Introduction

Recurrent flares cause disease progression and have a pronounced impact on the quality of life of people with Inflammatory Bowel Disease (IBD). Models using clinical characteristics only moderately predict flares and therefore early intervention or even prevention of flares is difficult in clinical practice. With the rise of remote monitoring platforms such as myIBDcoach, which capture besides clinical disease activity, modifiable lifestyle and psychosocial risk factors and patient-reported outcome measures (PROMs), there is a potential to harness real-world data to increase flare prediction. We build a predictive model to predict flares of IBD. The aim of this study was to validate the model in an independent dataset using the Dutch National IBD core outcome set including PROMS.

Aims & Methods

429 patients from the Patient-Reported Infections Questionnaire [PRIQ] cohort were selected to create the updated model. Data for these patients included both baseline clinical data and PROMs related to lifestyle and psychosocial factors from the myIBDcoach telemedicine platform (ClinicalTrials.gov, NCT02173002) from November 2022 till June 2024. The myIBDcoach data was captured monthly or every 3 months from the platform based on disease activity. Patients were followed for at least 12 months. A flare was defined as clinical disease activity (using the Monitor IBD At Home questionnaire) and one or more of the following: fecal calprotectin > 250g/g, endoscopy, MRI, or CT showing signs of disease activity. Associations between flares and baseline clinical variables (Montreal classification, demographic data and drug use) alone, flares and individual PROMs variable categories (subjective health, psychosocial or lifestyle variables) from the myIBDcoach platform, and between flares and the baseline clinical variables in incorporation with myIBDcoach data were estimated using stepwise group-Lasso logistic regression (G-LASSO), which were evaluated with performance matrices using accuracy, area under the curve (AUC), sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).

Results

The performance of the G-lasso regression model with baseline variables and myIBDcoach PROMs (psychosocial, lifestyle, and medication factors) was better (accuracy: 75%, ROC-AUC: 81%, sensitivity: 71%, specificity: 77%, PPV: 80%, NPV: 69%) than that of the model with baseline data alone (accuracy: 67%, ROC-AUC: 70%, sensitivity: 70%, specificity: 64%, PPV: 71%, NPV: 63%). Based on these results, a higher ROC-AUC suggests that integrating PROMs may improve discriminative capacity.

Conclusion

The inclusion of subjective health and modifiable lifestyle and psychosocial data improved flare prediction in contrast to clinical characteristics alone, which was evidenced in the model performance matrices (accuracy, AUC, sensitivity, specificity, PPV, NPV) while reducing uncertainty and misclassification

References

1. Lalisang RCA, Adriaans G, de Jong M, Van der Meulen-de Jong A, Romberg-Camps M, Mahmmod N, Markus-de Kwaadsteniet T, Dijkstra G, Haans J, Stamm C, Vanwersch R, Jonkers D, Almeida RJ, Pierik MJ, MyIBDcoach Study Group. Can lifestyle and psychosocial factors predict flares of IBD; an exploratory study using telemedicine. J Crohn’s Colitis. 2020;14:S059-60.
2. M. J. de Jong et al., “Telemedicine for management of inflammatory bowel disease (myIBDcoach): a pragmatic, multicentre, randomised controlled trial,” The Lancet, vol. 390, no. 10098, pp. 959–968, Sep. 2017, doi: 10.1016/S0140-6736(17)31327-2.

Disclosure

This project and the submitted abstract titled "Advancing Predictive Modeling of Inflammatory Bowel Disease (IBD) Flares: A Data-Driven Approach Using Lifestyle and Psychosocial Factors from a Remote Monitoring Platform" were supported by Takeda. Takeda provided funding for the research work that formed the basis of this abstract.

Introduction

Vedolizumab (VDZ), a gut-selective anti-lymphocyte trafficking drug indicated for ulcerative colitis (UC), is administered intravenously at Weeks 0, 2, and 6, then every 8 weeks (Q8W). Dose escalation to every 4 weeks (Q4W) may recapture response to treatment in ~50% of patients with inadequate response. Real-world outcomes and factors associated with VDZ dose escalation from Q8W to Q4W remain underexplored.

