Corticosteroid-sparing effects of risankizumab versus ustekinumab in patients with moderately to severely active Crohn's disease: post hoc results from the phase 3b SEQUENCE trial
In brief
Risankizumab yields about 25% more steroid-free remission than ustekinumab by week 48
In a head-to-head trial of Crohn's patients who failed anti-TNF therapy, risankizumab achieved corticosteroid-free clinical remission in 25% more patients and endoscopic remission in about 20% more patients than ustekinumab at 48 weeks. Both drugs were well tolerated, but the advantage suggests risankizumab may be the preferred biologic for steroid sparing, pending longer-term safety data.
- Journal
- Journal of Crohn's & colitis (Q1)
- Published
- 7 July 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Tim Raine, Silvio Danese, Stefan Schreiber, Xiang Gao, Stephen Hanauer, Joana Torres, et al.
- PMID
- 42479626
- DOI
- 10.1093/ecco-jcc/jjag104
Why clinicians should know about it
- Picked for Anesthesiology and Pain Medicine (paper of the day, 22 July 2026).
- Picked for Gastroenterology (paper of the day, 22 July 2026).
- Picked for Immunology and Allergy (paper of the day, 22 July 2026).
- Picked for Infectious Diseases (paper of the day, 22 July 2026).
Abstract
BACKGROUND: This post hoc analysis evaluated the corticosteroid-sparing effects of risankizumab (RZB) versus ustekinumab (UST) in patients with moderate to severe Crohn's disease (CD) with prior inadequate response or intolerance to ≥ 1 anti-tumor necrosis factor (TNF) therapy. METHODS: SEQUENCE (NCT04524611) was an open-label, multicenter, randomized, efficacy assessment-blinded study. Patients were randomized 1:1 to receive RZB (intravenous [IV] 600 mg induction dose at weeks 0, 4, and 8, then a subcutaneous [SC] 360 mg maintenance dose every 8 weeks [Q8w] starting at week 12) or UST (single weight-based IV induction dose, then a SC 90 mg maintenance dose Q8w starting at week 8) up to week 48. Patients tapered corticosteroids beginning at week 2. Achievement of clinical, endoscopic, and quality of life outcomes without concomitant use of steroids ("corticosteroid-free") and safety were assessed. RESULTS: In patients taking corticosteroids at baseline, response rate differences by the week 24 and 48 timepoints with RZB versus UST were 10.5% and 25.4% (P ≤ .01) for corticosteroid-free clinical remission per CD activity index and 20.4% (P ≤ .001) and 29.2% (P ≤ .01) per stool frequency/abdominal pain score, and 23.0% and 20.2% (both P ≤ .01) for corticosteroid-free endoscopic remission. Similar results were also observed for additional corticosteroid-free endpoints, including endoscopic, composite (clinical + endoscopic), and quality of life outcomes. Numerically higher exposure-adjusted event rates of serious infections and hypersensitivity with RZB and UST were observed with corticosteroid use. CONCLUSION: In patients with CD refractory to anti-TNF therapy, higher rates of corticosteroid-free clinical, endoscopic, and quality of life outcomes were achieved with RZB versus UST. Both treatments were well-tolerated. CLINICAL TRIAL REGISTRATION NUMBER: NCT04524611.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.