P1100 Effectiveness of Risankizumab in Crohn’s Disease, our real-world experience: Clinical, Biochemical and Ultrasonographic responses. A single centre, observational, retrospective study
Authors: Moralejo Lozano Ó , Jarrín Pesantes V C , Abanades Tercero M , Ruano Pérez L , Salmoral Luque R , Muñoz Rosas C , Gómez Rodriguez R Á 
Published: January 2025

Background

Risankizumab (RZB) is the first monoclonal antibody targeting IL-23 (p19 subunit) approved for 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% by week 52 at the maintenance trial (FORTIFY). Real world evidence is necessary to confirm these data.

Methods

We conducted an observational, retrospective, unicentric study including all adult patients with active CD who have initiated treatment with RZB. Primary endpoint is clinical remission defined as Harvey-Bradshaw Index (HBI) ≤4 for CD, both at week 12 and at the end of follow up. Secondary endpoints are: Steroid-free clinical remission, biochemical remission (defined as fecal calprotectin [FC] &lt;250μg/g, or c reactive protein [CRP] &lt;5mg/L), ultrasound response (defined using Ilvemark JFKF, et al 2021 Consensus Statement), and adverse events. Data are represented with median (range), and percentage. Wilcoxon, Student t-test (paired), and McNemar tests were used as appropriate.

Results

34 patients were included. Full demographic description can be found in Table 1. End of follow up for HBI was on day 132.5 (93, 210). Clinical remission both at week 12 and at the end of follow up was 58.82%, steroid-free clinical remission both at week 12 and at the end of follow up was 52.94%. HBI decreased significantly from 5 (3, 9) at baseline, to 4 (2, 6) at week 12 (p=0.0471), and down to 3 (2, 6) at the end of follow up (p=0.0203). Fecal calprotectin decreased from baseline 2098.5 (490, 3003.8), to 1357.8 (805, 3077.7) at week 12 (p=0.2386), and to 1300.5 (515, 2940.7) by the end (p=0.1056). No statistically significant differences were found in the FC remission rate, nor in the CRP values and its remission rate. Transmural response assessed with ultrasound was 40% (2/5) at week 12, and 50% (4/8) at the end of follow up; transmural remission was 20% (1/5) at week 12, and 25% (2/8) at the end. There were not found differences in the intestinal ultrasound activity scores for CD. RZB was stopped in 9 (26.47%) patients, due to: primary failure 5 (2 of them required intestinal resection), secondary failure 1, and adverse events 3. Adverse events occurred in 7 (20.59%) patients: 2 arthralgias, 1 mild-moderate infusion reaction, 1 worsening of atopic dermatitis, 1 renal function impairment, 1 mild urinary tract infection, and 1 device failure.

Conclusion

Real world RZB effectiveness seems comparable to the efficacy reported in clinical trials.

References

-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.

-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.

-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.

-Barreiro-de Acosta M, Nieto García L, Poncela M, et al. OP043 Real-world short-term effectiveness of Risankizumab in refractory Crohn’s disease: RISANCROHN study from the ENEIDA registry. UEG Week 2024 Oral Presentations. United European Gastroenterol J. 2024;12(Suppl 8): 2050-6406. doi.org/10.1002/ueg2.12614.