Multicenter Study

. 2025 Oct;13(8):1525-1540.

doi: 10.1002/ueg2.70050. Epub 2025 Jul 11.

Assessment of PredictSURE IBD Assay in a Multinational Cohort of Patients With Inflammatory Bowel Disease

Dahham Alsoud¹, Nurulamin M Noor^{2

3}, Lea Ann Chen⁴, Vivian Abadom⁵, Simon H C Anderson⁶, Lediona Ardolli⁷, Jordan Axelrad⁸, Peter Bossuyt⁹, Kenneth Croitoru¹⁰, Oriana M Damas¹¹, Lily Deng¹², Parakkal Deepak¹³, Juan De La Revilla Negro³, Shanika de Silva¹⁴, Marc Ferrante^{1

15}, Karen Hills¹⁶, Peter M Irving⁶, James O Lindsay¹⁷, Dana J Lukin¹⁸, Paul A Lyons^{2

19}, Eoin F McKinney^{2

19}, Maria Oliva-Hemker⁵, Caterina Oneto²⁰, Roohi Patel²¹, Miles Parkes^{2

3}, Lieven Pouillon⁹, João Sabino^{1

15}, Lawrence J Saubermann²², Jenny S Sauk²³, Sarah Sheibani²⁴, Kenneth G C Smith^{25

26}, Keith S Sultan²⁷, Tony C Tham²⁸, Sare Verstockt¹, Raluca Vrabie²⁹, Melissa Weidner³⁰, Huimin Yu³¹, Bram Verstockt^{1

15}, James C Lee^{32

33

34}, Séverine Vermeire^{1

15}

Affiliations

¹ Department of Chronic Diseases and Metabolism, Translational Research in Gastrointestinal Disorders, KU Leuven, Leuven, Belgium.
² Department of Medicine, University of Cambridge School of Clinical Medicine, Cambridge, UK.
³ Department of Gastroenterology, Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Cambridge, UK.
⁴ Division of Gastroenterology, Department of Medicine, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA.
⁵ Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
⁶ Department of Gastroenterology, Guy's & St Thomas' Hospital, London, UK.
⁷ PredictImmune Ltd, Cambridge, UK.
⁸ Division of Gastroenterology, Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA.
⁹ Department of Gastroenterology, Imelda GI Clinical Research Centre, Imelda General Hospital, Bonheiden, Belgium.
¹⁰ Division of Gastroenterology, University of Toronto, Mount Sinai Hospital, Toronto, Canada.
¹¹ Division of Digestive Health and Liver Diseases, University of Miami Miller School of Medicine, Miami, Florida, USA.
¹² Department of Medicine, Temple University Hospital, Philadelphia, Pennsylvania, USA.
¹³ Division of Gastroenterology and Inflammatory Bowel Diseases Center, Washington University in Saint Louis School of Medicine, St. Louis, Missouri, USA.
¹⁴ Department of Gastroenterology, Dudley Group NHS Foundation Trust, Dudley, UK.
¹⁵ Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.
¹⁶ Juneberry Ltd, Cambridge, UK.
¹⁷ Department of Gastroenterology, Barts Health NHS Trust, London, UK.
¹⁸ Department of Gastroenterology and Hepatology, New York Presbyterian Hospital-Weill Cornell Medicine, New York, New York, USA.
¹⁹ Cambridge Institute for Therapeutic Immunology and Infectious Disease, Jeffrey Cheah Biomedical Centre, Cambridge Biomedical Campus, Cambridge, UK.
²⁰ Vanguard Gastroenterology Clinic, New York, New York, USA.
²¹ Division of Gastroenterology and Hepatology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
²² Division of Gastroenterology and Hepatology, University of Rochester Medical Center, Rochester, New York, USA.
²³ Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.
²⁴ Division of Gastrointestinal and Liver Diseases, University of Southern California Keck School of Medicine, Los Angeles, California, USA.
²⁵ Walter and Eliza Hall Institute of Medical Research, Parkville, Australia.
²⁶ Department of Medical Biology, The University of Melbourne, Parkville, Australia.
²⁷ Department of Gastroenterology, North Shore University Hospital-Long Island Jewish Medical Center, Northwell Health, Manhasset, New York, USA.
²⁸ Division of Gastroenterology, Ulster Hospital, Dundonald, UK.
²⁹ Division of Gastroenterology, Northwell Long Island Jewish-Forest Hills Hospital, Queens, New York, USA.
³⁰ Division of Pediatric Gastroenterology, Department of Pediatrics, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA.
³¹ Division of Gastroenterology and Liver Diseases, Department of Medicine, The George Washington University School of Medicine and Health Sciences, Washington, DC, USA.
³² Genetic Mechanisms of Disease Laboratory, The Francis Crick Institute, London, UK.
³³ Department of Gastroenterology, Royal Free Hospital, London, UK.
³⁴ Division of Medicine, Institute for Liver and Digestive Health, University College London, London, UK.

