Trial reportJournal of Crohn's & colitis2025
Efficacy and safety of risankizumab in patients with moderately to severely active Crohn's disease: interim results from the SEQUENCE open-label extension study.
Trial report 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 trial NCT04524611 (A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF Therapy), which is not on this map. Cited by 2 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 Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF Therapy
Who cites it
2 citing papers in PubMed.
- Review
- High-Dose, Extended Half-Life IL-23 Inhibitors: the Next Big Step in Psoriasis Care?Dermatology and therapy · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
BACKGROUND AND
aimsRisankizumab, a selective interleukin-23 p19 inhibitor, is approved to treat moderately to severely active Crohn's disease (CD) in adults. We report interim results from part 2 of the ongoing SEQUENCE trial evaluating long-term efficacy and safety of risankizumab in patients with active CD and previous anti-tumor necrosis factor failure.
methodsPatients randomized to risankizumab who completed the part 1 Week 48 visit could continue receiving open-label subcutaneous risankizumab 360 mg every 8 weeks (part 2). Patients with inadequate response could receive rescue therapy (intravenous risankizumab 600 mg) before continuing regular treatment. This interim analysis assessed efficacy at Weeks 52, 76, and 100 of treatment; safety was evaluated throughout.
resultsOverall, 224 patients who received risankizumab 600 mg intravenous induction therapy and 360 mg subcutaneous maintenance therapy entered part 2. Clinical remission rates remained stable through Week 100 (as observed, ≥74.5%; nonresponder and modified non-responder imputation analyses showed similar trends). Most patients (>99%) achieving clinical remission were corticosteroid-free at the corresponding visit. CD-related hospitalization and surgery incidence were low (≤0.03 n/patient year), and Inflammatory Bowel Disease Questionnaire and 36-Item Short Form Health Survey improvements were sustained. Safety data were consistent with the known risankizumab safety profile; the exposure-adjusted serious adverse event rate was 11.8/100 patient-years.
conclusionsThis interim analysis of continuous open-label risankizumab therapy showed durable long-term clinical efficacy and no new safety signals in patients with moderately to severely active CD. Future analyses will evaluate longer-term clinical and endoscopic outcomes and safety. CLINICAL TRIAL REGISTRATION NUMBER: NCT04524611.
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