Inflammatory Bowel Diseases最新文献

{"title":"Fecal calprotectin is an accurate noninvasive screening tool for pouchitis.","authors":"Sérgio Bronze, Susanne Ibing, Darwin Jimenez, Pamela Reyes Mercedes, Maia Kayal","doi":"10.1093/ibd/izag029","DOIUrl":"https://doi.org/10.1093/ibd/izag029","url":null,"abstract":"<p><strong>Background: </strong>Pouchitis is the most common complication after ileal pouch anal anastomosis (IPAA), yet symptoms are non-specific, and diagnosis typically requires pouchoscopy. Fecal calprotectin (FC) is an established inflammatory bowel disease biomarker, but optimal thresholds and diagnostic performance across distinct pouch phenotypes remain unclear.</p><p><strong>Methods: </strong>We performed an analysis of a prospectively maintained IPAA registry (2022-2025) at Mount Sinai Hospital. Adults with ulcerative colitis who had underwent total proctocolectomy with IPAA and had FC testing within ±90 days of pouchoscopy were included. Phenotypes were categorized as normal pouch (NP), acute pouchitis (AP), chronic pouchitis (CP), or Crohn's disease-like pouch inflammation (CDLPI). FC was compared across phenotypes and tested for associations with endoscopic Pouchitis Disease Activity Index (PDAI) sub-score, histologic activity, and symptoms using non-parametric tests, Spearman correlation, log-linear regression, and receiver operating characteristic analysis.</p><p><strong>Results: </strong>Among 163 patients, FC differed significantly across pouch phenotypes (P <.01) with a median value of 50.5 µg/g in NP, 244 µg/g in AP, 370.5 µg/g in CP, and 231.5 µg/g in CDLPI. FC distinguished between inflammatory and normal pouches with an area under the curve (AUC) of 0.82, with an optimal threshold of ∼167 µg/g (specificity, 94%). FC correlated significantly with endoscopic PDAI sub-scores (Spearman ρ = 0.45, P <.001), and predicted severe endoscopic activity with an AUC of 0.82 and an optimal cutoff of 280 µg/g.</p><p><strong>Conclusion: </strong>FC is accurate for detecting and grading pouch inflammation. Thresholds near 167 and 280 µg/g reliably discriminate normal from inflamed pouches and mild from severe endoscopic disease, respectively.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":""},"PeriodicalIF":4.3,"publicationDate":"2026-03-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147389854","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}

{"title":"Incidence of acne in patients with inflammatory bowel disease treated with Janus kinase inhibitors: a systematic review and meta-analysis.","authors":"Mohammed Nabil Quraishi, Maryam A Alahmad, Thaer Khaleel Swaid, Antonio Facciorusso, Alyssa A Grimshaw, Badr Al-Bawardy","doi":"10.1093/ibd/izag032","DOIUrl":"https://doi.org/10.1093/ibd/izag032","url":null,"abstract":"<p><strong>Background: </strong>Janus kinase (JAK) inhibitors are effective oral therapies for inflammatory bowel disease (IBD). While acne is a known adverse event in dermatological cohorts, its incidence and risk factors in the IBD population are not well-defined. We aimed to determine the pooled incidence of acne in IBD patients treated with JAK inhibitors and to explore this risk across key clinical subgroups.</p><p><strong>Methods: </strong>We conducted a systematic review and meta-analysis following PRISMA guidelines. MEDLINE, EMBASE, and CENTRAL were searched from inception to September 2025 for randomized controlled trials (RCTs) and observational studies reporting acne incidence in IBD patients on JAK inhibitors. Data were pooled using a random-effects generalized linear mixed-effects model. Pre-specified subgroup analyses were performed.</p><p><strong>Results: </strong>A total of 50 studies (5 RCTs, 45 observational) involving 9902 IBD patients were included. The overall pooled incidence of acne was 8.6% (95% CI: 6.4%-11.6%). Acne rates were significantly higher (P < .0001) with the upadacitinib (12.2%), compared to tofacitinib (2.6%) and filgotinib (2.3%). A numerically higher incidence was observed during induction (8.6%) versus maintenance (4.2%) therapy, though this difference was not statistically significant (P = .07). The incidence was significantly higher in the pediatric population (12.2%) compared to adults (7.4%) (P = .03). In RCTs, JAK inhibitors were associated with significantly increased odds of acne compared to placebo (OR 2.43, 95% CI: 1.33-4.43, P = .019). No statistically significant difference was observed by IBD subtype.</p><p><strong>Conclusion: </strong>Acne is a common adverse event in IBD patients treated with JAK inhibitors. The reported incidence of acne was significantly higher with upadacitinib, in the pediatric population, and numerically higher during the induction phase of treatment.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":""},"PeriodicalIF":4.3,"publicationDate":"2026-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147354820","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}

