Evidence map›Paper›PMID 40701396›Full record

Trial reportGastroenterology2026

Early Infliximab Levels and Clearance Predict Outcomes After Infliximab Rescue in Acute Severe Ulcerative Colitis: Results From PREDICT-UC.

Christopher F D Li Wai Suen, Matthew C Choy, Danny Con, Kaylene Cheng, Julie Nigro, Kerry Breheney, Kristy Boyd, Raquel Pena, Kathryn Burrell, Ourania Rosella and 24 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Gastroenterology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02770040 (PREDICT UC), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02770040 phase4completednot on this map

PREDICT UC: Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis

TypeinterventionalSponsorAustin HealthRan2016 to 2022Enrolled138ConditionsUlcerative ColitisArmsInfliximab
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Article
  2. [Advances in the clinical management of acute severe ulcerative colitis].Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences · 2026
    Review
  3. Comparing the pharmacokinetics of adalimumab originator and biosimilar product in patients with Inflammatory bowel disease or autoimmune disease.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2026
    Article
  4. Article
  5. Editorial: Advances in the treatment of acute severe ulcerative colitis.Frontiers in gastroenterology (Lausanne, Switzerland) · 2026
    Article
  6. Article
  7. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

34 authors.

Christopher F D Li Wai SuenAustin Health, Department of Gastroenterology, Melbourne, Australia; St Vincent's Hospital Melbourne, Immunology Research Centre, Melbourne, Australia; University of Melbourne, Department of Medicine (Austin Health), Melbourne, Australia.
Matthew C ChoyAustin Health, Department of Gastroenterology, Melbourne, Australia; University of Melbourne, Department of Medicine (Austin Health), Melbourne, Australia.
Danny ConAustin Health, Department of Gastroenterology, Melbourne, Australia; University of Melbourne, Department of Medicine (Austin Health), Melbourne, Australia.
Kaylene ChengSt Vincent's Hospital Melbourne, Immunology Research Centre, Melbourne, Australia.
Julie NigroSt Vincent's Hospital Melbourne, Immunology Research Centre, Melbourne, Australia.
Kerry BreheneySt Vincent's Hospital Melbourne, Immunology Research Centre, Melbourne, Australia.
Kristy BoydAustin Health, Department of Gastroenterology, Melbourne, Australia.
Raquel PenaAustin Health, Department of Gastroenterology, Melbourne, Australia.
Kathryn BurrellAustin Health, Department of Gastroenterology, Melbourne, Australia.
Ourania RosellaAustin Health, Department of Gastroenterology, Melbourne, Australia.
David ProudAustin Health, Department of Colorectal Surgery, Melbourne, Australia.
Richard BrouwerAustin Health, Department of Colorectal Surgery, Melbourne, Australia.
Alexandra GorelikMonash University, School of Public Health and Preventive Medicine, Melbourne, Australia.
Danny LiewUniversity of Adelaide, Department of Medicine, Adelaide, Australia.
William R ConnellSt Vincent's Hospital Melbourne, Department of Gastroenterology, Melbourne, Australia.
Emily K WrightSt Vincent's Hospital Melbourne, Department of Gastroenterology, Melbourne, Australia; University of Melbourne, Department of Medicine (St Vincent's Hospital), Melbourne, Australia.
Kirstin M TaylorAlfred Health, Department of Gastroenterology, Melbourne, Australia.
Aviv PudipeddiConcord Hospital, Department of Gastroenterology, Sydney, Australia.
Michelle SawersBarwon Health, Department of Gastroenterology, Geelong, Australia.
Britt ChristensenUniversity of Melbourne, Department of Medicine (Royal Melbourne Hospital), Melbourne, Australia.
Watson NgLiverpool Hospital, Department of Gastroenterology, Sydney, Australia.
Jakob BegunMater Hospital, Department of Gastroenterology, Brisbane, Australia.
Graham L Radford-SmithRoyal Brisbane and Women's Hospital, Department of Gastroenterology, Brisbane, Australia; University of Queensland Faculty of Medicine, Brisbane, Australia; QIMR Berghofer Medical Research Institute, Brisbane, Australia.
Mayur GargNorthern Health, Department of Gastroenterology, Melbourne, Australia.
Neal MartinPrincess Alexandra Hospital, Department of Gastroenterology, Brisbane, Australia.
Daniel R van LangenbergEastern Health, Department of Gastroenterology, Melbourne, Australia.
Nik S DingSt Vincent's Hospital Melbourne, Department of Gastroenterology, Melbourne, Australia.
Lauren BeswickBarwon Health, Department of Gastroenterology, Geelong, Australia.
Rupert W LeongConcord Hospital, Department of Gastroenterology, Sydney, Australia.
Miles P SparrowAlfred Health, Department of Gastroenterology, Melbourne, Australia.
Christina Grosserichter-WagenerEssange Reagents, Amsterdam, the Netherlands.
Henk Te VelthuisEssange Reagents, Amsterdam, the Netherlands.
Kumar VisvanathanSt Vincent's Hospital Melbourne, Immunology Research Centre, Melbourne, Australia; University of Melbourne, Department of Medicine (St Vincent's Hospital), Melbourne, Australia.
Peter De CruzAustin Health, Department of Gastroenterology, Melbourne, Australia; University of Melbourne, Department of Medicine (Austin Health), Melbourne, Australia. Electronic address: ppdecruz@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND &

aimsThe role of infliximab therapeutic drug monitoring in acute severe ulcerative colitis (ASUC) management is unknown. We aimed to identify whether infliximab therapeutic drug monitoring is associated with ASUC outcomes.

methodsSerum and stool samples were collected from patients enrolled in the PREDICT-UC randomized controlled trial (NCT02770040), which compared intensified and standard infliximab rescue in steroid-refractory ASUC. Infliximab levels measured after trial conclusion and clearance derived using pharmacokinetic modelling were correlated with outcomes.

resultsInfliximab levels were measured in 681 serum and 198 fecal samples from 135 patients. Lower day 3 serum infliximab levels predicted infliximab failure on day 14 (area under the receiver operator characteristic curve = 0.63; P = .043) and colectomy by 3 months (area under the receiver operator characteristic curve = 0.77; P = .0027); a threshold of ≤57.9 μg/mL had 83% sensitivity, 67% specificity, 24% positive predictive value, and 97% negative predictive value for colectomy. Patients with high clearance between day 1 and 7 (≥0.62 L/d) were more likely to respond to an initial 10 mg/kg vs 5 mg/kg infliximab dose (risk ratio, 1.50; 95% confidence interval [CI], 1.01-2.23), and had a higher risk of colectomy if they received an initial 5 mg/kg vs 10 mg/kg dose (HR, 4.81; 95% CI, 1.09-21.37). In patients with high clearance who did not respond to the first infliximab dose, day 14 response rate was higher with a second 10 mg/kg vs 5 mg/kg dose (38% vs 11%; risk ratio, 3.43; 95% CI, 1.05-11.19). Day 3 fecal infliximab levels correlated with endoscopic severity and was associated with day 7 nonresponse (P = .016).

conclusionsEarly infliximab levels and clearance calculation can predict outcomes in ASUC. This is the first study to demonstrate that high infliximab clearance may be overcome by intensified infliximab dosing. (NCT02770040; Optimizing Infliximab Induction Therapy for Acute Severe Ulcerative Colitis).

Indexed as

Colitis, UlcerativeDrug MonitoringGastrointestinal AgentsInfliximabAcute DiseaseAdultColectomyFecesFemaleHumansMaleMiddle AgedPredictive Value of TestsSeverity of Illness IndexTime FactorsTreatment FailureGastrointestinal AgentsInfliximabBiologicColectomyDose-Response RelationshipDrugTherapeutic Drug Monitoring

Identifiers

PMID40701396

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.