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PREDICTORS OF ANTI-TNF TREATMENT FAILURE IN INFLAMMATORY BOWEL DISEASE PATIENTS NAÏVE TO BIOLOGIC DRUGS: A 20-YEAR REAL WORLD STUDY

Julia Lopez de la Cruz 1, Carla Jerusalén Gargallo-Puyuelo 2, Beatriz Gallego 3, Erika Alfambra 3, María Aso Gonzalvo 1, Viviana Laredo De La Torre 4, Javier Louro 2, Pablo Latorre 4, Teresa Arroyo Villarino 5, Fernando Gomollón 6

Affiliations

1 Hospital Universitario Lozano Blesa, Zaragoza, Spain

2 Hospital Lozano Blesa, Zaragoza, Spain

3 IIS Aragon, Zaragoza, Spain

4 Hospital Clinico Universitario Lozano Blesa, Zaragoza, Spain

5 H.c.u. lozano blesa, Zaragoza, Spain

6 Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain

Summary

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A retrospective cohort of 421 IBD patients identified HLA-DQA1*05 as a risk factor for loss of response to first-line anti-TNF therapy and HLA-DQA1*03 as protective, while female sex and infliximab use were associated with increased adverse effects.

Carrying HLA-DQA1*05 allele was associated with increased risk of loss of response to anti-TNF drugs (OR 1.83, p=0.009), while carrying HLA-DQA1*03 allele was protective (OR 0.37, p=0.026) in multivariate analysis.
Primary response rate at 24 weeks was 84.8 percent overall (infliximab 82.5 percent, adalimumab 87.8 percent), with loss of response occurring in 33.3 percent of patients at a mean of 5 years.
Female sex (OR 1.61, p=0.032), infliximab use (OR 2.00, p=0.003), and higher than standard infliximab induction doses (OR 3.28, p=0.034) were independent risk factors for adverse effects.
The study included 290 Crohn's disease and 131 ulcerative colitis patients who were biologic-naïve at treatment initiation between 2000 and 2022, with minimum 6-month follow-up.

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Abstract

Introduction

Biologic drugs are key in the current treatment of patients with inflammatory bowel disease (IBD). Identifying patients at high risk of primary non-response or loss of response is key to individualize treatment

Aims & Methods

Aim: To identify risk factors associated with primary nonresponse, loss of response and adverse effects to the first biologic drug used in patients with IBD.
Methoids: Single-centre retrospective cohort study including all consecutive patients with IBD naïve to biologic treatment who have started biologic treatment from 2000 to January 2022. A minimum follow-up of 6 months from the start of the biologic was required. Only the first biologic used in each patient was evaluated. HLA-DQA1 genotyping was done in all patients. Primary response rate was assessed at 24 weeks. Regression analyses were used to assess risk factors. The possible risk factors evaluated were sex, HLADQA1 genotype, smoking at diagnosis, body mass index, age at diagnosis, disease type, location, extent and phenotype disease according to Montreal classification, type biologic drug, disease severity at biologic initiation (Mayo index and Harvey Bradshaw index), combotherapy (≥ 6 months), and history of IBD resective surgery.

Results

A total of 421 patients were included, 290 with Crohn's disease and 131 with Ulcerative Colitis. 51.1% were male. The mean age at biologic initiation was 39 years. The most commonly used biologic was infliximab (IFX) (50.1%), followed by adalimumab (ADA) (46.8%). 46.1% carried HLADQA1*05 allele/s and 24.2% carried HLADQA1*03 allele/s. Almost half of the patients (47.7%) were treated with combotherapy ( biologic + inmmunomodulator). The primary response rate was high: 84.8% (IFX 82.5%, ADA 87.8%). The loss of response rate was 33.3% (IFX 29.9%, ADA 35.5%), with a mean time of 5 years. Adverse effects occurred in 22.1% of patients (IFX 28.9%, ADA 16.2%). In multivariate analysis, carrying HLADQA1*05 allele was the only factor of all evaluated that was associated with an increased risk of loss of response [Odds Ratio: 1.83 (1.16-2.87), p=0.009], while carrying an HLADQA1*03 allele was protective for loss of response [Odds ratio: 0.37 (0.15- 0.89), p=0.026]. Female sex [Odds ratio: 1.61 (1.04-2.49), p=0.032)], the use of infliximab [Odds ratio: 2.00 (1.28-3.14), p=0.003] and the use of higher than standard doses in the IFX induction regimen [Odds Ratio: 3.28 (1.10-9.81), p=0.034] were identified as risk factors for the development of adverse effects.

