Real-world effectiveness and safety of risankizumab induction and maintenance therapy in pediatric patients with Crohn's disease: a multicenter retrospective analysis
In brief
Risankizumab brought half of children with active Crohn's into remission by week 30
In this retrospective cohort of 96 children, 41% of those with active Crohn's disease reached steroid-free clinical remission after 12 weeks of risankizumab; half were in remission at weeks 30 and 54. Most remained on treatment after about a year, and no serious safety events occurred. The findings are encouraging, but controlled pediatric studies are still needed.
- Journal
- Journal of Crohn's & colitis (Q1)
- Published
- 3 September 2026
- Study design
- Retrospective cohort
- Evidence level
- Level 3, Low (CEBM 3b)
- Authors
- Elizabeth A Spencer, Quentin Buck, Lauren V Collen, Ronen Stein, Tyler Babinski, Dror S Shouval, et al.
- PMID
- 42814795
- DOI
- 10.1093/ecco-jcc/jjag134
Why clinicians should know about it
- Picked for Gastroenterology (paper of the day, 6 October 2026): Real‑world effectiveness of risankizumab in pediatric Crohn’s disease
Abstract
BACKGROUND & AIMS: Risankizumab is approved for adults with Crohn's disease (CD); pediatric data are limited. We evaluated real-world effectiveness, durability, safety, and dosing in children with CD. METHODS: Retrospective, global multicenter cohort of patients <18 years initiating risankizumab monotherapy (2022-2025). The outcomes were primary: corticosteroid-free clinical remission (CFR, wPCDAI < 12.5) post-induction (Week 12) among those with clinically active (wPCDAI ≥ 12.5) disease at start; secondary: clinical response (decrease wPCDAI ≥ 17.5-points), C-reactive protein (CRP) remission (<5 mg/L), CFR + CRP remission, intestinal ultrasound (IUS) remission, CFR at Weeks 30/54, therapy durability, and safety. RESULTS: Of the 96 (median age 15 [IQR: 13-16] years; 51% male; 70% ileocolonic; 38% prior ustekinumab) started on risankizumab, 68 (71%) had active disease at start. Nearly all (93/96, 97%) received the adult induction regimen-3 < 30 kg received a median 383 mg/m² (IQR: 339-397). Post-induction CFR was achieved in 28/68 (41%), clinical response in 37/68 (54%), and combined CFR + CRP in 22/68 (32%). Week 30 and 54 CFR were attained in 34/68 (50%) and 34/68 (50%), respectively. In the full cohort, median follow-up was 53.5 weeks (IQR: 47-60); 86/96 (90%) remained on risankizumab. Durability was greater with post-induction CFR (log-rank P = .008; Cox HR 0.21, 95% CI 0.06-0.75; P = .02). Lower baseline ESR predicted higher odds of post-induction CFR (OR 0.97 per mm/h; 95% CI 0.94-0.99; P = .01). No serious safety events occurred. CONCLUSIONS: In this multicenter pediatric cohort, risankizumab induced meaningful clinical and biomarker improvement with durable remission and a favorable safety profile, supporting risankizumab as an effective option for children with CD.
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.