Aims & Methods

Adults with moderate to severe UC initiating VDZ Q8W maintenance were prospectively followed in a Canadian patient support program (2015-2023). Two cohorts were included: 1) patients escalated to Q4W during maintenance after week 14 infusion (Q8W>Q4W maintenance) and 2) patients maintained on Q8W treatment for ≥2 years without escalating (Q8W maintenance). Rates of clinical remission (partial Mayo Score [PMS]<3) were described by prior biologic experience. Associations between baseline characteristics and clinical remission 3 months after Q4W dose escalation were assessed using Wilcoxon rank sum test and Fisher’s exact test. Treatment persistence at 12 and 24 months after initiation and dose escalation were evaluated in Q8W>Q4W maintenance using Kaplan-Meier survival analysis.

Results

373 patients (68% bio-naïve) and 300 patients (72% bio-naïve) were included in the Q8W>Q4W maintenance and Q8W maintenance cohorts, respectively. Median age at treatment initiation was 47 years in Q8W>Q4W maintenance and 48 years in Q8W maintenance. Both cohorts had a median baseline PMS score of 6. In Q8W>Q4W maintenance, median disease duration before treatment initiation was 4 years and median follow-up was 19 months. In Q8W maintenance, median disease and follow-up duration were 5 years and 35 months, respectively. 14 weeks post-treatment initiation, rates of remission in Q8W>Q4W maintenance were 49% (bio-naïve) and 42% (bio-experienced), and in Q8W maintenance were 72% (bio-naïve) and 70% (bio-experienced) (Table 1). Among patients in Q8W>Q4W maintenance not in remission when dose escalating, 40% achieved clinical remission 3 months after dose escalation. These patients were older at treatment initiation (49 vs. 41 years, p=0.043) and had longer disease duration (6 vs. 3 years, p=0.029) than those who did not achieve remission. In Q8W>Q4W maintenance, 12- and 24-month treatment persistence after initiation was 83% and 48% (bio-naïve) and 79% and 51% (bio-experienced), respectively. After dose escalation, 12- and 24-month treatment persistence was 48% and 39% (bio-naïve) and 53% and 45% (bio-experienced).

Conclusion

Patients with UC who underwent VDZ Q8W>Q4W dose escalation achieved lower rates of remission than those remaining on Q8W, regardless of prior bio-experience. Age at treatment initiation and disease duration were significantly associated with remission among those who escalated to Q4W.

