>y</i> = 0.00<i>x</i> - 0.31), whereas significant weight increase was maintained at T5 (<i>p</i> = 0.0005, <i>y</i> = 0.13<i>x</i> - 0.50). Patients on immunomodulators showed a height increase (<i>y</i> = 0.15<i>x</i> - 0.20) and a significant weight increase at T2 (<i>p</i> = 0.0047, <i>y</i> = 0.10<i>x</i> - 0.41). Height velocity z-scores showed a significant increase across both genders. Factors contributing to a decreased height z-score included male sex, age 10 and below at diagnosis, a concomitant corticosteroid treatment and a top-down treatment strategy.</p><p><strong>Conclusion: </strong>Our findings indicate that anti-TNF biologics are associated with significant short-term height and long-term weight gains in pediatric patients with Crohn's disease, similar to those observed with immunomodulators.</p>","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"10 1","pages":"347-358"},"PeriodicalIF":0.0,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12659624/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145648470","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-29eCollection Date: 2025-01-01DOI: 10.1159/000548160
Fenna M M Beeren, Britt Roosenboom, Marcel B W Spanier, Marcel J M Groenen, Peter D Siersema
Introduction: Fecal calprotectin (FCP) is a key biomarker for gastrointestinal inflammation, aiding in differentiating irritable bowel syndrome from active inflammatory bowel disease (IBD). Metabolic bariatric surgeries (MBSs), such as Roux-en-Y gastric bypass or sleeve gastrectomy, alter gastrointestinal physiology, potentially affecting the applicability of standard FCP cutoff values in this population.
Methods: This retrospective study included 340 patients who underwent MBS and subsequent FCP testing between January 2000 and June 2024. Patients with preoperative IBD were excluded. The primary outcome was to identify the optimal FCP cutoff values for relevant colonoscopy findings. Secondary outcomes included median FCP levels, colonoscopy results, and subgroup analyses based on sex, surgery type, and time to gastrointestinal evaluation.
Results: The median FCP level across all patients was 51 µg/g (IQR 30-82). Among 124 patients undergoing colonoscopy, the median FCP was 61 µg/g (IQR 34-104). There was no significant difference between patients with (69.5 µg/g, n = 50) or without (59 µg/g, n = 74) relevant findings, including malignancy or IBD (p = 0.101). No significant differences in FCP levels were observed between subgroups based on cholecystectomy status, biliopancreatic limb length, types of surgery, body mass index, time to presentation since MBS, or proton pump inhibitor use. ROC analysis identified an optimal cut off of 59.5 µg/g (sensitivity: 64.6%; specificity: 63.4%; area under the curve: 0.653; Youden's index 0.280).
Conclusion: In patients following MBS, the optimal FCP cutoff value would be at 59.5 µg/g. However, given the low Youden's index and the minimal difference compared to the standard cutoff value of 50 µg/g, maintaining this standard, seems more practical in clinical settings.
粪便钙保护蛋白(FCP)是胃肠道炎症的关键生物标志物,有助于区分肠易激综合征和活动性炎症性肠病(IBD)。代谢性减肥手术(MBSs),如Roux-en-Y胃旁路术或袖式胃切除术,会改变胃肠道生理,可能影响标准FCP临界值在该人群中的适用性。方法:这项回顾性研究包括340名在2000年1月至2024年6月期间接受MBS和随后FCP测试的患者。排除术前IBD患者。主要结果是确定相关结肠镜检查结果的最佳FCP临界值。次要结局包括中位FCP水平、结肠镜检查结果以及基于性别、手术类型和胃肠评估时间的亚组分析。结果:所有患者中位FCP水平为51µg/g (IQR 30-82)。124例接受结肠镜检查的患者中位FCP为61µg/g (IQR 34-104)。有(69.5µg/g, n = 50)或没有(59µg/g, n = 74)相关发现(包括恶性肿瘤或IBD)的患者之间无显著差异(p = 0.101)。基于胆囊切除术状态、胆管胰肢长度、手术类型、体重指数、MBS后就诊时间或使用质子泵抑制剂的亚组间FCP水平无显著差异。ROC分析确定最佳临界值为59.5µg/g(灵敏度:64.6%,特异性:63.4%,曲线下面积:0.653,约登指数0.280)。结论:MBS患者最佳FCP临界值为59.5µg/g。然而,考虑到较低的约登指数和与50 μ g/g的标准临界值相比的最小差异,维持这一标准在临床环境中似乎更实用。
{"title":"Fecal Calprotectin Levels in Post-Metabolic Bariatric Surgery Patients: A Retrospective Study.","authors":"Fenna M M Beeren, Britt Roosenboom, Marcel B W Spanier, Marcel J M Groenen, Peter D Siersema","doi":"10.1159/000548160","DOIUrl":"10.1159/000548160","url":null,"abstract":"<p><strong>Introduction: </strong>Fecal calprotectin (FCP) is a key biomarker for gastrointestinal inflammation, aiding in differentiating irritable bowel syndrome from active inflammatory bowel disease (IBD). Metabolic bariatric surgeries (MBSs), such as Roux-en-Y gastric bypass or sleeve gastrectomy, alter gastrointestinal physiology, potentially affecting the applicability of standard FCP cutoff values in this population.</p><p><strong>Methods: </strong>This retrospective study included 340 patients who underwent MBS and subsequent FCP testing between January 2000 and June 2024. Patients with preoperative IBD were excluded. The primary outcome was to identify the optimal FCP cutoff values for relevant colonoscopy findings. Secondary outcomes included median FCP levels, colonoscopy results, and subgroup analyses based on sex, surgery type, and time to gastrointestinal evaluation.