Inflammatory Bowel Diseases最新文献

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Comparative Effectiveness of Ozanimod and Vedolizumab as First-Line Advanced Therapies in Ulcerative Colitis: A Propensity-Matched Cohort Analysis. 奥扎莫德和维多珠单抗作为溃疡性结肠炎一线晚期疗法的疗效比较:倾向匹配队列分析》。
IF 4.5 3区 医学
Inflammatory Bowel Diseases Pub Date : 2025-07-07 DOI: 10.1093/ibd/izae251
Gursimran S Kochhar, Himsikhar Khataniar, Jana G Hashash, Fjona Tabaku, Miguel Regueiro, Francis A Farraye, Aakash Desai
{"title":"Comparative Effectiveness of Ozanimod and Vedolizumab as First-Line Advanced Therapies in Ulcerative Colitis: A Propensity-Matched Cohort Analysis.","authors":"Gursimran S Kochhar, Himsikhar Khataniar, Jana G Hashash, Fjona Tabaku, Miguel Regueiro, Francis A Farraye, Aakash Desai","doi":"10.1093/ibd/izae251","DOIUrl":"10.1093/ibd/izae251","url":null,"abstract":"<p><strong>Introduction: </strong>There is limited real-world evidence comparing the effectiveness of ozanimod to vedolizumab as first-line advanced therapies in patients with ulcerative colitis (UC).</p><p><strong>Methods: </strong>We conducted a retrospective cohort study using TriNetX, a multi-institutional US database in adults with UC who were initiated on ozanimod compared to vedolizumab between January 1, 2021 and 22 June, 2024. The primary outcome was to compare the risk of a composite outcome of corticosteroid use, colectomy, or change to another advanced therapy between the 2 cohorts within 12 months. 1:1 propensity score matching (PSM) was performed for demographics, comorbid conditions, disease extent, laboratory parameters, and previous corticosteroid use. The risk was expressed as an adjusted odds ratio (aOR) with 95% CIs.</p><p><strong>Results: </strong>We identified 222 patients in the ozanimod cohort (mean age 41.2 ± 15.7, 46.3% male sex, 68% White, and 22.5% ulcerative proctitis), and 4145 patients in the vedolizumab cohort (mean age 47.4 ± 18.3, 45.2% male sex, 69.7% White, and 17.2% ulcerative proctitis). After PSM, there was no significant difference in the risk of the composite outcome (aOR 0.92, 95% CI, 0.63-1.36) and corticosteroid use (aOR 0.80, 95% CI, 0.53-1.18) between the 2 cohorts within 12 months. There was a higher risk of change in therapy in the ozanimod cohort (aOR 1.95, 95% CI, 1.09-3.49) compared to the vedolizumab cohort. Colectomy rates were low in both cohorts (<0.04%).</p><p><strong>Conclusions: </strong>Our real-world study showed that ozanimod use is associated with similar corticosteroid use but higher odds of a change in therapy compared to vedolizumab when used as first-line therapy in patients with UC. Further prospective studies are needed to understand long-term outcomes.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"1868-1875"},"PeriodicalIF":4.5,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545238","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
Biologics and Oral Small Molecules Are Not Associated With Increased Major Adverse Cardiovascular Events or Venous Thromboembolism in Inflammatory Bowel Disease. 生物制剂和口服小分子药物与炎症性肠病主要不良心血管事件或静脉血栓栓塞的增加无关。
IF 4.5 3区 医学
Inflammatory Bowel Diseases Pub Date : 2025-07-07 DOI: 10.1093/ibd/izae267
Thabet Qapaja, Mohammed Abu-Rumaileh, Khaled Alsabbagh Alchirazi, Ahmad Gharaibeh, Ahmad Naser, Osama Hamid, Dina Alayan, Miguel Regueiro