{"title":"Prevalence of disability in inflammatory bowel disease: a systematic review and meta-analysis.","authors":"Olga Maria Nardone, Giulio Calabrese, Alexander C Ford, Fabiana Castiglione, Edoardo Vincenzo Savarino, Vipul Jairath, Yuhong Yuan, Silvio Danese, Tommaso Lorenzo Parigi, Brigida Barberio","doi":"10.1093/ibd/izag022","DOIUrl":"https://doi.org/10.1093/ibd/izag022","url":null,"abstract":"<p><strong>Background and aims: </strong>Disability is a multidimensional concept that includes physical, psychological, and social limitations affecting individuals with inflammatory bowel disease (IBD). Disability is shaped by cultural and health care factors that vary across countries and therefore disability prevalence and characteristics may differ globally. We conducted a systematic review with meta-analysis to assess the pooled prevalence of moderate-to-severe disability and investigate how IBD type, disease activity, geographic location, and questionnaire used influenced prevalence.</p><p><strong>Methods: </strong>We searched MEDLINE, Embase, and Embase Classic (from database inception to March 1, 2025) for cross-sectional, cohort, registry-based, and case-control studies reporting the prevalence of moderate-to-severe disability based on the IBD Disk or IBD-Disability Index in adults with confirmed IBD.</p><p><strong>Results: </strong>In total, 17 articles fulfilled the eligibility criteria, including 7897 patients in 17 countries. The pooled prevalence of moderate-to-severe disability in patients with IBD was 29.6% (95% CI, 22.6%-37.1%) and was higher in patients with active IBD (56.9%; 95% CI, 20.3%-89.9%) compared with those with inactive disease (27.0%, 95% CI, 3.3%-62.0%). Based on 3 studies, disease activity increased the odds of moderate-to-severe disability more than 3-fold (odds ratio [OR], 3.13, 95% CI, 1.74-5.64). Stratified by IBD type, moderate-to-severe disability was higher in patients with Crohn disease (36.9%; 95% CI, 25.7%-48.9%) than in ulcerative colitis (30.8%; 95% CI, 19.6%-43.2%), with OR 1.26 (95% CI, 1.06-1.51).</p><p><strong>Conclusions: </strong>This systematic review is the first, to our knowledge, to show that moderate-to-severe disability affects nearly one-third of patients with IBD, with higher rates in Crohn disease and active disease. Importantly, disability persists in a substantial proportion of patients even during remission, supporting the need for systematic assessment across clinical settings.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":""},"PeriodicalIF":4.3,"publicationDate":"2026-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147354887","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}

