P745 Assessment of Crohn’s disease patients following risankizumab initiation using intestinal ultrasound: A prospective study

Abstract Background Risankizumab (RIS) is a humanized monoclonal antibody that inhibits interleukin-23 by binding to its p19 subunit. The use of RIS in the treatment of moderate to severe Crohn’s Disease (CD) was approved in December 2022. Intestinal ultrasound (IUS) is an accurate and well-tolerated modality for evaluating response to therapy. Here, we assessed the IUS response at 3 and 6 months following RIS therapy. Methods CD patients initiating RIS were recruited and evaluated by IUS at baseline (within 14 days of initiation), 3, and 6 months. Data elements collected at baseline included demographics, medication exposures, surgical history, as well as inflammatory biomarkers. IUS response (decrease in bowel wall thickness (BWT) ≥ 25%)) and transmural remission (TR) (normalization of BWT normalization, color doppler signal (CDS, modified Limberg (ML) score 0), wall stratification, inflammatory fat)) for each segment were evaluated. Paired t-tests were used to compare values at 3 and 6 months relative to baseline. Results A total of thirty-three (20, 60.6% female) patients were recruited; 30 completed baseline and 3 month IUS, while 18 patients have also completed a 6 month IUS. Median age was 55 years (IQR 39-63), with a 12 year median CD duration (IQR 5-28). Five had inflammatory behaviour, 19 had stricturing, and 6 had fistulizing behaviour. CD distribution was 18 ileal, 1 colonic, and 11 ileocolonic. Baseline mean CRP (4.1 ± 4.9 mg/L) did not differ at 3 months (5.0 ± 6.8 mg/L, p=0.16), nor at 6 months for patients with values available (6.2mg/L ± 8.3, p = 0.38). Of patients with FC concentrations, 3 month mean FC (129.4 ±70 mcg/g) (9 patients) had significantly decreased from baseline (427.6 ± 271 mcg/g) (p=0.008), and similarly at 6 months (9 patients; baseline 396 ± 299 vs. 129 ± 75, p = 0.02). 80.0% (4/5) patients with colonic BWT > 3mm had IUS response (baseline mean BWT 5.6±1.4mm vs 3.5 ± 0.8mm at 3 months (p=0.011). IUS response was achieved in 20% (5/25) with ileal CD at 3 months (BWT 6.3 ± 2.1mm vs 3 month 6.0 ± 2.5mm (p=0.31). 21.4% (3/14) of ileal CD patients had an IUS response at 6 months. There was a non-significant ileal BWT reduction (5.4 ± 1.6mm) from baseline (6.0 ± 1.7mm) at 6 months. Of the 9 with moderate to severe CDS, 55% (5/9) had reduction to mild CDS by 3 months. TR was achieved by one patient with ileal CD at 6 months. Conclusion IUS response was achieved in 80.0% of CD patients with colonic disease at 3 months follow RIS initiation. IUS response was detected for 20% of ileal CD patients at 3 months and 21.4% at 6 months A significant FC reduction by 3 and 6 months was attained. Further prospective patient recruitment and IUS at 6 and 12 months to assess preliminary results and longer-term response is needed.

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