Disclosure

JFL: AbbVie, BMS, Janssen, Frenesius-Kabi, Pfizer, Sandoz, Takeda.
EJB: Participation in advisory boards or speaker services: Abbvie, Janssen, Takeda, Pfizer, Merck, Amgen, Pendopharm, Jamp, Fresenius, Kabi, Bausch Health, Celltrion, Eli Lilly, BMS, Grant/Research: Janssen, Abbvie, Any other investment or relationship that could be judged by a reasonable and knowledgeable participant to have the potential to influence the content of the training activity, Abbvie, Janssen, Takeda, Pfizer, Merck, Amgen, Pendopharm, Jamp, Fresenius, Kabi, Bausch Health, Celltrion, BMS.
AHS: Advisory Board Membership/Consultant: Abbvie, Amgen, BioJAMP, BMS, Celltrion, Fresenius Kabi, Janssen, McKesson, Mylan Pharmaceuticals, Organon, Pendopharm, Roche, Pfizer, Sandoz, Takeda, Viatris, Speakers’ Bureau: Abbvie, Amgen, Ferring, Fresenius Kabi, Janssen, Organon, Pfizer, Sandoz, Takeda, Research Grants: Abbvie, Arena, Celgene/BMS, Genentech, Janssen, Roche, Takeda.
PW: Personal fees from AbbVie, Ferring, Biogen, and Janssen
MJA, AW, RW: were employees of Takeda Canada Inc. at the time of the study.
RM, JW, CP: were employees of Pentavere Research Group Inc. at the time of the study.
LPB: Consulting from AbbVie, Alimentiv, Alma Bio Therapeutics, Amgen, Applied Molecular Transport, Arena, Biogen, BMS, Celltrion, CONNECT Biopharm, Cytoki Pharma, Enthera, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, Gossamer Bio, GSK, HACPharma, IAG Image Analysis, Index Pharmaceuticals, Inotrem, Janssen, Lilly, Medac, Mopac, Morphic, MSD, Norgine, Novartis, OM Pharma, ONO Pharma, OSE Immunotherapeutics, Pandion Therapeutics, Par’Immune, Pfizer, Prometheus, Protagonist, Roche, Sanofi, Sandoz, Takeda, Theravance, Thermo Fisher, Tigenix, Tillots, Viatris, Vifor, Ysopia, Abivax, Samsung, Ventyx, Roivant, and Vectivbio; grants from Takeda, Fresenius Kabi, and Celltrion; and lecture fees from Galapagos, AbbVie, Janssen, Genentech, Ferring, Tillots, Celltrion, Takeda, Pfizer, Sandoz, Biogen, MSD, Amgen, Vifor, Arena, Lilly, Gilead, Viatris, and Medac.
BB: Advisor/Speaker: Ferring, Janssen, Abbvie, Takeda, Pfizer, BMS, Merck, Sandoz, Organon, Lifelabs, Celltrion. Advisor: Alimentiv, Gilead, Iterative Health, AMT, Celgene, Merck, Amgen, Pendopharm, Eli Lilly, BMS, Fresenius Kabi, Mylan, Viatris, Bausch Health, Celltrion Healthcare, BioJamp Pharma, Eupraxia. Research support: Janssen, Abbvie, GSK, BMS, Amgen, Genentech, Merck. Stock Options: Qu Biologic.

Introduction

Aims & Methods

To establish a methodology for accurately estimating the required length of PICC lines.
Between November 2023 and April 2025, various body measurements were collected during PICC line placements. The depth of the selected vein was measured sonographically. Patients’ height, weight, and sex were documented. The PICC line length was determined based on clinical expertise. A post-insertion chest X-ray was performed to confirm the central position of the catheter tip. The distance from the catheter tip to the carina was measured to objectively define central placement. Multiple formulas in clinical use were compared for their accuracy. A regression analysis was conducted to develop a formula that is both accurate and simple to apply.

Results

​A total of 60 PICC lines were successfully inserted without complications. The median patient height was 168 cm (range: 164.3–175.8 cm), weight 59 kg (range: 50.0–83.8 kg), and age 56.5 years (range: 46–65.8). Thirty-five insertions were performed in female patients. The ideal PICC line length was 42 cm (range: 38–44.5 cm). Of the five tested formulas, the best correlations were found with Formula 5 (puncture site to jugulum + jugulum to 3rd intercostal space) with r = 0.68 (p = 0.0005), and Formula 3 (puncture site to acromion + clavicle length + jugulum to 4th intercostal space) with r = 0.67 (p = 0.0005). In simple linear regression, the distances from puncture site to acromion and to jugulum were significantly correlated (p = 0.0007 and p = 0.0019, respectively). The best-fit model in multiple regression included age, height, weight, arm side, puncture site to jugulum, and puncture site to 4th intercostal space (p = 0.0005).

Conclusion

An optimal formula for calculating the correct PICC line length has been identified.

References

Table 1: comparison between the various existing formulas and the newly developed one.

Introduction

Biologic therapies such as anti-TNF-alpha agents (infliximab, adalimumab), interleukin modulators, and gut-selective integrin antagonists like vedolizumab have significantly improved outcomes in inflammatory bowel disease (IBD), leading to enduring remission, better quality of life, and reduced surgical intervention and hospitalizations. However, many patients may eventually lose response, often due to factors like the formation of anti-drug antibodies, altered drug metabolism, or individual patient characteristics. Dose escalation—by increasing dosage or reducing intervals—is commonly used to counteract this loss, especially for anti-TNF therapies guided by therapeutic drug monitoring. Vedolizumab poses a greater challenge in this regard due to the lack of standardized monitoring protocols. We aimed to investigate the effectiveness of dose-escalated infliximab, adalimumab, and vedolizumab in IBD patients who worsened after initial response, evaluating outcomes such as treatment persistence and clinical remission, to guide more personalized, cost-effective treatment strategies.

