Background:Inflammatory bowel disease (IBD) has significantly increased over the past two decades. However, registries in Latin America remain scarce, prompting the creation of the Colombian pediatric IBD registry for patients under 18 years of age, designed as a continuous and periodically assessed database. Methods:A descriptive, longitudinal, ambispective, and multicenter observational study was conducted in children aged 0-18 years between January 1999 and December 2021. The analysis was performed based on the age of onset (Paris classification), with subdivisions for very early onset and phenotypes using the Pediatric IBD-classes algorithm. Data were collected in REDCap and analyzed with STATA 15.1. Results:A total of 209 patients were included, 54.5% male. The median age at diagnosis was 12.3 years (IQR 8.5-14.6). Phenotype distribution included: 104 (53.06%) typical ulcerative colitis (TUC), 52 (26.53%) Crohn's disease (CD), 18 (9.18%) unclassifiable IBD (U-IBD), 11 (5.61%) colonic Crohn's disease (CCD), and 11 (5.61%) atypical ulcerative colitis (AUC). The median time to diagnosis was 6.6 months, and treatment began after a median of 11.2 days. Coffee-cultivation zone 39%. Extraintestinal manifestations were reported in 43.9% of cases. Initial treatments included mesalamine ± steroids (35.86%), immunomodulators ± steroids (32%), exclusive/partial enteral nutrition (11.41%), and biologics ± immunomodulators (20.65%), which increased to 57.7% during follow-up. Relapse occurred in 53.26% of patients, while 35.32% achieved remission. Conclusions:This registry highlights the increasing incidence of pediatric IBD in Latin America, providing valuable insights into clinical presentations, diagnostic delays, treatment strategies, and outcomes, while revealing regional and global disparities.
Background:Tofacitinib is an oral Janus kinase inhibitor used for the treatment of ulcerative colitis. This study evaluated efficacy/safety of dose reduction to tofacitinib 5 mg twice daily (BID) versus remaining on 10 mg BID in patients in stable remission on 10 mg BID. Methods:RIVETING, a phase 3b/4, double-blind, randomized, parallel-group trial, enrolled patients in stable remission (≥6 months) and corticosteroid-free (≥4 weeks) who received tofacitinib 10 mg BID for ≥2 years. Efficacy was reported to month (M)30 and safety was reported throughout. Results:One hundred and forty patients were randomized (1:1) to tofacitinib 5 or 10 mg BID; 50.0% and 62.9%, respectively, maintained modified Mayo score remission at M30. Remission rate differences at M30 between doses were generally greater in patients with a baseline endoscopic subscore of 1 versus 0, and with versus without tumor necrosis factor inhibitor (TNFi) failure. 11/14 patients who dose-escalated from 5 to 10 mg BID following relapse recaptured remission (median 4.8 months). Serious infection and herpes zoster incidence rates were numerically higher with tofacitinib 10 versus 5 mg BID; overall, adverse event rates were generally similar between doses. Conclusions:Patients on tofacitinib 10 mg BID generally maintained modified Mayo score remission through M30 after reduction to 5 mg BID; most patients who relapsed recaptured remission after dose-escalating back to 10 mg BID. Efficacy was more likely to be maintained following dose reduction in patients with baseline endoscopic subscore 0 versus 1, without versus with prior TNFi failure. Serious infection and herpes zoster incidence was higher with tofacitinib 10 versus 5 mg BID, consistent with known safety profile. ClinicalTrialsgov:NCT03281304.
