Introduction

Information and communication technologies (ICTs) represent a novel approach to chronic disease management. However, their use in Inflammatory Bowel Disease (IBD) is scarce as no specific tools are available. Our aim was to develop a microlearning programme for IBD patients and to evaluate their outcomes with respect to adherence, medication beliefs and perception of the disease.

Aims & Methods

Prospective cohort study in adult IBD patients (18-70 years) who underwent a microlearning programme over 2 months, through 4-minute videos organised into individualised video pathways that were sent via mobile phone using a Telegram bot. All patients received the main pack of 4 videos, consisting of 2 videos with information about their disease (ulcerative colitis or Crohn's disease), 1 video on adherence and 1 video on corticosteroid treatment. We then add a video for each medication used by the patient in the management of their IBD. Before starting the programme and at 6 months, patients completed the BMQ (Beliefs Medicines Questionnaire) and Brief Illness Perception Questionnaire (BIPQ). We checked the medication possession rate (MPR) at these same intervals, considering a MPR ≥80% as adequate adherence.

Results

Between June and October 2022, 1226 videos were sent to 200 IBD patients: 51.5% female (103), Ulcerative colitis 52.5% (105), median age 46.1 (13.2) years (Table 1). The median of videos per patient was 6 (6-7). Attendance to the ADEII programme ranged from 78% to 90%. Baseline non-adherence in this cohort was 29.8% (59 patients), decreasing significantly to 18.1% (36) after the programme (p=0.02). Likewise, in the BMQ scales, we found significant decreases in the median and IQR of the BMQ scores : Medication Abuse: 8 (7-9) vs 8 (6-9) (p=0.001), BMQ-Medication Harm 10 (8 -12) vs 9.5 (7-11) (p=0.002) and BMQ-Treatment Concern 13.5 (11-16) vs 13 (10-16) (p=0.001), with no change in BMQ-Treatment Need. Regarding illness perception, on the post-intervention BIPQ scale there were significant decreases in P8 Negative Emotions 6 (3-8) vs 5 (3-7) (p=0.003) and P5 Identity 6 (4-8) vs 5 (3-7) (p=0.003), as well as a significant increase in P7 Understanding of illness 7 (5-9) vs 8 (7-9) (p=0.003).

Conclusion

The ICT-based ADEII educational programme was widely accepted by patients, demonstrating an improvement in adherence to treatment with a decrease in negative beliefs about medication and negative emotions and representations, improving the understanding of the disease.

Introduction

An increasing number of patients in clinical practice are transitioning from intravenous (IV) to subcutaneous (SC) dosing of infliximab. In this simulation study, we evaluated hypothetical dosing scenarios for both (normal to obese) adults and children switching from steady-state IV to SC infliximab, as well as those initiating SC infliximab therapy.

Aims & Methods

By combining two previous published infliximab models (1,2) we were able to simulate both IV and SC dosing in adults and children. Various dosing regimens were simulated using a large virtual population. In each scenario, the distribution of trough concentrations and area under the plasma concentration time curve (AUC) was calculated.

Results

Peak levels were higher after IV dosing compared to SC dosing, while trough levels were higher after SC dosing leading to more stable infliximab levels over time. Overall exposure remained largely similar when switching from a standard IV to SC dosing regimen. Patients with a high body mass index and those on high-frequency IV dosing regimens of infliximab demonstrated reduced exposure when transitioned to the fixed SC dose. Paediatric patients exhibited higher exposure on the fixed SC dose. Simulation of SC induction schemes demonstrated early achievement of steady state plasma levels.

Conclusion

Infliximab exposure (AUC) remains largely similar when transitioning from standard IV to SC dosing. Current dosing regimens may not be optimal for morbidly obese patients, paediatric patients and patients on high-frequency infliximab regimens. These findings provide a foundation for future clinical research to refine SC infliximab dosing in these populations.

References

1) Hanzel J, Bukkems LH, Gecse KB, D’Haens GR, Mathôt RAA. Population pharmacokinetics of subcutaneous infliximab CT-P13 in Crohn’s disease and ulcerative colitis. Aliment Pharmacol Ther. 2021;54:1309–19.
2) Fasanmade AA, Adedokun OJ, Blank M, Zhou H, Davis HM. Pharmacokinetic Properties of Infliximab in Children and Adults with Crohn’s Disease: A Retrospective Analysis of Data from 2 Phase III Clinical Trials. Clin Ther. 2011;33:946–64.

Disclosure

RW has no conflicts of interest. RK is an employee and stockholder of Insight RX, a company developing clinical decision software. LD has served as a speaker for AbbVie, Celltrion, Janssen-Cilag and Takeda and has developed continuing education materials for Ferring, all outside the submitted work.

Introduction

Recent developments in diagnostic imaging have increased the detection rate of lymphoma, for which a clear, histopathological diagnosis is critical for the subsequent choice of therapeutic regimen. Over the past decade, endoscopic ultrasound-guided fine needle aspiration/biopsy (EUS-FNA/B) has become widely-used means of tissue collection. However the open lymph node biopsy has conventionally been used to diagnose lymphoma histologically, and the evidence backing the use of EUS-FNA/B for this purpose is still limited.

