Background/Aims Diagnosis of cytomegalovirus (CMV) ileocolitis traditionally requires colonoscopy with tissue biopsy. Due to potential complications in high-risk patients, there is growing interest in serum and stool tests for diagnosing this condition. We aimed to evaluate the diagnostic accuracy of these noninvasive tests compared to traditional gold standards.
Methods Two independent reviewers performed a comprehensive search on MEDLINE and Embase from inception up to October 1, 2023. Prospective and retrospective studies evaluating the performance of serum CMV polymerase chain reaction (PCR), serum CMV antigen (Ag), and stool CMV PCR in diagnosing CMV ileocolitis were included. Tissue histopathology or tissue CMV PCR served as reference standards. Diagnostic performances of each serum and stool test were calculated based on a meta-analysis using random-effects model.
Results A total of 30 studies, comprising 23 studies of serum CMV PCR, 9 of serum CMV Ag, and 7 of stool CMV PCR, were included. The pooled sensitivity, specificity, and area under summary receiver operating characteristic curves were 62% (95% confidence interval [CI], 51%–72%), 90% (95% CI, 79%–96%), and 0.81 for serum CMV PCR, 38% (95% CI, 26%–51%), 94% (95% CI, 70%–99%), and 0.56 for serum CMV Ag, and 53% (95% CI, 35%–70%), 91% (95% CI, 84%–95%), and 0.84 for stool CMV PCR.
Conclusions Serum and stool tests cannot replace colonoscopy for diagnosing CMV ileocolitis due to their low sensitivities but may be useful when colonoscopy is not feasible. Positive results can aid diagnosis, given their high specificities. Serum and/or stool CMV PCR are preferred over CMV Ag.
Background/Aims Self-expandable metallic stents (SEMSs) are widely used as palliative or bridge to surgery treatments in patients with malignant colorectal obstruction (MCO). Stent occlusion is more common with uncovered stents, but stent migration is more common with covered stents. Our purpose was to compare the efficacy and safety of a newly designed covered SEMS with an uncovered proximal flared end (CSEMS-UPF) with that of the conventional uncovered SEMS (UCSEMS) in the treatment of MCO.
Methods This prospective randomized trial was conducted at a tertiary-care academic hospital. We enrolled 87 patients with stage 4 cancer and MCO: colorectal cancer in 60 patients and extracolonic cancer in 27 patients. Insertion of UCSEMS was randomly assigned to 43 patients, and 44 patients received the CSEMS-UPF. The primary outcome was the duration of stent patency after successful placement. The secondary outcomes were the number of patients with technical and clinical success and early and late complications from the stent insertion.
Results The median patency of the stent did not differ between the UCSEMS and CSEMS-UPF groups (484 [231–737] days vs. 216 [66–366] days, P= 0.242). The technical and clinical success rates did not differ significantly between the groups, either (100.0% vs. 93.2%, respectively, P= 0.241; 100.0% vs. 92.7%, respectively, P= 0.112), nor did the early (n = 2 [4.7%] vs. n = 4 [9.8%], P> 0.999) or late (n = 12 [27.9%] vs. n = 15 [36.6%], P> 0.999) stent complication rates differ between the groups.
Conclusions The UCSEMS and newly developed CSEMS-UPF are similarly effective treatments for MCO, with no differences in the stent migration or occlusion rates (Clinical trial registration number: NCT02640781).
Background/Aims In today’s age, celiac disease (CD) is no longer solely characterized by chronic diarrhea in a malnourished child. Obesity is gradually being acknowledged as part of CD’s clinical course. Both conditions have been linked to alterations of gut microbiome. Given the difficulty of strict gluten-free diet adherence, there is a need for less restrictive adjunctive therapies. We aimed to investigate the prevalence of obesity in patients diagnosed with CD with the goal of developing new therapeutic approaches.
Methods Baseline data from the National Institute of Health’s All of Us Research Program, was used to evaluate the relationship between CD and obesity. A retrospective cohort study was conducted where groups of individuals with CD and without CD were matched by age range and health surveys. Statistical analysis with odds ratios (OR) with 95% confidence intervals (CI) were reported.
Results The prevalence of obesity was 32.6% in the CD group compared to 18.4% in the control group (OR, 2.111; 95% CI, 1.914–2.328; P< 0.0001). Women accounted for a greater population of patients with CD and obesity. The largest percentage of patients with CD and obesity were older than 65 years. The highest percentage of individuals in both the experimental and control groups were white, followed by African Americans.
Conclusions Our data shows a significant association between CD and increased prevalence of obesity. These results warrant further investigation into microbial changes and dietary exposures that affect the pathogenesis of both diseases.
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Background/Aims Growing evidence suggests histologic healing (HH) improves clinical outcomes in ulcerative colitis (UC) patients beyond endoscopic healing (EH). We hypothesize that HH is associated with better clinical outcomes in Asian UC patients, for whom data is lacking.
Methods We performed a retrospective study of UC patients in clinical remission (CR) with a follow-up colonoscopy and minimum 1-year follow-up post-colonoscopy. Primary outcome was clinical relapse (CRL), defined as either a Simple Clinical Colitis Activity Index score of > 2, medication escalation, hospitalization or colectomy. Predictors of CRL and HH were assessed.
Results One hundred patients were included with a median follow-up of 22 months. At index colonoscopy, 80 patients were in EH. On follow-up, 41 patients experienced CRL. Of 80 patients in EH, 34 (42.5%) had persistent histologic activity (Nancy Index ≥ 2) and 29 (36.3%) relapsed during the follow-up period. Amongst patients in CR and EH, those with HH had lower CRL rate (26.1% vs. 50.0%, P= 0.028) and longer CRL-free survival (mean 46.1 months vs. 31.5 months, P= 0.015) than those with persistent histologic activity. On bivariable analysis of 100 patients in CR, HH, and Mayo endoscopic score (MES) of 0 were significantly associated with lower risk of CRL. On multivariable analysis, only MES 0 remained predictive of lower CRL risk.
Conclusions Above and beyond CR and EH, achieving HH improves clinical outcomes in Asian UC patients. However, HH may not confer incremental benefit if MES 0 has been achieved. Further prospective studies evaluating the benefit of histologically guided therapeutic decisions are needed.
Background/Aims Serum leucine-rich alpha-2 glycoprotein (LRG) is a potential biomarker of Crohn’s disease (CD). This study aimed to evaluate the usefulness of LRG in predicting clinical relapse in patients in remission with CD.