Conclusion

1) Our results support that carrying HLADQA1*05 increases the risk of secondary loss of response to anti-TNF drugs and suggest that carrying HLADQA1*03 decreases this risk.
2) Female sex is an independent risk factor for the development of adverse effects to anti-TNF drugs.
3) Infliximab is the biologic drug with the highest rate of adverse effects and the use of higher than standard doses during induction is associated with an increased risk of adverse effects.

Conference

UEG Week Copenhagen 2023

Topics

IBD

Submission format

Abstract

Session

PP 05 IBD (Posters)

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

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BEYOND RECURRENT ACUTE PANCREATITIS: EARLY CHRONIC PANCREATITIS AS A DISTINCT PHENOTYPE IN THE PANCREATITIS CONTINUUM

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BEYOND RECURRENT ACUTE PANCREATITIS: EARLY CHRONIC PANCREATITIS AS A DISTINCT PHENOTYPE IN THE PANCREATITIS CONTINUUM

Viktoria Venglovecz 1, Zsolt Abonyi Tóth 2, Vivien Vass 3, Petra Széplaki 2, Dalma Dobszai 3, Daniel Marino 4, Tamas Gonda 5, Zsófia Román 2, Balint Eross 2, Peter Jeno Hegyi 2, Áron Vincze 6, Ferenc Izbéki 7, Mária Papp 8, Alexandra Mikó 9, Katalin Márta 10, Andrea Szentesi 6, Peter Hegyi 11

Affiliations

1 University of Szeged, Szeged, Hungary

2 Centre for Translational Medicine, Semmelweis University, Budapest, Hungary, Budapest, Hungary

3 Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary

4 Division of Gastroenterology, New York University, New York, United States

5 Columbia University, New York, United States

6 University of Pécs, Pécs, Hungary

7 Saint George University Hospital, Szekesfehervar, Hungary

8 University of Debrecen, Debrecen, Hungary

9 University of Pécs, Medical School, Pécs, Hungary

10 Semmelweis University, Budapest, Hungary

11 Semmelweis University, Pecs, Hungary

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Abstract

Introduction

Recurrent episodes of acute pancreatitis (AP) are associated with an increased risk of chronic pancreatitis (CP). We previously proposed early chronic pancreatitis (ECP), defined as ≥3 AP episodes without radiological features of CP, as an intermediate stage within this continuum. This study aimed to determine whether ECP has a distinct clinical phenotype compared with recurrent acute pancreatitis (RAP) and established CP.

Aims & Methods

We conducted a post hoc analysis of prospectively collected data from the Hungarian Pancreatic Study Group AP Registry. A total of 1,717 patients enrolled between 2017 and 2025 were classified as AP (one episode; n=1,143), RAP (two episodes without CP morphology; n=215), ECP (≥3 episodes without CP morphology; n=152), or acute-on-chronic pancreatitis (ACP; AP with radiological features of CP; n=207). Demographic, etiological, lifestyle, clinical, and endoscopic characteristics were compared across disease stages.

Results

ECP displayed several characteristics that differed from RAP and approached those observed in ACP. The proportion of male patients increased from 58% in RAP to 72% in ECP and 79% in ACP. Alcohol-related etiology increased from 23% to 36% and 45%, respectively, while smoking prevalence increased from 36% in RAP to 49% in ECP and 68% in ACP. Endoscopic management also showed a distinct pattern across disease stages. Prophylactic pancreatic stenting predominated in AP (71%) and RAP (67%), whereas pancreatic duct-directed interventions accounted for 42% of procedures in ECP and became predominant in ACP (77%). Thus, despite the absence of radiological CP, ECP already demonstrated epidemiological, etiological, and endoscopic features resembling more established pancreatic disease.

Conclusion

ECP is clinically distinguishable from RAP and represents a distinct transitional phenotype within the pancreatitis continuum. Recognition of patients with ≥3 AP episodes may facilitate earlier risk-factor modification, specialist evaluation, and tailored management before established morphological CP develops. Funding: National Research, Development and Innovation Office (SNN152834) and the Albert Szent-Györgyi Research Grant of the Albert Szent-Györgyi Medical School, University of Szeged.

