Introduction

Inflammatory bowel disease (IBD), ulcerative colitis (UC) and Crohn’s disease (CD), is a group of chronic inflammatory disorders. Biologics are indicated for patients failing conventional maintenance therapy with moderate to severe activity. Different routes of administration, intravenous (IV), subcutaneous (SC) or oral have been approved. For chronic diseases such as IBD, some patients may prefer self-administered SC dosing to IV dosing as a less time-intensive and more convenient treatment option.

Aims & Methods

This study aims to evaluate evaluate the success of infliximab subcutaneous administration after switching from intravenous administration in IBD patients. The transition from IV to SC administration was proposed to 60 IBD patients in clinical remission. Data on medical history and laboratory tests were collected from electronic health records. Moreover, patients filled a paper questionnaire 8 weeks after the switch focused on the level of satisfaction and onset of adverse event (AE).

Results

Overall 60 patients were enrolled for switching from IV to SC therapy. Most of patients (>80%) did not experience any difficulties in handling the device and respected the correct time-table of administration. The switch was a complete success in 50 out of 60 patients (83.3%). Ten patients stopped subcutaneous formulation: five of these switched back to intravenous formulation for adverse event or patient’s preference, four swap or swop to other therapy and one withdraw from biologic. No predictor of loss of response was found at multivariate analysis. Faecal calprotectin and C-reactive protein values significantly improve after the switch at 3, 6 and 12 months (p= 0.03, p= 0.004, p = 0.01 and p= 0.06, p= 0.001, p= 0.007 respectively). About 16.7 % of patients had at least one side effect after switching. Local pain and swelling at site of injection were the most common AEs. The vast majority of AE were mild and lasted only a few days. No serious AEs were reported and no patient was hospitalized.

Conclusion

Effectiveness of switching from intravenous to subcutaneous infliximab administration in IBD patients is confirmed in our real world cohort of patients.

Introduction

EUS-guided gastroenterostomy (EUS-GE) is increasingly used in the management of Gastric Outlet Obstruction. However, significant variability exists in technical choices which might account for heterogeneous clinical outcomes. The aim of this Delphi methodology was to address open questions and establish a consensus on best practices to gather expert opinions on key aspects of EUS-GE.

Aims & Methods

A panel of 25 international leading experts in EUS-GE was invited to revise literature around the technique. A Delphi process was conducted over three rounds, with each round involving anonymous voting on 29 predefined statements, using a 5-point Likert scale (1: strongly disagree – 5: totally agree). Responses were analysed through Medians [Interquartile Ranges], with pre-defined thresholds for approval, revision or discard of the statement. Statements reaching final consensus were graded based on the strength of agreement, defined as the proportion of responses rated 4 or 5.

Results

Response rate was 88% in Round 1 and 100% in Round 2 and 3. Among 29 statements, eight were approved at Round 1, eighteen at Round 2 and four at Round 3, while two were ultimately rejected.
There was early and excellent agreement (>95%) on the need of fluoroscopy for EUS-GE, the need for electrocautery-enhanced Lumen Apposing Metal Stent (LAMS), and the preference for free-hand release. All panellists agreed that endoscopists performing EUS-GE should be familiar with management of Adverse Events (AEs) such as bleedings or perforations. After discussion, excellent agreement was obtained for the management of AEs (misdeployments and bleedings) and LAMS dysfunctions.
Final Strong agreement (>90%) was reached for preferred patient positioning, the required sedation and the preference for saline solution for jejunal distention.
Extensive discussion with final Moderate agreement (>80%) was reached on the use of dye, the preference for catheter-assisted EUS-GE instead of endoscope- or needle-directed instillation, the typical location for EUS-GE and the operative space required for LAMS release.
Statements on the use of contrast and the choice between WEST and EPASS techniques were removed due to lack of agreement.

Conclusion

Despite technical differences (such as the preference of a jejunal catheter or a double-balloon catheter) most EUS-GE experts agree on key technical principles, providing valuable guidance on the standardization of EUS-GE in clinical practice. Conversely, certain topics showed limited agreement, identifying future research priorities in the field of EUS-GE.