Background:Complications such as intermittent pouchitis (IP) and chronic inflammatory disorders of the pouch (CP) are common after ileal pouch-anal anastomosis (IPAA), particularly among patients with both ulcerative colitis and primary sclerosing cholangitis (PSC). There are no standardized approaches for prophylaxis against these complications for patients with PSC undergoing IPAA. We compared outcomes among patients with PSC and IPAA who received antibiotic or immunosuppressive therapies to those who did not. Methods:We designed a retrospective cohort study that included patients with ulcerative colitis and PSC from 7 tertiary care centers that underwent IPAA between 1994 and 2023. Patients were categorized on whether they received medications following IPAA that may provide primary prophylactic benefit, such as antibiotics, probiotics, immunomodulators, or biologic medications; and the proportion of patients developing IP and CP was evaluated. Results:A total of 172 patients were included in the cohort, and 13 (7.6%) patients received antibiotics or immunosuppressant medications. Antibiotics and probiotics were the most common therapy (5 patients, 2.9%), followed by biologics, small-molecule inhibitors, immunomodulators, or mesalamine (all 1 patient, 0.6%). Compared to patients not receiving antibiotics or immunosuppression, patients receiving antibiotics or immunosuppression were significantly less likely to develop IP (69.2% vs 91.2%; P = .03; odds ratio 0.22; 95% CI, 0.06-0.80) and CP (23.1% vs 56.0%, P = 0.04; OR 0.24, 95% CI, 0.06-0.89). Conclusions:In this retrospective cohort of patients with ulcerative colitis and PSC undergoing IPAA, usage of concomitant antibiotics or immunosuppression was low. However, use of concomitant antibiotics or immunosuppression may decrease the burden of inflammatory conditions of the pouch in these high-risk patients.
Background:In hospitalized patients with ulcerative colitis (UC), timely endoscopy may be constrained. We evaluated whether the inflammatory burden index (IBI; C-reactive protein × neutrophil-to-lymphocyte ratio [CRP×NLR]) is associated with endoscopic activity. Methods:We retrospectively studied adults hospitalized with UC between 2023 and 2025 who underwent index lower endoscopy during the same admission, with blood sampling within 24 hours of admission and endoscopy within 72 hours of admission. Endoscopic activity was graded by Mayo Endoscopic Subscore (MES) and dichotomized as MES 0-1 versus ≥2. Associations with MES ≥2 were examined using logistic regression with adjustment for age, sex, and body mass index, with IBI modeled as log(IBI + 1). Discrimination was assessed by receiver operating characteristic analysis with same-sample DeLong testing. Sensitivity analyses were restricted to endoscopy within 48 hours after blood sampling. Results:Among 107 patients, 83 (77.6%) had MES ≥2. IBI correlated with MES (ρ = 0.58; P < .001) and remained independently associated with MES ≥2 (adjusted OR, 5.28; 95% CI, 2.12-13.14; P < .001). Discrimination was reasonable (AUC, 0.83; 95% CI, 0.76-0.90). CRP alone performed similarly (AUC, 0.80; 95% CI, 0.71-0.88; P = .227 vs IBI), as did a CRP+NLR model (AUC, 0.84; 95% CI, 0.77-0.91; P = .40 vs IBI). Findings were directionally consistent in the ≤48-hour sensitivity analysis. The Youden-derived IBI cutoff was 3.65 (sensitivity, 72.3%; specificity, 91.7%) and should be considered exploratory. Conclusions:In this cohort, IBI was associated with moderate-to-severe endoscopic activity. Performance was comparable to CRP alone, and findings should be interpreted as exploratory rather than as evidence for a standalone clinical decision tool.
Background:Crohn's disease (CD) patients achieving deep remission, defined as clinical remission with endoscopic healing (EH), have a lower rate of CD-related adverse events. EH can be achieved with anti-tumor necrosis factor (TNF) dose optimizations directed by pharmacokinetic (PK) and pharmacodynamic (PD) biomarkers. The primary aim was to identify PK metrics and PD biomarker cut-points associated with EH. Methods:In this multicenter, cross-sectional study, we enrolled CD patients (age 1-22 years) who received an anti-TNF biologic (infliximab or adalimumab) for >6 months and underwent ileocolonoscopy. EH was defined as a simple endoscopic score-CD (SES-CD) < 3. Results:Eighty-seven patients were enrolled with EH found in 55.2%. Lower levels of novel biomarkers neutrophil CD64, monocyte CD64, and soluble CD64 were associated with EH with cut-points of <4.5 ratio (AUROC 0.76), <44.6 ratio (AUROC 0.67), and <15.9 ng/mL (AUROC 0.67), respectively. There was no difference in the mean trough concentrations of infliximab or adalimumab between EH and non-EH, but the median infliximab clearance was higher in non-EH (0.26 L/day) compared to EH (0.21 L/day, P = .02). In our infliximab multivariable model, slower infliximab clearance, lower platelet count, and higher serum albumin were strong predictors for EH (AUC 0.90). Conclusions:We identified novel PK and PD cut-points for biomarkers associated with EH, including infliximab clearance and the novel CD64 biomarkers. Furthermore, we developed a multivariable PK and PD model for EH that, following validation, could guide dose escalation (PK failures) or prompt a switch to an alternate advanced therapeutic for PD failures.
