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PARTIAL RESPONSE FOLLOWING INDUCTION OF REMISSION WITH INTRAVENOUS VEDOLIZUMAB (PRIVEDO): EARLY OPTIMIZATION OR SWITCH TO SUBCUTANEOUS FORMULATION? A SN-IBD PROSPECTIVE OBSERVATIONAL STUDY

Fabio Salvatore Macaluso 1, Walter Fries 2, Anna Viola 2, Maria Cappello 3, Piera Melatti 3, Filippo Mocciaro 4, Barbara Scrivo 4, Simona Di Caro 5, Stefano Muscarella 5, Concetta Laura Ferracane 6, Emiliano Giangreco 7, maria giovanna minissale 8, Mauro Grova 9, Raffaele Li Voti 1, Giuseppe Mistretta 1, Sara Renna 1, Angelo Casà 1, Ambrogio Orlando 1

Affiliations

1 Inflammatory bowel disease Unit, “Villa Sofia-Cervello” Hospital, Palermo, Italy

2 Inflammatory bowel disease Unit, "G. Martino” Hospital, Messina, Italy

3 Gastroenterology & Hepatology Section, PROMISE, University of Palermo,, Palermo, Italy

4 Gastroenterology and Endoscopy Unit, Arnas Civico-Di Cristina-Benfratelli Hospital, Palermo, Italy

5 Gastroenterology and Endoscopy Unit, “S. Antonio Abate” Hospital, Trapani, Italy

6 Gastroenterology Unit, “Vittorio Emanuele” Hospital, Catania, Italy

7 Gastroenterology Unit, “Guzzardi” Hospital, Vittoria, Italy

8 Gastroenterology and Endoscopy Unit, “Buccheri La Ferla Fatebenefratelli” Hospital, Palermo, Italy

9 Endoscopy Unit, “Villa Sofia-Cervello” Hospital, Palermo, Italy

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Abstract

Introduction

The optimal management strategy for patients with Crohn’s disease (CD) and ulcerative colitis (UC) who exhibit a partial response following induction therapy with intravenous (IV) vedolizumab (VDZ) remains undefined.

Aims & Methods

The Partial Response Following Induction of Remission with Intravenous Vedolizumab (PRIVEDO) study is a prospective, multicenter investigation conducted within the Sicilian Network for Inflammatory Bowel Disease (SN-IBD). The study aims to evaluate the efficacy of subcutaneous (SC) vedolizumab compared to early optimization of the IV formulation in patients with CD or UC who experienced a partial response after IV induction therapy. Eligible adult patients with active CD or UC who demonstrated a partial response at week 14 following IV VDZ induction were subsequently treated in a 1:1 ratio to receive either SC VDZ (108 mg every two weeks) or IV VDZ (300 mg every four weeks).
Partial response was defined as either: (i) achievement of clinical remission with persistent faecal calprotectin >250 µg/g and/or continued use of systemic corticosteroids; or (ii) a reduction in the Harvey-Bradshaw Index by ≥3 points (for CD) or in the Partial Mayo Score by ≥2 points (for UC) from baseline, without fulfilling clinical remission criteria, regardless of oral steroid use. The primary endpoint was the proportion of patients achieving steroid-free clinical remission and faecal calprotectin <250 µg/g at weeks 26 and 52. The secondary endpoint was the rate of clinical benefit—defined as steroid-free clinical remission or partial response—regardless of faecal calprotectin levels at the same time points. Here, we report interim data on 88 patients at week 26 and 69 patients at week 52.

Results

A total of 106 patients were enrolled [CD: n=57 (53.8%); UC: n=49 (46.2%)], with 52 patients (49.1%) allocated to the IV group and 54 (50.9%) to the SC group. Baseline characteristics were comparable between the two treatment arms. At week 26, the primary endpoint was achieved more frequently in the SC group compared to the IV group (42.9% vs. 10.9%; p=0.006). The proportion of patients achieving clinical benefit (secondary endpoint) was also higher in the SC group (73.8% vs. 58.7%), although this difference was not statistically significant (p=0.13). At week 52, the proportion of patients meeting the primary endpoint was 35.5% in the SC group and 18.4% in the IV group (p=0.29). Clinical benefit rates at this time point were 41.9% and 36.8%, respectively (p=0.67).

Conclusion

These preliminary findings suggest that in patients with an incomplete response to VDZ induction, switching to SC administration may offer a more profound remission at mid-term follow-up (26 weeks) compared to continued intensified IV therapy. Further analysis of the complete 52-week data set is required to confirm these observations.