{"title":"Biologics and Oral Small Molecules Are Not Associated With Increased Major Adverse Cardiovascular Events or Venous Thromboembolism in Inflammatory Bowel Disease.","authors":"Thabet Qapaja, Mohammed Abu-Rumaileh, Khaled Alsabbagh Alchirazi, Ahmad Gharaibeh, Ahmad Naser, Osama Hamid, Dina Alayan, Miguel Regueiro","doi":"10.1093/ibd/izae267","DOIUrl":"10.1093/ibd/izae267","url":null,"abstract":"<p><strong>Background: </strong>Biologics and oral small molecules (OSM) effectively treat inflammatory bowel disease (IBD), but some are linked to higher risks of major adverse cardiovascular events (MACE) and venous thromboembolism (VTE). This study evaluates the MACE and VTE risks in IBD patients treated with biologics or OSM.</p><p><strong>Methods: </strong>Using the TrinNetX multi-institutional database, we examined MACE and VTE in adult IBD patients on biologics and compared them to IBD patients not on biologics. We also compared IBD patients on OSM to those not on OSM. We performed 1:1 propensity score matching. MACE (myocardial infarction [MI], stroke, and all-cause mortality) and VTE were assessed from 30 days to 3 years after drug prescription.</p><p><strong>Results: </strong>After matching, IBD patients on biologics had reduced risk of MI, stroke, and all-cause mortality at 1 year, compared to those not on biologics (P < .05). No significant difference in VTE was observed (P = .5). At 3 years, biologic-treated patients had lower risks of MI, stroke, all-cause mortality, and VTE (P < .05). Inflammatory bowel disease patients on OSM showed no significant differences in MI, stroke, or VTE at 1 and 3 years, but had lower all-cause mortality (P < .05). In older IBD patients with at least 1 cardiovascular risk factor, OSM usage showed no significant difference in MI, stroke, or VTE risk compared to nonusers; however, all-cause mortality was decreased at 3 years (P < .05).</p><p><strong>Conclusions: </strong>Inflammatory bowel disease patients treated with biologics or OSM were not at increased risk of MACE or VTE. Although further studies and longer follow-up periods are needed to confirm these findings, our results provide reassurance regarding the safety of these medications in IBD.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"1910-1916"},"PeriodicalIF":4.5,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142619640","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
Autologous Microfragmented Adipose Tissue Injection in Refractory Complex Crohn's Perianal Fistulas: Long-Term Results at 6.7 Years Mean Follow-up. 自体微碎片脂肪组织注射治疗难治性复杂克罗恩病肛周瘘:平均随访 6.7 年的长期结果。
IF 4.5 3区 医学
Inflammatory Bowel Diseases Pub Date : 2025-07-07 DOI: 10.1093/ibd/izae283
Silvio Laureti, Alberta Cappelli, Claudio Isopi, Lorenzo Gentilini, Riccardo Villani, Gioia Sorbi, Fernando Rizzello, Alessandra Menon, Nikolas Konstantine Dussias, Paolo Gionchetti, Gilberto Poggioli
{"title":"Autologous Microfragmented Adipose Tissue Injection in Refractory Complex Crohn's Perianal Fistulas: Long-Term Results at 6.7 Years Mean Follow-up.","authors":"Silvio Laureti, Alberta Cappelli, Claudio Isopi, Lorenzo Gentilini, Riccardo Villani, Gioia Sorbi, Fernando Rizzello, Alessandra Menon, Nikolas Konstantine Dussias, Paolo Gionchetti, Gilberto Poggioli","doi":"10.1093/ibd/izae283","DOIUrl":"10.1093/ibd/izae283","url":null,"abstract":"<p><strong>Background: </strong>Nowadays, there is a clear need for new viable therapeutic options to face complex perianal Crohn's disease (PCD). Results of our previous pilot study demonstrated the efficacy and safety of local injection of autologous microfragmented adipose tissue (MFat) in this setting. This study aims to evaluate the long-term follow-up results in the same cohort of patients.</p><p><strong>Methods: </strong>Data on clinical and radiological remission and surgical recurrence rates were prospectively collected on the 15 patients with complex fistulizing PCD refractory to combined bio-surgical therapy, originally treated with local MFat injection, with a mean 6.7 years follow-up.</p><p><strong>Results: </strong>In our previous study, at 24-week follow-up, combined remission was reported in 66.7% of patients, while clinical remission was achieved in 93% of cases. At a 6.7-year follow-up, 9 of the 10 healed patients maintained remission. The patient with recurrence was successfully reoperated. Three out of 5 patients who failed primary combined remission were retreated, with 2 obtaining combined remission and 1 failing. One patient refused any subsequent treatment due to good quality of life. The last patient presented delayed healing at a 1-year follow-up. Overall success rate after rescue therapy at the final follow-up reached 86.6%. Safety was maintained throughout all follow-up periods.