Background:Individuals with inflammatory bowel disease (IBD) experience mental health disorders at rates 1.5-2 times higher than the general population. Many are affected during major life stages such as pregnancy, yet data on how IBD influences anxiety and depression in pregnancy remain limited. Methods:This retrospective survey study included patients from the "Preconception and Pregnancy in IBD" clinic who conceived before January 1, 2022. Standardized pre-visit surveys assessed anxiety (general anxiety disorder-7 [GAD-7]), depression (patient health questionnaire-9 [PHQ-9]), and IBD activity using pMayo6 for ulcerative colitis (UC) and mHBI for Crohn's disease (CD). Demographic variables included age, marital and employment status, smoking, alcohol and cannabis use, prior anxiety/depression diagnoses, IBD subtype, surgical history, and medication use. Linear regression models evaluated associations between disease activity and mental health outcomes, adjusting for medication type and stratifying by trimester and IBD subtype. Results:Ninety-four patients were included: 42 patients had UC (44.7%), and 52 patients had CD (55.3%). Median age was 32 (interquartile range [IQR] 31-35.8) for UC and 32.7 (IQR 30-35.2) for CD. Active UC in the second trimester was associated with significantly higher anxiety (P = 0.034) and depression (P = 0.022) scores compared to those with inactive UC. In the third trimester, this pattern persisted, with active UC again associated with elevated anxiety (P = 0.030) and depression (P = 0.027) scores. Active CD in the second trimester was significantly associated with higher anxiety (P = 0.024) and depression scores (P = 0.021) compared to those in remission. Conclusions:Active IBD during pregnancy is significantly associated with increased anxiety and depression. Multidisciplinary care, including mental health support, is imperative for pregnant people with IBD.
Background:Research is needed to evaluate challenges associated with payers' and patients' uptake of vedolizumab and infliximab subcutaneous (SC) formulations, which were recently approved by the U.S. Food and Drug Administration. Methods:A single center, ambispective study evaluated patients with inflammatory bowel disease with a referral to start or transition to SC vedolizumab or infliximab between September 2023 and December 2024. The primary outcome was time to SC formulation access. Secondary outcomes included whether patients were approved for SC therapy, method of approval, and number of patients not starting SC maintenance therapy after referral. Results:Of the 248 patients included in the regression analyses, most patients (72%) referred to SC were approved, with over half of those approvals occurring via prior authorization (56%). Of the 179 patients approved to start therapy, 21% of patients did not start therapy, largely due to patient decision (45%). The median time to access was 11 days (interquartile range 1-43) with a range of 0-457 days. Patients with commercial pharmacy insurance were 3 times more likely to have a longer time to medication access (odds ratios [OR]: 3.40, 95% confidence interval [CI]: 1.5-6.1, P = .003). Patients not in remission at baseline were 90% more likely to have a longer time to medication access than patients in remission (OR: 1.9, 95% CI 0.8-4.2, P = .127). Conclusions:Over a quarter of patients prescribed SC vedolizumab or infliximab do not start due to payer restrictions or patient preference. Patients with commercial insurance may be less likely to access SC therapy.