Event

UEG Week Barcelona 2026

Topics

Immunology Pancreas Mechanisms & Personalised Medicine Histopathology Hepatobiliary Digestive Oncology

Submission format

Late-Breaking Abstract

Session

Late-Breaking: Advances in liver and pancreatic disease

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

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UEG Presentation

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The floppy pouch: An emerging problem

Willem A. Bemelman 1

Affiliations

1 Academisch Medisch centrum Dept. of Surgery - Department of Surgery, Academisch Medisch centrum Dept, Amsterdam, Netherlands

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Abstract

Event

UEG Week Barcelona 2026

Topics

Surgery Primary Care

Session

The troublesome pouch

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

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Peter Irving

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Jean-Luc Van Laethem

UEG Presentation

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

Untangling the Knots: Exploring the Dynamics of Complex Relationships between Ulcerative Colitis and Clostridioides difficile Infections (Tillotts Pharma AG) (Complete Session)

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Untangling the Knots: Exploring the Dynamics of Complex Relationships between Ulcerative Colitis and Clostridioides difficile Infections (Tillotts Pharma AG) (Complete Session)

Johan Burisch 1, Peter Irving 2, Deepa Nayar 3

Affiliations

1 Hvidovre University Hospital, Virum, Denmark

2 Guy’s and St Thomas’ NHS Foundation Trust, London, United Kingdom

3 Consultant Microbiologist, Newcastle Upon Tyne NHS Foundation Trust, Newcastle, United Kingdom

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Abstract

Publisher

Tillotts Pharma AG

Event

UEG Week Copenhagen 2023

Session

Untangling the Knots: Exploring the Dynamics of Complex Relationships between Ulcerative Colitis and Clostridioides difficile Infections (Tillotts Pharma AG)

Published

2023

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BEYOND RECURRENT ACUTE PANCREATITIS: EARLY CHRONIC PANCREATITIS AS A DISTINCT PHENOTYPE IN THE PANCREATITIS CONTINUUM

Peter Hegyi

The floppy pouch: An emerging problem

Willem A. Bemelman

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Peter Irving

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Ankur Jindal

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Peter Irving

Endoscopy in pancreatic NENs: Detection, RFA and beyond

Jean-Luc Van Laethem

UEG Presentation

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

EARLY VERSUS STANDARD INITIATION OF TERLIPRESSIN FOR HRS-AKI IN ACUTE-ON-CHRONIC LIVER FAILURE - A RANDOMIZED CONTROLLED TRIAL (ETERLI STUDY) (NCT04416282)

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EARLY VERSUS STANDARD INITIATION OF TERLIPRESSIN FOR HRS-AKI IN ACUTE-ON-CHRONIC LIVER FAILURE - A RANDOMIZED CONTROLLED TRIAL (ETERLI STUDY) (NCT04416282)

Ankur Jindal 1, Ankur Jindal 1, Ankur Jindal 1

Affiliations

1 Institute of Liver and Biliary Sciences, New Delhi, India

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Abstract

Introduction

Terlipressin infusion is effective in treatment of hepatorenal syndrome (HRS-AKI). However, its efficacy in HRS-AKI in acute-on-chronic liver failure (ACLF) patients has been suboptimal. Progression of AKI is rapid in ACLF patients. Response to terlipressin correlates with stage of AKI and ACLF. We investigated whether early initiation of terlipressin (eTerli) therapy can improve response in HRS-AKI patients.

Aims & Methods

Consecutive ACLF patients with stage II/III AKI despite albumin resuscitation (40g) for 12 hours were randomized to receive early terlipressin at 2mg/24 hour plus albumin (ET, n=35) or standard therapy (ST, n=35) with albumin alone for 48 hours followed by terlipressin. The primary end-point was AKI reversal by day 7. Secondary end-points included need for dialysis, treatment-related adverse effects and mortality at day 28 and Day 90.

Results

Baseline parameters including AKI stage and ACLF AARC scores in two arms were comparable. Full AKI response at day 7 was observed in 24/35 (68.6%) patients in ET arm compared to 11/35(31.4%) in ST arm [P-0.03]. Full AKI response at day 3 was observed in 11/35 (31.4%) patients in ET group vs. 4/35(11.4%) in ST group [P-0.04]. ST compared to ET [HR: 4.321(95%CI: 1.189-15.702); P-0.026] and day 3 serum creatinine >1.6 [HR: 9.143(95% CI:2.568-32.551); AUROC-0.866; P <0.001] were independent predictors of HRS non-response at day 7. Patients in ET arm showed significant improvement in ACLF grade (ACLF grade II to I – 16 patients), mean arterial pressure (68.2 ± 1.2 to 82.3 ± 1.4 mm Hg; P-0.05) and urine output (26.4 ± 0.9 to 52.4 ± 1.2 ml/h; P-0.001) at day 3. Five patients in each arm developed progressive AKI requiring dialysis. The total dose of albumin (baseline to day 7) was higher in ST (177.5 ± 40.3g) than ET arm (149.1 ± 41.8g)[P-0.006]. Significantly more patients died within 28 days in ST than ET arm [23/35; 65.7 % vs. 14/35, 40%, P-0.031] and ST compared to ET [HR: 2.079(95%CI: 1.042-4.149); P-0.038], HE at presentation [HR: 2.929(95% CI:1.201-7.142); P-0.018] and Day 3 serum creatinine >1.46 [HR:1.369 (95%CI: 1.075-1.743); P-0.011] were independent predictors of mortality. Overall, 15(21.4%) patients had terlipressin related adverse effects, none was life threatening.

