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. 2025 May 19:18:17562848251338743.
doi: 10.1177/17562848251338743. eCollection 2025.

Clinical insights into IL-23 inhibition: risankizumab for Crohn's disease through a systematic review and meta-analysis of randomized controlled trials

Po-Feng Huang  1   2 , Tien-Yu Huang  2 , Yi-Chiao Cheng  3 , Peng-Jen Chen  2 , Wei-Kuo Chang  2 , Chao-Feng Chang  4
Affiliations

Clinical insights into IL-23 inhibition: risankizumab for Crohn's disease through a systematic review and meta-analysis of randomized controlled trials

Po-Feng Huang et al. Therap Adv Gastroenterol. .

Abstract

Background and aims: Crohn's disease is a chronic inflammatory disorder with rising global prevalence, marked by abdominal pain, diarrhea, and fatigue. Interleukin (IL)-23 plays a pivotal role in Crohn's disease pathogenesis, making it a therapeutic target. Risankizumab, a monoclonal antibody targeting the IL-23 p19 subunit, has shown potential in clinical trials.

Objectives: This meta-analysis evaluates the efficacy and safety of Risankizumab in achieving clinical remission, clinical response, and endoscopic remission in patients with moderate-to-severe Crohn's disease.

Design: A systematic review and meta-analysis were conducted following PRISMA 2020 guidelines.

Data sources and methods: A comprehensive search of PubMed, Embase, Cochrane CENTRAL, Web of Science, and ClinicalTrials.gov was performed to identify randomized controlled trials (RCTs) assessing Risankizumab in Crohn's disease. Primary outcomes were clinical remission, clinical response, and endoscopic remission, with secondary outcomes focusing on treatment-related adverse events. A random-effects model estimated odds ratios (ORs) with 95% confidence intervals. Meta-regression analyzed dose- and duration-dependent effects.

Results: Four RCTs involving 1774 participants showed that Risankizumab significantly improved clinical remission (OR = 2.223), clinical response (OR = 2.483), and endoscopic remission (OR = 4.112). Dose-dependent improvements were observed, with treatment duration affecting clinical remission (p = 0.0158) but not clinical response or endoscopic remission. Adverse event rates were comparable between Risankizumab and placebo groups (OR = 0.872, p = 0.592).

Conclusion: Risankizumab is effective in achieving clinical and endoscopic outcomes in moderate-to-severe Crohn's disease, demonstrating dose-dependent benefits and a favorable safety profile, supporting its use as a therapeutic option. However, the limited number of studies may affect the robustness of these findings. Further large-scale RCTs are needed to validate its long-term efficacy, safety in elderly populations, and effectiveness in biologic-naïve patients.

Trial registration: This systematic review and meta-analysis were registered with the INPLASY database under registration number INPLASY202530014. The full protocol is accessible at DOI: 10.37766/inplasy2025.3.0014.

Keywords: Crohn’s disease; IL-23 inhibitors; Risankizumab; clinical remission; endoscopic remission; meta-analysis.

Plain language summary

How Risankizumab helps treat Crohn’s disease: a review of clinical trial results Crohn’s disease is a long-term condition that causes inflammation in the digestive system. People with Crohn’s disease often experience symptoms like stomach pain, diarrhea, and tiredness, which can significantly affect their daily lives. Researchers have found that a protein called interleukin-23 (IL-23) plays a key role in this disease. Targeting IL-23 may help control the inflammation. Risankizumab is a medicine designed to block a part of IL-23, and it has been tested in clinical trials to see if it can help people with moderate-to-severe Crohn’s disease. To understand how well it works and whether it is safe, we combined the results of multiple high-quality studies in a process called a metaanalysis. Our analysis included four studies with a total of 1,774 patients. We found that Risankizumab significantly improved three key outcomes: Clinical remission: Fewer or no symptoms of Crohn’s disease. Clinical response: Noticeable improvement in symptoms. Endoscopic remission: Healing of the digestive tract, confirmed by a camera test. Patients who received Risankizumab were more likely to achieve these outcomes compared to those who received a placebo. The benefits were stronger with higher doses of the medication and with longer treatment durations for clinical remission. Importantly, the medicine was found to be safe. The rates of side effects were similar between patients taking Risankizumab and those taking a placebo. In conclusion, Risankizumab is an effective and safe treatment for people with moderate-to-severe Crohn’s disease. It helps reduce symptoms, promotes healing in the digestive tract, and works better at higher doses. This makes it a promising option for managing this challenging condition.

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Conflict of interest statement

The authors declare that there is no conflict of interest.

Figures

Figure 1.
Figure 1.
The PRISMA flowchart.
Figure 2.
Figure 2.
Summary of quality assessment of studies included in the meta-analysis using Cochrane risk of bias 2 tool.
Figure 3.
Figure 3.
Forest plot showing the significant efficacy of Crohn’s disease with Risankizumab across four trials. (a) Clinical remission (OR = 2.223, 95% CI = 1.630–3.033, p < 0.001, I2 < 0.01%). (b) Clinical response (OR = 2.483, 95% CI = 1.739–3.544, p < 0.001, I2 = 50.95%). (c) Endoscopic remission (OR = 4.112, 95% CI = 2.884–5.861, p < 0.001, I2 < 0.01%). CI, confidence interval; OR, odds ratio.
Figure 4.
Figure 4.
Sensitivity analysis confirming consistent Risankizumab effects on (a) clinical remission, (b) clinical response, and (c) endoscopic remission, with significance maintained across all study removals.
Figure 5.
Figure 5.
Meta-regression showing the correlation between treatment dosage and outcome. (a) Clinical remission (coefficient = 0.0008 per mg, p = 0.0491). (b) Clinical response (coefficient = 0.0018 per mg, p = 0.0004). (c) Endoscopic remission (coefficient = 0.0012 per mg, p = 0.0001).
Figure 6.
Figure 6.
Meta-regression showing the correlation between treatment duration and outcome. (a) Clinical remission (coefficient = 0.0034 per day, p = 0.0158), achieved statistical significance. (b) Clinical response without statistical significance (coefficient = 0.0055 per day, p = 0.0670). (c) Endoscopic remission without statistical significance (coefficient = 0.0026 per day, p = 0.3171).
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