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). Real world evidence is needed to confirm these findings. Methods We conducted a single-centre, observational, retrospective study including all adult patients with active CD who initiated treatment with RZB. Primary endpoint was clinical remission defined as Harvey-Bradshaw Index (HBI) ≤4 for CD (assessed both at week 12 and at week 52). Secondary endpoints included Steroid-free clinical remission, biochemical remission (defined as fecal calprotectin FC 250μg/g, or C-reactive protein CRP 5mg/L), ultrasound response (defined using Ilvemark JFKF, et al 2021 Consensus Statement), and adverse events. Data are presented as median (range), and percentage. Wilcoxon and McNemar tests were used as appropriate. Results 80 patients were included. Full demographic characteristics can be found in Table 1. End of follow up for HBI was on day 264.5 (164, 421). Clinical remission both at week 12 and week 52 was 74.03% and 55.10%, steroid-free clinical remission at week 12 and week 52 was 67.53% and 55.10%. HBI decreased significantly from 5 (2, 7) at baseline, to 2 (0, 5) at week 12 (p 0.0001), and to 2 (0, 5) at week 52 (p = 0.0001), Figure 1A. Fecal calprotectin decreased from baseline 1924.85 (1067, 3042)μg/g, to 1377.6 (515, 2122.6)μg/g at week 12 (p = 0.0097), and to 1338 (339.5, 2046)μg/g at week 52 (p = 0.0087), Figure1B. Baseline CRP was 4.2 (1.8, 10.2)mg/L, decreasing to 3.2 (1.9, 10.2)mg/L at week 12 (p = 0.9989), and to 3.8 (1.5, 6.5)mg/L at week 52 (p = 0.0041), Figure 1C. No statistically significant differences were observed in the FC or CRP remission rate. Ultrasound-assessed transmural 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. RZB was stopped in 19 (23.75%) patients, due to: primary non-response (n = 9, 47.37%), secondary loss of response (n = 5, 26.32%), adverse events (n = 4, 21.05%), and extraintestinal manifestations (n = 1, 5.26%). Adverse events occurred in 10 patients (12.50%): asthenia (n = 3), musculoskeletal pain (n = 2), mild–moderate infusion reaction (n = 1), worsening of atopic dermatitis (n = 1), renal function impairment (n = 1), mild urinary tract infection (n = 1), and device failure (n = 1). Conclusion In real-world practice, the effectiveness of RZB at 12 and 52 weeks appears comparable to the efficacy reported in clinical trials. 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. Barreiro-de Acosta M, Nieto-Garcia L, Poncela M, Aguas M, Martinez Cuevas C, Argüelles-Arias F, et al. Real-world short and long-term effectiveness of risankizumab in refractory Crohn’s disease: RISANCROHN study from the ENEIDA Registry. J Crohns Colitis. 2025;19(Suppl 1):i1208-i1209. doi:10.1093/ecco-jcc/jjae190.0783 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 Gigante González De La Aleja, Gema: No conflicts Carrillo Ramos, Maria Jesus: María Jesús Carrillo Ramos has served as a speaker for Takeda and Alfasigma. Ruano Díaz, Lucía: No conflict of interest Salmoral Luque, Rosario: Alfasigma, Janssen Gómez Rodriguez, Rafael Ángel: No conflict of interest
Lozano et al. (Thu,) studied this question.