Risankizumab: a real-world Israeli data in severe refractory IBD patients

Abstract

Abstract Background: Inflammatory bowel disease (IBD), namely Crohn’s disease (CD) and ulcerative colitis (UC), is a life-long, relapsing disease. Since resistance mechanisms are often developed, the landscape of IBD treatments is rapidly expanding. Risankizumab (Skyrizi®), an antibody targeting the p19 subunit of IL23 was shown effective in phase 3 trials for CD. Aim: Since real-world data is scarce, we present herein a 52 week follow-up data on 33 patients with severe refractory disease who have received risankizumab as a compassionate treatment. Methods: Prospective Israeli multicenter study on moderate-to-severe refractory IBD (28 CD, 5 UC) who received Risankizumab (IV 600-1800mg at 0, 4, 8 weeks; then SC 180 or 360mg every 8 weeks) for up to 52 weeks. Results: 33 patients refractory to all available biologics agents were included. At week 12, there was a significant reduction in Harvey Bradshaw index (HBI) for CD and in CRP values vs. week 0 (10±6.5 to 4.9±4.2, p=0.016; 3.8±3 to 1.56±1.5, p=0.002, respectively). Mayo score for UC was also reduced (6.7±2.5 to 3±2, p=0.044, both doses, n=4). Moreover, 10/16 (62.5%) of the 180mg dose and 3/12 (25%) of the 360mg dose group achieved clinical remission, all steroid free. Additionally, 13/16 (81.3%) of the 180mg dose and 5/12 (41.7%) of the 360mg dose achieved clinical response. 4/5 UC patients showed clinical response on week 12. No serious adverse events were reported. Conclusion: Our real-world cohort shows that risankizumab holds a great therapeutic promise, even for patients with resistant disease refractory to multiple biologics.