</p><p><strong>Results: </strong>The median FCP level across all patients was 51 µg/g (IQR 30-82). Among 124 patients undergoing colonoscopy, the median FCP was 61 µg/g (IQR 34-104). There was no significant difference between patients with (69.5 µg/g, <i>n</i> = 50) or without (59 µg/g, <i>n</i> = 74) relevant findings, including malignancy or IBD (<i>p</i> = 0.101). No significant differences in FCP levels were observed between subgroups based on cholecystectomy status, biliopancreatic limb length, types of surgery, body mass index, time to presentation since MBS, or proton pump inhibitor use. ROC analysis identified an optimal cut off of 59.5 µg/g (sensitivity: 64.6%; specificity: 63.4%; area under the curve: 0.653; Youden's index 0.280).</p><p><strong>Conclusion: </strong>In patients following MBS, the optimal FCP cutoff value would be at 59.5 µg/g. However, given the low Youden's index and the minimal difference compared to the standard cutoff value of 50 µg/g, maintaining this standard, seems more practical in clinical settings.</p>","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"10 1","pages":"329-336"},"PeriodicalIF":0.0,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12659408/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145648499","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-15eCollection Date: 2025-01-01DOI: 10.1159/000548449
Abdullah D Alotaibi
Introduction: The association with Helicobacter pylori infection and inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), is conflicting, with the former studies reporting a protective effect while others report increased inflammation. This study examines the effect of H. pylori infection on systemic inflammation - C-reactive protein levels - among IBD patients.
Methods: This retrospective cross-sectional study was conducted at Imam Abdulrahman Bin Faisal University Hospital, Al Khobar, Saudi Arabia, by reviewing the electronic medical records of 630 patients diagnosed with H. pylori infection, CD, or UC from January 2020 to December 2024. The levels of CRP were measured with a turbidimetric immunoassay of high sensitivity and categorized as normal or less than or equal to 1 mg/dL, moderate with a value of 1-10 mg/dL, or raised if the value is above 10 mg/dL. Kruskal-Wallis and Mann-Whitney U tests were used for statistical comparisons of CRP levels between groups.
Results: Mean CRP levels were highest in H. pylori-positive CD patients (12.69 mg/dL), UC patients (11.18 mg/dL), compared to H. pylori-negative matches (6.74 mg/dL for CD and 4.55 mg/dL for UC). The H. pylori-only group had the lowest average in CRP (2.62 mg/dL). Differences in patient categories were significant (p < 0.001); CD had 50% cases with elevated CRP, 40% for UC, and 60% for moderate elevations in H. pylori-only patients.
Conclusion: H. pylori infection is also accompanied by higher systemic inflammation in IBD, specifically in CD, characterized by high CRP.
{"title":"C-Reactive Protein Levels in Patients with Isolated Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) and Coexisting <i>H. pylori</i> Infection and IBD: A Comparative Study.","authors":"Abdullah D Alotaibi","doi":"10.1159/000548449","DOIUrl":"10.1159/000548449","url":null,"abstract":"<p><strong>Introduction: </strong>The association with <i>Helicobacter pylori</i> infection and inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), is conflicting, with the former studies reporting a protective effect while others report increased inflammation. This study examines the effect of <i>H. pylori</i> infection on systemic inflammation - C-reactive protein levels - among IBD patients.</p><p><strong>Methods: </strong>This retrospective cross-sectional study was conducted at Imam Abdulrahman Bin Faisal University Hospital, Al Khobar, Saudi Arabia, by reviewing the electronic medical records of 630 patients diagnosed with <i>H. pylori</i> infection, CD, or UC from January 2020 to December 2024. The levels of CRP were measured with a turbidimetric immunoassay of high sensitivity and categorized as normal or less than or equal to 1 mg/dL, moderate with a value of 1-10 mg/dL, or raised if the value is above 10 mg/dL. Kruskal-Wallis and Mann-Whitney U tests were used for statistical comparisons of CRP levels between groups.</p><p><strong>Results: </strong>Mean CRP levels were highest in <i>H. pylori</i>-positive CD patients (12.69 mg/dL), UC patients (11.18 mg/dL), compared to <i>H. pylori</i>-negative matches (6.74 mg/dL for CD and 4.55 mg/dL for UC). The <i>H. pylori</i>-only group had the lowest average in CRP (2.62 mg/dL). Differences in patient categories were significant (<i>p</i> < 0.001); CD had 50% cases with elevated CRP, 40% for UC, and 60% for moderate elevations in <i>H. pylori</i>-only patients.</p><p><strong>Conclusion: </strong><i>H. pylori</i> infection is also accompanied by higher systemic inflammation in IBD, specifically in CD, characterized by high CRP.</p>","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"10 1","pages":"318-328"},"PeriodicalIF":0.0,"publicationDate":"2025-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12659158/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145648513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: Both mesalazine and ozanimod are oral treatment options for patients with moderately active ulcerative colitis (UC).