Disclosure

FSM served as an advisory board member and/or received lecture grants from AbbVie, Ferring, Galapagos, Giuliani, Janssen, Lilly, Liohealth s.r.l., Pfizer, Sandoz, Takeda Pharmaceuticals. WF served as an advisory board member and/or received lecture grants from Abbvie, MSD, Takeda, Pfizer, Biogen, Sandoz, Zambon, Ferring, Sofar. AV received lecture grants from Pfizer. MC served as an advisory board member for AbbVie, MSD, Takeda Pharmaceuticals, and received lecture grants from AbbVie, MSD, Chiesi, and Takeda Pharmaceuticals. MC served as an advisory board member for AbbVie, MSD, Takeda Pharmaceuticals, and received lecture grants from AbbVie, MSD, Chiesi, and Takeda Pharmaceuticals. FM served as an advisory board member for Janssen and Galapagos, and received lecture grants from Takeda Pharmaceuticals. SR served as an advisory board member for AbbVie, Janssen, and MSD Pharmaceuticals, and received lecture grants from AbbVie, Galapagos, Janssen, MSD, Pfizer, and Takeda Pharmaceuticals. AO served as an advisory board member for AbbVie, Ferring, Galapagos, Lilly, MSD, Janssen, Pfizer, Samsung Bioepis, and Takeda Pharmaceuticals, and received lecture grants from AbbVie, Fresenius Kabi, Galapagos, Lionheath s.r.l., MSD, Sofar, Chiesi, Janssen, Pfizer, and Takeda Pharmaceuticals. All other authors: nothing to disclose.

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

Advanced IBD therapies: Lessons over time (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Personalising treatment: Tailoring to precision

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Personalising treatment: Tailoring to precision

Francesco Sclafani 1

Affiliations

1 Université libre de Bruxelles, Bruxelles, Belgium

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Abstract

Event

UEG Week Berlin 2025

Topics

Colorectal Digestive Oncology Mechanisms & Personalised Medicine

Session

Catching up with every day's practise in colorectal cancer treatment

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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EUS guided therapeutic procedures

Roy LJ van Wanrooij 1

Affiliations

1 Amsterdam UMC, Amsterdam, Netherlands

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Abstract

Event

UEG Postgraduate Teaching Programme Berlin 2025

Topics

Endoscopy Surgery

Session

Is there really an added value for all new EUS/ERCP techniques?

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Share via Email Share on Facebook Share on X Share on LinkedIn Share on Bluesky

Summary: Is there really an added value for all new EUS/ERCP techniques?

This content is part of Gutflix. Log in with your myUEG account, or create one free, to watch it.

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Summary: Is there really an added value for all new EUS/ERCP techniques?

Jeanin van Hooft 1

Affiliations

1 Leiden University Medical Center, Leiden, Netherlands

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Abstract

Event

UEG Postgraduate Teaching Programme Berlin 2025

Topics

Endoscopy Surgery

Session

Is there really an added value for all new EUS/ERCP techniques?

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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EUS-guided therapy of gastric varices: The role of endoscopic nurse-team work

Katarzyna Pawlak

Endoscopic management of pancreatic fistulas

Robert C. Verdonk

UEG Presentation

Share via Email Share on Facebook Share on X Share on LinkedIn Share on Bluesky

PLASMA PROTEOMIC PROFILES FOR PREDICTING HEPATIC COMPLICATIONS UP TO 16 YEARS BEFORE ONSET

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PLASMA PROTEOMIC PROFILES FOR PREDICTING HEPATIC COMPLICATIONS UP TO 16 YEARS BEFORE ONSET

Shuo Chen 1, Jing Feng 1, Yajie Zhang 1, Tong Lin 1, Wuzheng Xia 2, Weihong Sha 1, Hao Chen 1

Affiliations

1 Department of Gastroenterology, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China

2 Department of Organ transplantation, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China

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Abstract

Introduction

Chronic liver disease is a major global health concerns, contributing to over 1.4 million annual deaths worldwide¹. Its primary fatal outcomes, hepatic complications^2,3, arise from liver cirrhosis, hepatocellular carcinoma and hepatic decompensation. The early, reversible stages of chronic liver disease are frequently asymptomatic and overlooked, leading to delayed diagnoses and irreversible complications that treatment options are limited.^4,5. Therefore, reliable tools to identify whether a person will develop hepatic complications in the future have become a public health priority, enabling early diagnosis and timely intervention in high-risk populations.

Aims & Methods

This study aimed to employ machine learning to develop proteomics-based models for the early identification of hepatic complications. In this study, 37,178 adults without hepatic complications at baseline were analyzed from a prospective cohort from United Kingdom, with plasma levels of 2,736 proteins measured using Olink technology. Cox regression was used to identify significant proteins associated with incident hepatic complications. Models based on importance-top-ranking proteins were constructed using LightGBM learners of Automated Machine Learning (AutoML) and internal validated through 5-fold cross validation in the derivation set (n = 37,178). Independent validation was then conducted in a geographically distinct UKB cohort (n = 15,767).