{"title":"Mirikizumab four-year sustained and durable efficacy and safety in ulcerative colitis: Final findings from the LUCENT-3 open-label extension study.","authors":"Bruce E Sands, David B Clemow, Geert D'Haens, Peter M Irving, Taku Kobayashi, Laurent Peyrin-Biroulet, Karen Samaan, Anil Gaur, Ravneet Arora, Kris Todd, Richard Moses, Axel Dignass","doi":"10.1093/ibd/izag007","DOIUrl":"10.1093/ibd/izag007","url":null,"abstract":"<p><strong>Background: </strong>Mirikizumab, an anti-interleukin-23 monoclonal antibody targeting the p19 subunit, has shown efficacy in inducing and maintaining clinical remission in patients with moderately-to-severely active ulcerative colitis (UC). This report summarizes the final long-term outcomes from the LUCENT-3 open-label extension (OLE) through week (W)212 of continuous treatment.</p><p><strong>Methods: </strong>Among 868 participants who received mirikizumab induction therapy in the LUCENT clinical trial program, 544 achieved clinical response. Of these, 365 were rerandomized to mirikizumab maintenance, with 324 completing W52, 316 entering the OLE, and 182 completing the OLE (4 years of continuous treatment), resulting in 835.3 total patient years of exposure. These analyses include efficacy and safety data from the LUCENT-3 cohort, stratified by LUCENT-1 baseline biologic experience, W52 remitter, and W52 responder status on entering the OLE study. Outcomes were analyzed using modified nonresponder imputation, traditional nonresponder imputation, and observed cases (OC) to handle missing data.</p><p><strong>Results: </strong>At W212, W52 Maintenance Remitters showed 77.7% clinical, 77.7% corticosteroid-free (CSF), 81.3% endoscopic, 66.0% histologic-endoscopic mucosal (HEMR), 94.3% symptomatic, and 73.6% bowel urgency (BU) remission rates (OC); 67.9% achieved histologic-endoscopic mucosal improvement (HEMI), 97.1% sustained clinical response, and 92.9% achieved BU clinically meaningful improvement (CMI). At W212, W52 Maintenance Responders showed 68.7% clinical, 68.7% CSF, 70.2% endoscopic, 55.1% HEMR, 92.7% symptomatic, and 74.8% BU remission rates (OC). For W52 Maintenance Completers, reductions in stool frequency, rectal bleeding, bowel urgency, and abdominal pain from baseline were sustained to W212. W52 Maintenance Remitters and Responders achieved Inflammatory Bowel Disease Questionnaire (IBDQ; quality of life measure) response (70%) and remission (>66%) at W212. Across biologic failed and bionaive subgroups, efficacy results were generally similar. For over 160 weeks of OLE treatment in the safety population, no new safety signals emerged from long-term exposure compared with induction and maintenance treatment.</p><p><strong>Conclusions: </strong>Mirikizumab provided sustained symptomatic, clinical, endoscopic, and histologic benefits over 4 years in responding patients with moderately-to-severely active UC, including those with prior biologic failure. These treatment goals, which are integral to comprehensive disease management, support the long-term use of mirikizumab.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":""},"PeriodicalIF":4.3,"publicationDate":"2026-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147348225","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}

{"title":"Exploring the EPIcenter of VEOIBD: defining the genetic drivers of intestinal epithelial cellular dysfunction-authors' reply.","authors":"Zahra Shojaei Jeshvaghani, Edward Nieuwenhuis, Ewart Kuijk","doi":"10.1093/ibd/izaf309","DOIUrl":"10.1093/ibd/izaf309","url":null,"abstract":"","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"595-596"},"PeriodicalIF":4.3,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145742395","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}

{"title":"Association of Geography With Screening and Development of Cervical Neoplasia in Those With Inflammatory Bowel Disease.","authors":"Quinn Goddard, Stephanie Coward, Cynthia H Seow, Stefania Bertazzon, Sarah Glaze, Gilaad G Kaplan","doi":"10.1093/ibd/izaf249","DOIUrl":"10.1093/ibd/izaf249","url":null,"abstract":"<p><strong>Background: </strong>While cancer risk is elevated in inflammatory bowel disease (IBD), results are less clear for cervical cancer. Screening has made cervical cancer relatively preventable, but geography impacts access, possibly increasing rates of cancer in rural and remote areas. We investigated (1) odds of cervical cancer, (2) cervical cancer screening participation, and (3) impact of geography (eg, rurality) and immunosuppression on the odds of cervical cancer and cervical cancer screening participation in the IBD population in Alberta, Canada.</p><p><strong>Methods: </strong>A population-based cohort using administrative healthcare databases (fiscal year 2003/04-2021/22) was used to identify females with IBD (n = 22 245), age- and sex-matched 10 to 1 to control subjects (n = 161 070). The average annual percent change of screening rates and incidence of cervical cancer was calculated through Poisson regression. The odds of cervical cancer were calculated with conditional logistic regression. The role of geography and immunosuppression were assessed in each analysis.</p><p><strong>Results: </strong>Individuals with IBD had lower odds of cervical cancer (odds ratio, 0.75; 95% confidence interval [CI], 0.68 to 0.83), but immunosuppressed individuals were at greater risk (odds ratio, 1.79; 95% CI, 1.48 to 2.15). Cases and controls had similar screening rates, but immunosuppressed individuals were screened more (incidence rate ratio, 1.05; 95% CI, 1.03 to 1.07). Screening declined among individuals with IBD (average annual percentage change, -5.15; 95% CI, -5.30 to -4.99), but incidence rates of cervical cancer remained stable (average annual percentage change, -1.95%; 95% CI, -4.25 to 0.41). While urban and metropolitan individuals with IBD were screened more, we observed no geographic variation in risk of cervical cancer.</p><p><strong>Conclusions: </strong>Similarities in screening between cases and controls suggest that lifestyle factors (eg, human papillomavirus vaccination, sexual history) may underpin the reduced odds of cervical cancer, rather than screening frequency. Efforts should be made to increase screening in immunosuppressed individuals.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"488-497"},"PeriodicalIF":4.3,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145563758","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}