Methods This retrospective observational study assessed the relationships among patient-reported outcome (PRO2), LRG, and other blood markers. The influence of LRG on clinical relapse was assessed in patients in remission with CD.
Results Data of 94 patients tested for LRG between January 2021 and May 2023 were collected. LRG level did not correlate with PRO2 score (ρ = 0.06); however, it strongly correlated with C-reactive protein (CRP) level (r=0.79) and serum albumin level (r=–0.70). Among 69 patients in clinical remission, relapse occurred in 22 patients (31.9%). In the context of predicting relapse, LRG showed the highest area under the curve, followed by CRP level, platelet count, and albumin level. Multivariate analysis revealed that only LRG (P= 0.02) was an independent factor for predicting clinical remission. The cumulative non-relapse rate was significantly higher in patients with LRG < 13.8 μg/mL than in patients in remission with LRG ≥ 13.8 μg/mL and normal CRP level (P= 0.002) or normal albumin level (P= 0.001). Cumulative non-relapse rate was also higher in patients with LRG < 13.8 μg/mL compared to those with LRG ≥ 13.8 μg/mL in patients with L3 or B2+B3 of Montreal calcification.
Conclusions LRG is useful in predicting clinical relapse in patients with CD during biological remission. LRG is a useful biomarker for predicting prognosis, even in patients with intestinal stenosis, or previous/present fistulas.
Background/Aims Bowel urgency is an important symptom for quality of life determination in patients with ulcerative colitis (UC). Few clinical studies have focused on bowel urgency as an efficacy endpoint. Budesonide foam enema has shown efficacy for clinical and endoscopic improvement in mild-to-moderate UC. We evaluated the improvement of clinical symptoms (bowel urgency), safety, and treatment impact of twice-daily budesonide foam enema on the quality of life in patients with UC.
Methods This open-label, multicenter, prospective observational study comprised a 4-week observation period assessing the effectiveness and safety of twice-daily budesonide foam enema. Mild-to-moderate UC patients who had bowel urgency were included. Patients collected data daily in an electronic patient-reported outcome system or logbooks. The primary endpoint was the rate of resolution of bowel urgency at the end of the 4-week observation period. The rate of bowel incontinence was also assessed.
Results Sixty-one patients were enrolled. Of patients with a final evaluation, the rate of resolution of bowel urgency was 58.5% (31/53; 95% confidence interval, 44.1%–71.9%). Bowel urgency decreased over time, with a significant difference observed on day 7 versus day 0. Bowel incontinence showed a decreasing trend from day 5, with a significant difference confirmed on day 12 versus day 0. The clinical remission rate was 64.4% (38/59; 95% confidence interval, 50.9%–76.4%). One adverse event not related to budesonide rectal foam occurred.
Conclusions The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed.
Background/Aims Accurate assessment of disease activity is crucial for effective management and treatment of ulcerative colitis (UC). This study evaluated the correlation between clinical, endoscopic, and histologic measures of disease activity in UC.
Methods Clinical, biochemical, endoscopic, and histologic disease activity was studied in 347 patients with UC. Agreements among various histologic classification systems, namely the Geboes Score (GS), Continuous GS, Nancy Index (NI), and Robarts Histopathology Index (RHI), were analyzed. The predictive accuracy of fecal calprotectin (FC) for endoscopic and histologic remission was assessed.
Results We demonstrate a fair to moderate correlation between clinical, endoscopic, and histologic measures of disease activity in UC. There was a robust concordance among GS, Continuous GS, NI, and RHI in distinguishing between patients in histologic remission or activity. The NI detected 75% of patients who met the remission criteria according to the RHI, whereas the RHI identified all patients in remission as defined by the NI. FC levels below 150 μg/g had >70% accuracy in predicting endoscopic remission. FC levels below 150 μg/g showed ≥80% accuracy, and FC levels below 100 μg/g demonstrated ≥ 85% accuracy in predicting histologic remission, regardless of the scoring index applied. Elevated FC levels were associated with both acute and chronic inflammatory infiltrates in biopsy samples.
Conclusions FC is a reliable predictor of histologic remission, with higher accuracy at lower thresholds. The GS, Continuous GS, NI, and RHI demonstrate comparable performance. FC could help stratify patients’ need for colonoscopy for the assessment of endoscopic and histologic remission.
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Background/Aims We investigated the incidences of overall and site-specific malignancies and chemopreventive effects of statin, metformin, and aspirin in patients with ulcerative colitis.
Methods We collected data using the Health Insurance Review and Assessment claims database from January 2007 to April 2020.
Results The overall malignancy risk among the 35,189 ulcerative colitis patients was similar to that of the general population (standardized incidence ratio, 0.94; 95% confidence interval, 0.88–1.00). In male patients, standardized incidence ratios were high for thyroid cancer and low for stomach cancer, colorectal cancer, liver cancer, and lung cancer. Concurrently, standard incidence ratios were high for liver cancer and central nervous system cancer in female patients. While 122 cases of colorectal cancer occurred in the study patients, the standardized incidence ratio was 0.83 (95% confidence interval, 0.69–0.99). Treatment for ulcerative colitis was not associated with an increased adjusted hazard ratio, while comorbidities increased it for all malignancies. Treatment for ulcerative colitis was associated with an increased adjusted hazard ratio, while comorbidities did not increase it for colorectal cancer. After adjusting for age, sex, comorbidities, and ulcerative colitis treatment, statins showed a dose-dependent chemopreventive effect for all malignancies (P=0.002), while metformin and aspirin did not show any.
Conclusions In ulcerative colitis patients, standardized incidence ratios for all malignancies and colorectal cancer did not increase. Adjusted hazard ratios for all malignancies increased with comorbidities and those for colorectal cancer with ulcerative colitis treatment. Statins have a dose-dependent chemopreventive effect for all malignancies.