Background:Interstitial lung disease (ILD) is a rare extraintestinal manifestation associated with inflammatory bowel disease (IBD). Limited information is available regarding the prevalence and risk factors of ILD in IBD. This study aimed to determine the association of ILD in Crohn's disease (CD) and ulcerative colitis (UC), while analyzing various contributory factors. Methods:A retrospective analysis of patient data at two major tertiary healthcare centers in the southeastern United States from 2012 to 2022 was conducted. Patient demographics, healthcare utilization patterns, and coexisting diagnoses of IBD and ILD were analyzed using comparative statistical analysis. Results:A total of 8865 IBD patients were included in the study, of which 408 (4.6%) had concomitant IBD and ILD. Patients with UC had a significantly higher prevalence of ILD compared to those with CD (P < .001). There were no statistically significant differences in demographics between UC-ILD and CD-ILD patients. There was a significant difference in prevalence between White patients and minority patients with IBD and any form of ILD (P < .001). Finally, individuals with IBD-ILD were significantly older, had a higher proportion of emergency department (ED) visits, had a higher proportion of hospitalizations, had a higher proportion of patients with steroid use, and had a lower proportion of patients with mesalamine prescribed (P < .001), compared with IBD-only patients. Conclusions:Our findings confirm the established literature that ILD is more associated with UC compared to CD, while providing new insight into demographic and healthcare utilization factors between CD-ILD and UC-ILD patients and between IBD-ILD compared to IBD-only patients.
Background:Infliximab and adalimumab are effective anti-tumor necrosis factor (anti-TNF) therapies for the treatment of pediatric Crohn's disease (CD). The aim of this study was to compare the effectiveness of infliximab and adalimumab in a real-world cohort of children with CD. Methods:Data from biological-naïve children with luminal CD (age 3-18 years) who commenced anti-TNF and completed at least 1 year of follow-up were collected from the prospective multicenter observational PIBD-SETQuality study. The primary outcome was steroid-free clinical remission (SFCR), defined as clinical remission (weighted pediatric Crohn's disease activity index [wPCDAI] <12.5) without systemic steroids or luminal surgery at 1 year. The relative risk (RR) of SFCR was calculated using standardization, correcting for the following baseline covariates: age, upfront anti-TNF, C-reactive protein, erythrocyte sedimentation rate, albumin, leukocytes, disease behavior, wPCDAI, perianal disease, and concomitant immunomodulator use. Secondary outcomes included the durability of anti-TNF treatment without luminal surgery. Results:Between January 1, 2017, and June 14, 2024, 178 patients with anti-TNF were included (infliximab: n = 121 [68%], adalimumab: n = 57 [32%]). At 12 months, 34/56 (61%) patients treated with adalimumab and 66/120 (55%) patients treated with infliximab had reached SFCR. The RR of SFCR at 1 year with adalimumab compared to infliximab was 1.25 (95% confidence interval [CI] 0.94-1.66], P = .13. Adalimumab was associated with a significant lower adjusted hazard ratio (aHR) of treatment discontinuation than infliximab in patients with a concomitant immunomodulator (aHR 0.17 [95% CI 0.04-0.75], P = .020), adjusted for upfront anti-TNF. Conclusions:In this prospective cohort of children with CD, adalimumab and infliximab showed comparable clinical effectiveness 1 year after the start of anti-TNF treatment. Clinical trial registration:The ClincalTrials.gov ID of this study is NCT03571373.
Background and Aims:Inflammatory bowel disease (IBD), which includes Crohn's disease (CD) and ulcerative colitis (UC), requires long-term management. Besides pharmacotherapy, nutritional care is considered to be important; however, its real-world status in Japan remains unclear. Methods:In this study, a web-based survey on 150 patients with IBD (CD, 75; UC, 75) was conducted between October 30 and November 4, 2025. Patient demographics, self-perceived relapse frequency, self-perceived relapse triggers, implementation of nutritional therapy, and the use of health management apps were evaluated. Results:Patients with CD reported a higher self-perceived relapse frequency than did patients with UC (≥1 episode/year: 52% vs 32%) and were more likely to perceive diet as a self-perceived relapse trigger (77% vs 39%). Nutritional therapy was introduced in 53% of patients with CD and 12% of patients with UC, and 31% of patients with CD were currently using elemental diets. Most patients consumed 300-900 kcal/day, and some reported symptom improvement, although discontinuation was often due to the physician's decision or difficulty in intake. Dietary management awareness was higher in the CD group than in the UC group (77% vs 48%), whereas supplement use showed no significant difference (37% vs 29%). Health app usage was <10%, with common reasons for nonuse being a lack of awareness and perceived necessity. Conclusions:Nutritional therapy is more frequently administered to patients with CD in Japan, suggesting its clinical relevance. Strategies are required to enhance dietary guidance, support the continued use of elemental diets, and promote digital health tools.