Methods: Comparative analysis comparing efficacy endpoints of an 8-week non-inferiority induction study (TP0503) with 3.2 g/day mesalazine (n = 321) to the True North 10-week induction study of 1 mg/day ozanimod (n = 281). We compared the efficacy of oral mesalazine (Asacol) as monotherapy and ozanimod (Zeposia) as add-on therapy to mesalazine, without concomitant corticosteroids, following induction treatment in mesalazine-exposed but immunomodulator- and advanced therapy-naïve UC patients. Endpoints from the non-inferiority study were re-calculated using the definitions from the True North study.
Results: The two cohorts had similar age (45 ± 14 years vs. 44 ± 13.5 years) and baseline disease severity (total Mayo score; 8.5 ± 0.8 vs. 8.6 ± 1.1) for mesalazine- and ozanimod-treated patients, respectively. No differences were observed in patients achieving clinical response (reduction from baseline in the 3-component Mayo score [sum of rectal bleeding subscore/RBS, stool frequency subscore/SFS, and Mayo endoscopic score/MES) of ≥2 points and ≥35%, and a reduction from baseline in the RBS of ≥1 point or an absolute RBS ≤1} (58% vs. 58%; p = 0.917) and clinical remission (RBS = 0, SFS ≤1 [and decreases of ≥1 point from baseline SFS], and MES ≤1) (22% vs. 28%; p = 0.074) treated with mesalazine (at 8 weeks) and ozanimod (at 10 weeks), respectively. A higher percentage of patients treated with ozanimod achieved endoscopic improvement (MES ≤1 without friability) compared to mesalazine (38% vs. 29%, p = 0.018).
Conclusion: Among individuals previously exposed to mesalazine, a similar effect on clinical efficacy was observed between patients treated with mesalazine and those treated with ozanimod.
{"title":"Comparative Efficacy of Mesalazine and Ozanimod following Induction Treatment in Mesalazine-Exposed Advanced Therapy-Naïve Adult Ulcerative Colitis Patients.","authors":"Geert D'Haens, Ekaterina Safroneeva, Laurent Peyrin-Biroulet, Silvio Danese, Vipul Jairath, Helen Thorne, Raphaël Laoun","doi":"10.1159/000548243","DOIUrl":"10.1159/000548243","url":null,"abstract":"<p><strong>Introduction: </strong>Both mesalazine and ozanimod are oral treatment options for patients with moderately active ulcerative colitis (UC).</p><p><strong>Methods: </strong>Comparative analysis comparing efficacy endpoints of an 8-week non-inferiority induction study (TP0503) with 3.2 g/day mesalazine (<i>n</i> = 321) to the True North 10-week induction study of 1 mg/day ozanimod (<i>n</i> = 281). We compared the efficacy of oral mesalazine (Asacol) as monotherapy and ozanimod (Zeposia) as add-on therapy to mesalazine, without concomitant corticosteroids, following induction treatment in mesalazine-exposed but immunomodulator- and advanced therapy-naïve UC patients. Endpoints from the non-inferiority study were re-calculated using the definitions from the True North study.</p><p><strong>Results: </strong>The two cohorts had similar age (45 ± 14 years vs. 44 ± 13.5 years) and baseline disease severity (total Mayo score; 8.5 ± 0.8 vs. 8.6 ± 1.1) for mesalazine- and ozanimod-treated patients, respectively. No differences were observed in patients achieving clinical response (reduction from baseline in the 3-component Mayo score [sum of rectal bleeding subscore/RBS, stool frequency subscore/SFS, and Mayo endoscopic score/MES) of ≥2 points and ≥35%, and a reduction from baseline in the RBS of ≥1 point or an absolute RBS ≤1} (58% vs. 58%; <i>p</i> = 0.917) and clinical remission (RBS = 0, SFS ≤1 [and decreases of ≥1 point from baseline SFS], and MES ≤1) (22% vs. 28%; <i>p</i> = 0.074) treated with mesalazine (at 8 weeks) and ozanimod (at 10 weeks), respectively. A higher percentage of patients treated with ozanimod achieved endoscopic improvement (MES ≤1 without friability) compared to mesalazine (38% vs. 29%, <i>p</i> = 0.018).</p><p><strong>Conclusion: </strong>Among individuals previously exposed to mesalazine, a similar effect on clinical efficacy was observed between patients treated with mesalazine and those treated with ozanimod.</p>","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"10 1","pages":"337-346"},"PeriodicalIF":0.0,"publicationDate":"2025-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12659452/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145648426","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}