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Thyroid disorders and inflammatory bowel disease: an association present in adults but also in children and adolescents Valeria Calcaterra, Francesca Penagini, Virginia Rossi, Luisa Abbattista, Alice Bianchi, Massimiliano Turzi, Lucia Cococcioni, Gianvincenzo Zuccotti Frontiers in Endocrinology.2025;[Epub] CrossRef
Does statin have a chemopreventive effect in patients with ulcerative colitis? Yoon Suk Jung Intestinal Research.2025; 23(2): 113. CrossRef
Antonio Tursi, Daniele Piovani, Giovanni Brandimarte, Francesco Di Mario, Walter Elisei, Marcello Picchio, Gisella Figlioli, Gabrio Bassotti, Leonardo Allegretta, Maria Laura Annunziata, Mauro Bafutto, Maria Antonia Bianco, Raffaele Colucci, Rita Conigliaro, Dan L. Dumitrascu, Ricardo Escalante, Luciano Ferrini, Giacomo Forti, Marilisa Franceschi, Maria Giovanna Graziani, Frank Lammert, Giovanni Latella, Daniele Lisi, Giovanni Maconi, Debora Compare, Gerardo Nardone, Lucia Camara de Castro Oliveira, Chaves Oliveira Enio, Savvas Papagrigoriadis, Anna Pietrzak, Stefano Pontone, Ieva Stundiene, Tomas Poškus, Giuseppe Pranzo, Matthias Christian Reichert, Stefano Rodino, Jaroslaw Regula, Giuseppe Scaccianoce, Franco Scaldaferri, Roberto Vassallo, Costantino Zampaletta, Angelo Zullo, Erasmo Spaziani, Stefanos Bonovas, Alfredo Papa, Silvio Danese, DICA International Group
Intest Res 2025;23(1):96-106. Published online August 12, 2024
Background/Aims Patients with diverticular disease (DD) frequently have abnormal bowel movements. However, it is unknown whether the entity of these alterations is associated with the severity of DD. We aimed to assess bowel habits and their relationship with the severity of DD according to Diverticular Inflammation and Complication Assessment (DICA) classification, Combined Overview on Diverticular Assessment (CODA) score, and fecal calprotectin (FC).
Methods An international, multicenter, prospective cohort study was conducted in 43 centers. A 10-point visual analog scale (VAS) was used to assess the severity of constipation and diarrhea. The association of constipation and diarrhea with DICA classification, CODA score, and basal FC was tested using non-parametric tests. Survival methods for censored observations were applied to test the association of constipation and diarrhea with the incidence of acute diverticulitis over a 3-year follow-up.
Results Of 871 patients with DD were included in the study. Of these, 208 (23.9%) and 199 (22.9%) reported a VAS score for constipation and diarrhea at least 3 at baseline, respectively. Higher constipation and diarrhea scores were associated with increasing DICA classification, CODA score and basal FC (P< 0.001). Constipation and diarrhea scores were independently associated with an increased hazard of developing acute diverticulitis (hazard ratio [HR]constipation = 1.15 per 1-VAS point increase, 95% confidence interval [CI], 1.04–1.27; P=0.004; and HRdiarrhea =1.14; 95% CI, 1.03–1.26; P=0.014, respectively).
Conclusions In newly diagnosed patients with DD, higher endoscopic and combined scores of DD severity were associated with higher scores of constipation and diarrhea at baseline. Both constipation and diarrhea were independent prognostic factors of acute diverticulitis.
Background/Aims Despite of the coronavirus disease 2019 (COVID-19) pandemic, there is little data regarding its impact on colorectal cancer (CRC)-related clinical practice. This study aimed to assess the changes in its impact during the COVID-19 pandemic.
Methods This was a retrospective national population-based study using the Health Insurance Review and Assessment database from January 2019 to December 2021. The number of patients in 2020 and 2021 was compared with those in 2019 for the diagnostic and therapeutic colonoscopy, CRC-related operation, and any treatment for CRC.
Results The annual number of patients undergoing diagnostic colonoscopies decreased by 6.9% in 2020 but increased 8.1% in 2021, compared to those in 2019; number of patients undergoing therapeutic colonoscopies increased by 6.0% and 37.7% in 2020 and 2021, respectively; number of patients operated for CRC decreased by 4.2% in 2020 and increased by 2.3% in 2021. The number of patients treated for CRC decreased by 2.8% in 2020 and increased by 4.4% in 2021. Diagnostic and therapeutic colonoscopies and any CRC-related treatment decreased by 43.8%, 37.5%, and 11.3% in March 2020, during the first surge of COVID-19, but increased by 26.0%, 58.1%, and 9.5% in June 2021, respectively. CRC-related operations decreased by 24.1% in April 2020 and increased by 12.6% in August 2021.
Conclusions Negative impact of the COVID-19 pandemic on clinical practices related to CRC completely recovered within second year. It could be considered for the development of an optimal strategy on CRC management in response to the pandemic-driven crisis.
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Background/Aims Nonalcoholic fatty liver disease (NAFLD) is a common disease with severe inflammatory processes associated with numerous gastrointestinal diseases, such as inflammatory bowel disease (IBD). Therefore, we investigated the relationship between NAFLD and IBD and the possible risk factors associated with the diagnosis of IBD.
Methods This longitudinal nationwide cohort study investigated the risk of IBD in patients with NAFLD alone. General characteristics, comorbidities, and incidence of IBD were also compared.
Results Patients diagnosed with NAFLD had a significant risk of developing IBD compared to control individuals, who were associated with a 2.245-fold risk of the diagnosis of IBD and a 2.260- and 2.231-fold of increased diagnosis of ulcerative colitis and Crohn’s disease, respectively (P< 0.001). The cumulative risk of IBD increased annually during the follow-up of patients with NAFLD (P< 0.001).
Conclusions Our results emphasize that NAFLD significantly impacts its incidence in patients with NAFLD. If patients with NAFLD present with risk factors, such as diabetes mellitus and dyslipidemia, these conditions should be properly treated with regular follow-ups. Furthermore, we believe that these causes may be associated with the second peak of IBD.
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Background/Aims Obtaining and maintaining corticosteroid-free remission are important goals of treatment for ulcerative colitis (UC). Characteristics associated with achieving corticosteroid-free remission were assessed in filgotinib-treated patients in SELECTION, a 58-week, phase 2b/3 trial in moderately to severely active UC.
Methods This post hoc analysis used data from filgotinib-treated patients receiving corticosteroids at maintenance baseline in SELECTION. Univariate logistic regression was performed to assess induction baseline characteristics associated with 6 months of corticosteroid-free remission at week 58, defined as clinical remission without using corticosteroids for at least 6 months.
Results At maintenance baseline, 92 and 81 patients were receiving corticosteroids in the filgotinib 200 mg and filgotinib 100 mg groups, respectively. Age, body mass index, history of pancolitis, disease duration, fecal calprotectin levels, C-reactive protein levels, Mayo Clinic Score, concomitant corticosteroids, immunomodulators, and aminosalicylates had no statistically significant effect on the likelihood of achieving corticosteroid-free remission. Baseline characteristics associated with increased odds of corticosteroid-free remission were Mayo Clinic Endoscopic Subscore of 2 (vs. 3) in the filgotinib 200 mg and filgotinib 100 mg groups, and female (vs. male) sex, current (vs. former or never) smoking, and being biologic‑naive (vs. experienced) in the filgotinib 200 mg group.