{"title":"Reliability and Validity of Mesenteric Fat Assessment by Intestinal Ultrasound in Pediatric Crohn's Disease Using the Chicago Mesenteric Fat Index.","authors":"Amelia Kellar, Tessa George, Michael T Dolinger, Matthew Smyth, Noa Krugliak Cleveland, David T Rubin, Joëlle St-Pierre","doi":"10.1093/ibd/izaf238","DOIUrl":"10.1093/ibd/izaf238","url":null,"abstract":"<p><strong>Background: </strong>Intestinal ultrasound (IUS) provides a noninvasive means of assessing Crohn's disease (CD), including visualization of mesenteric fat (MF) wrapping. Reliability of MF assessment and correlation with disease activity biomarkers in children is unknown. This study assessed the interrater reliability (IRR) of a binary assessment and a novel semi-quantitative index for grading MF wrapping using IUS (Chicago Mesenteric Fat Index [CMFI]) and correlation with disease activity biomarkers in pediatric patients with CD.</p><p><strong>Methods: </strong>Children (≤18 years of age) with ileal CD who underwent IUS at 2 centers were enrolled. Three expert sonographers independently graded MF as present/absent and by the CMFI. IRR was calculated using Fleiss' kappa coefficient. Correlations between MF and clinical characteristics, inflammatory markers, and IUS data were calculated.</p><p><strong>Results: </strong>Eighty IUS exams in 67 patients were included. The IRR was substantial for binary MF (κ = 0.744) and CMFI (κ = 0.618). Increasing CMFI grade was associated with bowel wall thickness (P < .001; odds ratio [OR], 16.35; 95% confidence interval [CI], 5.74-46.58), presence of ileal stricture (P < .001; OR, 30.32; 95% CI, 5.74-160.15), and presence of hyperemia (P = .001; OR, 6.59; 95% CI, 2.27-19.09).</p><p><strong>Conclusion: </strong>Assessment of MF on IUS is reproducible and reliable in pediatric CD. The CMFI can be used as a biomarker that mirrors biochemical and sonographic indicators of pediatric CD activity.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"444-451"},"PeriodicalIF":4.3,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145476948","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}

{"title":"Safety and Efficacy of Ozanimod in Patients With Moderately to Severely Active Ulcerative Colitis Stratified by Age.","authors":"Adam S Faye, David T Rubin, Corey A Siegel, Millie D Long, Nabeel Khan, Silvio Danese, Peter M Irving, Raymond K Cross, Irina Blumenstein, Alessandro Armuzzi, Sara N Horst, Axel Dignass, Taku Kobayashi, Garrett Lawlor, Anthony Krakovich, AnnKatrin Petersen, Zhaohui Liu, Dong Wang, Anjali Jain, Ashwin N Ananthakrishnan, João Sabino","doi":"10.1093/ibd/izaf258","DOIUrl":"10.1093/ibd/izaf258","url":null,"abstract":"<p><strong>Background: </strong>Older adults with ulcerative colitis (UC) have unique treatment challenges. Ozanimod is approved for the treatment of moderately to severely active UC in adults based on the phase 3 True North (TN) study results. Here, we analyzed the impact of patient age on ozanimod safety and efficacy in TN and during the open-label extension (OLE).</p><p><strong>Methods: </strong>Patients were stratified by age at TN baseline: <40, 40 to 60, and >60 years (cutoff: 75 years). Safety was evaluated in all patients during TN and the OLE; efficacy was assessed at weeks 10 and 52 in TN and up to OLE week 190 in patients who entered as TN week 52 ozanimod clinical responders.</p><p><strong>Results: </strong>Of 1012 patients analyzed, 492 were <40 years of age, 404 were 40 to 60 years of age, and 116 were >60 years of age. Infection, malignancy, cardiac events, and macular edema were low throughout TN across all ages. Exposure-adjusted incidence rates (EAIRs) of opportunistic and serious infections increased with age during the OLE. Patients ≥40 years of age had higher hypertension EAIRs than those <40 years of age, but EAIRs of other cardiovascular TEAEs were low. No cases of progressive multifocal leukoencephalopathy occurred over 242 weeks of ozanimod exposure. Efficacy rates for evaluated clinical and mucosal endpoints at weeks 10 and 52 with ozanimod were generally consistent across age groups with the overall population; similar trends were observed in the OLE.</p><p><strong>Conclusions: </strong>Ozanimod safety was similar and efficacy was generally comparable across age groups, although statistical significance vs placebo was not achieved in patients >60 years of age.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"512-525"},"PeriodicalIF":4.3,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12794806/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145581680","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}

