Crohn's & colitis 360 · 2025
Real-World Effectiveness of Risankizumab in Crohn's Disease: Outcome Data for an IL-23 Inhibitor from the Middle East.
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Alzaabi Mohamed Nasir, Swaid Thaer Khaleel, Ahmed Hosameldin Abdelrahman, Alahmad Maryam A, Omar Nadeen Mamon, Chitra Kumar Kishore Kumar, Ahmed Enas Fouad, Malik Talha A, Quraishi Mohammed Nabil
Аннотация
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.
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.