Conclusions Steroid tapering can be achieved in patients with UC receiving filgotinib 200 mg independently of baseline characteristics such as clinical activity and duration of illness. However, the likelihood of achieving corticosteroid-free remission was higher among patients who were biologic-naive, current smokers, had low endoscopic inflammatory burden and who were female.
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Background/Aims One complication of restorative proctocolectomy with ileo-anal pouch anastomosis is fistula formation in the pouch. Fistulas can be associated with significant morbidity and pouch failure. We conducted a systematic review with meta- analysis to try and understand the prevalence of pouch fistulas in patients with ulcerative colitis following restorative proctocolectomy.
Methods The Embase, Embase Classic, and PubMed databases were searched between January 1979 and April 2022. Studies were included if there were cross-sectional, case-controlled, population-based or cohort studies reporting on prevalence of pouch fistulas in ulcerative colitis. Studies had to report the number of patients with pouch fistulas using either clinical, endoscopic, or radiological diagnosis in an adult population.
Results Thirty-three studies screened met the inclusion criteria. The pooled prevalence of developing at least 1 fistula was 0.05 (95% confidence interval [CI], 0.04–0.07). The pooled prevalence of pouch failure in patients with pouch fistula was found to be 0.24 (95% CI, 0.19–0.30). The pooled prevalence of developing a pouch fistula at 3 years, 5 years and more than 5 years was 0.04 (95% CI, 0.02–0.07), 0.05 (95% CI, 0.02–0.07), and 0.05 (95% CI, 0.02–0.10), respectively.
Conclusions This is the first systematic review and meta-analysis to report the prevalence of pouch fistula. It also provides a pooled prevalence of pouch failure in these patients. These results can help to shape future guidelines, power future studies, and help counsel patients.
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Background/Aims Crohn’s disease (CD) has a progressive nature and commonly perianal involvement. The aim of this study is to assess the prevalence, surgical treatment, and outcome of perianal fistulizing CD with associated risk factors in a large Chinese cohort.
Methods Hospitalized patients diagnosed with CD in our center were consecutively enrolled between January 2000 and December 2018. Transition of disease behavior was classified according to the presence or absence of penetrating behavior (B3 in the Montreal classification) at diagnosis and at a median follow-up of 102 months.
Results A total of 504 patients were included, of whom 207 (41.1%) were classified as B3 and 348 (69.0%) as L2/3 at follow-up. Transition of behavior to B3 was observed in 86 patients (17.1%). The incidence of perianal fistulizing lesions was 10.9% at 10 years with a final prevalence of 27.0% (n = 136) at the end of follow-up. Multivariate Cox regression identified independent risks of perianal fistulizing lesions for persistent B3 (hazard ratio, 4.72; 95% confidence interval, 1.91–11.66) and behavior transition of progressed to B3 (hazard ratio, 9.90; 95% confidence interval, 4.60–21.33). Perianal surgical treatments were performed in 104 patients (20.6%). Thirty-six cases (7.1%) were refractory, and it is independently associated with behavior of persistent B3 (P= 0.011).
Conclusions Perianal fistulizing lesions occurred frequently in Chinese CD patients. Its incidence and refractory outcome were closely associated with the penetrating CD behavior. An additional risk of perianal fistulizing lesions was indicated for CD patients with behavior of progressing to B3, suggesting further attention.
Background/Aims Leucine-rich α-2-glycoprotein (LRG) is a new serum biomarker reflecting the disease activity of ulcerative colitis (UC), but its change during the acute phase has not been enough investigated.
Methods Patients with UC who initiated the induction therapy with steroid or advanced therapy (biologics or Janus kinase inhibitors) were prospectively enrolled. Associations of LRG, C-reactive protein (CRP) and fecal calprotectin (FC) at baseline, week 1, and week 8 with clinical remission at week 8 and subsequent endoscopic improvement within 1 year (Mayo endoscopic subscore of 0 or 1) were assessed.
Results A total of 143 patients with UC were included. LRG and CRP at week 1 were significantly lower in the clinical remission group than in the non-remission group (LRG, 20.6 μg/mL vs. 28.4 μg/mL, P< 0.001; CRP, 0.9 mg/dL vs. 2.3 mg/dL, P< 0.001) while FC demonstrated the difference between groups only at week 8. The area under the curves of week 1 LRG, CRP, and FC for week 8 clinical remission using the receiver operating characteristic curves analysis were 0.68, 0.71, and 0.57, respectively. Furthermore, LRG and CRP predicted subsequent endoscopic improvement as early as week 1, while FC was predictive only at week 8.
Conclusions LRG can be an early-phase biomarker predicting subsequent clinical and endoscopic response to induction therapy.
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Background/Aims Small bowel capsule endoscopy (SBCE) is an evaluation method for small bowel (SB) lesions in Crohn’s disease (CD). However, the relationship between SBCE findings and the serological biomarker leucine-rich alpha-2 glycoprotein (LRG) remains unclear. We aimed to establish appropriate cutoff values of LRG to predict the presence of SB lesions in CD through SBCE.
Methods Patients with CD with SB lesions who had undergone SBCE and LRG measurements 1 month before and after the SBCE were included. The LRG values for ulcers ≥0.5 cm and other inflammatory lesions noted in SBCE were determined using the Youden Index, and the sensitivity and specificity were calculated. Additionally, the correlation between the SBCE scores (CD Activity in Capsule Endoscopy) and LRG values was evaluated.
Results Forty patients without active colorectal lesions were included in the study. When the cutoff value of LRG for SB ulcers ≥ 0.5 cm was set at 14 μg/mL, the sensitivity was 92.3%, specificity was 81.5%, positive predictive value (PPV) was 70.6%, and negative predictive value (NPV) was 95.7%. In contrast, an LRG cutoff value of 12 μg/mL without inflammatory findings had a sensitivity of 91.7%, specificity of 82.1%, PPV of 68.8%, and NPV of 95.8%. CD Activity in Capsule Endoscopy correlated well with LRG values (Spearman’s rank correlation coefficient ρ = 0.681, P< 0.001).