{"title":"Exploring the EPIcenter of VEOIBD: Defining the Genetic Drivers of Intestinal Epithelial Cellular Dysfunction.","authors":"Christian E Wong-Valencia, Robert Barrett","doi":"10.1093/ibd/izaf300","DOIUrl":"10.1093/ibd/izaf300","url":null,"abstract":"","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"589-591"},"PeriodicalIF":4.3,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145603587","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}

{"title":"Efficacy and Safety with Upadacitinib by Baseline Corticosteroid Use in Patients with Moderately to Severely Active Crohn's Disease.","authors":"Marla C Dubinsky, Geert D'Haens, Olivier Dewit, Pascal Juillerat, Remo Panaccione, Toshimitsu Fujii, Elena Dubcenco, Ana Paula Lacerda, Samuel I Anyanwu, Sharanya Ford, Colla Cunneen, Irina Fish, Namita Joshi, Andrew Garrison, Edward V Loftus","doi":"10.1093/ibd/izaf250","DOIUrl":"10.1093/ibd/izaf250","url":null,"abstract":"<p><strong>Importance and objective: </strong>Upadacitinib, an oral, reversible Janus kinase inhibitor, is approved for the treatment of moderate-to-severe Crohn's disease (CD). Limiting corticosteroid exposure is an important goal in treating CD. This posthoc analysis evaluated the corticosteroid-sparing effects of upadacitinib in patients with CD.</p><p><strong>Design and setting: </strong>This study included pooled data from two phase 3, multicenter, double-blind induction trials and one maintenance trial. Randomization was stratified by corticosteroid use at induction baseline, with a mandatory corticosteroid taper starting at induction week 4. Efficacy was evaluated by baseline corticosteroid use and by achieving corticosteroid-free outcomes through year 2 of maintenance therapy. Safety was also assessed.</p><p><strong>Results: </strong>At baseline, 34.7% (234/674) and 35.7% (124/347) of upadacitinib 45 mg and placebo-treated patients were taking corticosteroids, respectively. At induction week 12 and maintenance week 52, higher rates of upadacitinib-treated patients were corticosteroid-free among all patients and among patients with baseline corticosteroid use compared with placebo; upadacitinib-treated patients achieved higher rates of corticosteroid-free outcomes, compared with placebo, including corticosteroid-free clinical remission (stool frequency/abdominal pain score [SF/APS]: 42.7% vs 16.1%; CD activity index [CDAI]: 41.2% vs 23.4%) and corticosteroid-free endoscopic response (37.0% vs 8.1%), with similar results observed among responders to upadacitinib induction therapy at maintenance week 52. Corticosteroid-free outcomes were sustained through year 2 of maintenance therapy. The safety profile was similar to the overall population, with no new safety risks identified.</p><p><strong>Conclusions and relevance: </strong>The results from pivotal studies demonstrated that upadacitinib effectively induced early and sustainable corticosteroid-free clinical remission with a manageable safety profile in patients with moderate-to-severe CD.</p><p><strong>Clinical trial identifiers: </strong>U-EXCEL, U-EXCEED, and U-ENDURE ClinicalTrials.gov numbers, NCT03345849, NCT03345836, and NCT03345823.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":"498-511"},"PeriodicalIF":4.3,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145444848","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}