Minerva gastroenterology · 2026
Comparative efficacy and safety of risankizumab versus ustekinumab in moderate-to-severe Crohn's disease: a systematic review and meta-analysis.
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Moon Suhyeon, Choi Yeo Jin, Shin Sooyoung
Аннотация
BACKGROUND: Risankizumab and ustekinumab are biologics targeting the interleukin-23 pathway through distinct mechanisms (selective p19 versus shared p40 inhibition). Both are key options for moderate-to-severe Crohn's disease, but comparative evidence remains limited. We aimed to evaluate their relative efficacy and safety using direct and indirect evidence to inform treatment decisions.
METHODS: We searched major databases for randomized controlled trials (RCTs) in adults with moderate-to-severe Crohn's disease comparing risankizumab or ustekinumab with placebo or each other. Random-effects models were used for pairwise meta-analyses, and a Bayesian network meta-analysis (NMA) integrated direct and indirect evidence. Treatments were ranked using the surface under the cumulative ranking curve (SUCRA).
RESULTS: Nine RCTs (N.=4814) were included. Versus placebo, risankizumab significantly improved clinical remission (odds ratio [OR] 2.24, 95% CI: 1.73-2.91) and response (OR=2.70, 95% CI: 2.02-3.61). Ustekinumab also increased remission (OR=2.14, 95% CI: 1.68-2.73) and response (OR=2.16, 95% CI: 1.67-2.80). In the NMA, risankizumab ranked highest for remission (SUCRA 96.9%) and response (98.1%), while ustekinumab occupied intermediate positions. Both agents were well tolerated; risankizumab ranked more favorably for serious adverse events and serious infections, whereas ustekinumab ranked slightly higher for total adverse events.
CONCLUSIONS: Risankizumab and ustekinumab were both effective and generally well tolerated in moderate-to-severe Crohn's disease. Risankizumab showed a more favorable efficacy pattern for remission and response and ranked more favorably for serious adverse events, whereas overall safety profiles were otherwise broadly comparable. These findings support treatment selection according to clinical priorities.
METHODS: We searched major databases for randomized controlled trials (RCTs) in adults with moderate-to-severe Crohn's disease comparing risankizumab or ustekinumab with placebo or each other. Random-effects models were used for pairwise meta-analyses, and a Bayesian network meta-analysis (NMA) integrated direct and indirect evidence. Treatments were ranked using the surface under the cumulative ranking curve (SUCRA).
RESULTS: Nine RCTs (N.=4814) were included. Versus placebo, risankizumab significantly improved clinical remission (odds ratio [OR] 2.24, 95% CI: 1.73-2.91) and response (OR=2.70, 95% CI: 2.02-3.61). Ustekinumab also increased remission (OR=2.14, 95% CI: 1.68-2.73) and response (OR=2.16, 95% CI: 1.67-2.80). In the NMA, risankizumab ranked highest for remission (SUCRA 96.9%) and response (98.1%), while ustekinumab occupied intermediate positions. Both agents were well tolerated; risankizumab ranked more favorably for serious adverse events and serious infections, whereas ustekinumab ranked slightly higher for total adverse events.
CONCLUSIONS: Risankizumab and ustekinumab were both effective and generally well tolerated in moderate-to-severe Crohn's disease. Risankizumab showed a more favorable efficacy pattern for remission and response and ranked more favorably for serious adverse events, whereas overall safety profiles were otherwise broadly comparable. These findings support treatment selection according to clinical priorities.