(1) Background: Transition is a planned movement of paediatric patients to adult healthcare systems, and its implementation is not yet established in all inflammatory bowel disease (IBD) units. The aim of the study was to evaluate the impact of transition on IBD outcomes. (2) Methods: Multicentre, retrospective and observational study of IBD paediatric patients transferred to an adult IBD unit between 2017–2020. Two groups were compared: transition (≥1 joint visit involving the gastroenterologist, the paediatrician, a programme coordinator, the parents and the patient) and no-transition. Outcomes within one year after transfer were analysed. The main variable was poor clinical outcome (IBD flare, hospitalisation, surgery or any change in the treatment because of a flare). Predictive factors of poor clinical outcome were identified with multivariable analysis. (3) Results: A total of 278 patients from 34 Spanish hospitals were included. One hundred eighty-five patients (67%) from twenty-two hospitals (65%) performed a structured transition. Eighty-nine patients had poor clinical outcome at one year after transfer: 27% in the transition and 43% in the no-transition group (p = 0.005). One year after transfer, no-transition patients were more likely to have a flare (36% vs. 22%; p = 0.018) and reported more hospitalisations (10% vs. 3%; p = 0.025). The lack of transition, as well as parameters at transfer, including IBD activity, body mass index < 18.5 and corticosteroid treatment, were associated with poor clinical outcome. One patient in the transition group (0.4%) was lost to follow-up. (4) Conclusion: Transition care programmes improve patients’ outcomes after the transfer from paediatric to adult IBD units. Active IBD at transfer impairs outcomes.

INTRODUCTION: Clinical trials are the key to research in inflammatory bowel disease therapeutics. However, their external validity has been poorly evaluated, as have the outcomes in patients who do not meet the inclusion criteria. METHODS: This retrospective observational study at Miguel Servet University Hospital, Zaragoza, Spain, included all consecutive patients diagnosed with Crohn's disease or ulcerative colitis who initiated biologic treatments between January 2017 and December 2022. Eligibility was assessed against the criteria of pivotal randomized clinical trials (RCTs) for adalimumab, infliximab, golimumab, ustekinumab, or vedolizumab. Clinical effectiveness and safety were evaluated at 14–16 weeks and 54 weeks, with treatment persistence assessed using survival analysis. Effectiveness and persistence were assessed to analyze whether patient selection has an impact on different clinical outcomes. RESULTS: A total of 631 biologic treatments were initiated in 477 patients. Only 16.9% met the RCT criteria according to pivotal RCTs and 8% with newer RCTs. Disease-related criteria were the most frequently unmet (57.3%). Patients with ulcerative colitis were less likely to meet the criteria compared with patients with Crohn's disease (23% vs 4%, P < 0.001). No significant differences were observed in response rates, remission rates, adverse events, or drug discontinuation between eligible and noneligible patients. Survival analysis showed no differences in treatment persistence between both groups (hazard ratio 1.01, 95% confidence interval 0.73–1.38). DISCUSSION: Only a minority of real-world patients with inflammatory bowel disease would qualify for corresponding RCTs, questioning the external validity of these trials. However, real-world use of biologics demonstrated similar effectiveness and safety in eligible and noneligible patients, underscoring the importance of practical clinical judgement in therapeutic decisions.

Background: Telemonitoring for inflammatory bowel disease (IBD) has not consistently demonstrated superiority over standard care; however, noninferiority may be an acceptable outcome if remote care proves to be more efficient. Objective: This study aims to compare the remission time and quality of life of patients with active IBD managed through standard care versus the TECCU (Telemonitoring of Crohn Disease and Ulcerative Colitis) app. Methods: A 2-arm, randomized, multicenter trial with a noninferiority design was conducted across 24 hospitals in Spain. The study included adult patients with IBD who were starting immunosuppressive or biological therapy. Participants were randomized into 2 groups: the telemonitoring group (G_TECCU) and the standard care group (G_Control). The follow-up schedule for the telemonitoring group (G_TECCU) was based on contacts via the TECCU app, while the control group (G_Control) adhered to standard clinical practice, which included in-person visits and telephone calls. In both groups, treatment adjustments were made based on the progression of disease activity and medication adherence, assessed using specific indices and biological markers at each check-up. The primary outcome was the duration of remission after 12 weeks, while secondary outcomes included quality of life, medication adherence, adverse events, and patient satisfaction. Results: Of the 169 patients enrolled, 158 were randomized and 150 were analyzed per protocol: telemonitoring (n=71) and control (n=79). After 12 weeks, the time in clinical remission was not inferior in the telemonitoring group (mean 4.20, SD 3.73 weeks) compared with the control group (mean 4.32, SD 3.28 weeks), with a mean difference between arms of –0.12 weeks (95% CI –1.25 to 1.01; noninferiority P=.02). The mean reduction in C-reactive protein values was –15.40 mg/L (SD 90.15 mg/L; P=.19) in the G_TECCU group and –13.16 mg/L (SD 54.61 mg/L; P=.05) in the G_Control group, with no significant differences between the 2 arms (P=.73). Similarly, the mean improvement in fecal calprotectin levels was 832.3 mg/L (SD 1825.0 mg/L; P=.003) in the G_TECCU group and 1073.5 mg/L (SD 3105.7 mg/L; P=.03) in the G_Control group; however, the differences were not statistically significant (P=.96). Quality of life improved in both groups, with a mean increase in the 9-item Inflammatory Bowel Disease Questionnaire score of 13.44 points (SD 19.1 points; P<.001) in the G_TECCU group and 18.23 points (SD 22.9 points; P=.001) in the G_Control group. Additionally, the proportion of patients who adhered to their medication significantly increased from 35% (25/71) to 68% (48/71) in the G_TECCU group (P=.001) and from 46% (36/79) to 73% (58/79) in the G_Control group (P=.001). The satisfaction rate remained stable at around 90%, although noninferiority was not demonstrated for the secondary outcomes. Conclusions: Telemonitoring patients with active IBD is not inferior to standard care for achieving and maintaining short-term remission. The TECCU app may serve as a viable alternative follow-up tool, pending confirmation of improved health outcomes and cost-effectiveness over the long-term. Trial Registration: ClinicalTrials.gov NCT06031038; https://clinicaltrials.gov/ct2/show/NCT06031038 International Registered Report Identifier (IRRID): RR2-10.2196/resprot.9639

