P0721Predictors of long-term clinical remission with risankizumab in patients with Crohn’s disease. A single centre, observational, retrospective study: a regression analysis.

Abstract Background Risankizumab (RZB) is the first monoclonal antibody targeting the IL-23 p19 subunit approved for moderate-to-severe Crohn’s disease (CD). Induction trials (ADVANCE, MOTIVATE) reported clinical remission rates of 42–45% at week 12, and maintenance trial (FORTIFY) showed up to 52% at week 52. In a therapeutic landscape with multiple options, identifying predictors of long-term response is needed. Methods Single-center, retrospective observational study including all adults with active CD (clinically, biochemically, or endoscopically) who initiated RZB. The primary endpoint was to identify factors associated with clinical remission at week 52, assessed at baseline and week 12. Logistic regression analyses (univariate and multivariate) were performed, and results are expressed as Odds Ratios (OR). Results Eighty patients were included. Full demographic characteristics are shown in Table 1. Demographic and disease characteristics showed no significant association with week 52 remission. Psoriasis displayed a high OR but lacked significance, likely due to small sample size and wide confidence intervals. Baseline Harvey-Bradshaw Index (HBI) was inversely associated with remission (OR 0.78, p = 0.012), while baseline remission (HBI ≤4) markedly increased odds (OR 6.00, p = 0.008). At week 12, clinical remission strongly predicted long-term remission (OR 26.00, p 0.001), and lower HBI was also significant (OR 0.60, p = 0.001). Clinical response showed a trend (OR 3.33, p = 0.051). Among biomarkers, lower C-reactive protein (CRP) at week 12 was associated with remission (OR 0.94, p = 0.043), whereas fecal calprotectin and ultrasound scores were not predictive. Prior Ustekinumab use was not predictive or response/failure. Multivariate analysis confirmed early clinical status as the most relevant predictor. Clinical remission at baseline (OR 92.39, p = 0.047) and week 12 (OR 82.13, p = 0.043) were independently associated with week 52 remission, despite wide confidence intervals. CRP at week 12 retained significance (OR 0.85, p = 0.006), reinforcing its role as a negative predictor. Baseline and week 12 HBI lost significance after adjustment. Conclusion Early clinical remission and CRP normalization at week 12 are strong predictors of sustained remission at week 52. Fecal calprotectin and ultrasound lacked predictive value. Ultrasound results may be affected by sample size limitations (ultrasound data available in just a few patients). Psoriasis coexistence was not associated with long-term remission, though its high OR warrants further investigation in larger cohorts. 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 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