Journal of Crohn's & colitis最新文献

{"title":"MR Cell Size Imaging Revealing Intestinal Fibrosis to Predict Intestinal Disease Progression in Patients with Crohn's Disease.","authors":"Xinyue Wang, Li Huang, Shaochun Lin, Xiaodi Shen, Qingzhu Zheng, Ruonan Zhang, Yangdi Wang, Luyao Wu, Yaoqi Ke, Xiaomin Wu, Zhoulei Li, Zhenpeng Peng, Canhui Sun, Ren Mao, Shi-Ting Feng, Xuehua Li","doi":"10.1093/ecco-jcc/jjaf119","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjaf119","url":null,"abstract":"<p><strong>Background: </strong>Intestinal fibrosis in Crohn's disease (CD) is driven by mesenchymal cell activation, resulting in adverse outcomes. We aimed to evaluate the efficacy of time-dependent diffusion MRI (TD-dMRI) in characterizing fibrosis-associated cellular properties and predicting disease progression in CD.</p><p><strong>Methods: </strong>This prospective study enrolled 145 CD patients undergoing TD-dMRI to map fibrotic cellular characteristics (e.g., cell diameter [d]). The performance of TD-dMRI was evaluated in surgical cohort 1 (31 patients, 63 specimens) based on myofibroblasts/fibroblasts-area-ratio from immunohistochemical staining, and further validated in surgical cohort 2 (21 patients, 25 specimens) using vimentin+ cells diameter from immunofluorescent staining. A follow-up cohort of 93 patients with different baseline mesenchymal cell phenotypes characterized by TD-dMRI parameter was monitored for disease progression.</p><p><strong>Results: </strong>TD-dMRI-derived d correlated strongly with myofibroblasts/fibroblasts-area-ratio in surgical cohort 1 (r=0.58; P<0.001) and with vimentin+ cells diameter (r=0.70; P<0.001) in surgical cohort 2. d was the most discriminative parameter for distinguishing diseased and normal samples (AUC=0.86; P < 0.001), with d≥11 μm indicating profibrotic mesenchymal cell activation state. In all cohorts, d correlated positively with wall thickness and negatively with the narrowest lumen diameter and stenosis index (|r|=0.43∼0.51, all P<0.001). CD patients with d≥11 μm exhibited higher disease progression rate (33% vs. 7%; P=0.008) and shorter disease-progression-free survival (P=0.003) than those with d<11 μm. Moreover, d was the most prominent predictor for disease progression (HR: 1.3; P<0.001).</p><p><strong>Conclusions: </strong>TD-dMRI-derived d serves as a noninvasively microstructural biomarker for intestinal fibrosis in CD, which significantly enhances the accuracy in predicting disease progression risk.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144585899","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Recombinant Herpes Zoster Vaccine Lowers Shingles Complication Risk in Patients with Inflammatory Bowel Disease.","authors":"Yichen Wang, Yuting Huang, Jana Al Hashash, Tarek Odah, Mary Hayney, Freddy Caldera, Francis A Farraye","doi":"10.1093/ecco-jcc/jjaf116","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjaf116","url":null,"abstract":"<p><strong>Background: </strong>Patients with inflammatory bowel disease (IBD) are at increased risk of herpes zoster (HZ) due to innate immune abnormalities in patients with IBD and use of immunosuppressive therapy. The recombinant zoster vaccine (RZV) is recommended, but its efficacy in preventing recurrent HZ among patients with IBD is not well established.</p><p><strong>Methods: </strong>Using data from the TriNetX Linked Network, we conducted a retrospective cohort study of adults (≥18 years) with IBD and a prior uncomplicated HZ episode. Patients with IBD who received RZV were propensity score-matched 1:1 with those who did not. The primary outcome was subsequent HZ complications. Secondary outcomes included subtypes of HZ complications and recurrent uncomplicated HZ. Hazard ratios (HRs) and 95% CIs were estimated via Cox proportional hazards models.</p><p><strong>Results: </strong>After matching, 1,260 vaccinated and 1,260 unvaccinated patients with IBD were included. Compared to the unvaccinated cohort, patients receiving RZV had a significantly reduced incidence of HZ complications (7.4% vs. 14.5%; HR, 0.75; 95% CI, 0.58-0.97; p = 0.028). Postherpetic neuralgia was notably decreased (5.8% vs. 12.5%; HR, 0.66; p = 0.010), and no central nervous system involvement occurred among vaccinated patients. Protective effects were more pronounced in patients with ulcerative colitis, females, and those not receiving immunosuppressive therapy.