</p><p><strong>Conclusions: </strong>This is the longest follow-up published trial on MFat injection for PCD. Our results show that patients who achieved closure in the first 24 weeks sustained response at long-term evaluation. In addition, there may be a rationale in repeating treatment as rescue therapy in not responding to patients.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"1943-1951"},"PeriodicalIF":4.5,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142828442","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
Reply: Extraintestinal Manifestations in Patients With Ulcerative Colitis Post-Restorative Proctocolectomy and Ileal Pouch-Anal Anastomosis. 回复:溃疡性结肠炎恢复性直结肠切除术和回肠袋肛管吻合术后的肠外表现。
IF 4.5 3区 医学
Inflammatory Bowel Diseases Pub Date : 2025-07-07 DOI: 10.1093/ibd/izaf091
Alex Barenboim, Nitsan Maharshak
{"title":"Reply: Extraintestinal Manifestations in Patients With Ulcerative Colitis Post-Restorative Proctocolectomy and Ileal Pouch-Anal Anastomosis.","authors":"Alex Barenboim, Nitsan Maharshak","doi":"10.1093/ibd/izaf091","DOIUrl":"10.1093/ibd/izaf091","url":null,"abstract":"","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"2052-2053"},"PeriodicalIF":4.5,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144010245","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
Association Between Maternal Infections in Pregnancy and the Risk of Inflammatory Bowel Disease in the Offspring: Findings From Two Scandinavian Birth Cohorts. 妊娠期母体感染与后代患炎症性肠病风险之间的关系:两个斯堪的纳维亚出生队列的研究结果。
IF 4.5 3区 医学
Inflammatory Bowel Diseases Pub Date : 2025-07-07 DOI: 10.1093/ibd/izae209
Annie Guo, Johnny Ludvigsson, Tereza Lerchova, Henrik Imberg, Ketil Størdal, Karl Mårild
{"title":"Association Between Maternal Infections in Pregnancy and the Risk of Inflammatory Bowel Disease in the Offspring: Findings From Two Scandinavian Birth Cohorts.","authors":"Annie Guo, Johnny Ludvigsson, Tereza Lerchova, Henrik Imberg, Ketil Størdal, Karl Mårild","doi":"10.1093/ibd/izae209","DOIUrl":"10.1093/ibd/izae209","url":null,"abstract":"<p><strong>Background: </strong>The association of infections and antibiotic use in pregnancy and the risk of inflammatory bowel disease (IBD) development in the offspring have been scarcely investigated. We examined infection and antibiotic use in pregnancy and the risk of IBD in offspring.</p><p><strong>Methods: </strong>We followed participants from the All Babies in Southeast Sweden (ABIS) and the Norwegian mother father and child cohort (MoBa) from birth (1997-2009) until 2020-2021. IBD diagnosis was classified as ≥2 records in national registers. Information on infections (any, gastrointestinal, and respiratory), their timing (early or late in pregnancy), and antibiotic use in pregnancy were collected from questionnaires. Cox proportional-hazard regression and meta-analytic methods were used to estimate pooled adjusted hazard ratios (aHRs) for IBD and its subtypes, adjusted for parental IBD, maternal smoking, and education. Sensitivity analyses accounted for exposure to antibiotics and infections 0-12 months of age.</p><p><strong>Results: </strong>We followed 117 493 children for 2 024 299 person-years (follow-up 22.3 years in ABIS and 16.4 years in MoBa), including 451 IBD cases. The aHRs for any infection and respiratory infections in pregnancy and offspring IBD were close to one (aHR = 0.99 [95% CI = 0.73-1.33] and aHR = 1.00 [95% CI = 0.81-1.23], respectively). However, any versus no infection in early pregnancy was associated with IBD development (aHR = 1.26 [95% CI = 1.02-1.55]), particularly Crohn's disease (CD; aHR = 1.40 [95% CI = 1.01-1.93]). Any versus no gastrointestinal infection in late pregnancy was associated with offspring CD (aHR = 1.95 [95% CI = 1.34-2.84]). Antibiotic use in pregnancy was not associated with IBD in the child (aHR = 1.15 [95% CI = 0.93-1.44]).