Background:In pediatric inflammatory bowel disease (IBD), the optimal timing to begin therapeutic drug monitoring (TDM) of infliximab (IFX) is unclear. We hypothesized that TDM during induction of IFX improves clinical outcomes in children with IBD. Methods:This retrospective cohort study utilized data from an internal database at Nationwide Children's Hospital between January 1, 2020, and December 31, 2023. Pediatric IBD patients receiving IFX with induction-phase TDM (I-TDM) at Week 6 were compared to those with maintenance-phase TDM (M-TDM) at Week 14. Propensity score matching (PSM) was used for sex, disease, and age at IFX start. The primary outcome was time to clinical remission. Results:In total, 68 patients were matched from each group. The I-TDM group experienced a shorter median time to clinical remission (140 days [95% CI: 108, 167]) compared to the M-TDM group (203 days [95% CI: 167, 232]; P = .006). When adjusting for baseline variations, I-TDM remained independently associated with accelerated clinical remission (aHR = 1.68, 95% CI: 1.10, 2.55; P = .016). While time to therapeutic maintenance IFX levels was similar, post hoc analysis showed that 75% of patients in the I-TDM group achieved target levels in 134 days (95% CI: 114, 182) versus 183 days (95% CI: 153, 224) in the M-TDM group. There were no significant differences in long-term complications between the groups. Conclusions:Induction-phase TDM before the third infusion shortens the time to clinical remission, allowing for more prompt dose adjustments and improving patient outcomes. This approach warrants consideration in clinical practice for children with IBD.
Abstract Background Subcutaneous (SC) infliximab offers pharmacokinetic and convenience advantages over intravenous (IV) therapy, but real-world data from the Middle East are lacking. This study evaluated SC infliximab outcomes in a prospective Middle Eastern IBD cohort. Methods A prospective observational cohort study was conducted in the United Arab Emirates. Adult IBD patients were enrolled as switchers (transitioning from stable IV to SC infliximab 120 mg or 240 mg Q2W) or new starters (SC 120 mg Q2W following IV induction). Clinical outcomes and pharmacokinetics were assessed. Results Fifty-eight patients were included (33 switchers [10 receiving 120 mg Q2W, 23 receiving 240 mg Q2W] and 25 new starters), with median follow-up of 10.1 months (IQR 7.3 to 12.9). In the switcher cohort, 90.9% maintained clinical remission post-switch, with stable CRP, serum albumin, and faecal calprotectin, and significant increases in median trough concentrations: 9.5 to 20.0 mcg/mL in the 120 mg group (p = 0.044) and 8.0 to 42.0 mcg/mL in the 240 mg group (p = 0.001). Among new starters, 88% achieved clinical remission post-induction, with a median post-induction trough level of 16.0 mcg/mL; significant improvements in CRP, serum albumin, and faecal calprotectin were observed. Dose intensification was required in 28% of new starters. Drug persistence was high and comparable across all groups (log-rank p = 0.61), with 12-month rates of over 92% across all cohorts. Conclusions SC infliximab is effective for both switching and de novo IBD management in a Middle Eastern population, delivering high clinical remission rates, robust drug exposure, and durable treatment persistence.