Aims & Methods

The present study aimed to compare the performance of EUS-FNA/B and the open biopsy for diagnosing lymphoma by retrospectively analyzing 1113 patients with 1224 lesions who underwent either of the two methods at the study center between 2012 and 2024. The patients’ background, pathological diagnosis, procedural factors, and complications were evaluated. The performance of the open biopsy was compared with that of EUS-FNAB in diagnosing lymphoma in accordance with the 5^th edition of the World Health Organization classification of hematolymphoid tumours ¹⁾ (WHO classification).

Results

An open biopsy was performed for 943 lesions, 621 of which were malignant lymphomas, with the face, head, neck, axilla or groin, limb, and other areas being the site of 46, 556, 96, 225, 4, and 16 lesions, respectively. EUS-FNAB was performed for 281 lesions, 82 of which were malignant lymphomas, with the intra-abdominal area, mediastinum, and rectum being the site of 270, 10, and 1 lesion, respectively. The needle gauge used for FNA was 19G, 22G, and 25G in 1, 143, and 36 lesions, respectively, while and the needle gauge for FNB was 20G, 22G, and 25G in 3, 74, and 3 lesions, respectively. The mean number of punctures was 2.3 (range 1-9). EUS-FNAB involved significantly fewer, procedural complications than the open biopsy (14/943 vs 0/281; p=0.04). According to the WHO classification, the diagnostic performance (95% confidence interval) of the open biopsy has sensitivity 93.4 % (91.1-95.2), specificity 100.0 % (98.3-100.0), positive predictive value 100.0 % (99.0-100.0), and negative predictive value 88.7 % (85.0-91.8). The diagnostic performance (95% confidence interval) of EUS-FNAB according to the same classification has sensitivity 79.3 % (68.9-87.4), specificity 100.0 % (97.2-100.0), positive predictive value 100 % (91.8-100.0), and negative predictive value 92.1 % (87.7-95.3 %). Between the groups, there was no significant difference in the proportion of lesions for which immunostaining was able to be performed (615/621 vs 80/82; p = 0.24). The positive diagnosis rate was significantly higher for the open biopsy (580/621 vs 27/40; p < 0.001) but did not differ significantly for the EUS-FNB (580/621 vs 38/42; p = 0.52). Univariate and multivariate analyses found that needle type (FNB needle) was a procedural factor in EUS (needle type, gauge, number of punctures, stroke length) contributing to the diagnosis of lymphoma (odds ratio: 3.83; p = 0.037).

Conclusion

EUS was less complicated than the open biopsy as means of collecting tissue for histologically diagnosing lymphoma, and EUS-FNB had a positive diagnosis rate comparable to that of the open biopsy.

References

1. The 5th edition of the World Health Organization Classification of Haematolymphoid Tumours: Myeloid and Histiocytic/Dendritic Neoplasms. Leukemia. 2022 Jul;36(7):1703-1719.

Introduction

Crohn’s disease (CD) is a chronic inflammatory disease of the gastrointestinal tract. Current therapies include monoclonal antibodies, such as adalimumab (ADA) and infliximab (IFX), that target the inflammatory cytokine tumor necrosis factor alpha, collectively known as anti-TNF. While it has been shown that anti-TNF is effective at inducing and maintaining remission in patients with CD, this treatment fails in up to 40% of CD patients^​. Ineffective treatment results in disease progression and complications, emphasizing the need to understand mechanisms behind non-response and to define prognostic biomarkers. We previously identified differences in the peripheral blood DNA methylome associated with response and non-response. However, it is unclear how differential methylation can affect the transcriptome.

Aims & Methods

In this study, we assembled a cohort of 58 adult CD patients that were scheduled to start ADA or IFX treatment. Response to treatment was assessed after 6-9 months based on strict combination of endoscopic (≥50% reduction SES-CD), biochemical (CRP reduction ≥50% or CRP≤5 mg/L and FCP reduction ≥50% or FCP ≤250 µg/g) and clinical criteria (≥3 point drop in HBI or HBI ≤4 without corticosteroids). Whole peripheral blood leukocytes (PBL) were collected from patients before baseline endoscopy or at first infusion/injection, and 6-9 months later. mRNA was extracted using QIAsymphony system, converted into cDNA and sequenced in a paired-end format on the Illumina NovaSeq at the Amsterdam UMC Core Facility Genomics. Differential expression (DE) analysis was carried out within the R statistical environment (v 4.3.1) using the Bioconductor package DESeq2 (v 1.40.2).

Results

Prior to the start of treatment, we identified 504 and 750 differentially expressed genes (DEGs) distinguishing responders from non-responders in ADA and IFX cohorts, respectively. While 13 genes presented response-associated differential expression for both ADA and IFX, no overall correlation was observed between response-associated differential expression profiles. However, based on canonical pathway analysis, we found that expression differed in both ADA and IFX responders and non-responders at the level of neutrophil degranulation, B-cell receptor regulation, and cell growth and differentiation.

Conclusion

Our data suggest that response to ADA and IFX can be associated to the PBL transcriptome prior to treatment. Furthermore, while the differences between responders and non-responders to ADA and IFX display limited overlap in DEGs, we observe that response-associated pathways are shared.