Abstract Background Risankizumab, an anti IL23-p19 antibody is approved for use in moderate to severe Crohn’s disease. The objective of this study was to evaluate the efficacy and safety of Risankizumab in patients with Crohn’s disease. Methods This is a clinical audit of all patients with prescribed Risankizumab (as documented on the pharmacy database) from December 2023 to April 2025 for Crohn’s disease in a large tertiary inflammatory bowel disease (IBD) centre in the UK. Response to therapy was assessed based on steroid free clinical remission rate, biomarker normalisation (defined as C-reactive protein CRP 5 mg/L and/or stool calprotectin 100 ug/g n), endoscopic remission (as defined as SES-CD 3) and imaging, where available. Harvey Bradshaw Index (HBI), patient reported outcomes (PROMs) in the form of IBD control and EQ-5D-3L were collected from our remote web-based monitoring system (TrueColours-IBD). Electronic medical records were reviewed for safety events. Those who did not complete 3 doses of induction therapy (n = 8), had a follow up period of less than 6 months (n = 12) or short gut syndrome (n = 6) were excluded. Patients with existing ostomy were excluded from the Harvey Bradshaw Index (HBI) assessment. Results A total of 115 patients were included in the study, mean age of 42 (range 19-78) years, 56. 5% males. The mean disease duration was 15 (ranges 1-52) years with 67% having Crohn’s disease for at least 5 years. Ileocolonic involvement was predominant (51%). All patients were bio-experienced, with majority (80%) being anti-TNF exposed and 50% ustekinumab exposed. The baseline demographics and disease characteristics are shown in Table 1. The mean follow up duration was 56 weeks with a primary non-response rate of 9. 6%. The drug persistence was 80% at six months and 65% at 12 months. The rate of steroid free clinical remission and biomarker normalisation were 62. 3% and 61%, respectively, at the end of follow up period. In patients who had a repeat endoscopy, 51. 2% achieved endoscopic remission. Treatment response was reflected in serial HBI, CRP, and PROMs, as shown in Table 2. There were 5. 2% reported infectious complications, 7% IBD-related hospitalisations, 12. 2% had steroid use for disease flare, 4. 3% underwent perianal surgery, 2. 7% required abdominal surgery and 2. 7% had endoscopic balloon dilatation. There was a new diagnosis of perianal squamous cell carcinoma in a patient with long standing perianal Crohn’s disease, six months after commencing Risankizumab. Conclusion Risankizumab is an effective therapy in patients who had previous biologic exposure for Crohn’s disease. Our audit highlights the utility of web-based monitoring and importance of systematic PROMs tracking in patients with IBD. References: 1. D’Haens G, Panaccione R, Baert F, et al. Risankizumab as induction therapy for Crohn’s disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022;399 (10340): 2015-2030. doi: 10. 1016/S0140-6736 (22) 00467-6 2. Turner D, Ricciuto A, Lewis A, et al. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology. 2021;160 (5): 1570-1583. doi: 10. 1053/j. gastro. 2020. 12. 031 Conflict of interest: Ms. Tan, Chin Kimg: No conflict of interest Azzu, Hanan: No conflict of interest Cripps, Sarah: Consultancy fees: Abbvie, Advanz, Dr Falk, Galapagos, Pfizer, Lilly, SALTs healthcare, Sandoz, Takeda Sponsorship: Abbvie, BMS, Celltrion, Gilead, Lilly, Tillots Dunbar, Grace: No conflict of interest Punj Sharda, Anita: No conflict of interest Matini, Lawrence: Speaker fees: AbbVie, Galapagos, Bristol Myers Squibb Brain, Oliver: Speaker and Advisory Board Fees from AbbVie, Janssen-Cilag, Galapagos, BMS, Takeda, Pfizer Walsh, Alissa: Grant: Alfasigma, Helmsley Trust, Johnson & Johnson, Pfizer, Takeda Personal Fees: AbbVie, Alfasigma, Bristol Meyers Squibb, Dr Falk, Ferring, Johnson & Johnson, Lilly, Pfizer, Takeda, Tillotts
Tan et al. (Thu,) studied this question.