Conclusions An LRG cutoff value of 14 μg/mL may be useful in predicting the presence of SB ulcers ≥ 0.5 cm, and an LRG cutoff value of 12 μg/mL may be useful in predicting the absence of SB inflammatory findings.
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Background/Aims The prevalence and incidence of ulcerative colitis (UC) in Korea is increasing. Each patient has a different disease course and treatment response. Recently, with the development of biologic agents, histological remission has become a treatment goal. In this study, we aimed to identify the predictors of histological remission after first-line biologic agent treatment in patients with biologic agent-naïve UC.
Methods We retrospectively analyzed the medical records of 92 patients who had been diagnosed with UC and treated with first-line biologic agent treatment at our center, between 2015 and 2022. The clinical characteristics, laboratory test results, and endoscopic and biopsy findings were analyzed. Histological remission was defined as the absence of cryptitis, crypt abscesses, and inflammatory cells on histology. Univariate and multivariate logistic regression analyses were performed to identify the predictors of histological remission after first-line treatment.
Results Of the total 92 patients, 25 (27.2%) achieved histological remission. Each cohort had a varied body mass index (BMI) distribution, with a statistically significant overweight ratio, as defined by the Asian-Pacific BMI category of 23–25 kg/m2, of 48.0% in the histological remission cohort (P= 0.026). A causal correlation between the overweight category and histological remission was confirmed (odds ratio, 3.883; 95% confidence interval, 1.141–13.212; P= 0.030).
Conclusions We confirmed that the overweight category was a predictor of histological remission after first-line treatment with a biological agent. However, as BMI does not account for skeletal muscle mass, future studies are required to confirm the correlation between skeletal muscle mass and histological remission.
Background/Aims Robust management algorithms are required to reduce the residual risk of colectomy in acute severe ulcerative colitis (ASUC) refractory to standard infliximab salvage therapy. The aim of this study was to evaluate the performance and benefits of alternative ASUC management strategies using simulated prediction models of varying accuracy.
Methods This was a simulation-based modeling study using a hypothetical cohort of 5,000 steroid-refractory ASUC patients receiving standard infliximab induction. Simulated predictive models were used to risk-stratify patients and escalate treatment in patients at high risk of failing standard infliximab induction. The main outcome of interest was colectomy by 3 months.
Results The 3-month colectomy rate in the base scenario where all 5,000 patients received standard infliximab induction was 23%. The best-performing management strategy assigned high-risk patients to sequential Janus kinase inhibitor inhibition and mediumrisk patients to accelerated infliximab induction. Using a 90% area under the curve (AUC) prediction model and optimistic treatment efficacy assumptions, this strategy reduced the 3-month colectomy rate to 8% (65% residual risk reduction). Using an 80% AUC prediction model with only modest treatment efficacy assumptions, the 3-month colectomy rate was reduced to 15% (35% residual risk reduction). Overall management strategy efficacy was highly dependent on predictive model accuracy and underlying treatment efficacy assumptions.
Conclusions This is the first study to simulate predictive model-based management strategies in steroid-refractory ASUC and evaluate their effect on short-term colectomy rates. Future studies on predictive model development should incorporate simulation studies to better understand their expected benefit.
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Medical management of acute severe ulcerative colitis in the hospitalized patient Loren G Rabinowitz, Ajay Gade, Joseph D. Feuerstein Expert Review of Gastroenterology & Hepatology.2025; 19(5): 467. CrossRef
Background/Aims Poorly differentiated adenocarcinoma, signet-ring cell carcinoma, and mucinous adenocarcinoma (por/sig/muc), which are considered to be histologic subtypes with a poor prognosis, occur more frequently with colitis-associated cancer than with sporadic tumors. However, their invasiveness and manifestations are unclear. This study aimed to determine the prevalence of the por/sig/muc component in ulcerative colitis-associated neoplasms (UCANs) and its association with invasiveness and to clarify its clinicohistologic and endoscopic features.
Methods This retrospective observational study included patients diagnosed with ulcerative colitis-associated high-grade dysplasia or adenocarcinoma from 1997 to 2022 who were divided according to the presence or absence of a por/sig/muc component.
Results Thirty-five patients had UCAN with a por/sig/muc component and 66 had UCAN without this component. The 5-year survival rate was significantly lower in the por/sig/muc group than in the tub group (67% vs. 96%, P= 0.001), which was attributed to disease above stage III and depth to below the subserosa. Biopsy-based diagnosis before resection detected a por/sig/muc component in only 40% of lesions (14/35). Lesions with a por/sig/muc component were prevalent even in the early stages: stage 0 (4/36, 11%), I (8/20, 40%), II (7/12, 58%), III (10/14, 71%), and IV (6/8, 75%).
Conclusions This is the first investigation that shows UCANs with a por/sig/muc component tended to be deeply invasive and were often not recognized preoperatively. Endoscopists should be aware that UCAN often has a por/sig/muc component that is not always recognized on biopsy, and the optimal treatment strategy needs to be carefully considered.
Background/Aims Vedolizumab (VDZ) is a gut-selective agent with a favorable safety profile. We aimed to assess the feasibility of elective switch from other advanced therapies to VDZ and subsequent live-attenuated vaccination while continuing VDZ in patients with inflammatory bowel diseases (IBD).
Methods We measured antibody titers specific for measles, rubella, mumps, and varicella viruses in IBD patients under immunosuppressive therapy. Those with negative titers and without vaccination history were judged unimmunized. Patients were administered vaccines while continuing VDZ or switched to VDZ if receiving other advanced therapies and then administered vaccines. Co-primary outcomes were the rate of maintaining disease severity after vaccination and the rate without vaccine-induced infection.
Results Among 107 unimmunized patients, 37 agreed to receive live-attenuated vaccines while continuing VDZ (17 patients) or after switching to VDZ (20 patients). In the 20 patients who electively switched to VDZ, disease severity was maintained except for 1 patient who developed intestinal infection. After 54 weeks, 18 patients (90%) continued to receive VDZ, excluding 2 patients who reverted to their originally administered biologics. In all 37 patients administered live-attenuated vaccines under VDZ treatment, disease severity was maintained after vaccination. Antibody titers became positive or equivocal in 34 patients (91.9%). There were no cases of vaccine-induced infection during a median observation period of 121 weeks.
Conclusions While live-attenuated vaccines are contraindicated under immunosuppressive therapy, they may be safely administered while receiving VDZ immunotherapy. Switching from other advanced therapies to VDZ and subsequently receiving live-attenuated vaccines may be a safe alternative in unimmunized patients.