Conclusion

In patients with ACLF, early initiation of terlipressin for AKI persisting despite 12 hours of volume expansion with albumin helps in significant short-term mortality benefit along with early reversal of AKI, improvement in hemodynamic parameters and regression of ACLF stage.

References

Jindal A, Bhadoria AS, Maiwall R, Sarin SK. Evaluation of acute kidney injury and its response to terlipressin in patients with acute-on-chronic liver failure. Liver Int 2016;36:59-67.
Maiwall R, Kumar S, Sarin SK, Kumar G, Rastogi A, Bihari C, et al. AKI in patients with acute on chronic liver failure is different from acute decompensation of cirrhosis. Hepatol Int 2015;9:627-639.
Piano S, Schmidt HH, Ariza X, Amoros A, Romano A, Husing-Kabar A, et al. Association between grade of acute on chronic liver failure and response to terlipressin and albumin in patients with hepatorenal syndrome. Clin Gastroenterol Hepatol. 2018; 16(1792–1800):e1793.

Disclosure

Part of abstract was presented as a oral plenary presentation at the AASLD 2022.
No other conflict of interest

Event

UEG Week Copenhagen 2023

Topics

Hepatobiliary

Submission format

Abstract

Session

Update on pathophysiology and management in cirrhosis

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

More Like This:

BEYOND RECURRENT ACUTE PANCREATITIS: EARLY CHRONIC PANCREATITIS AS A DISTINCT PHENOTYPE IN THE PANCREATITIS CONTINUUM

Peter Hegyi

The floppy pouch: An emerging problem

Willem A. Bemelman

Untangling the Knots: Exploring the Dynamics of Complex Relationships between Ulcerative Colitis and Clostridioides difficile Infections (Tillotts Pharma AG) (Complete Session)

Peter Irving

EARLY VERSUS STANDARD INITIATION OF TERLIPRESSIN FOR HRS-AKI IN ACUTE-ON-CHRONIC LIVER FAILURE - A RANDOMIZED CONTROLLED TRIAL (ETERLI STUDY) (NCT04416282)

Ankur Jindal

PROGNOSTIC VALUE OF THE VEDOLIZUMAB CROHN’S DISEASE CLINICAL DECISION SUPPORT TOOL IN A REAL-WORLD COHORT

Peter Irving

Endoscopy in pancreatic NENs: Detection, RFA and beyond

Jean-Luc Van Laethem

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PROGNOSTIC VALUE OF THE VEDOLIZUMAB CROHN’S DISEASE CLINICAL DECISION SUPPORT TOOL IN A REAL-WORLD COHORT

Xin Yi Choon 1, Christopher White 1, Esha Sharma 1, Robin Dart 1, Krisztina Barbara Gecse 1, Joel Mawdsley 1, Simon H. Anderson 1, Shuvra Ray 1, Peter Irving 1, Mark A Samaan 1

Affiliations

1 Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom

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Abstract

Introduction

The vedolizumab clinical decision support tool (VDZ-CDST) was developed and validated as a clinical prediction tool for vedolizumab (VDZ) use in Crohn’s disease (CD). It has demonstrated prognostic value with the ability to stratify patients by probability of clinical and endoscopic response to VDZ at week 26. We examined the applicability of the tool in a real-world dataset of VDZ treated CD patients.

Aims & Methods

We performed a retrospective data collection and analysis at a single tertiary centre on patients who had started VDZ between January 2015 to February 2022. We collected baseline data to calculate the CDST: prior exposure to tumour necrosis factor (TNF) antagonists, prior surgery for CD, prior fistulating disease, baseline albumin and C reactive protein (CRP). Our main endpoints were treatment persistence at 12 and 24 months. We also retrieved the following parameters of disease activity at 12 month follow up: CRP, faecal calprotectin (FCP), mucosal healing (defined as ulcer free endoscopy) and progression to surgery. Chi square for trend was used for 12 month persistence and Kaplan-Meier curves with log rank test for trend was used for 24 month persistence. ANOVA was used for comparing continuous variables.