Background:Inflammatory bowel disease (IBD) can lead to a hypercoagulable state, particularly at initial diagnosis. Consequently, venous thromboembolism (VTE) represents a serious complication associated with IBD. For children, the risk of VTE near the time of IBD diagnosis has not yet been quantified, and guidance for VTE prophylaxis remains unclear. Methods:This multisite matched case-control study examined pediatric patients with a new diagnosis of IBD from 2019-2024. Cases were those who developed VTE ≤30 days prior or ≤90 days post IBD diagnosis. Controls were newly diagnosed IBD patients without VTE. Each case was matched to 2-6 controls based on IBD subtype and age at IBD diagnosis. Demographics, laboratory values, prothrombotic risk factors and treatments were compared between matched cases and controls using conditional logistic regression stratified, by case sets. Results:Study subjects included 15 cases and 52 controls, resulting in 70 matched pairs. Factors associated with early VTE included lower hemoglobin (P = .003), lower albumin (P = .002), corticosteroids use (P = .01), central line (P = .002), and any surgery ≤90 days post IBD diagnosis (P = .001). No association with VTE was detected for platelets, C-reactive protein, fecal calprotectin, family history of IBD or body mass index. Conclusions:Albumin, hemoglobin, steroid use, central line, and any surgery ≤90 days post IBD diagnosis were associated with early VTE. These risk factors may be used in a future prediction model to stratify newly diagnosed pediatric IBD patients by their risk for early VTE development.
Background:The Crohn's disease (CD) exclusion diet (CDED) is an emerging dietary therapy for inducing remission in CD. However, data on its effects on gut microbiome in adults remain limited. This study investigated microbial responses to CDED in adults with mild-to-moderate CD and compared them with pediatric patients and healthy pediatric controls. Methods:Microbiome data were analyzed from a randomized controlled trial (RCT) in adults (baseline, weeks 6, 12, 24) and a pediatric RCT (baseline, weeks 6, 12). Baseline microbial composition, diversity, and functional potential were compared between patients who achieved sustained clinical remission (SCR) at both weeks 12 and 24 and those who did-not. Functional profiling was performed using gene ortholog annotations, linear discriminant analysis, and metabolite inference. Results:Baseline microbial and functional profiles differed between patients with and without SCR. SCR was associated with lower alpha diversity, higher relative abundances of Alistipes and Faecalibacterium, and increased flagellin gene expression. SCR was associated with enrichment of genes for redox balance, fatty acid metabolism, and DNA repair, while non-SCR showed elevated NAD biosynthesis, bacterial adhesion, and pro-inflammatory pathways. Haemophilus and Prevotella were negatively linked to SCR. Compositional and functional microbiome analyses revealed a microbiome shift during CDED-induced remission toward a profile more similar to healthy pediatric controls. Conclusions:Before and during CDED, distinct baseline microbial and functional profiles were associated with SCR. These highlight the potential of the gut microbiome as a biomarker for identifying patients most likely to benefit from sustained effects of dietary therapy, supporting a more personalized approach to CD management.
Background:Bowel urgency (BU) is a disruptive ulcerative colitis (UC) symptom. Etrasimod, a sphingosine 1-phosphate (S1P)1,4,5 receptor modulator, improved BU in the ELEVATE UC clinical program. Methods:We assessed associations between BU and efficacy endpoints, health-related quality of life (HRQoL), and biomarkers (Weeks 12 and 52) in patients receiving etrasimod in ELEVATE UC 52. A patient-reported numerical rating scale (NRS; 0-10; none to worst BU) assessed BU at baseline, Week 12, and Week 52. Binary BU outcomes were BU remission (NRS ≤1), clinically meaningful improvement in BU (NRS ≥3-point decrease), and complete BU remission (NRS = 0). Results:At Week 12, etrasimod-treated patients with BU remission were 4.0 times more likely to be in clinical remission (odds ratio [95% confidence interval (CI)]: 4.0 [2.3-7.1]; P < .0001) and 3.6 times more likely to show endoscopic improvement (3.6 [2.1-6.2]; P < .0001) versus patients without BU remission. Patients with BU remission also had significantly greater improvement in Inflammatory Bowel Disease Questionnaire: Total score (least squares mean difference [95% CI] 21.8 [13.5-30.1], P < .0001) and significantly lower fecal calprotectin and high-sensitivity C-reactive protein (mean [standard deviation] 744.5 [1,758.0] vs 2,314.2 [5,182.2] and 3.2 [5.8] vs 10.5 [24.9], respectively, both P < .0001). A similar association was seen for clinically meaningful improvement in BU and complete BU remission at Week 12 and all BU outcomes at Week 52. Conclusions:In etrasimod-treated patients, bowel urgency outcomes are positively associated with efficacy endpoints, HRQoL scores, and inflammatory biomarkers, and may be surrogate markers of disease activity and HRQoL improvement. ClinicalTrialsgov:NCT03945188.
