ArticleJournal of Crohn's & colitis2025
Risankizumab Is Associated With Normalization of Biomarkers in Patients With Crohn's Disease: Results From the Phase 3 ADVANCE, MOTIVATE, and FORTIFY Studies.
Article in Journal of Crohn's & colitis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 5 papers.
What it found
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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.
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.
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
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
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
Who cites it
5 citing papers in PubMed.
- Efficacy and safety of risankizumab in patients with moderately to severely active Crohn's disease: interim results from the SEQUENCE open-label extension study.Journal of Crohn's & colitis · 2025Trial
- Real-World Effectiveness of Risankizumab in Refractory Crohn's Disease: The RISANCROHN Study From the ENEIDA Registry.Alimentary pharmacology & therapeutics · 2026Observational
- Advancing IBD Management: A Literature Review on the Role of Non-Invasive Blood-Based Biomarkers in Predicting and Assessing Pharmacodynamic Response to Treatment.Clinical and translational science · 2026Review
- Deciphering the immunocellular regulatory network in inflammatory bowel disease: from susceptibility genes to cellular effectors and toward precision therapies.Frontiers in immunology · 2025Review
- Landscape of new drugs and targets in inflammatory bowel disease.United European gastroenterology journal · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
aimsNormalization of high-sensitivity C-reactive protein (hs-CRP) and fecal calprotectin (FCP) are suggested as intermediate treatment targets for Crohn's disease (CD). This analysis evaluates achievement of biomarker normalization and the relationship between improvements in biomarker concentrations and clinical and endoscopic outcomes among patients treated with risankizumab.
methodsThis post hoc analysis included patients with moderately to severely active CD and elevated baseline hs-CRP (>5 mg/L) or FCP (>250 µg/g) concentrations from the 12-week ADVANCE and MOTIVATE induction studies, and the 52-week FORTIFY maintenance study. We assessed the proportion of patients achieving biomarker normalization, defined as hs-CRP ≤5 mg/L and FCP ≤250 µg/g, and the association between achieving biomarker normalization and improved clinical and endoscopic outcomes.
resultsAmong 748 patients with elevated baseline hs-CRP or FCP concentrations, higher proportions of patients treated with risankizumab vs placebo achieved normalization of hs-CRP (Week 12: placebo, 17.5%; risankizumab 600 mg, 48.5%; Week 52: placebo, 29.5%; risankizumab 180 mg, 45.2%; risankizumab 360 mg, 40.8%) and FCP (Week 12: placebo, 9.1%; risankizumab 600 mg, 26.0%; Week 52: placebo, 28.0%; risankizumab 180 mg, 43.0%; risankizumab 360 mg, 44.0%; nominal p < 0.05 vs placebo for all comparisons). Achievement of both clinical or endoscopic outcomes and improvement of biomarker concentrations occurred at higher rates among patients treated with risankizumab vs placebo, regardless of prior exposure to biologic therapies.
conclusionsRisankizumab treatment led to sustained normalization of inflammatory biomarkers with improved clinical and endoscopic results. CLINICAL TRIAL REGISTRATION NUMBER: ADVANCE, NCT03105128; MOTIVATE, NCT03104413; FORTIFY, NCT03105102.
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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.