Aims & Methods

We conducted a retrospective analysis of IBD patients who underwent Infliximab (IFX), vedolizumab, or adalimumab (ADA) therapy dose escalation between 2020-2024 at a tertiary IBD centre. Primary outcomes included clinical remission using disease activity scores (Simple Clinical Colitis Activity/SCCAI Index for UC, Harvey-Bradshaw Index/HBI for CD), biochemical markers (CRP, faecal calprotectin) and treatment persistence, evaluated at 3-12 months, 12 months, and annually up to 36 months post-escalation.

Results

A total of 155 patients (median age 31 years, 46% female) were included, of which 89 patients (57%) were prescribed dose-escalated IFX, 48 patients (31%) were prescribed dose-escalated ADA and 18 patients (12%) were prescribed dose-escalated Vedolizumab. Of those included, 118 patients (76%) had Crohn’s disease, 36 patients (23%) had ulcerative colitis (UC) and 1 patient (1%) had indeterminate disease. Indications for dose escalation included secondary loss of response (SLOR) (105/155; 68%) and/or low drug levels (65/155; 42%). Dose-escalated IFX led to significant improvements in disease activity scores at 3 months (HBI: p=0.002; SCCAI: p=0.0003). Improvement in SCCAI was maintained at 12 months (p=0.00007), 2 years (p=0.0008) and 3 years (p=0.025). Improvement in HBI was maintained at 2 years (p=0.01) and 3 years (p=0.049). Significant improvement in CRP following dose-escalated IFX was reported at 3 months (p=0.011), 12 months (p=0.004), 2 years (p=0.006) and 3 years (p=0.03). Dose-escalated ADA led to a significant improvement in HBI at 3 months (p=0.023). This improvement was maintained at 12 months (p=0.005) and 2 years (p=0.008). Early improvement in faecal calprotectin was reported at 3 months (p=0.046). Significant initial improvement in SCCAI following dose-escalated Vedolizumab was reported at 3 months (p=0.043). This improvement was not maintained at any further follow-up points (p>0.05). Minor adverse events were reported in 3 patients receiving dose escalated ADA and in 6 patients receiving dose escalated IFX.

Conclusion

Our study demonstrates that biologic dose escalation is an effective and safe mechanism to recapture clinical remission, with high rates of treatment persistence.

Introduction

Upadacitinib (UPA) has shown promising results in the pivotal trials, which require validation in clinical practice. Primary aim: To assess the durability of UPA treatment in patients with ulcerative colitis (UC). Secondary aims: To assess the short and long-term effectiveness, dose optimization and response to dosage adjustments, the impact of extraintestinal manifestations (EIM) and immunomediated diseases (IMIDs), and the tolerability of UPA in UC in a real-world setting.

Aims & Methods

Adult patients who started UPA for UC treatment at least 8 weeks prior to data collection and were part of the prospectively maintained ENEIDA registry of GETECCU were included. Patients on concomitant biologic agents or with a history of colectomy were excluded. Patients were followed-up from the first UPA dose until treatment discontinuation or the last visit. Effectiveness analysis was restricted to patients with active disease [Partial Mayo Score (PMS)>2] at UPA initiation. Clinical effectiveness was measured using PMS, and concomitant steroid use was assessed at each visit. Patients who discontinued UPA before their last visit were considered not in remission at subsequent time points (negative imputation).