</p><p><strong>Conclusions: </strong>In this binational birth cohort study, the risk of offspring IBD varied by infection type and timing but not with maternal antibiotic use in pregnancy.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"1761-1771"},"PeriodicalIF":4.5,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12235132/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142153897","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
Screen Failures and Causes in Inflammatory Bowel Disease Randomized Controlled Trials: A Study of 16 913 Screened Patients. 炎症性肠病随机对照试验中筛查失败及其原因:16 913 名筛查患者的研究。
IF 4.5 3区 医学
Inflammatory Bowel Diseases Pub Date : 2025-07-07 DOI: 10.1093/ibd/izae233
Mathieu Uzzan, Georgi Georgiev, Laurent Peyrin-Biroulet, Yoram Bouhnik, Neeraj Narula, Vipul Jairath, Ryan Ungaro, Johan Burisch, Julien Kirchgesner, Bram Verstockt, Fez Hussain, Walter Reinisch
{"title":"Screen Failures and Causes in Inflammatory Bowel Disease Randomized Controlled Trials: A Study of 16 913 Screened Patients.","authors":"Mathieu Uzzan, Georgi Georgiev, Laurent Peyrin-Biroulet, Yoram Bouhnik, Neeraj Narula, Vipul Jairath, Ryan Ungaro, Johan Burisch, Julien Kirchgesner, Bram Verstockt, Fez Hussain, Walter Reinisch","doi":"10.1093/ibd/izae233","DOIUrl":"10.1093/ibd/izae233","url":null,"abstract":"<p><strong>Introduction: </strong>While recruitment rates in inflammatory bowel disease (IBD) trials are continuously decreasing, the underlying reasons are likely multifactorial but remain poorly defined. Screen failure (SF) proportions and causes have not been extensively explored in IBD.</p><p><strong>Aim: </strong>We assessed SF proportions and underlying SF reasons in IBD phase 2 and 3 clinical trials.</p><p><strong>Methods: </strong>We analyzed SF-related data from 17 randomized controlled phase 2 or 3 IBD trials. Twelve trials were in ulcerative colitis (UC) and 5 trials were in Crohn's disease (CD) operated by a single contract research organization, IQVIA. Differences between patient groups were tested for significance by Mann-Whitney and Fisher's tests when appropriate.</p><p><strong>Results: </strong>We analyzed a total of 11 161 patients with UC and 5752 patients with CD. The mean SF proportion was 0.43 per trial in UC. The primary reason for SFs in UC was not meeting the overall (modified) Mayo score inclusion threshold and/or the endoscopic subscore of at least 2 (33.8% of all SF). In CD clinical trials, the mean SF proportion was at 0.53. The primary cause for SFs was not meeting the CDAI eligibility criteria (23.1% of all SFs). SF proportions were significantly higher in CD versus UC trials (P = .027). Clostridium difficile or any other intestinal infection and not meeting tuberculosis screening criteria were other major reasons for SFs both in UC and CD.</p><p><strong>Conclusion: </strong>High SF proportion in IBD clinical trials, particularly for CD studies, pose obstacles to patient recruitment. While underlying causes are diverse, arbitrarily defined clinical and/or endoscopic eligibility criteria remain the major limiting factors.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"1811-1818"},"PeriodicalIF":4.5,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142345992","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
The Bidirectional Relationship Between Sleep and Pain in Crohn's Disease: A Daily Diary Study. 克罗恩病患者睡眠与疼痛之间的双向关系:每日日记研究
IF 4.5 3区 医学
Inflammatory Bowel Diseases Pub Date : 2025-07-07 DOI: 10.1093/ibd/izae265
Jessica K Salwen-Deremer, Sarah J Westvold, Corey A Siegel, Michael T Smith
