P0283Assessment of the ultrasound response to risankizumab at weeks 12 and 52 in patients with Crohn’s disease. A single centre, observational, retrospective study.

Abstract Background Risankizumab (RZB) is the first monoclonal antibody targeting IL-23 (p19 subunit) approved for patients with moderate-to-severe Crohn’s disease (CD) patients. Clinical remission at week 12 has been reported 42-45% in the induction trials (ADVANCE, MOTIVATE), and up to 52% at week 52 at the maintenance trial (FORTIFY). Currently, there are no published data on the response to risankizumab assessed by intestinal ultrasound. Methods We conducted a single-centre, observational, retrospective study including all adult patients with active CD who initiated treatment with RZB at our centre. The primary endpoint was to assess the ultrasound response to RZB in CD patients, both at week 12 and week 52. Ultrasound response was defined as a reduction of bowel wall thickness 25%, or 2.0 mm, or 1.0 mm and one colour Doppler signal reduction (Limberg score). Transmural remission was defined as bowel wall thickness ≤3 mm with normal (score 0) colour Doppler signal. Intestinal ultrasound activity scores for CD were assessed: IBUS-SAS, SUS-CD, BUSS, Simple US Score. Data are presented as median (range), and percentage. Chi-2, Mann-Whitney, or Wilcoxon test were used as appropriate. Results Eighty patients were included, of which 40 (50.0%) had an intestinal ultrasound assessment at some point (baseline, week 12, or week 52). Full demographic characteristics are shown in Table 1. Ultrasound-assessed response was 20% (1/5) at week 12, and 42.11% (8/19) at week 52; transmural remission was 18.18% (2/11) at week 12, and 21.05% (4/19) at week 52. Baseline intestinal ultrasound scores were: IBUS-SAS 51.3 (37.1, 76) n = 32, SUS-CD 4 (4, 5) n = 32, BUSS 6.9 (5.4, 7.125) n = 26, Simple US Score 9 (8, 10) n = 32. Week 12 intestinal ultrasound scores were: IBUS-SAS 30.0 (14, 91) n = 11, SUS-CD 5 (1, 6) n = 11, BUSS 4.65 (2.625, 7.65) n = 11, Simple US Score 7 (3.5, 11) n = 11. Week 52 intestinal ultrasound scores were: IBUS-SAS 36.4 (21.8, 53) n = 20, SUS-CD 4 (2, 5.5) n = 20, BUSS 5.775 (4.35, 6.53) n = 19, Simple US Score 8 (4.7, 9.435) n = 20, Figure 1. No significant differences were found compared with baseline. Ultrasound response at week 12 was associated with clinical remission at week 52 (p = 0.046), whereas transmural remission at week 12 was not statisticaly associated (p = 0.408). Week 12 IBUS-SAS, SUS-CD, BUSS, and Simple US Score were not associated with clinical remission at week 52. Conclusion To our knowledge this is the largest series of CD patients treated with RZB with intestinal ultrasound assessment reported to date. Further prospective studies are needed to evaluate intestinal ultrasound response and its predictive value for clinical outcomes. 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. Ferrante M, Panaccione R, Baert F, et al. Risankizumab as maintenance therapy for moderately to severely active Crohn’s disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022;399(10340):2031-2046. doi:10.1016/S0140-6736(22)00466-4. 3. Ilvemark JFKF, Hansen T, Goodsall TM, et al. Defining Transabdominal Intestinal Ultrasound Treatment Response and Remission in Inflammatory Bowel Disease: Systematic Review and Expert Consensus Statement. J Crohns Colitis. 2022;16(4):554-580. doi:10.1093/ecco-jcc/jjab173. 4. A258 Ultrasound assessment of Crohn’s disease patients following risankizumab initiation: baseline, 3- and 6-month follow-up. J Can Assoc Gastroenterol. 2024;7(Suppl 1):207-208. doi:10.1093/jcag/gwad061.258. Conflict of interest: Mr. Moralejo Lozano, Óscar: I have received educational funding from Abbvie, Johnson & Johnson, Takeda, Kern Pharma, Alfasigma, Pfizer, Lilly, Sandoz, Dr. Falk Pharma, Ferring, and Tillotts. I have also served as a speaker for Abbvie, Takeda, Alfasigma, and Lilly. Jarrín Pesantes, Vanessa Camila: No conflict of interest González de Frutos, Concepción: No conflict of interest Abanades Tercero, María: No conflict of interest Carrillo Ramos, Maria Jesus: María Jesús Carrillo Ramos has served as a speaker for Takeda and Alfasigma. Gigante González De La Aleja, Gema: No conflicts Ruano Díaz, Lucía: No conflict of interest Salmoral Luque, Rosario: Alfasigma, Janssen Gómez Rodriguez, Rafael Ángel: No conflict of interest