Introduction

Risankizumab (RZB) is a high-affinity humanised immunoglobulin (Ig) G1 monoclonal antibody that selectively binds to the p19 subunit of the interleukin-23 (IL-23) cytokine and inhibits its interaction with the IL-23 receptor.^1,2 Long-term RZB therapy for 3 years of maintenance showed durable efficacy and a well-tolerated safety profile in patients with ulcerative colitis (UC) in the COMMAND open-label extension (OLE) study.^1,3 This post hoc analysis evaluated the long-term efficacy of RZB in improving patient-reported outcomes through week (wk) 96 of the ongoing COMMAND OLE study.

Aims & Methods

COMMAND OLE is a 220-wk study enrolling patients who completed 52-wks maintenance dosing or enrolled directly as responders to induction.^1,3 This analysis included patients who completed 52 wks maintenance and an additional 96 wks of RZB treatment in the OLE. All patients received subcutaneous (SC) RZB180 Q8w starting at OLE wk 0, except patients who had prior rescue therapy (single RZB 1200 mg intravenous dose, then SC RZB360 Q8w) who continued RZB360 in the OLE. The OLE study was not designed to compare RZB180 and RZB360 groups. The data cut-off date for this interim analysis was 30 June 2024. Efficacy outcomes included the percentage of patients who achieved the absence of abdominal pain, bowel urgency, faecal incontinence, nocturnal bowel movements, tenesmus, sleep disruption due to UC symptoms; Inflammatory Bowel Disease Questionnaire (IBDQ) response; a meaningful within-person change (MWPC) in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, Short-Form Health Survey-36 version 2 Mental Component Score (SF-36v2 MCS), and SF-36v2 Physical Component Score (PCS). Results were reported using as-observed (AO; Table) and nonresponder imputation (NRI) methods (Table). Safety was reported previously.³

Results

Of the 1003 patients (RZB180 = 701; RZB360 = 302) who entered the OLE, 398 (39.7%) patients (RZB180 = 262; RZB360 = 136) completed wk 96 at data cut-off date. In the AO analysis, RZB180- or RZB360-treated patients showed sustained improvements from OLE wks 0 to 96 in the absence of abdominal pain, bowel urgency, nocturnal bowel movements, tenesmus, faecal incontinence, sleep disruption due to UC symptoms, IBDQ response, MWPC in FACIT-Fatigue, SF-36 PCSv2, and SF-36v2 MCS (Table). Using the more conservative NRI analysis, similar results were observed for most endpoints through OLE wk 96 (Table). Despite RZB360-treated patients were more likely to have numerically higher clinical and endoscopic activity at OLE wk 0 compared with RZB180-treated patients (Adapted Mayo Score [AMS], mean [standard deviation], RZB180, 2.0 [1.4]; RZB360, 3.5 [2.0]; endoscopic subscore: RZB180, 1.1 [1.0]; RZB360, 1.9 [1.0]; clinical remission per AMS, RZB180, 54.8%; RZB360, 24.8%), at OLE wk 96, both RZB dosing regimens exhibited consistent and similar sustained improvements throughout all investigated patient-reported outcomes.

Conclusion

RZB-treated patients who completed OLE wk 96 (3 years of total maintenance therapy) experienced sustained improvement in quality of life and patient-reported outcomes.

References

1. Louis E, et al. JAMA. 2024; 332:881-97.
2. Singh S, et al. mAbs. 2015;7:778-91.
3. Atreya R, et al. J Crohn’s Colitis. 2025;19(S1):i108-i110 [Abstract].