{"title":"The Bidirectional Relationship Between Sleep and Pain in Crohn's Disease: A Daily Diary Study.","authors":"Jessica K Salwen-Deremer, Sarah J Westvold, Corey A Siegel, Michael T Smith","doi":"10.1093/ibd/izae265","DOIUrl":"10.1093/ibd/izae265","url":null,"abstract":"<p><strong>Background: </strong>Pain is common in Crohn's disease (CD) even after endoscopic healing is achieved. Depression, sleep disturbances, fatigue, and worry about pain impact the pain experience. There is a bidirectional relationship between sleep and pain, though it has received minimal attention in CD. Herein, we sought to comprehensively assess this relationship in CD using daily diaries.</p><p><strong>Method: </strong>Patients with active symptoms of insomnia and CD were recruited as part of an ongoing clinical trial. Participants completed 14-day diaries on sleep patterns and CD symptoms. Temporal associations between sleep and pain were assessed using cross-lagged path analysis and controlled for age, sex, and menstrual cycle.</p><p><strong>Results: </strong>Overall, 26 participants completed 14-day diaries. All assessed aspects of sleep continuity disturbance were associated with worse next-day abdominal pain (Ps < 0.01). When assessed microlongitudinally, sleep onset latency predicted next-day pain (P = 0.07) and vice versa (P = 0.03). Similarly, nightly awakenings predicted next day pain (P = 0.02) and vice versa (P = 0.04). Sleep efficiency (P = 0.003), sleep quality (P < 0.001), and total sleep time (P = 0.04) predicted next-day pain whereas models with pain as the predictor were not significant.</p><p><strong>Conclusions: </strong>Sleep continuity and abdominal pain are closely related, with sleep efficiency, total sleep time, and sleep quality potentially driving next-day abdominal pain. As interventions for pain in IBD are limited, it may be important to capitalize on the impact of sleep disturbances on pain to optimize overall wellbeing in people with CD.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"1926-1933"},"PeriodicalIF":4.5,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12235134/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142619703","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
Three-Year Efficacy and Safety of Mirikizumab Following 152 Weeks of Continuous Treatment for Ulcerative Colitis: Results From the LUCENT-3 Open-Label Extension Study. 米利珠单抗持续治疗溃疡性结肠炎 152 周后的三年疗效和安全性:LUCENT-3开放标签扩展研究的结果。
IF 4.5 3区 医学
Inflammatory Bowel Diseases Pub Date : 2025-07-07 DOI: 10.1093/ibd/izae253
Bruce E Sands, Geert D'Haens, David B Clemow, Peter M Irving, Jordan T Johns, Theresa Hunter Gibble, Maria T Abreu, Scott D Lee, Tadakazu Hisamatsu, Taku Kobayashi, Marla C Dubinsky, Severine Vermeire, Corey A Siegel, Laurent Peyrin-Biroulet, Richard E Moses, Joe Milata, Remo Panaccione, Axel Dignass
{"title":"Three-Year Efficacy and Safety of Mirikizumab Following 152 Weeks of Continuous Treatment for Ulcerative Colitis: Results From the LUCENT-3 Open-Label Extension Study.","authors":"Bruce E Sands, Geert D'Haens, David B Clemow, Peter M Irving, Jordan T Johns, Theresa Hunter Gibble, Maria T Abreu, Scott D Lee, Tadakazu Hisamatsu, Taku Kobayashi, Marla C Dubinsky, Severine Vermeire, Corey A Siegel, Laurent Peyrin-Biroulet, Richard E Moses, Joe Milata, Remo Panaccione, Axel Dignass","doi":"10.1093/ibd/izae253","DOIUrl":"10.1093/ibd/izae253","url":null,"abstract":"<p><strong>Background: </strong>Mirikizumab, a p19-directed interleukin-23 monoclonal antibody, has demonstrated induction of clinical remission at week 12 with maintenance through week 104 in patients with moderately-to-severely active ulcerative colitis (UC). Results are presented from the LUCENT-3 open-label extension study through week 152.