Crohn’s disease (CD) is a chronic immune-mediated inflammatory disorder characterized by transmural inflammation and a progressive course that frequently leads to structural complications such as intestinal fibrosis. Fibrostenosing disease represents a major clinical challenge, affecting up to 50% of patients over time and often requiring surgical intervention. Despite advances in anti-inflammatory therapies, no effective treatments currently exist to prevent or reverse established fibrosis. Intestinal fibrosis arises from a dysregulated tissue remodeling process driven by excessive extracellular matrix deposition and persistent activation of mesenchymal cells, particularly fibroblasts and myofibroblasts. This process is orchestrated through complex interactions between immune and non-immune cells and mediated by key signaling pathways, including transforming growth factor beta (TGF-β1) and the TL1A/DR3 axis. Genetic susceptibility, notably variants in NOD2 and other fibrosis-related genes, contributes not only to disease risk but also to phenotype progression. Epigenetic mechanisms, particularly microRNAs such as the miR-29 and miR-200 families, further modulate fibrogenesis and represent promising non-invasive biomarkers. Additionally, intestinal dysbiosis and specific microbial signatures, including reduced short-chain fatty acid-producing bacteria and the presence of adherent-invasive Escherichia coli, play a critical role in promoting fibrotic pathways. Mesenteric adipose tissue, especially creeping fat, also contributes to fibrosis through immune and metabolic signaling. Emerging biomarkers related to collagen metabolism and advances in molecular profiling are improving early detection strategies. Novel therapeutic approaches targeting fibrogenic pathways, including anti-TL1A agents, show promising preliminary results. A deeper understanding of these mechanisms is essential to develop effective antifibrotic therapies and improve long-term outcomes in CD.

Inflammatory bowel disease (IBD) has variability in the pharmacokinetics of adalimumab, which may predispose patients to subtherapeutic concentrations, therapeutic failure, and/or drug immunogenicity. Population pharmacokinetic (popPK) models estimate individual pharmacokinetic parameters and allow to personalize therapeutic regimens through Model-Informed Precision Dosing (MIPD). This retrospective, longitudinal study evaluated the predictive performance of six population pharmacokinetic models of adalimumab in adult patients with IBD treated at a tertiary hospital. The adequacy and prediction of the models were externally validated using visual analysis of the goodness-of-fit (GOF) plots, prediction-corrected visual predicted checks (pcVPC), analysis of residuals, and statistical metrics such as the Akaike Information Criteria. Bias and prediction were also calculated using mean prediction error, mean absolute percentage error and root mean square error. Bootstrap resampling was applied for statistical comparisons. Pharmacokinetic parameters were estimated using Bayesian methods and compared to theoretical values. A total of 201 subjects were included, 88% with Crohn’s disease, mean age 48.6 (± 16.2) years, 44.8% women. Overall, Berends and Vande models demonstrated the best predictive performance in the majority of comparative analyses: higher coverage in pcVPC and correlation between observed and predicted values, lower bias and precision values, the lowest AIC, and a homogeneous distribution of residuals. However, both models overestimated adalimumab population clearance. These findings support the application of the Berends and Vande models in clinical MIPD strategies. Therefore, pending broader evidence in different populations, driving MIPD adoption is critical to optimize adalimumab regimens and maximize sustained clinical outcomes.