Evidence map›Paper›PMID 40300779›Full record

Trial reportInflammatory bowel diseases2025

Comparing Outcomes With Subcutaneous Infliximab (CT-P13 SC) by Baseline Immunosuppressant Use: A Post Hoc Analysis of the LIBERTY-CD and LIBERTY-UC Studies.

Stefan Schreiber, Jean-Frederic Colombel, Stephen B Hanauer, William J Sandborn, Silvio Danese, Sang Joon Lee, Sung Hyun Kim, Yun Ju Bae, Sun Hee Lee, Seul Gi Lee and 7 more

Abstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in Inflammatory bowel diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
  2. Practical guidelines on medical management of adults with moderate-to-severe inflammatory bowel disease.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2026
    Article
  3. Article
  4. Review
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Stefan SchreiberDepartment of Internal Medicine I, University Hospital Schleswig-Holstein, Kiel, Germany.
Jean-Frederic ColombelDr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Stephen B HanauerDivision of Gastroenterology and Hepatology, Department of Medicine, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.
William J SandbornDivision of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, CA, USA.
Silvio DaneseDepartment of Gastroenterology, IRCCS San Raffaele Hospital and Vita-Salute University, Milan, Italy.ORCID 0000-0001-7341-1351
Sang Joon LeeData Science Institute, Celltrion, Inc., Incheon, Republic of Korea.
Sung Hyun KimMedical Science Division, Celltrion, Inc., Incheon, Republic of Korea.
Yun Ju BaeMedical Science Division, Celltrion, Inc., Incheon, Republic of Korea.
Sun Hee LeeMedical Science Division, Celltrion, Inc., Incheon, Republic of Korea.
Seul Gi LeeData Science Institute, Celltrion, Inc., Incheon, Republic of Korea.
Joon Ho LeeMedical Science Division, Celltrion, Inc., Incheon, Republic of Korea.
Jong Min KimData Science Institute, Celltrion, Inc., Incheon, Republic of Korea.
Ga Hee ParkData Science Institute, Celltrion, Inc., Incheon, Republic of Korea.
Jimin LeeMedical Science Division, Celltrion, Inc., Incheon, Republic of Korea.
Ju Hyun LeeMedical Science Division, Celltrion, Inc., Incheon, Republic of Korea.
Chae Young KimMedical Science Division, Celltrion, Inc., Incheon, Republic of Korea.
Bruce E SandsDr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.ORCID 0000-0001-5762-5042

Funding

Celltrion, Inc.
6 · The paper itself

Abstract

backgroundSuperior efficacy of subcutaneous infliximab (CT-P13 SC) over placebo for maintenance therapy in patients with Crohn's disease (CD) and ulcerative colitis (UC) was demonstrated in the randomized LIBERTY-CD and LIBERTY-UC studies. The current post hoc analysis compared outcomes with CT-P13 SC by baseline immunosuppressant use.

methodsPatients with moderately to severely active CD or UC randomized to the CT-P13 SC maintenance arm of the 54-week LIBERTY trials at week 10 and who were treated in the open-label extension (weeks 56-102) were included. Pharmacokinetic, efficacy, biomarker, safety, and immunogenicity endpoints were evaluated by baseline immunosuppressant use (monotherapy vs combination therapy).

resultsA total of 192 patients with CD (monotherapy, n = 126; combination therapy, n = 66) and 237 patients with UC (monotherapy, n = 180; combination therapy, n = 57) were included. In both studies, efficacy outcomes were generally comparable between monotherapy and combination therapy at week 54 or week 102. Serum concentrations were generally higher, and antidrug antibody-positive conversion rates were lower, with combination therapy relative to monotherapy. In combined analyses of CD and UC, comparable safety profiles were observed between monotherapy and combination therapy.

conclusionsDespite some differences in pharmacokinetics and immunogenicity between CT-P13 SC received alone or in combination with immunosuppressants in patients with CD or UC, efficacy outcomes at week 54 or week 102 were generally comparable. The overall safety profile and incidence of systemic injection reactions were also comparable between monotherapy and combination therapy.

Indexed as

Antibodies, MonoclonalColitis, UlcerativeCrohn DiseaseGastrointestinal AgentsImmunosuppressive AgentsInfliximabAdultDrug Therapy, CombinationFemaleHumansInjections, SubcutaneousMaleMiddle AgedTreatment OutcomeAntibodies, MonoclonalCT-P13Gastrointestinal AgentsImmunosuppressive AgentsInfliximabCT-P13 SCimmunosuppressantsinflammatory bowel diseaseLIBERTYsubcutaneous infliximab

Identifiers

PMID40300779
PMCPMC12558576

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.