</p><p><strong>Methods: </strong>Of 868 LUCENT clinical trial program mirikizumab-treated induction patients, 544 were responders of whom 365 were rerandomized to mirikizumab maintenance. Of these, 324 completed week 52 and 316 entered extension treatment (286 week 52 responders; 179 week 52 remitters). Efficacy and safety outcomes are reported for mirikizumab-treated LUCENT-3 participants, including biologic-failed patients, with data for week 52 maintenance responders/remitters. Discontinuations or missing data were handled by nonresponder imputation, modified nonresponder imputation (mNRI), and observed cases.</p><p><strong>Results: </strong>Using mNRI, 81.6% of week 52 responders demonstrated clinical response at week 152. Week 152 remission rates for week 52 responders included clinical (56.1%), corticosteroid-free (CSF; 54.5%), endoscopic (61.0%), histologic-endoscopic mucosal remission (HEMR; 52.6%), symptomatic (74.9%), and bowel urgency (BU; 58.6%). At week 152, 53.3% of week 52 responders achieved histologic-endoscopic mucosal improvement (HEMI) and 74.3% achieved BU clinically meaningful improvement (CMI). Among week 52 remitters, 85.4% showed a clinical response at week 152, with clinical (70.1%), CSF (68.9%), endoscopic (72.0%), HEMR (63.4%), symptomatic (81.4%), and BU (60.8%) remission. At week 152, among week 52 remitters, 64.0% of patients achieved HEMI and 75.6% achieved BU CMI. Stool frequency, rectal bleeding, BU, and abdominal pain score reductions from induction baseline to maintenance week 52 were sustained through week 152 for week 52 completers. Overall, in the safety population, 7.4% of patients reported severe adverse events (AEs); 5.3% discontinued treatment due to AEs. AEs of special interest included opportunistic infection (1.8%), hepatic disorders (3.2%), cerebrocardiovascular events (1.5%), and malignancy (0.3%). Patients with antidrug antibodies reduced over time from 23.6% in year 1 to 3.2% in year 3.</p><p><strong>Conclusions: </strong>Symptomatic, clinical, endoscopic, histologic, and quality-of-life outcomes support long-term sustained benefit of mirikizumab treatment up to 152 weeks in patients with UC, including biologic-failed patients, with no new safety concerns.</p><p><strong>Clinical trial registry: </strong>ClinicalTrials.gov: NCT03518086; NCT03524092; NCT03519945.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"1876-1890"},"PeriodicalIF":4.5,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12235137/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142499653","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
The Impact of Hormone Therapy on Inflammatory Bowel Disease in Transgender and Nonbinary Individuals. 激素疗法对变性人和非二元个体炎症性肠病的影响。
IF 4.5 3区 医学
Inflammatory Bowel Diseases Pub Date : 2025-07-07 DOI: 10.1093/ibd/izae236
Bashar Hassan, Andrew Suchan, Madyson Brown, Arman Kishan, Fan Liang, Brindusa Truta
{"title":"The Impact of Hormone Therapy on Inflammatory Bowel Disease in Transgender and Nonbinary Individuals.","authors":"Bashar Hassan, Andrew Suchan, Madyson Brown, Arman Kishan, Fan Liang, Brindusa Truta","doi":"10.1093/ibd/izae236","DOIUrl":"10.1093/ibd/izae236","url":null,"abstract":"<p><strong>Background: </strong>Inflammatory bowel disease (IBD) is a global healthcare problem that affects around 3 million people in the United States. Although the impact of gender-affirming hormone therapy (GAHT) on IBD severity has been studied in cisgender patients, there is currently no literature on the impact of exogenous hormone therapy (HT) in transgender and nonbinary (TGNB) individuals.</p><p><strong>Methods: </strong>We conducted a retrospective chart review of TGNB adults diagnosed with IBD and treated with HT for gender dysphoria at Johns Hopkins Hospital (2015-2022). We aimed to determine whether the use of GAHT was associated with subsequent increase in IBD severity. We compared the incidence of flares before vs after GAHT.