Real-World Effectiveness of Risankizumab in Crohn’s Disease: Outcome Data for an IL-23 Inhibitor from the Middle East

Introduction
Crohn’s disease (CD) in the Middle East is often aggressive, yet regional patients are underrepresented in pivotal trials for new therapies. This study is the first real-world evaluation of risankizumab’s effectiveness, safety, and dose optimization in a predominantly Emirati cohort with moderate-to-severe CD.

Methods
This prospective cohort included 60 UAE patients with moderate-to-severe CD initiating risankizumab. Endpoints included clinical remission (CDAI <150) and biochemical remission (normalised C-reactive protein <5 mg/L and faecal calprotectin <250 µg/g), assessed post-induction (weeks 12-20) and at maintenance (10-14 months). Logistic regression models were used to identify predictors of remission and the need for dose intensification.

Results
The median age was 33 years, and 61.7% were advanced therapy (AT)-exposed. Post-induction, clinical remission was achieved in 46.7% of patients, with significantly higher rates in AT-naïve vs AT-exposed patients (69.6% vs 32.4%, P = .011). Biochemical remission was achieved in 53.3% overall, again favouring the AT-naïve group (78.3% vs 37.8%, P = 0.005). At maintenance (n = 48), clinical and biochemical remission rates were 72.9% and 70.8%, respectively. Later-line risankizumab use was a significiant predictor of lower odds of post-induction remission (OR 0.27, P = .001). In AT-exposed patients, prior ustekinumab exposure was associated with lower remission rates (OR 0.11, P = .021) and a higher likelihood of dose intensification (OR 5.67, P = .045). Dose intensification recaptured clinical response in 62.5% (5/8) of patients. No new safety signals were identified.

Conclusion
This first Middle Eastern real-world study confirms risankizumab is effective and safe for complex CD and supports its use across different treatment lines.