</p><p><strong>Conclusions: </strong>RZV substantially lowers the risk of HZ complications in patients with IBD, offering significant clinical benefits to those at high risk due to immunosuppression. These findings underscore the importance of RZV as part of preventive care strategies in patients with IBD.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144585900","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tofacitinib Versus Vedolizumab Among Bio-naive Patients With Ulcerative Colitis: A Real-World Propensity-Weighted Comparison.","authors":"Beatriz Gros, Nathan Constantine-Cooke, Jake Kennedy, Alexander T Elford, Claire O'Hare, Colin Noble, Gareth-Rhys Jones, Ian D Arnott, Charlie W Lees, Nikolas Plevris","doi":"10.1093/ecco-jcc/jjae188","DOIUrl":"10.1093/ecco-jcc/jjae188","url":null,"abstract":"<p><strong>Background and aims: </strong>Over the last decade, treatment options for moderate-to-severe ulcerative colitis (UC) have expanded. However, comparative studies between these agents are limited, especially among biologic-naive patients. We aimed to compare the persistence, effectiveness, and safety of tofacitinib and vedolizumab as the first advanced treatment for patients with UC.</p><p><strong>Methods: </strong>Patients who received either tofacitinib or vedolizumab as their first advanced therapy for UC in NHS Lothian were included. We used inverse probability of treatment weighting. The probability of treatment assignment was calculated via logistic regression using age, sex, UC duration, Montreal extent, C-reactive protein, concomitant corticosteroids, and partial Mayo score at drug commencement.</p><p><strong>Results: </strong>We included n = 158 patients, of whom n = 81 (51.3%) received vedolizumab and n = 77 (48.7%) tofacitinib. Median follow-up for vedolizumab patients was 3.1 years (interquartile range [IQR] 1.6-4.8) and for tofacitinib patients 1.5 years (IQR 0.3-2.3). The cohort was 59.5% male with a median age of 41.1 years (IQR 31.5-51.8). At 2 years, vedolizumab persistence was superior to tofacitinib (p = 0.005). At Weeks 12 and 52, clinical, biochemical, and fecal biomarker steroid-free remission were comparable between groups. Primary nonresponse and secondary loss of response were 9.9% and 17.3% for vedolizumab and 23.4% and 13% for tofacitinib, respectively. The frequency of adverse events was comparable (11 [13.6%] vedolizumab vs 19 [24.7%] tofacitinib, p = 0.629).</p><p><strong>Conclusions: </strong>We found that the persistence and tolerability of vedolizumab were superior to tofacitinib in bio-naive UC, although the rates of clinical and biomarker remission were comparable. These data may help inform the positioning of advanced therapy.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12260496/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142808901","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}

{"title":"Endo-Histo foundational fusion model: a novel artificial intelligence for assessing histologic remission and response to therapy in ulcerative colitis clinical trial.","authors":"Marietta Iacucci, Giovanni Santacroce, Pablo Meseguer, Alejandro Diéguez, Rocio Del Amor, Bisi Bode Kolawole, Ujwala Chaudhari, Irene Zammarchi, Brian Hayes, Rory Crotty, Davide Zardo, Yasuharu Maeda, Miguel Puga-Tejada, Ilaria Ditonno, Valentina Vadori, Louise Burke, Ferdinando D'Amico, Subrata Ghosh, Enrico Grisan, Valery Naranjo","doi":"10.1093/ecco-jcc/jjaf108","DOIUrl":"10.1093/ecco-jcc/jjaf108","url":null,"abstract":"<p><strong>Background and aims: </strong>Artificial intelligence (AI)-enabled endoscopy and histology offer accurate, objective, and rapid assessment of disease activity in ulcerative colitis (UC). Emerging multi-source AI models may enhance standardized disease evaluation and outcome prediction. This investigation aimed to develop a novel AI model fusing endoscopic and histologic features to improve the assessment of disease remission and response to therapy in UC clinical trials.