Evidence map›Paper›PMID 30032288›Full record

Trial reportJournal of Crohn's & colitis2018

Selective IL-23 Inhibition by Risankizumab Modulates the Molecular Profile in the Colon and Ileum of Patients With Active Crohn's Disease: Results From a Randomised Phase II Biopsy Sub-study.

Sudha Visvanathan, Patrick Baum, Azucena Salas, Richard Vinisko, Ramona Schmid, Kristie M Grebe, Justin W Davis, Kori Wallace, Wulf O Böcher, Steven J Padula and 2 more

Open access · bronzeAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Journal of Crohn's & colitis, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
4.5field-weighted citation impact, top 5% of its field
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

23 citing papers in PubMed, 44 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Divergent T Cell Phenotypes Define Pediatric Crohn's Disease and Ulcerative Colitis.medRxiv : the preprint server for health sciences · 2025
    Article
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Blockade of IL-23: What is in the Pipeline?Journal of Crohn's & colitis · 2022
    Review
  12. Review
  13. Article
  14. Review
  15. Bacterial Translocation as Inflammatory Driver in Crohn's Disease.Frontiers in cell and developmental biology · 2021
    Review
  16. Review
  17. Review
  18. Article
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  20. Review
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

12 authors at 5 institutions in 3 countries.

Sudha VisvanathanBoehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
Patrick BaumBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
Azucena SalasHospital Clinic Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.
Richard ViniskoBoehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
Ramona SchmidBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
Kristie M GrebeAbbVie Inc., Worcester, MA, USA.
Justin W DavisAbbVie Inc., North Chicago, IL, USA.
Kori WallaceAbbVie Inc., North Chicago, IL, USA.
Wulf O BöcherBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
Steven J PadulaBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
Jay S FineBoehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
Julián PanésHospital Clinic Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.
Boehringer Ingelheim (Germany) · DEAbbVie (United States) · USBoehringer Ingelheim (United States) · USCentro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas · ESHospital Clínic de Barcelona · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsWe aimed to investigate the underlying mechanism of action of risankizumab, a monoclonal antibody targeting the IL-23 p19 subunit, previously reported to induce clinical and endoscopic remission in a randomised phase II study in patients with active Crohn's disease.

methodsIleum and colon biopsies obtained at screening and Week 12 from a subgroup of patients [n = 106] in the risankizumab phase II study were analysed by transcriptome-wide RNA-Seq profiling. Univariate associations were assessed using linear modelling.

resultsBy Week 12, risankizumab significantly decreased [p < 0.005] the expression of 1880 and 765 genes in the colon [false-discovery rate = 0.02] and ileum [false-discovery rate = 0.05], respectively. These genes were associated with the IL-23/IL-17 axis, Th1 pathway, innate immunity, and tissue turnover. Colonic transcriptomic profiles following risankizumab treatment reflected the transcriptomic changes observed in patients achieving endoscopic response and remission at Week 12 and were significantly different from placebo [p < 0.005]. The colonic transcriptomic profile, significantly modulated by risankizumab at Week 12, was indicative of suppression of pathways associated with epithelial biology. Furthermore, pathways associated with Crohn's disease modulated by risankizumab treatment included second messenger-mediated signalling, immune response, lymphocyte and leucocyte activation, lymphocyte differentiation and cell-cell adhesion.

conclusionsEndoscopic remission and response observed with risankizumab in patients with active Crohn's disease was associated with significant transcriptomic changes in the colon, compared with placebo. Differentiated expression of genes associated with the IL-23/IL-17 axis was observed in the colon and ileum 12 weeks after risankizumab treatment.

Indexed as

Antibodies, MonoclonalColonCrohn DiseaseIleumInterleukin-23 Subunit p19AdultBiopsyDouble-Blind MethodDrug MonitoringEndoscopy, Digestive SystemFemaleGene ExpressionGene Expression ProfilingHumansImmunosuppressive AgentsInterleukin-17Antibodies, MonoclonalImmunosuppressive AgentsInterleukin-17Interleukin-23 Subunit p19risankizumab

Identifiers

PMID30032288
PMCPMC6225973
OpenAlexW2884774799

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.