Disclosure

Funding: AbbVie funded this study (COMMAND; NCT03398135) and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship.
Acknowledgments: AbbVie and the authors thank the participants, study sites, and investigators who participated in this clinical trial. Paulette A. Krishack, PhD, of AbbVie, provided medical writing support; S. Michael Austin, of AbbVie, provided editorial support.
Disclosures: Luc Biedermann has received lecture and consulting fees from Takeda, Sanofi, AbbVie, Falk, Bristol Myer Squibb, and Pfizer and is on advisory boards for AbbVie, Amgen, Bristol Myers Squibb, Falk, Janssen, Pfizer, Takeda, and Sanofi.
Julian Panés received consultancy fees/honorarium from AbbVie, Alimentiv, Athos, Atomwise, Boehringer Ingelheim, Celsius, Ferring, Galapagos, Genentech/Roche, GlaxoSmithKline, Janssen, Mirum, Nimbus, Pfizer, Progenity, Prometheus, Protagonist, Revolo, Sanofi, Sorriso, Surrozen, Takeda, and Wasserman, and has served on a data safety monitoring board for Alimentiv, Mirum, Sorriso, Sanofi, and Surrozen.
Silvio Danese has received consultancy fees from AbbVie, Allergan, Amgen, AstraZeneca, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Enthera, Ferring, Gilead, Hospira, Janssen, Johnson & Johnson, Lilly, Merck Sharp and Dohme, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, TiGenix, UCB and Vifor.
Satoshi Tanida received speaker fees from JIMRO, Mitsubishi Tanabe Pharma, AbbVie, Janssen, Kissei, writing fees from Pfizer, and research funding from AbbVie.
Parambir S. Dulai received research support and/or consulting for AbbVie, Abivax, Adiso, Alimentiv, Bristol Meyer Squibb, Celltrion, Genentech/Roche, Geneoscopy, Janssen, Pfizer, Takeda.
Nidhi Shukla, Jasmina Kalabic, Pierre Morisset, Cecile Holweg, and Dolly Sharma, are employees of AbbVie and may own stock options.
Joana Torres has received grant funding/speaker fees from and/or has participated in advisory boards for AbbVie, Galapagos, Janssen, and Pfizer.

Introduction

Biliary and gastric outlet obstruction (GOO) are common complications in patients with pancreatic cancer, often delaying essential cancer treatments. While endoscopic ultrasound-guided
gastroenterostomy (EUS-GE) has been shown to be superior to duodenal self-expandable metal stents (dSEMS) for managing GOO, the optimal strategy for biliary drainage (BD) in this setting remains unclear. Specifically, there is no consensus on whether to prefer EUS-guided choledochoduodenostomy (EUS-CDS) or EUS-guided hepaticogastrostomy (EUS-HGS).

Aims & Methods

We conducted a systematic review and meta-analysis to identify the optimal biliary drainage approach in patients undergoing EUS-GE for concomitant GOO and biliary obstruction. We searched Medline, Scopus, and EMBASE up to February 2025. Studies were included if they reported outcomes of EUS-CDS or EUS-HGS in patients with biliary obstruction and concomitant GOO
treated by EUS-GE. Pooled outcomes included technical and clinical success, stent dysfunction, and adverse events, analyzed using a random-effects model. Results were reported as relative risks (RRs) with 95% confidence intervals (CIs).

Results

Five studies met inclusion criteria, comprising 128 patients (female = 45.5%; mean age range 63.0–73.0 years), with 61 undergoing EUS-CDS and 67 undergoing EUS-HGS. Four studies were conducted in Europe and one in the United States; one study was prospective. Technical success rates were similar between groups (RR 0.96, 95% CI 0.83–1.11; I² = 0%; EUS-CDS 94.5% vs EUS-HGS 96.4%), as were clinical success rates (RR 1.04, 95% CI 0.92–1.19; I² = 0%; EUS-CDS 96.5% vs EUS-HGS 89.1%). However, the risk of stent dysfunction was significantly higher in the EUS-CDS group compared to EUS-HGS (RR 4.42, 95% CI 1.71–11.43; I² = 0%; EUS-CDS 45.1% vs EUS-HGS 10.9%). The incidence of procedure-related adverse events was comparable between the two approaches (RR 1.14, 95% CI 0.24–5.50; I² = 40.8%; EUS-CDS 10.7% vs EUS-HGS 16.0%).

Conclusion

This meta-analysis suggests that both EUS-CDS and EUS-HGS are similarly safe and effective for managing malignant biliary obstruction in the setting of concomitant GOO. However, EUS-CDS is associated with a more than four-fold increase in the risk of stent dysfunction, which may result in delays to critical cancer treatments.

Disclosure

None