Evidence map›Paper›PMID 42151576›Full record

SynthesisDigestive diseases and sciences2026

Efficacy and Safety of Risankizumab in Crohn's Disease: A Systematic Review and Meta-Analysis of Randomized Trials and Real-World Evidence.

Alaa Abdrabou Abouelmagd, Mazen Negmeldin Yassin, Dina Essam Abo-Elnour, Menna M Aboelkhier, Nada G Hamam, Abdelrahman A Elareef, Mohamed Saad Sayed, Mazen Ibrahem Gado, Talaat M Elqadi, Ahmed Elazab and 3 more

Abstract readSystematic ReviewMeta-Analysis
PubMed Publisher
In one paragraph

Synthesis in Digestive diseases and sciences, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

13 authors.

Alaa Abdrabou AbouelmagdFaculty of Medicine, South Valley University, Qena, Egypt. Alaa.AbdRabbo@med.svu.edu.eg.ORCID http://orcid.org/0009-0004-5449-8833
Mazen Negmeldin YassinFaculty of Medicine, Kasr Al-Ainy, Cairo University, Cairo, Egypt.
Dina Essam Abo-ElnourFaculty of Medicine, Zagazig University, Zagazig, Egypt.
Menna M AboelkhierMaster- Program, Faculty of Science Cairo University, Cairo, Egypt.
Nada G HamamFaculty of Medicine, Kasr Al-Ainy, Cairo University, Cairo, Egypt.
Abdelrahman A ElareefFaculty of Medicine, Alexandria University, Alexandria, Egypt.
Mohamed Saad SayedFaculty of Medicine, Beni-Suef University, Beni Suef, Egypt.
Mazen Ibrahem GadoFaculty of Medicine, Mansoura University, Mansoura, Egypt.
Talaat M ElqadiFaculty of Medicine, Alexandria University, Alexandria, Egypt.
Ahmed ElazabFaculty of Medicine, South Valley University, Qena, Egypt.
Yasser M MousaFaculty of Medicine, South Valley University, Qena, Egypt.
Mohamed Diaa GabraFaculty of Medicine, South Valley University, Qena, Egypt.
Bram VerstocktDepartment of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Louvain, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCrohn's disease (CD) management remains challenging, particularly in patients refractory to multiple biologics. Risankizumab (RZB), a selective IL-23 p19 inhibitor, has recently been approved for CD. We performed a systematic review and meta-analysis to assess the efficacy and safety of RZB in moderate-to-severe CD using both randomized controlled trials (RCTs) and real-world evidence (RWE).

methodsWe searched PubMed, Scopus, Web of Science, and Embase from inception to April 2025. We included RCTs comparing RZB with placebo and observational studies evaluating RZB in CD. Primary endpoints were clinical remission at induction and maintenance. Secondary endpoints included endoscopic remission and safety outcomes. This study was registered with PROSPERO (CRD420251030978).

resultsFive RCTs and nine observational studies (n = 3275) were included. In RCTs, RZB significantly increased clinical remission rates at induction (RR: 1.90, 95% CI [1.63; 2.20]) and maintenance (RR: 1.34, 95% CI [1.15; 1.55]) compared with placebo. Endoscopic remission was also significantly higher with RZB compared to placebo at induction (RR: 3.25, 95% CI [2.43; 4.35]) and maintenance (RR: 2.04, 95% CI [1.22; 3.42]). Pooled RWE demonstrated clinical remission rates of 57% at 12 weeks and 44% at 1 year. Subgroup analyses confirmed efficacy in patients with prior ustekinumab failure. No increased risk of serious adverse events was observed.

conclusionsRisankizumab demonstrates robust efficacy in inducing and maintaining clinical and endoscopic remission in moderate-to-severe CD. Real-world data confirm its sustained effectiveness and favorable safety profile in refractory populations (defined as patients with prior failure of one or more biologics or advanced therapies), supporting its positioning in the therapeutic landscape.

Indexed as

Antibodies, MonoclonalCrohn DiseaseGastrointestinal AgentsHumansRandomized Controlled Trials as TopicRemission InductionTreatment OutcomeAntibodies, MonoclonalGastrointestinal AgentsrisankizumabCrohn’s diseaseIL-23 inhibitorMeta-analysisReal-world evidenceRisankizumabSystematic review

Identifiers

PMID42151576

What OpenQuestion holds

Textmetadata
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.