Background:Subcutaneous (SC) infliximab offers pharmacokinetic and convenience advantages over intravenous (IV) therapy, but real-world data from the Middle East are lacking. This study evaluated SC infliximab outcomes in a prospective middle eastern inflammatory bowel disease (IBD) cohort. Methods:A prospective observational cohort study was conducted in the United Arab Emirates. Adult IBD patients were enrolled as switchers (transitioning from stable IV to SC infliximab 120 or 240 mg Q2W) or new starters (SC 120 mg Q2W following IV induction). Clinical outcomes and pharmacokinetics were assessed. Results:Fifty-eight patients were included (33 switchers [10 receiving 120 mg Q2W, 23 receiving 240 mg Q2W] and 25 new starters), with median follow-up of 10.1 months (interquartile range [IQR] 7.3-12.9). In the switcher cohort, 90.9% maintained clinical remission post-switch, with stable C-reactive protein (CRP), serum albumin, and fecal calprotectin, and significant increases in median trough concentrations: 9.5-20.0 mcg/mL in the 120 mg group (P = .044) and 8.0-42.0 mcg/mL in the 240 mg group (P = .001). Among new starters, 88% achieved clinical remission post-induction, with a median post-induction trough level of 16.0 mcg/mL; significant improvements in CRP, serum albumin, and fecal calprotectin were observed. Dose intensification was required in 28% of new starters. Drug persistence was high and comparable across all groups (log-rank P = .61), with 12-month rates of over 92% across all cohorts. Conclusions:SC infliximab is effective for both switching and de novo IBD management in a middle eastern population, delivering high clinical remission rates, robust drug exposure, and durable treatment persistence.
Background:Inflammatory bowel disease (IBD) represents an increasing public health challenge in Latin America, where structural inequities and limited access to standardized education contribute to gaps in health literacy. Despite the recognized role of patient education in IBD care, region-wide, structured digital initiatives remain limited. Objective:To describe the implementation, reach, and educational performance of PANACEA (PANamerican Crohn's and Colitis Educational Approach), a multinational digital education program for patients with IBD and caregivers in Latin America. Methods:We conducted a multicenter observational descriptive study evaluating four consecutive PANACEA cohorts delivered between 2024 and 2025 through an asynchronous e-learning platform. Adults with IBD or caregivers voluntarily enrolled and completed standardized pre- and post-module knowledge assessments and satisfaction surveys. Program adherence, baseline characteristics, knowledge change, normalized learning gain, and user satisfaction were analyzed using descriptive statistics. Results:A total of 1366 participants from 15 Latin American countries completed baseline assessments (mean age 41.4 years; 80% female). Sustained adherence to the platform was 53.1%. Cohorts with intermediate baseline knowledge demonstrated improvements in program-specific knowledge assessments (absolute improvement 8-9 points; normalized gain 0.43-0.52), while cohorts with high baseline scores exhibited ceiling effects. Participants with lower baseline knowledge tended to demonstrate greater relative improvements in knowledge scores. Satisfaction exceeded 90% across content quality, usability, and perceived usefulness. Conclusions:This observational evaluation demonstrates that PANACEA is a feasible and scalable digital education model for IBD in Latin America, achieving broad regional reach, high user satisfaction, and improvements in program-specific knowledge scores, particularly among participants with lower baseline knowledge levels.
