Evidence map›Paper›PMID 37368103›Full record

Trial reportAdvances in therapy2023

Matching-Adjusted Indirect Comparison Between Risankizumab and Ustekinumab for Induction and Maintenance Treatment of Moderately to Severely Active Crohn's Disease.

Marla Dubinsky, Christopher Ma, Jenny Griffith, Marjorie Crowell, Ezequiel Neimark, Kristina Kligys, Tom O'Connell

6 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Advances in therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
3.8field-weighted citation impact, top 6% 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.

NCT01369329 phase3completednot on this map

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1)

TypeinterventionalSponsorJanssen Research & Development, LLCRan2011 to 2013Enrolled769ConditionsCrohn's Disease, IBD, Colitis, Inflammatory Bowel DiseaseArmsGroup 2 ustekinumab 130 mg, Group 3: ustekinumab approximately 6 mg/kg, Group 1: Placebo
NCT01369342 phase3completednot on this map

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease (UNITI-2)

TypeinterventionalSponsorJanssen Research & Development, LLCRan2011 to 2014Enrolled640ConditionsCrohn's Disease, Inflammatory Bowel Disease, IBD, ColitisArmsGroup 1: Placebo, Group 2 ustekinumab 130 mg, Group 3: ustekinumab approximately 6 mg/kg
NCT01369355 phase3completednot on this map

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease

TypeinterventionalSponsorJanssen Research & Development, LLCRan2011 to 2019Enrolled1,282ConditionsCrohn's Disease, Colitis, IBD, Inflammatory Bowel DiseaseArmsPlacebo SC, Placebo IV, Ustekinumab 90 mg SC q8w, Ustekinumab 130 mg IV, Ustekinumab 90 mg SC q12w
NCT03104413 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

TypeinterventionalSponsorAbbVieRan2017 to 2021Enrolled618ConditionsCrohn's DiseaseArmsplacebo for risankizumab IV, risankizumab SC, risankizumab IV
NCT03105102 phase3active not recruitingnot on this map

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease

TypeinterventionalSponsorAbbVieRan2018 to 2029Enrolled1,336ConditionsCrohn's DiseaseArmsPlacebo for Risankizumab SC, Risankizumab IV, Placebo for Risankizumab IV, Risankizumab SC, Risankizumab On-Body Injector (OBI)
NCT03105128 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease

TypeinterventionalSponsorAbbVieRan2017 to 2021Enrolled931ConditionsCrohn's DiseaseArmsplacebo for risankizumab, risankizumab IV, risankizumab SC
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. New Interleukin-23 Antagonists' Use in Crohn's Disease.Pharmaceuticals (Basel, Switzerland) · 2025
    Review
  7. Review
  8. Article
  9. Review
  10. 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

7 authors at 2 institutions in 2 countries.

Marla DubinskyDepartment of Pediatrics, Susan and Leonard Feinstein IBD Center, Icahn School of Medicine, Mount Sinai, New York, NY, USA.
Christopher MaDivision of Gastroenterology & Hepatology, Departments of Medicine & Community Health Sciences, University of Calgary, Calgary, AB, Canada.
Jenny GriffithAbbVie Inc., North Chicago, IL, USA.
Marjorie CrowellMedicus Economics LLC, 2 Stonehill Lane, Milton, MA, 02186, USA.
Ezequiel NeimarkAbbVie Inc., North Chicago, IL, USA.
Kristina KligysAbbVie Inc., North Chicago, IL, USA.
Tom O'ConnellMedicus Economics LLC, 2 Stonehill Lane, Milton, MA, 02186, USA. thomas.oconnell@medicuseconomics.com.
AbbVie (United States) · USUniversity of Calgary · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRisankizumab (RZB) and ustekinumab (UST), interleukin (IL)-23 and IL-12/23 inhibitors, respectively, are approved treatments for moderately to severely active Crohn's disease (CD); direct comparison between the two is ongoing. We indirectly compared efficacy of RZB versus UST using data from phase 3 trials (RZB: NCT03104413; NCT03105128; NCT03105102; UST: NCT01369329; NCT01369342; NCT01369355).

methodsMatching-adjusted indirect comparison was conducted using individual patient-level data from RZB trials and published aggregated data from UST trials. During induction, patients received RZB 600 mg intravenous (IV) at weeks 0, 4, and 8 or a single dose of UST 6 mg/kg IV at week 0. During maintenance, patients received RZB 180 or 360 mg subcutaneous (SC) or UST 90 mg SC every 8 or 12 weeks to 52 weeks. Outcomes included proportion of patients achieving Crohn's Disease Activity Index (CDAI) response (decrease of ≥ 100 points or total score < 150) or remission (CDAI ≤ 150) and endoscopic improvement (measured by the Simple Endoscopic Score in CD [SES-CD]; response, ≥ 50% reduction from baseline; remission, SES-CD ≤ 2) following induction/baseline.

resultsHigher proportions of patients achieved clinical and endoscopic outcomes with RZB vs. UST induction treatment, resulting in significantly (p ≤ 0.05) greater percent differences (95% confidence intervals) between groups for CDAI remission (15% [5%, 25%]) and endoscopic response (26% [13%, 40%]) and remission (9% [0%, 19%]). Following maintenance, rates of CDAI remission were similar (range - 0.3% to - 5.0%) for RZB vs. UST. Differences for endoscopic response and remission ranged from 9.3% to 27.7% and 11.6% to 12.5%, respectively; differences were significant (p < 0.05) for endoscopic response for both doses of RZB compared to UST 12-week dosing.

conclusionsThis indirect comparison demonstrated higher rates of clinical and endoscopic outcomes during induction for RZB compared to UST; CDAI remission following maintenance was comparable. Direct comparisons of RZB and UST are warranted to validate these findings.

Indexed as

Crohn DiseaseUstekinumabAntibodies, MonoclonalHumansRemission InductionTreatment OutcomeAntibodies, MonoclonalrisankizumabUstekinumabCDAICrohn’s diseaseEndoscopic improvementMatching-adjusted indirect comparisonRisankizumabUstekinumab

Identifiers

PMID37368103
PMCPMC10427520
OpenAlexW4382182642

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.