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Live Typhoid and Yellow Fever Vaccines Administered to a Patient With Ulcerative Colitis on Vedolizumab Yash Hegde, Mary S. Hayney, Freddy Caldera ACG Case Reports Journal.2024; 11(10): e01507. CrossRef
Background/Aims The efficacy and safety of tofacitinib for the treatment of refractory ulcerative colitis (UC) has been demonstrated in clinical trials. Although, a series of reports with real-world evidence of its short-term efficacy and safety profiles have already been published, reports of long-term real-world data have been limited. We aimed to show our 3-year evidence on the clinical use of tofacitinib for the treatment of UC, focusing on its efficacy and safety profiles.
Methods A retrospective observational study was conducted on patients who started tofacitinib for active refractory UC at our hospital. The primary outcome was the retention rate until 156 weeks after initiating tofacitinib. The secondary outcomes were short-term efficacy at 4, 8, and 12 weeks; long-term efficacy at 52, 104, and 156 weeks; prognostic factors related to the cumulative retention rate; loss of response; and safety profile, including adverse events.
Results Forty-six patients who were able to be monitored for up to 156 weeks after tofacitinib initiation, were enrolled in this study. Continuation of tofacitinib was possible until 156 weeks in 54.3%, with > 50% response rates and > 40% remission rates. Among patients in whom response or remission was achieved and tofacitinib was deescalated after 8 weeks of induction treatment, 54.3% experienced relapse but were successfully rescued by and retained on reinduction treatment, except for 1 patient. No serious AEs were observed in the study.
Conclusions Tofacitinib is effective and safe as long-term treatment in a refractory cohort of UC patients in real-world clinical practice.
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In which patients with ulcerative colitis would filgotinib be effective? Jihye Park Intestinal Research.2025; 23(1): 1. CrossRef
Tofacitinib for ulcerative colitis in Brazil: a multicenter observational study on effectiveness and safety Rogério Serafim Parra, Renata de Sá Brito Fróes, Daniela Oliveira Magro, Sandro da Costa Ferreira, Munique Kurtz de Mello, Matheus Freitas Cardoso de Azevedo, Aderson Omar Mourão Cintra Damião, Alexandre de Sousa Carlos, Luísa Leite Barros, Maria Luiza Qu BMC Gastroenterology.2025;[Epub] CrossRef
Background/Aims Data on the natural course of Chinese patients with ulcerative colitis (UC) was lacking. This study aimed to evaluate the natural history and prognosis of patients with UC in the past 15 years in China.
Methods This cohort study included patients with UC in a tertiary hospital in southern China from 2007 to 2021 (cohort I: 2007–2011, cohort II: 2012–2016, cohort III: 2017–2021). Patients’ clinical characteristics and natural history were analyzed retrospectively.
Results Of 1,139 included patients, 683 patients presented with proctitis or left-sided colitis at diagnosis and 38.5% of them (263/683) developed proximal disease extension. Fifty-eight percent of patients experienced relapse, chronic continuous and intermittent active course. Five patients (0.4%) developed colorectal tumors/dysplasia. The overall surgery rate was 8.6%, and the rates were 14.2%, 7.8%, and 8.0% in the 3 cohorts, respectively (P= 0.059). Average time from diagnosis to surgery decreased from cohorts I to III (144 months vs. 36 months, P< 0.001), so did the use of glucocorticoids (58.2% vs. 43.5%, P< 0.001) and immunosuppressants (14.1% vs. 13.4%, P= 0.016), and days of hospitalization (13 days vs. 9 days, P< 0.001). Biologics were used more frequently during the first year (0.8%, 2.1%, and 13.7% for cohorts I to III, respectively; P< 0.001). The rate of mucosal healing increased over time.
Conclusions In Chinese UC patients, one-third of patients experienced proximal disease extension. The rates of malignancy and mortality were low. More biologics were used, while use of immunosuppressants and glucocorticoids were reduced over time. Early biologics use seemed to promote mucosal healing, but the rate of colectomy has not dramatically decreased.
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The effects of biologics on ulcerative colitis–related colectomy rate: results of a 22-year study Nur Beyza Tukek, Oguz Kagan Bakkaloglu, Gozde Sen, İbrahim Hatemi, Aykut Ferhat Celik, Yusuf Ziya Erzin Scandinavian Journal of Gastroenterology.2025; 60(6): 548. CrossRef
Background/Aims To describe the role of ustekinumab in inducing remission and endoscopic healing in anti-tumor necrosis factor α nonresponsive pediatric ulcerative colitis patients at a tertiary care inflammatory bowel disease center.
Methods A retrospective chart review was performed on patients with ulcerative colitis receiving ustekinumab. Primary outcome was steroidfree clinical remission at follow-up. Secondary outcomes were biochemical remission and endoscopic healing.
Results Ten children were analyzed; 7 (70%) had ulcerative colitis, and 3 (30%) had inflammatory bowel disease unspecified with colitis. Median follow-up period was 56 weeks. Nine patients (90%) achieved steroid-free clinical remission and biochemical remission. Seven patients had follow-up colonoscopies, out of which 6 (86%) achieved endoscopic remission, while 1 (14%) underwent colectomy. Out of the 3 patients without a follow-up colonoscopy, fecal calprotectin levels downtrended to < 150 mg/kg in 2 patients and < 400 mg/kg in 1 patient from baseline level of > 2,000 mg/kg.
Conclusions Ustekinumab appears efficacious in achieving not only clinical and biochemical remission but also has promising role in inducing endoscopic healing end point in patients who fail other biologics.
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Positionspapier der Gesellschaft für Pädiatrische Gastroenterologie und Ernährung (GPGE) zum zulassungsüberschreitenden Gebrauch von für Erwachsene mit CED zugelassenen Biologika und Signalinhibitoren bei Kindern und Jugendlichen Jan Däbritz, Martin Classen, Kathrin Krohn, Andreas Krahl, Stephan Buderus, Elke Lainka, Jan de Laffolie, Carsten Posovszky Zeitschrift für Gastroenterologie.2025; 63(03): 255. CrossRef
New Therapeutic Challenges in Pediatric Gastroenterology: A Narrative Review Valeria Dipasquale, Claudio Romano Healthcare.2025; 13(8): 923. CrossRef
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Jung Hyun Ji, Seung Hwan Shin, Yong Eun Park, Jihye Park, Jae Jun Park, Jae Hee Cheon, Tae Il Kim, Sang-Bum Kang, Sang Hyoung Park, Soo Jung Park, IBD Research Group of the Korean Association for the Study of Intestinal Diseases (KASID)
Intest Res 2024;22(3):336-350. Published online March 26, 2024
Background/Aims The impact of vaccination on inflammatory bowel disease (IBD) patients is still unknown, and no studies have assessed the changes in patient-reported outcomes (PROs) after vaccination in patients with IBD. Therefore, in this study, we investigated the impact of vaccines on the PROs of patients with IBD.