PMID: 40641434
PMCID: PMC12528995
DOI: 10.1002/ueg2.70050

Multicenter Study

Assessment of PredictSURE IBD Assay in a Multinational Cohort of Patients With Inflammatory Bowel Disease

Dahham Alsoud et al. United European Gastroenterol J. 2025 Oct.

. 2025 Oct;13(8):1525-1540.

doi: 10.1002/ueg2.70050. Epub 2025 Jul 11.

Authors

Affiliations

¹ Department of Chronic Diseases and Metabolism, Translational Research in Gastrointestinal Disorders, KU Leuven, Leuven, Belgium.
² Department of Medicine, University of Cambridge School of Clinical Medicine, Cambridge, UK.
³ Department of Gastroenterology, Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Cambridge, UK.
⁴ Division of Gastroenterology, Department of Medicine, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA.
⁵ Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
⁶ Department of Gastroenterology, Guy's & St Thomas' Hospital, London, UK.
⁷ PredictImmune Ltd, Cambridge, UK.
⁸ Division of Gastroenterology, Department of Medicine, New York University Grossman School of Medicine, New York, New York, USA.
⁹ Department of Gastroenterology, Imelda GI Clinical Research Centre, Imelda General Hospital, Bonheiden, Belgium.
¹⁰ Division of Gastroenterology, University of Toronto, Mount Sinai Hospital, Toronto, Canada.
¹¹ Division of Digestive Health and Liver Diseases, University of Miami Miller School of Medicine, Miami, Florida, USA.
¹² Department of Medicine, Temple University Hospital, Philadelphia, Pennsylvania, USA.
¹³ Division of Gastroenterology and Inflammatory Bowel Diseases Center, Washington University in Saint Louis School of Medicine, St. Louis, Missouri, USA.
¹⁴ Department of Gastroenterology, Dudley Group NHS Foundation Trust, Dudley, UK.
¹⁵ Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.
¹⁶ Juneberry Ltd, Cambridge, UK.
¹⁷ Department of Gastroenterology, Barts Health NHS Trust, London, UK.
¹⁸ Department of Gastroenterology and Hepatology, New York Presbyterian Hospital-Weill Cornell Medicine, New York, New York, USA.
¹⁹ Cambridge Institute for Therapeutic Immunology and Infectious Disease, Jeffrey Cheah Biomedical Centre, Cambridge Biomedical Campus, Cambridge, UK.
²⁰ Vanguard Gastroenterology Clinic, New York, New York, USA.
²¹ Division of Gastroenterology and Hepatology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
²² Division of Gastroenterology and Hepatology, University of Rochester Medical Center, Rochester, New York, USA.
²³ Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.
²⁴ Division of Gastrointestinal and Liver Diseases, University of Southern California Keck School of Medicine, Los Angeles, California, USA.
²⁵ Walter and Eliza Hall Institute of Medical Research, Parkville, Australia.
²⁶ Department of Medical Biology, The University of Melbourne, Parkville, Australia.
²⁷ Department of Gastroenterology, North Shore University Hospital-Long Island Jewish Medical Center, Northwell Health, Manhasset, New York, USA.
²⁸ Division of Gastroenterology, Ulster Hospital, Dundonald, UK.
²⁹ Division of Gastroenterology, Northwell Long Island Jewish-Forest Hills Hospital, Queens, New York, USA.
³⁰ Division of Pediatric Gastroenterology, Department of Pediatrics, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA.
³¹ Division of Gastroenterology and Liver Diseases, Department of Medicine, The George Washington University School of Medicine and Health Sciences, Washington, DC, USA.
³² Genetic Mechanisms of Disease Laboratory, The Francis Crick Institute, London, UK.
³³ Department of Gastroenterology, Royal Free Hospital, London, UK.
³⁴ Division of Medicine, Institute for Liver and Digestive Health, University College London, London, UK.