</p><p><strong>Methods: </strong>A novel multimodal AI model was developed that fuses endoscopic videos and histologic whole-slide images from a Phase 2 clinical trial of Mirikizumab in UC (NCT02589665). Informative endoscopic frames were predicted using convolutional neural networks and processed with BioMedCLIP, while histologic features were extracted using the CONCH foundational model. Multimodal features were then integrated via multi-head self-attention to generate a patient-level assessment. Model performance for assessing histologic remission (HR) and treatment response at weeks 12 and 52, based on histologic endpoints, was evaluated by cross-validation.</p><p><strong>Results: </strong>The fusion model outperformed single-modality assessments for HR, achieving a sensitivity of 89.72% (95% CI, 82.35-94.76), specificity of 89.67% (95% CI, 84.34-93.67), and accuracy of 89.69% (95% CI, 85.61-92.94). It showed a sensitivity of 97.96% (95% CI, 89.15-99.95), specificity of 86.84% (95% CI, 71.91-95.59), and accuracy of 93.10% (95% CI, 85.59-97.43) for assessing HR at week 52. Substantial agreement was observed between the AI-fusion model and central readout.</p><p><strong>Conclusion: </strong>This novel tool significantly advances precision medicine in clinical trials by potentially standardizing central readouts and enabling automated disease assessment.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12239202/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144532021","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}

{"title":"ECCO Topical Review on Pouch Disorders.","authors":"Maia Kayal, Gabriele Bislenghi, Michel Adamina, Zaid S Ardalan, Nicolas Avellaneda, Anthony de Buck van Overstraeten, Marjolijn Duijvestein, Maria Manuela Estevinho, Federica Furfaro, Ailsa L Hart, Stefan Holubar, Triana Lobaton, Jacob Ollech, Stephan R Vavricka, MarC Ferrante","doi":"10.1093/ecco-jcc/jjaf103","DOIUrl":"10.1093/ecco-jcc/jjaf103","url":null,"abstract":"<p><strong>Background: </strong>Pouch disorders are common and may present with symptoms of increased stool frequency, urgency, incontinence, pelvic cramping, obstructed defecation, and perianal drainage, which can result in poor sleep, fatigue, and disability. This topical review aims to offer expert consensus practice recommendations for the diagnosis and management of the most common inflammatory, functional, structural, and neoplastic J-pouch disorders.</p><p><strong>Methods: </strong>A multidisciplinary panel of gastroenterologists and colorectal surgeons performed a systematic review of the relevant literature on pouch disorders and developed current practice positions.</p><p><strong>Results: </strong>Seventeen current practice positions were developed on the diagnosis and management of inflammatory, functional, structural, and neoplastic pouch disorders.</p><p><strong>Conclusions: </strong>A multidisciplinary approach is essential for the diagnosis and management of pouch disorders.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144510064","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association between food diversity in the infant period and the risk of inflammatory bowel disease: a nationwide cohort study in South Korea.","authors":"Kyung A Kim, Junhyun Kwon, Woo-Jeong Shon, Joo Sung Kim, Byeong Gwan Kim, Jong Pil Im, Hyun Jung Lee, Hyunsun Park, Seong-Joon Koh","doi":"10.1093/ecco-jcc/jjaf101","DOIUrl":"10.1093/ecco-jcc/jjaf101","url":null,"abstract":"<p><strong>Background: </strong>Emerging evidence suggests that diet plays a significant role in the development of inflammatory bowel diseases. This study aimed to assess the association between early-life food diversity and the incidence of inflammatory bowel diseases from a nationwide retrospective cohort study in South Korea.</p><p><strong>Methods: </strong>This study incorporated 1 242 295 South Korean infants who participated in the National Health Insurance Service. Food diversity was categorized as \"high\" or \"low\" based on vegetables, fruits, grains, meats, fish, and eggs consumed during weaning. The association between food diversity and inflammatory bowel disease incidence was examined and subgroup analysis was conducted according to food diversity groups. The Cox proportional hazards model was used to estimate the risk of inflammatory bowel disease, with hazard ratios adjusted for demographic factors. Propensity score matching was employed for evaluating the general characteristics of the study population.