Methods We conducted a questionnaire survey of patients with IBD who visited outpatient clinics at 4 specialized IBD clinics of referral university hospitals from April 2022 to June 2022. A total of 309 IBD patients were included in the study. Patient information was collected from a questionnaire and their medical records, including laboratory findings, were reviewed retrospectively. Risk factors associated with an increase in PROs after COVID-19 vaccination were analyzed using logistic regression analyses. In addition, we assessed whether there were differences in variables by vaccine order using the linear mixed model.
Results In multivariate analysis, young age ( < 40 years) and ulcerative colitis (UC) were found to be independent risk factors for aggravation of PROs in patients with IBD. In all patients, platelet count significantly increased with continued vaccination in multiple pairwise comparisons. In UC patients, PROs such as the short health scale, UC-abdominal signs and symptoms, and UC-bowel signs and symptoms were aggravated significantly with continued vaccination. There was no significant increase in the variables of patients with Crohn’s disease.
Conclusions Therefore, there may be a need to counsel patients with IBD younger than 40 years of age, and patients with UC before they receive COVID-19 vaccinations.
Background/Aims A previous study demonstrated that half of patients started oral corticosteroids (OCS) for ulcerative colitis (UC) exacerbations at lower doses than recommended by Japanese treatment guidelines (initial OCS prednisolone equivalent dose, 30–40 mg). This may relate to physician’s concern about infection, especially pneumonia including Pneumocystis jirovecii pneumonia (PJP), from high OCS doses. We assessed whether pneumonia incidence is increased with guideline-recommended OCS initial doses.
Methods This retrospective cohort study used the Japan Medical Data Center claims database (2012–2021). The whole cohort consisted of all UC patients who started OCS during the study period meeting the inclusion and exclusion criteria. The matched cohort was created by propensity score matching; the lower (initial OCS dose < 30 mg), guideline-recommended (30–40 mg), and higher groups ( > 40 mg) in a 2:2:1 ratio. Pneumonia incidence in the primary analysis was evaluated in the matched cohort. A Poisson regression model determined pneumonia-related risk factors in the whole cohort.
Results After screening, 3,349 patients comprised the whole cohort; 1,775 patients comprised the matched cohort (lower dose, n = 710; guideline-recommended dose, n = 710; higher dose, n = 355). The incidence of any pneumonia was low; no differences were observed in incidence rates across these dose subgroups. In total, 3 PJP cases were found in the whole cohort, but not detected in the matched cohort. Several risk factors for any pneumonia were identified, including age, higher comorbidities index, treatment in large facility and hospitalization.
Conclusions The incidence of pneumonia, including PJP, in UC patients was low across initial OCS dose treatment subgroups.
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Metabolic Disorders and Inflammatory Bowel Diseases Hye Kyung Hyun, Jae Hee Cheon Gut and Liver.2025; 19(3): 307. CrossRef
Background/Aims Patients of ulcerative colitis (UC) on follow-up are routinely evaluated by sigmoidoscopy. There is no prospective literature to support this practice. We assessed agreement between sigmoidoscopy and colonoscopy prospectively in patients with disease extent beyond the sigmoid colon.
Methods We conducted a prospective observational study at a tertiary care institute for agreement between sigmoidoscopy and colonoscopy. We assessed endoscopic activity using the Mayo Endoscopic Score (MES) and Ulcerative Colitis Endoscopic Index of Severity (UCEIS) and histological activity using the Nancy Index (NI), Robarts Histopathology Index (RHI), and Simplified Geboes Score (SGS).
Results Sigmoidoscopy showed a strong agreement with colonoscopy for MES and UCEIS with a kappa (κ) of 0.96 and 0.94 respectively. The misclassification rate for MES and UCEIS was 3% and 5% respectively. Sigmoidoscopy showed perfect agreement (κ = 1.00) with colonoscopy for assessment of the presence of endoscopic activity in the colon using MES ≥ 1 as activity criteria and strong agreement (κ = 0.93) using MES > 1 as activity criteria. Sigmoidoscopy showed strong agreement with colonoscopy for assessment of the presence of endoscopic activity using UCEIS (κ = 0.92). Strong agreement was observed between sigmoidoscopy and colonoscopy using NI (κ = 0.86), RHI (κ = 1.00), and SGS (κ = 0.92) for the detection of histological activity. The misclassification rate for the detection of histological activity was 2%, 0%, and 1% for NI, RHI, and SGS respectively.
Conclusions Sigmoidoscopy showed strong agreement with colonoscopy for endoscopic and histologic disease activity. Sigmoidoscopy is adequate for assessment of disease activity in patients with UC during follow-up evaluation.
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Comments on “Adequacy of sigmoidoscopy as compared to colonoscopy for assessment of disease activity in patients of ulcerative colitis: a prospective study” Sidharth Harindranath Intestinal Research.2025; 23(2): 225. CrossRef
Background/Aims Intestinal Behçet disease is typically associated with ileocecal punched-out ulcers and significant morbidity and mortality. Intestinal ultrasound is a noninvasive imaging technique for disease monitoring. However, no previous reports have compared intestinal ultrasound with endoscopic ulcer activity or histopathological findings for intestinal Behçet disease. We evaluated the usefulness of intestinal ultrasound for assessing the activity of ileocecal ulcers in intestinal Behçet disease.
Methods We retrospectively compared intestinal ultrasound findings with 73 corresponding endoscopic images and 6 resected specimens. The intestinal ultrasound findings were assessed for 7 parameters (bowel wall thickness, vascularity [evaluated using the modified Limberg score with color Doppler], bowel wall stratification, white-plaque sign [strong hyperechogenic lines or spots], mesenteric lymphadenopathy, extramural phlegmons, and fistulas), and endoscopic ulcer activity was classified into active, healing, and scar stages. Histopathological findings were evaluated by consensus among experienced pathologists.