PMID: 40641434
PMCID: PMC12528995
DOI: 10.1002/ueg2.70050

Abstract

Background and aims: PredictSURE IBD is a prognostic blood test that classifies newly diagnosed, treatment-naïve Inflammatory Bowel Disease (IBD) patients into 'IBDhi' (high-risk) or 'IBDlo' (low-risk) groups (risk of future aggressive disease). We evaluated this assay in a multinational cohort and explored the effect of concomitant corticosteroids on its discrimination.

Methods: One hundred thirty-six (71 Ulcerative colitis [UC], 65 Crohn's Disease [CD]) and 41 (15 UC, 26 CD) patients with active IBD were 'unexposed' and 'exposed', respectively, to corticosteroids at baseline blood sampling. The number of treatment escalations, time to first escalation, and need for repeated escalations were compared between the biomarker subgroups. Another 20 patients (13 UC, 7 CD) were longitudinally sampled over 6 weeks after commencing corticosteroids.

Results: In corticosteroids-naïve UC and CD patients, all bowel surgeries (n = 6) and multiple therapy escalations (n = 10) occurred in IBDhi patients. IBDhi UC patients required significantly more treatment escalations, had a shorter time to first escalation, and a greater need for multiple escalations than IBDlo patients. No statistically significant differences were observed among CD patients. In corticosteroid-exposed patients, 66.6% of 'misclassifications' were IBDlo patients who required escalations. Among corticosteroid-treated patients with longitudinal sampling, 81.3% of those classified as IBDhi before steroids switched to IBDlo during therapy.

Conclusions: No significant differences in treatment escalations were observed between biomarker-defined subgroups in CD. However, IBDhi UC patients required significantly earlier and more frequent therapy escalations, highlighting the need to further investigate PredictSURE IBD in UC. Notably, the discrimination ability of the biomarker was unreliable in patients receiving corticosteroid therapy.

Keywords: biomarker; blood tests; corticosteroids; crohn's disease; inflammatory bowel diseases; personalised management; prognosis; treatment; ulcerative colitis.

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Conflict of interest statement

D.A. declares no conflicts of interest.

N.M.N. has received educational grants and/or speaker fees from AbbVie, B.M.S., Celltrion, Dr Falk Pharma, Ferring, Galapagos, Janssen, Lilly, Pfizer, Pharmacosmos, Takeda and Tillotts Pharma AG.

L.A.C. has received consulting fees from Pfizer, Bristol Myers Squibb, Eli Lilly, and PredictImmune.

V.A. declares no conflicts of interest.

S.H.C.A. declares no conflicts of interest.

L.A. declares no conflicts of interest.

J.A. has received research grants from BioFire Diagnostics and Genentech; consultancy fees, advisory board members, or honorarium from Abbvie, Adiso, BioFire Diagnostics, bioMérieux, Bristol‐Myers Squibb, Celltrion, Fresnius, Ferring, Johnson and Johnson, Pfizer, and Vedanta.

P.B. has received financial support for research from AbbVie, Amgen, Celltrion, Mylan, Pfizer, and Takeda; lecture fees from AbbVie, Celltrion, Janssen, Lilly, and Takeda; and advisory board fees from AbbVie, Arena Pharmaceuticals, BMS, Celltrion, Dr Falk, Galapagos, Janssen, Lilly, Pentax, PSI‐CRO, Roche, Takeda, and Tetrameros.

