Journal of Crohn's & colitis · 2026
Real-world effectiveness and safety of risankizumab induction and maintenance therapy in pediatric patients with Crohn's disease: a multicenter retrospective analysis.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Spencer Elizabeth A, Buck Quentin, Collen Lauren V, Stein Ronen, Babinski Tyler, Shouval Dror S, Rinawi Firas, Russell Richard K, Zifman Eyal, Topf-Olivestone Chani, Tzvinikos Christos, Slae Mordechai, Lev-Tzion Raffi, Turner Dan, Dubinsky Marla C, Assa Amit
Аннотация
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.
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.