</p><p><strong>Results: </strong>Among the infants evaluated, 71.3% of those who developed ulcerative colitis and 66.0% of those who developed Crohn's disease did not consume high-diversity food. Individually, food diversity, solid food intake frequency, antibiotic usage, and breastfeeding status were not significantly associated with inflammatory bowel disease incidence. However, the combination of high food diversity and frequent solid food intake (≥3 times/day) was associated with a lower risk of ulcerative colitis by 48% (adjusted hazard ratio: 0.52, CI 0.28-0.98, P = .0426).</p><p><strong>Conclusions: </strong>Food diversity, combined with the frequency of solid food intake, during infancy is associated with the incidence of ulcerative colitis. Promoting a diverse diet during infancy may be important in preventing the development of IBD.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144259711","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ultrasound-guided strategies in ulcerative colitis: early prediction and targeting.","authors":"Mariangela Allocca, Emma Calabrese","doi":"10.1093/ecco-jcc/jjaf113","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjaf113","url":null,"abstract":"","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":"19 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144639108","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of complete vs partial endoscopic healing on long-term outcomes in Crohn's disease: a prospective multicenter study.","authors":"Clara Yzet, Franck Brazier, Elise Derval, Pierre Vanelslander, Valérie Dejour, Dumitrita Pricope, Momar Diouf, Mathurin Fumery","doi":"10.1093/ecco-jcc/jjaf104","DOIUrl":"10.1093/ecco-jcc/jjaf104","url":null,"abstract":"<p><strong>Introduction: </strong>The STRIDE II guidelines recognize endoscopic healing (EH), defined by an SES-CD score ≤ 2, as one of the main therapeutic targets in Crohn's disease (CD). Nevertheless, complete EH could further reduce the risk of long-term complications in CD. We aimed to assess the risk of long-term complications in CD according to the degree of EH achieved.</p><p><strong>Method: </strong>We conducted a prospective multicenter study including all patients with EH assessment (2019-2022) in 3 centers and compared the outcomes of patients with complete EH (CDEIS = 0) vs partial EH (CDEIS > 0 but < 4). The primary endpoint was therapeutic failure (need for drug intensification and/or corticosteroid initiation and/or CD-related hospitalization and/or intestinal resection and/or development of a luminal stricture/fistula and/or perianal CD).</p><p><strong>Results: </strong>In total, 128 patients were included. Patients had been on treatment for a median of 12 months (8.3-24.3) before colonoscopy. After a median follow-up of 22 months (interquartile range, 19-23), 40 (31%) patients experienced therapeutic failure. The risk of therapeutic failure was significantly higher among patients with partial EH (25% vs 43%, P = .036). The risk of CD-related hospitalization was significantly higher for patients with partial EH (2.5% vs 17%, P = .005; hazard ratio = 6.89, Interval confidence 95% (IC95%) = [1.46-32.4], P = .015). The risk of intestinal resection, steroid initiation, and drug intensification among patients with complete and partial EH, were 0% vs 4.3% (P = .13), 2.5% vs 11% (P = .1); and 22% vs 36% (P = .088), respectively.</p><p><strong>Conclusion: </strong>Although higher-powered studies are needed to confirm these findings, current results suggest that complete EH may be associated with more favorable long-term outcomes than partial EH in patients with CD.