K.C. declares that it has received financial support for research from Abbvie and Janssen; speaking fees from Ferring and Janssen and advisory board fees from Abbvie, Takeda, Celltrion, Sandoz, Pfizer; and consulting fees from Goodcap and Microbiome Insights.

O.M.D. has received consultancy and/or advisory board fees from Abbvie and Janssen, and research funding from Pfizer.

L.D. declares no conflicts of interest.

P.D. has received research support under a sponsored research agreement unrelated to the data in the paper and/or consulting from AbbVie, Arena Pharmaceuticals, Boehringer Ingelheim, Bristol Myers Squibb, Johnson and Johnson, Pfizer, Prometheus Biosciences, Takeda Pharmaceuticals, Roche Genentech, Fresenius Kabi, Teva Pharmaceuticals, Landos Pharmaceuticals, Sandoz, AGMB, ExeGi, Tr1X, Direct Biologics, Astra Zeneca, Alimentiv, Merck, LEK consulting, Celltrion and CorEvitas LLC.

J.D.R.N. has received an educational grant from Galapagos.

S.d.S. has received speaker fees/and or consulting fees‐ Abbvie, Tillots, Janssen, Dr Falk, Takeda.

M.F. has received research grants from AbbVie, Biogen, EG, Janssen, Pfizer, Takeda and Viatris; consultancy fees from: AbbVie, AgomAb Therapeutics, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Janssen‐Cilag, MRM Health, MSD, Pfizer, Takeda and ThermoFisher; and speakers' fees from AbbVie, Biogen, Boehringer Ingelheim, Falk, Ferring, Janssen‐Cilag, MSD, Pfizer, Takeda, Truvion Healthcare and Viatris.

K.H. declares no conflicts of interest.

P.M.I. has served as a consultant for AbbVie and Bristol Myers Squibb; received lecture fees from AbbVie, Bristol Myers Squibb, Celgene, Celltrion, Falk Pharma, Galapagos, Janssen, Lilly, Pfizer, and Takeda; served on Data Safety Monitoring Boards or advisory boards for AbbVie, Arena, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Genentech, Gilead, Hospira, Janssen, Lilly, MSD, Pfizer, Prometheus, Roche, Sandoz, Samsung Bioepis, and Takeda; and financial support for research from Celltrion, Galapagos, Pfizer, and Takeda.

J.O.L. declares consultant and advisory board participant for AbbVie, Bristol Myers Squibb, Celgene, Celltrion, Eli Lilly, Engytix Ferring Pharmaceuticals, Galapagos, Gilead, GSK, Janssen, MSD, Napp, Pfizer, Shire, Takeda, and Vifor Pharma; has received speaker fees and sponsorship for academic meetings from AbbVie, Ferring Pharmaceuticals, Janssen, MSD, Napp, Norgine, Pfizer, Shire, Tillotts Pharma, and Takeda; and investigator‐led research grants from AbbVie, Gilead, Pfizer, Shire and Takeda.

D.J.L. declares consultancy fees from Abbvie, Altrubio, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Johnson & Johnson, Palatin Technologies, Pfizer, Prime Therapeutics, Prometheus Laboratories, PSI, Takeda, and Vedanta; has received speaker fees from Abbvie and Johnson & Johnson; and has received grants from Abbvie, Boehringer Ingelheim, Crohn's & Colitis Foundation, Johnson & Johnson, and Takeda.

P.A.L. was a co‐founder of PredictImmune Ltd. and received consultancy fees from the company.

E.F.M. declares that he was the Chief Scientific Officer of PredictImmune Ltd 2017–2023.

M.O.H. has received research grants from Takeda Pharmaceuticals and Pfizer and has served on advisory boards for Takeda and Janssen Research& Development.

C.O. declares speaker bureau and/or advisory board participants for Salix, Abbvie, BMS, Pfizer, Ferring, Takeda, and Phathom.

R.P. declares no conflicts of interest.

M.P. has received research funding from Astra Zeneca, Gilead, Lilly, and Pfizer and speaker fees from Takeda and Janssen.

