P340 Risankizumab in Inflammatory Bowel Disease: Real World Experience from a Pre-Approval Access Program. (21st January 2022)

• Record Type: Journal Article
• Authors: Dawson, P; Sharma, E; Dart, R J; Lim, S; Anderson, S H; Ray, S; Mawdsley, J; Irving, P M; Samaan, M A
• Is Part Of: Journal of Crohn's and colitis. Volume 16(2022)Supplement 1
• Page Start: i355
• Page End: i355
• Publication Date: 2022-01-21
• Subjects: Inflammatory bowel diseases -- Periodicals; 616.344005
• DOI: 10.1093/ecco-jcc/jjab232.467
• Languages: English
• ISSNs: 1873-9946

Abstract

Abstract: Background: Risankizumab is a new generation monoclonal antibody which inhibits interleukin-23A. It has applications in several immune mediated inflammatory diseases including moderate-to-severe CD. Pre-approval access was granted for a cohort of patients who had active disease and prior use of all European licenced biologic therapies for CD. We aimed to define the effectiveness and tolerability of risankizumab in this real-world, treatment refractory cohort. Methods: We performed a retrospective cohort analysis of prospectively maintained data for patients starting risankizumab between January and September, 2021. All patients received doses at four weekly intervals (IV, 600mg doses for CD and SC, 300mg doses for IBD-U). Clinical disease activity, biochemical activity and quality of life were measured using HBI, CRP and IBD-C scores, respectively. Study evaluations were made at baseline, weeks, 4 and, 12. Data were analysed in GraphPad prism and are described as median (range). Results: Since January, 2021, 16 patients have started risankizumab. We included, 13 patients who had completed the, 12 week induction period at the time of submission;, 12 with CD and, 1 with IBD-U. Demographics are shown in Table, 1. The characteristics are consistent with a more aggressive phenotype with the majority of patients (9 (75%)) having perianal involvement as well as having either stricturing (5(42%)) or internal penetrating disease (3(25%)). Nine (75%) patients had undergone prior luminal surgery, 7 of whom still had stomas, therefore were not included in the analysis for HBI. Median HBI at baseline was, 5 (0–10) vs, 2 (0–8) at week, 4 and, 1.5 (0–2) at week, 12 and due to small patient numbers was not statistically significant. There was an improvement in IBD-C scores. Median IBD-C score at baseline was, 5 (0–14) vs, 11 (4–16) at week, 4 (p=0.034) and, 12 (2–16) at week, 12 (p=0.067). CRP decreased from, 12 mg/L (1–48) at baseline to, 8 mg/L (1–20) at week, 4 (p=0.23) and to, 6 mg/L (1–34) at week, 12 (p=0.022). Results are represented in Figure, 1. Two patients experienced mild headaches, no other side effects were reported. At initiation two patients were being treated with steroids; one has since discontinued and one has remained on steroids. No other patients initiated steroids. No patients discontinued risankizumab during the study period. Conclusion: We present a heterogeneous cohort of patients with refractory CD despite multiple biologic mechanisms. Overall, there was a positive impact of risankizumab induction over a, 12 week period with respect to symptoms, quality of life and CRP, showing the effectiveness of risankizumab in this refractory cohort. We will follow up, and at week, 24 will objectively assess disease activity with cross sectional imaging and/or endoscopy.