</p><p><strong>Results: </strong>Twenty-two patients were analyzed. More than half (59%) of them were assigned female at birth, identified as transmen, and underwent masculinizing HT. Their median (interquartile range) age was 30 (25-36) years. More patients had Crohn's disease compared with ulcerative colitis (13 [59.1%] vs 9 [40.9%], P = .23) with a median IBD duration of 6.2 (1.8-12.3) years. Nine (41%) patients were on biologics. Of 15 patients on HT, 8 (36.3%) experienced at least one flare. Most of them were treated with steroids (66.7%), and 6 (40%) required hospital or emergency room admission. The proportion of patients who flared after GAHT was similar to that before GAHT: 9 (60%) vs 8 (53.3%), P = 1.0.</p><p><strong>Conclusions: </strong>GAHT was not associated with increased incidence of flares. Larger prospective randomized studies are needed to confirm our findings and understand the interaction between GAHT and IBD in TGNB individuals.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"1833-1840"},"PeriodicalIF":4.5,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142464339","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
Myosteatosis Evaluated Based on Intramuscular Adipose Tissue Content Is a Risk Factor for Postoperative Complications in Crohn's Disease. 根据肌内脂肪组织含量评估的肌骨肥大症是克罗恩病术后并发症的风险因素。
IF 4.5 3区 医学
Inflammatory Bowel Diseases Pub Date : 2025-07-07 DOI: 10.1093/ibd/izae247
Tadahiro Kojima, Kiyotaka Kurachi, Kyota Tatsuta, Kosuke Sugiyama, Toshiya Akai, Kakeru Torii, Mayu Sakata, Yoshifumi Morita, Hirotoshi Kikuchi, Yoshihiro Hiramatsu, Hiroya Takeuchi
{"title":"Myosteatosis Evaluated Based on Intramuscular Adipose Tissue Content Is a Risk Factor for Postoperative Complications in Crohn's Disease.","authors":"Tadahiro Kojima, Kiyotaka Kurachi, Kyota Tatsuta, Kosuke Sugiyama, Toshiya Akai, Kakeru Torii, Mayu Sakata, Yoshifumi Morita, Hirotoshi Kikuchi, Yoshihiro Hiramatsu, Hiroya Takeuchi","doi":"10.1093/ibd/izae247","DOIUrl":"10.1093/ibd/izae247","url":null,"abstract":"<p><strong>Background: </strong>Crohn's disease causes acute and chronic inflammation that often make the preoperative evaluation of surgical risks difficult. Myosteatosis is used for the evaluation of muscle quality to assess sarcopenia. However, data on the relationship between myosteatosis and surgical outcomes in patients with Crohn's disease are lacking.</p><p><strong>Methods: </strong>Among patients with Crohn's disease who underwent surgery between 2007 and 2022, we investigated the impact of myosteatosis on postoperative complications using intramuscular adipose tissue content (IMAC). Our study included data from 97 patients who underwent analysis for cutoff values and factors associated with IMAC and 72 who underwent analysis for risk factors of postoperative complications.</p><p><strong>Results: </strong>Body mass index (BMI; P < .001) and visceral adipose tissue/height index (P < .001) were significantly correlated with IMAC. High BMI (P < .001) and a history of abdominal surgery for Crohn's disease (P = .012) were identified as factors affected with high IMAC. Multivariate analysis revealed high IMAC and external fistulas as independent risk factors for postoperative complications (odds ratio [OR], 5.010; 95% CI, 1.300-19.30; P = .019 and OR, 7.850; 95% CI, 1.640-37.50; P = .010, respectively), especially infectious complications.</p><p><strong>Conclusions: </strong>This study established IMAC as a valuable marker for sarcopenic obesity and predicting postoperative complications in patients with Crohn's disease. Furthermore, evaluating myosteatosis using IMAC will facilitate the decision of the optimal timing of surgery, prediction of complications, and treatment of sarcopenia in patients with Crohn's disease.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"1851-1860"},"PeriodicalIF":4.5,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142619696","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
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