L.P. has received advisory board fees from Celltrion, Galápagos, Janssen‐Cilag, Sandoz and Takeda; consultancy fees from Ipsos NV and Ismar Healthcare funded by Viatris; presentation fees from AbbVie, Celltrion, Ferring and Galápagos; and personal fees (congress support) from AbbVie, Ferring, Galápagos, Norgine and Takeda.

J.S. has received speaker's fees from Pfizer, Abbvie, Ferring, Falk, Takeda, Janssen, Fresenius, and Galapagos; consultancy fees from Pfizer, Janssen, Ferring, Fresenius, Abbvie, Galapagos, Celltrion, Pharmacosmos, and Pharmanovia; and research support from Galapagos and Viatris.

L.J.S. declares no conflicts of interest.

J.S.S. has received speaker's fees from Abbvie and Prometheus; consultancy fees or advisory board fees from CorEvitas, Roivant and Janssen; and research support from Crohn's and Colitis Foundation.

S.S. declares no conflicts of interest.

K.G.C.S. was a co‐founder of PredictImmune Ltd. and has received consultancy fees from GSK.

K.S.S. declares no conflicts of interest.

T.C.T. has received honoraria for advisory boards, speaking and chairing from Amgen, Bristol Myers Squibb, Lilley.

S.V., R.V., M.W., and H.Y., declares no conflicts of interest.

B.V. has received research support from AbbVie, Biora Therapeutics, Landos, Pfizer, Sossei Heptares and Takeda; speaker's fees from Abbvie, Biogen, Bristol Myers Squibb, Celltrion, Chiesi, Falk, Ferring, Galapagos, Janssen, Lily, MSD, Pfizer, R‐Biopharm, Sandoz, Takeda, Tillots Pharma, Truvion and Viatris; consultancy fees from Abbvie, Alfasigma, Alimentiv, Applied Strategic, Astrazeneca, Atheneum, BenevolentAI, Biora Therapeutics, Boxer Capital, Bristol Myers Squibb, Galapagos, Guidepont, Landos, Lily, Merck, Mylan, Nxera, Inotrem, Ipsos, Janssen, Pfizer, Progenity, Sandoz, Sanofi, Santa Ana Bio, Sapphire Therapeutics, Sosei Heptares, Takeda, Tillots Pharma and Viatris; stock options from Vagustim.

J.C.L. has received consultancy and/or advisory board fees from PredictImmune, C4X Discovery, Abbvie and Janssen.

S.V. has received grants from AbbVie, J&J, Pfizer, Galapagos and Takeda; consulting and/or speaking fees from AbbVie, Abivax, AbolerIS Pharma, AgomAb, Alimentiv, Arena Pharmaceuticals, AstraZeneca, Avaxia, BMS, Boehringer Ingelheim, Celgene, CVasThera, Dr Falk Pharma, Ferring, Galapagos, Genentech‐Roche, Gilead, GSK, Hospira, Imidomics, Janssen, J&J, Lilly, Materia Prima, MiroBio, Morphic, MrMHealth, Mundipharma, MSD, Pfizer, Prodigest, Progenity, Prometheus, Robarts Clinical Trials, Second Genome, Shire, Surrozen, Takeda, Theravance, Tillots Pharma AG and Zealand Pharma.

Figures

**FIGURE 1**
Real‐life treatment escalations during the first 12 months of follow‐up in ulcerative colitis and Crohn's disease patients unexposed to steroids in cohorts 1, 2 and 3.

**FIGURE 2**
Time to first treatment escalation during the first 12 months of follow‐up in ulcerative colitis and Crohn's disease patients unexposed to steroids in cohorts 1, 2 and 3.

**FIGURE 3**
Time to first treatment escalation during the first 18 months of follow‐up in ulcerative colitis and Crohn's disease patients exposed to steroids in cohort 1.

See this image and copyright information in PMC

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Assessment of PredictSURE IBD Assay in a Multinational Cohort of Patients With Inflammatory Bowel Disease

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Assessment of PredictSURE IBD Assay in a Multinational Cohort of Patients With Inflammatory Bowel Disease

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Abstract

Conflict of interest statement

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