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Efficacy and safety of Risankizumab for moderate-to-severe Crohn's disease: first Asian real-world data (STAR trial)
Chen-Shuan Chung1,2, Chung-Hsin Chang3, Chia-Jung Kuo2,4,5
1Division of Gastroenterology and Hepatology, Department of Internal Medicine, Far Eastern Memorial Hospital, No. 21, Nanya South Road, Banciao District, New Taipei City 220, Taiwan. Program A, Department of Electrical Engineering, Yuan Ze University, Taoyuan, Taiwan.
Background:
Crohn's disease (CD) remains a challenging condition, especially in patients with moderate-to-severe disease. Risankizumab (RZB), an anti-IL-23p19 monoclonal antibody, has shown efficacy in clinical trials. However, real-world data (RWD) in Asian populations are limited.
Objectives:
To assess the effectiveness and safety of Risankizumab in Asian patients with CD.
Design:
Multicenter cohort study.
Methods:
This study enrolled adult patients with moderate-to-severe CD who received Risankizumab between September 2024 and May 2025 in Taiwan. Efficacy was assessed at weeks 4, 8, and 12 using CD Activity Index (CDAI), patient-reported outcomes-2 (PRO2), and inflammatory bowel disease (IBD)-disk scores. Safety outcomes and treatment response by prior biologic exposure, including Ustekinumab (UST), were evaluated.
Results:
Forty-nine patients (mean age 41.5 years, 69.4% male) were included. Clinical response rates were 53.1%, 75.5%, and 91.8% at weeks 4, 8, and 12, respectively; clinical remission was achieved in 12.2%, 22.4%, and 42.9%. PRO2 remission reached 53.5% by week 12. Both CDAI and IBD-Disk scores improved at weeks 4, 8, and 12 with statistical significance (p < 0.0001). Transmural healing was observed in 16.3% of patients at week 12. Clinical remission at week 12 was consistent regardless of prior Ustekinumab exposure (exposed 36.36% vs naïve 44.74%, p = 0.630) or biologic-naïve status (exposed 36.84% vs naïve 63.63%, p = 0.119). No severe adverse events were reported, but mild events included headache and transient liver enzyme elevation (each 2.04%).
Conclusion:
Risankizumab may demonstrate significant short-term efficacy and favorable safety in real-world treatment of moderate-to-severe CD in an Asian cohort. Long-term data are needed to confirm sustained outcomes and guide their optimal use across diverse CD populations.
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