Affiliation:
1. Shaare Zedek Medical Center
2. Wolfson Medical Center
3. Barzilai Medical Center
4. Tel Aviv Sourasky Medical Center
5. Hebrew University Hadassah Medical Center
6. Sheba Medical Center
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.
Publisher
Research Square Platform LLC