Results Bowel wall thickness (P< 0.001), vascularity (P< 0.001), loss of bowel wall stratification (P= 0.015), and white-plague sign (P= 0.013) were significantly exacerbated in the endoscopic active ulcer stage. Receiver operating characteristic curve analysis revealed that a bowel wall thickness of > 5.5 mm (sensitivity 89.7%, specificity 85.3%) was potentially useful for detecting active lesions. When compared with histopathological findings, an increase in bowel wall thickness reflected the ulcer marginal ridge, and the white-plaque sign reflected the ulcer bottom.
Conclusions Intestinal ultrasound is useful for monitoring intestinal ulcer activity in intestinal Behçet disease.
Background/Aims Colorectal cancer (CRC) and colorectal polyps are intimately linked, with polyps acting as precursors to CRC. Understanding the molecular mechanisms governing their development is crucial for advancing diagnosis and treatment. Employing a systems biology approach, we investigated the molecular similarities between polyp and CRC.
Methods We analyzed gene expression profiles, protein-protein interactions, transcription factors, and gene ontology to identify common differentially expressed genes (DEGs) and unravel shared molecular pathways.
Results Our analysis revealed 520 commonly dysregulated genes in polyps and CRC, serving as potential biomarkers and pivotal contributors to disease progression. Gene ontology analysis elucidated distinct biological processes associated with upregulated and downregulated DEGs in both conditions, highlighting common pathways, including signal transduction, cell adhesion, and positive regulation of cell proliferation. Moreover, protein-protein interaction networks shed light on subnetworks involved in rRNA processing, positive regulation of cell proliferation, mRNA splicing, and cell division. Transcription factor analysis identified major regulators and differentially expressed transcription factors in polyp and CRC. Notably, we identified common differentially expressed transcription factors, including ZNF217, NR3C1, KLF5, GATA6, and STAT3, with STAT3 and NR3C1 exhibiting increased expression.
Conclusions This comprehensive analysis enriches our understanding of the molecular mechanisms underlying polyp formation and CRC development, providing potential targets for further investigation and therapeutic intervention. Our findings contribute substantively to crafting personalized strategies for refining the diagnosis and treatment of polyps and CRC.
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Chronic Kidney Disease Increases Risk of Delayed Post‐Polypectomy Bleeding: A Large‐Scale Propensity Score‐Matched Analysis Hye Kyung Hyun, Nak‐Hoon Son, So Hyeon Gwon, Hyun Chul Lim, Jihye Park, Soo Jung Park, Jae Jun Park, Jae Hee Cheon, Tae Il Kim, Tae‐Hyun Yoo, Shin‐Wook Kang, Hae‐Ryong Yun, Cheal Wung Huh United European Gastroenterology Journal.2025;[Epub] CrossRef
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Jeongseok Kim, Tae-Geun Gweon, Min Seob Kwak, Su Young Kim, Seong Jung Kim, Hyun Gun Kim, Eun Ran Kim, Sung Noh Hong, Eun Sun Kim, Chang Mo Moon, Dae Seong Myung, Dong Hoon Baek, Shin Ju Oh, Hyun Jung Lee, Ji Young Lee, Yunho Jung, Jaeyoung Chun, Dong-Hoon Yang, on behalf of the Intestinal Tumor Research Group of the Korean Association for the Study of Intestinal Diseases (KASID)
Intest Res 2024;22(2):186-207. Published online April 25, 2024
Background/Aims We investigated the clinical practice patterns of post-polypectomy colonoscopic surveillance among Korean endoscopists.
Methods In a web-based survey conducted between September and November 2021, participants were asked about their preferred surveillance intervals and the patient age at which surveillance was discontinued. Adherence to the recent guidelines of the U.S. Multi-Society Task Force on Colorectal Cancer (USMSTF) was also analyzed.
Results In total, 196 endoscopists completed the survey. The most preferred first surveillance intervals were: a 5-year interval after the removal of 1–2 tubular adenomas < 10 mm; a 3-year interval after the removal of 3–10 tubular adenomas < 10 mm, adenomas ≥ 10 mm, tubulovillous or villous adenomas, ≤ 20 hyperplastic polyps < 10 mm, 1–4 sessile serrated lesions (SSLs) < 10 mm, hyperplastic polyps or SSLs ≥ 10 mm, and traditional serrated adenomas; and a 1-year interval after the removal of adenomas with highgrade dysplasia, >10 adenomas, 5–10 SSLs, and SSLs with dysplasia. In piecemeal resections of large polyps ( > 20 mm), surveillance colonoscopy was mostly preferred after 1 year for adenomas and 6 months for SSLs. The mean USMSTF guideline adherence rate was 30.7%. The largest proportion of respondents (40.8%–55.1%) discontinued the surveillance at the patient age of 80–84 years.
Conclusions A significant discrepancy was observed between the preferred post-polypectomy surveillance intervals and recent international guidelines. Individualized measures are required to increase adherence to the guidelines.
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Background/Aims Mirikizumab is a p19-directed anti-interleukin-23 antibody with potential efficacy against ulcerative colitis (UC). We evaluated the efficacy and safety of mirikizumab in a Japanese subpopulation with moderately to severely active UC from the LUCENT-1 and LUCENT-2 studies.
Methods LUCENT-1 and LUCENT-2 were phase 3, randomized, double-blind, placebo-controlled trials of mirikizumab therapy in adults with moderately to severely active UC. LUCENT-1 was a 12-week induction trial where patients were randomized 3:1 to receive intravenous mirikizumab 300 mg or placebo every 4 weeks (Q4W). Patients achieving a clinical response with mirikizumab following the induction study were re-randomized 2:1 to double-blind treatment with either mirikizumab 200 mg or placebo subcutaneously Q4W during the 40-week maintenance study. The primary outcomes were clinical remission at week 12 of LUCENT-1 and week 40 of LUCENT-2.
Results A total of 137 patients enrolled in Japan were randomized to mirikizumab (n = 102) or placebo (n = 35). Compared with placebo, patients who received mirikizumab showed numerically higher clinical remission at week 12 of induction (32.4% [n = 33] vs. 2.9% [n = 1]) and at week 40 of maintenance (48.9% [n = 23] vs. 28.0% [n = 7]). A greater number of patients achieved key secondary endpoints in the mirikizumab group compared with placebo. The frequency of treatment-emergent adverse events was similar across mirikizumab and placebo groups. Efficacy and safety results observed in the Japanese subpopulation were generally consistent with those in the overall population.
Conclusions Mirikizumab induction and maintenance treatments were effective in Japanese patients with moderately to severely active UC. No new safety concerns were identified.
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