Results

130 patients were included. 74.6% had prior TNF antagonist exposure, median baseline CRP was 4 mg/L, and median albumin was 43 g/L. Using the CDST at baseline, 3 groups were defined – 9 (7%) were low, 51 (39%) were intermediate, and 70 (54%) had a high probability of treatment response. One year treatment persistence rates were 56%, 69%, and 80% in the low, intermediate and high probability groups respectively (p=0.048). Kaplan-Meier analysis demonstrate increasing rates of persistence at 24 months in keeping with CDST-defined probability of response (p=0.035). There were also statistically significant differences in outcomes across the 3 groups, with lower CRP at 12 months, higher rates of mucosal healing and lower rates of progression to surgery in the high probability group versus the low and intermediate groups.

	Low probability group n = 9 (%)	Intermediate probability group n = 51 (%)	High probability group n = 70 (%)	p value
Treatment persistence at 12 months	5 (56)	35 (69)	56 (80)	0.048
CRP at 12 months, median (mg/L)	10	3	2	0.015
FCP at 12 months, median (μg/g)	223	209	92	0.59
Mucosal healing	1/5 (20)	13/28 (46)	28/37 (76)	0.0023
Surgery for CD	3 (33)	16 (31)	11 (16)	0.042

Conclusion

The prognostic value of the VDZ-CDST appears valid in a real-world CD cohort with high rates of prior TNF antagonist exposure. The tool has demonstrated predictive ability for long-term treatment persistence as well as measures of biochemical and endoscopic activity. Our study is consistent with a growing body of published evidence on the applicability of CDST and suggests a role for CDST in guiding therapeutic decision making in routine clinical practice.

References

1. Dulai PS, Boland BS, Singh S, Chaudrey K, Koliani-Pace JL, Kochhar G, Parikh MP, Shmidt E, Hartke J, Chilukuri P, Meserve J. Development and validation of a scoring system to predict outcomes of vedolizumab treatment in patients with Crohn’s disease. Gastroenterology. 2018 Sep 1;155(3):687-95.
2. Dulai PS, Amiot A, Peyrin-Biroulet L, Jairath V, Serrero M, Filippi J, Singh S, Pariente B, Loftus EV Jr, Roblin X, Kane S, Buisson A, Siegel CA, Bouhnik Y, Sandborn WJ, Lasch K, Rosario M, Feagan BG, Bojic D, Trang-Poisson C, Shen B, Altwegg R, Sands BE, Colombel JF, Carbonnel F; GETAID OBSERV-IBD, VICTORY Cohorts Collaboration*. A clinical decision support tool may help to optimise vedolizumab therapy in Crohn's disease. Aliment Pharmacol Ther. 2020 Mar;51(5):553-564. doi: 10.1111/apt.15609. Epub 2019 Dec 22. Erratum in: Aliment Pharmacol Ther. 2021 Apr;53(8):963. PMID: 31867766; PMCID: PMC7028036.

Conference

UEG Week Vienna 2024

Topics

IBD

Submission format

Abstract

Session

Biomarkers and prediction of treatment responses in IBD (Posters)

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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Willem A. Bemelman

Untangling the Knots: Exploring the Dynamics of Complex Relationships between Ulcerative Colitis and Clostridioides difficile Infections (Tillotts Pharma AG) (Complete Session)

Peter Irving

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Peter Irving

Endoscopy in pancreatic NENs: Detection, RFA and beyond

Jean-Luc Van Laethem

UEG Presentation

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

Endoscopy in pancreatic NENs: Detection, RFA and beyond

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

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Endoscopy in pancreatic NENs: Detection, RFA and beyond

Jean-Luc Van Laethem 1

Affiliations

1 Erasme University Hopsital-ULB, Bruxelles, Belgium

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Abstract

Event

UEG Week Vienna 2024

Topics

Digestive Oncology Endoscopy Surgery

Session

Neuroendocrine neoplasms: The zebras of the cancer world

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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BEYOND RECURRENT ACUTE PANCREATITIS: EARLY CHRONIC PANCREATITIS AS A DISTINCT PHENOTYPE IN THE PANCREATITIS CONTINUUM

Peter Hegyi

The floppy pouch: An emerging problem

Willem A. Bemelman

Untangling the Knots: Exploring the Dynamics of Complex Relationships between Ulcerative Colitis and Clostridioides difficile Infections (Tillotts Pharma AG) (Complete Session)

Peter Irving

EARLY VERSUS STANDARD INITIATION OF TERLIPRESSIN FOR HRS-AKI IN ACUTE-ON-CHRONIC LIVER FAILURE - A RANDOMIZED CONTROLLED TRIAL (ETERLI STUDY) (NCT04416282)

Ankur Jindal

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Peter Irving

Endoscopy in pancreatic NENs: Detection, RFA and beyond

Jean-Luc Van Laethem