Results

Over a median follow-up of 13.8 years, 338 participants developed hepatic complications. Cox regression identified 593 proteins significantly associated with incident hepatic complications. Among them, GDF15, PROC, GGT1, ANXA10, IL18, MFAP4, COL4A1, CDCP1 and IL6 were ranked highest in protein importance ordering. The protein model showed a considerable predictive accuracy for hepatic complications under different time scenarios in the UKB validation set: all-year (area under the curve [AUC] = 0.89), within 5 years (AUC = 0.88), within 10 years (AUC = 0.91), over 10 years (AUC = 0.81), and achieved superior predictive performance compared to models with demographic predictors, laboratory indicators, polygenic risk score (PRS) and traditional risk score models (Protein 0.89 vs. Demographics 0.83, Laboratory 0.85, PRS 0.49; Fibrosis-4 index [FIB-4] 0.76, Aspartate aminotransferase to platelet ratio index [APRI] 0.78; all P < 0.05). Combined with clinical data and PRS, the predictor performance is further enhanced: all-year (AUC = 0.91), within 5 years (AUC = 0.91), within 10 years (AUC = 0.90), over 10 years (AUC = 0.83). Individuals in the high-risk group stratified by the protein model were 16.27 times more likely to develop hepatic complications.

Conclusion

Our study constructed a novel protein model for hepatic complications risk stratification and could be used to predict individuals who will develop hepatic complications up to 16 years in advance in the general population.

References

1. Tham EKJ, Tan DJH, Danpanichkul P, et al. The Global Burden of Cirrhosis and Other Chronic Liver Diseases in 2021. Liver Int 2025;45:e70001.
2. Åberg F, Asteljoki J, Männistö V, et al. Combined use of the CLivD score and FIB-4 for prediction of liver-related outcomes in the population. Hepatol Baltim Md 2024;80:163–172.
3. Innes H, Morling JR, Buch S, et al. Performance of routine risk scores for predicting cirrhosis-related morbidity in the community. J Hepatol 2022;77:365–376.
4. Karlsen TH, Sheron N, Zelber-Sagi S, et al. The EASL–Lancet Liver Commission: protecting the next generation of Europeans against liver disease complications and premature mortality. The Lancet 2022;399:61–116.
5. Serra-Burriel M, Juanola A, Serra-Burriel F, et al. Development, validation, and prognostic evaluation of a risk score for long-term liver-related outcomes in the general population: a multicohort study. Lancet Lond Engl 2023;402:988–996.

Event

UEG Week Berlin 2025

Topics

Hepatobiliary IBD Mechanisms & Personalised Medicine

Submission format

Abstract

Session

Predicting and understanding early stages of advanced liver disease

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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PLASMA PROTEOMIC PROFILES FOR PREDICTING HEPATIC COMPLICATIONS UP TO 16 YEARS BEFORE ONSET

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EUS-guided therapy of gastric varices: The role of endoscopic nurse-team work

Katarzyna Pawlak

Endoscopic management of pancreatic fistulas

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UEG Presentation

Share via Email Share on Facebook Share on X Share on LinkedIn Share on Bluesky

EUS-guided therapy of gastric varices: The role of endoscopic nurse-team work

This content is part of Gutflix. Log in with your myUEG account, or create one free, to watch it.

Not sure what you can access? Learn more about account types.

EUS-guided therapy of gastric varices: The role of endoscopic nurse-team work

Ela Bak 1, Katarzyna Pawlak 2

Affiliations

1 Wojskowy Instytut Medyczny, Warsaw, Poland

2 Hospital of the Ministry of Interior and Administration, Szczecin, Poland

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Abstract

Event

UEG Week Berlin 2025

Topics

Nurses

Session

Endoscopic techniques: Emergency and difficult situations

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

More Like This:

Personalising treatment: Tailoring to precision

Francesco Sclafani

EUS guided therapeutic procedures

Roy LJ van Wanrooij

Summary: Is there really an added value for all new EUS/ERCP techniques?

Jeanin van Hooft

PLASMA PROTEOMIC PROFILES FOR PREDICTING HEPATIC COMPLICATIONS UP TO 16 YEARS BEFORE ONSET

Hao Chen

EUS-guided therapy of gastric varices: The role of endoscopic nurse-team work

Katarzyna Pawlak

Endoscopic management of pancreatic fistulas

Robert C. Verdonk

UEG Presentation

Share via Email Share on Facebook Share on X Share on LinkedIn Share on Bluesky

Endoscopic management of pancreatic fistulas

This content is part of Gutflix. Log in with your myUEG account, or create one free, to watch it.

Not sure what you can access? Learn more about account types.

Endoscopic management of pancreatic fistulas

Robert C. Verdonk 1

Affiliations

1 St. Antonius Ziekenhuis, Nieuwegein, Netherlands

Summary

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Abstract

Event

UEG Week Berlin 2025

Topics

Hepatobiliary Pancreas Surgery

Session

Post-OP complications: When do we need to step in?

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Personalising treatment: Tailoring to precision

Francesco Sclafani

EUS guided therapeutic procedures

Roy LJ van Wanrooij

Summary: Is there really an added value for all new EUS/ERCP techniques?

Jeanin van Hooft

PLASMA PROTEOMIC PROFILES FOR PREDICTING HEPATIC COMPLICATIONS UP TO 16 YEARS BEFORE ONSET

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EUS-guided therapy of gastric varices: The role of endoscopic nurse-team work

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UEG's educational platform for gastroenterology education bringing recordings, courses, guidelines, and more together in one place.

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