Results

The study included 168 patients, 89% with active disease; 48% had been previously exposed to JAK inhibitors (JAKi), and 31% to all approved therapeutic targets. Mean time of follow-up was 5.6 months (interquartile range = 2.7-11 months). The proportion of patients under 45 mg/day of UPA was 77% at week 8 and 40% at week 16. A total of 29 patients discontinued treatment during a median follow-up time of 4.3 months. The incidence rate of UPA discontinuation was 27% per patient-year of follow-up, with no significant differences related to prior JAKi exposure (log-rank p-value > 0.05). The main reason for UPA discontinuation was loss of response (34%), with colectomy being the main subsequent treatment (21%). No predictive factors for UPA discontinuation were identified (including severity, number of previous advanced therapies, and prior JAKi exposure). Proportions of patients in steroid-free clinical remission (SFCR) were 67%, 71%, 65%, 60% and 75% at week 8, week 16, month 6, month 12 and month 18, respectively. In multivariate analysis, PMS at baseline [Odds ratio (OR) = 0.79, 95% confidence interval (CI) = 0.63-0.98] and previous exposure to JAKi (OR = 0.29, 95%CI = 0.14-0.61) were associated with lower probability of SFCR at week 8. Among 100 patients in SFCR at week 8, 13 (13%) lost response (31% per patient-year), and 10 (77%) of these had dose escalation, with 9 (90%) regaining SFCR. Of 31 patients (18%) with active EIM/IMIDs at the start of UPA, 15 (48%) showed improvement. Adverse events occurred in 45 patients (27%), with hypercholesterolemia being the most common, but no major cardiovascular or thromboembolic events were reported.

Conclusion

This study, the largest of its kind in clinical practice, confirms the short- and long-term benefits and the safety profile of UPA for UC. Although prior JAKi exposure reduced short-term effectiveness, it did not impact drug survival, indicating that UPA could be a viable option even for patients who have experienced JAKi failure.

Disclosure

María Chaparro has served as speaker, consultant or research or education funding from MSD, Abbvie, Hospira, Pfizer, Takeda, Janssen, Ferring, Shire Pharmaceuticals, Dr. Falk Pharma, Tillotts Pharma, Biogen, Gilead and Lilly.
Luisa de Castro has received grants for conference attendance from Abbvie, Johnsson and Johnsson, Takeda, Falk and Pfizer. She has received grants or participated as a speaker for Johnsson and Johnsson, Falk and Tillots.
Iago Rodríguez Lago has received financial support for traveling and educational activities from or has served as an advisory board member for Abbvie, Adacyte, Biogen, Celltrion, Chiesi, Faes Farma, Ferring, Fresenius Kabi, Galapagos, Janssen, Lilly, Mirum Pharmaceuticals, MSD, Pfizer, Roche, Takeda, and Tillotts Pharma. Research support from AbbVie. Iago Rodriguez Lago is supported by a research grant from Gobierno Vasco-Eusko Jaurlaritza [Grant No 2020111061].
Carla J. Gargallo-Puyuelo Conflicts with Abbvie, Takeda, Janssen, Ferring, Lilly.
Marisa Iborra reports grants and personal fees from MSD, Janssen, Abbvie, Takeda, Kern and Pfizer, during the conduct of the study.
Manuel Barreiro has served as a speaker, consultant and advisory member for or have received research funding from MSD, AbbVie, Janssen, Kern Pharma, Celltrion, Takeda, Gillead, Celgene, Pfizer, Sandoz, Biogen, Fresenius, Ferring, Faes Farma, Dr. Falk Pharma, Chiesi, Gebro Pharma, Adacyte, Vifor Pharma and Oncostellae.
Ruth de Francisco has received support for conference attendance, and research support from AbbVie, Faes Pharma, Ferring, Janssen, Pfizer, Takeda, and Galapagos.
R Pajares Villarroya has received financial support for educational activities from Takeda.
Trapero Martínez Ana María Conflict of interest; Abbvie, Jansen, Lilly, MSD.
Lara Arias García scientific advice, research support and/or training activities for Abbvie FAES Pharma, Kern Pharma, Ferring and MSD.
Raquel Camargo has received funding for different types of training activities from Johnson&Johnson, Avbbie, Pfizer, Ferring, Falk and Galapagos.
Margalida Calafat has served as a speaker or has received research or education funding or advisory fees from Takeda, Janssen, Faes Farma, Falk, Abbvie, Pfizer, Adacyte Therapeutics, Ferring, Gilead, Kern Pharma, and MSD.
MT Diz-Lois Palomares has received funding for training activities/congresses/lectures: Abbvie, Ferring, Johnson and Johnson, Lilly, Takeda.
F. Bermejo has been a speaker, consultant and advisory member or has received research funding from Abbvie, Takeda, Janssen, Pfizer, Lilly, MSD, Biogen, Amgen, Galapagos, Ferring, Faes Farma, Tillotts Pharma, Chiesi, Vifor Pharma.
Marta Calvo Moya has received support for conference attendance, speaker fees, research support, and consultancy fees from AbbVie, MSD, Takeda, Janssen, Pfizer, Lilly, Shire, Chiesi, DrFalk Pharma, Faes Pharma, Ferring, Kern Pharma, and Tillotts Pharma.
MJ Casanova, has received education funding from Pfizer, Takeda, Janssen, MSD, Dr. Falk, Shire, Ferring, Galápagos and Abbvie.
Francisco Mesonero has received funding for educational activities, conferences and scientific advice/consultations from MSD, AbbVie, Takeda, Janssen, Pfizer, Ferring, Kern Pharma, Dr. Falk Pharma, Celltrion Healthcare, Galapagos, Chiesi, Tillots Pharma and Faes Farma.
Yamile Zabana has received support for conference attendance, speaker fees, research support and consulting fees from: AbbVie, Adacyte, Alfa-Sigma, Almirall, Amgen, Boehringer Ingelheim, Dr Falk Pharma, FAES Pharma, Fresenius Kabi, Ferring, Galapagos, Janssen, J&J, Kern, Lilly, MSD, Otsuka, Pfizer, Sanofi, Shire, Takeda, Tillots.
Mónica Sierra has participated as a speaker and attended courses financed by MSD, Abbvie, Takeda, Pfizer, Lilly, Ferring, Sandoz.
B Caballol has received support for congress and conference attendance, speaker fees, research support or consulting fees from Abbvie, Ferring, Janssen, Pfizer, Takeda, Galapagos, Kern Pharma and Lilly.
Javier P. Gisbert has served as speaker, consultant, and advisory member for or has received research funding from MSD, Abbvie, Pfizer, Kern Pharma, Biogen, Mylan, Takeda, Janssen, Roche, Sandoz, Celgene/Bristol Myers, Gilead/Galapagos, Lilly, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Tillotts Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, Norgine and Vifor Pharma.