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144512865","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The long-term disease course of microscopic colitis: a European prospective incident cohort study.","authors":"Bas P M Verhaegh, Andreas Münch, Danila Guagnozzi, Signe Wildt, Wojciech Cebula, Natalia Pedersen, Vytautas Kiudelis, Alfredo J Lucendo, Ivan Lyutakov, Gian-Eugenio Tontini, Flavia Pigò, Evangelos Russo, Henrik Hjortswang, Lars K Munck","doi":"10.1093/ecco-jcc/jjaf110","DOIUrl":"10.1093/ecco-jcc/jjaf110","url":null,"abstract":"<p><strong>Background and aims: </strong>The disease course of microscopic colitis is largely unknown and current knowledge is based on retrospective data. The aim of the PRO-MC Collaboration is to prospectively describe the long-term disease course and prognostic factors.</p><p><strong>Methods: </strong>Incident patients of microscopic colitis were included in a prospective, European, multicenter, web-based registry. Data on patient characteristics, symptoms, treatment, and quality of life were systematically registered at baseline and during fixed follow-up intervals. Four disease course phenotypes were defined.</p><p><strong>Results: </strong>Of 422 registered incident patients, 220 had a complete 5-year follow-up. After 5 years, 6% had a quiescent disease course, 54% achieved remission after treatment, 33% had a relapsing disease course, and 7% a chronic active disease course. Patients with a relapsing or chronic active disease course had a more impaired quality of life and were more often in need for long-term budesonide treatment. The disease course in the first year after diagnosis was the only predictor of the disease course.</p><p><strong>Conclusions: </strong>Microscopic colitis is a chronic condition with relapsing or continuous disease course in nearly half of the patients during the first 5 years after diagnosis. The disease course in the first year predicts the long-term disease course.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144532022","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of mirikizumab treatment on fatigue in patients with moderately to severely active Crohn's disease: results from the phase 3 VIVID-1 study.","authors":"Miguel Regueiro, Monika Fischer, Peter Bossuyt, Marijana Protic, Kristina Traxler, Guanglei Yu, Huaiyu Zang, Aisha Vadhariya, Tadakazu Hisamatsu, Pascal Juillerat, Alessandro Armuzzi, Javier P Gisbert, Alissa Walsh","doi":"10.1093/ecco-jcc/jjaf100","DOIUrl":"10.1093/ecco-jcc/jjaf100","url":null,"abstract":"<p><strong>Background: </strong>Fatigue is a debilitating multifactorial symptom experienced by patients with Crohn's disease (CD). Mirikizumab, an anti-interleukin-23p19 antibody, demonstrated significant efficacy and safety in the patients with moderately to severely active CD. This analysis investigated the impact of mirikizumab on fatigue and the association between changes in clinical, endoscopic, and patient-reported outcomes with improvement in fatigue from baseline in the Phase 3 VIVID-1 study.</p><p><strong>Methods: </strong>Adult patients with moderately to severely active CD that failed at least 1 biologic agent or conventional therapy were randomized to receive mirikizumab or placebo. Fatigue was assessed via the validated Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire. Fatigue associations with patient-reported outcomes, endoscopic, and clinical measures were assessed via Pearson correlation analysis.</p><p><strong>Results: </strong>At Week 12, 43% and 33%, and at Week 52, 46% and 36% of mirikizumab-treated patients achieved ≥ 6 and ≥ 9 fatigue score improvements vs placebo (Week 12, 31%, 22%; Week 52, 20%, 16%), respectively. Baseline fatigue scores were strongly associated with depressive symptoms and moderately associated with quality of life (QoL) at baseline. Improvements in fatigue at Weeks 12 and 52 were strongly associated with QoL and patient-reported outcomes and weakly with objective markers of inflammation and disease activity.</p><p><strong>Conclusions: </strong>Mirikizumab-treated patients with CD achieved higher rates of clinically meaningful improvement in fatigue vs placebo at Weeks 12 and 52, which correlated with improvement in clinical and patient-reported outcomes. Baseline fatigue severity was strongly associated with depressive symptoms in VIVID-1 (NCT03926130).</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12231548/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144259712","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}