Background and Aims:The therapeutic role of enteral nutrition and diet in patients with ulcerative colitis (UC) has not been adequately explored. We aimed to evaluate the effectiveness of partial enteral nutrition (PEN) in combination with an exclusion diet (ED) in patients with UC. Methods:In this prospective, open-label, non-randomized, quasi-experimental study, patients with mild-to-moderate UC (simple clinical colitis activity index [SCCAI]3-9) were non-randomly allocated to either PEN+ED along with standard of care (SOC) or SOC alone for 4 weeks. The primary outcome was clinical remission (SCCAI ≤2) at week 4. In addition, fecal microbiota analysis was performed at baseline and at week 4 for 14 participants in the PEN+ED group. Results:Sixty patients were included (PEN+ED = 30; SOC = 30). Baseline disease activity parameters were similar between the two groups. At week 4, 66.7% (20/30) of patients in the PEN+ED arm achieved clinical remission compared to 83.3% (25/30) receiving SOC. The proportion of patients with rectal bleeding score "0" was significantly lower in PEN+ED (56.7% vs 86.7%, P = .01) arm at week 4. A numerically higher number of patients required steroids in SOC arm compared to the PEN+ED arm, but it was not significant (23.3% vs 16.7%, P = .748). Microbiome analysis showed significant improvements in alpha diversity, increased relative abundance of beneficial gut microbes, depletion of pathobionts, and shift toward a healthier microbial profile, which was in turn shown to be negatively associated with disease severity. Conclusions:Although PEN+ED does not appear to have additional clinical benefit to SOC at week 4, it was associated with significant improvement in gut microbiota. Long-term benefits of dietary interventions should be explored in future studies. Clinical trial registration number:ISRCTN15559229.
Background:Malnutrition is common in inflammatory bowel disease (IBD) patients and associated with worse outcomes and quality of life. This study aimed to assess the feasibility of referring outpatient IBD patients with qualifying modified malnutrition universal screening tool (mMUST) scores to in-person registered dietitian (RD) evaluations. The secondary aim was to analyze the nutritional data collected. Methods:IBD patients seen at a tertiary care center between August and December 2022 were screened with the mMUST. Those with mMUST ≥1 were referred to an RD for comprehensive nutritional evaluation. Data were extracted via chart review and analyzed using t-tests and Fisher's exact tests. Results:Of 1698 patients, 990 (58%) were screened with the mMUST. Of those who screened positive and were referred, 19 (20%) completed RD evaluations. Among these, 37% consumed less than 75% of the nutritional needs. Body mass indices were evenly distributed between low, normal, and high. Though 26% of patients met a formal definition for moderate or severe protein-calorie malnutrition, 53% had muscle depletion and 42% had fat depletion. Conclusions:A simple screening tool can identify IBD patients at risk for malnutrition; however, patient- and provider-sided barriers prevent appropriate evaluation. The RD evaluations revealed body composition changes and signs of malnutrition that were not reflected in weight or routine labs. These findings highlight the need for routine malnutrition screening and comprehensive dietitian evaluation for all at-risk IBD patients, not just those who appear underweight or frail.
Introduction:Ileocecal resection (ICR) is the most common procedure for primary Crohn's disease. While outcomes of ICR have been extensively studied in Europe and North America, data from North Africa remains scarce. This study reports a 17-year Tunisian experience, evaluating the feasibility of laparoscopic ICR in a low-income country in comparison to open surgery. Methods:This retrospective, single-center study reviewed patients who underwent ICR for histologically confirmed Crohn's disease between 2004 and 2020. Postoperative outcomes of laparoscopic and open approaches were compared. The endpoint was postoperative morbidity and mortality, intraoperative parameters, and recovery metrics. Results:A total of 336 patients underwent surgery for non-recurrent ileocecal Crohn's disease, with laparoscopic resection performed in 80% of cases. Conversion to open surgery occurred in 14.9%, mainly due to hemorrhagic dissection. Postoperative complications occurred in 9.2% of patients, with anastomotic leakage being the most frequent surgical issue. Medical complications were rare (1.2%). Laparoscopy was associated with faster recovery, shorter hospital stays, and lower analgesic requirements, although complication rates were not significantly different. The only significant predictor of anastomotic fistula was low body mass index (BMI) (P < .001). Postoperative mortality was 0.5%. Conclusion:In low-income countries, including North Africa, access to laparoscopy has expanded, with outcomes such as conversion rates and operative times approaching international standards. In our 17-year Tunisian experience, laparoscopic ICR proved feasible, reproducible, and safe. These findings contribute to the limited regional evidence and support the broader adoption of laparoscopy as the preferred surgical approach for Crohn's disease.