Introduction

Systemic corticosteroids are the first-line treatment for moderate to severe immune checkpoint inhibitor-induced enterocolitis (ICIec). Infliximab (IFX) is recommended for steroid-refractory cases; however, up to 28% of patients do not respond. Repeated-dose IFX regimens may improve outcomes and reduce recurrence, but optimal management strategies remain undefined. Here, we describe a series of patients treated with dashboard-guided IFX for ICIec.

Aims & Methods

A retrospective, descriptive case series was conducted at the IBD clinic of Hospital Universitari Vall d’Hebron between January 2021 and February 2025. The study included adult patients with ICIec who received IFX guided by a pharmacokinetic (pK) model. Demographic and clinical data were collected and analyzed.

Results

The dashboard model was applied in five patients to provide additional guidance for treatment decisions. The median age was 60 years, and three patients were female. The median time between the first immunotherapy dose and development of ICIec was 14.8 weeks. Endoscopy revealed extensive disease in 60% of patients, and 40% also had upper GI involvement. At baseline, 40% had severe inflammation. Median IFX levels at weeks 1 and 2 following the first IFX dose were 23.5 µg/mL and 22.3 µg/mL, respectively. The median interval between the first and second IFX doses was 12 days. Clinical remission was achieved in 4 out of 5 patients (80%). With a median follow-up of 16.7 ± 8 weeks, 4 of 5 patients (80%) remained in clinical remission without ICIec recurrence; one patient died due to an infectious complication.

Conclusion

Dashboard-guided IFX dosing showed benefit in ICIec patients. Use of pharmacokinetic modeling may support more tailored IFX dosing strategies, potentially improving treatment outcomes in a subset of ICIec patients with severe or extensive disease. Prospective studies are needed to better define optimal treatment strategies for ICIec.