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MID-TERM OUTCOMES OF RISANKIZUMAB IN REFRACTORY CROHN’S DISEASE: A MULTICENTER REAL-WORLD STUDY IN ANDALUSIA, SPAIN

Antonio M Caballero-Mateos 1, Raúl Olmedo-Martín 2, Melody Moreno Barrueco 3, Nuria Fernandez Moreno 4, Maria Mar Martin Rodriguez 5, Federico Argüelles-Arias 6, Francisco Javier Rodriguez-González 7, Alvaro Hernández Martínez 8, JOSE MANUEL BENITEZ CANTERO 9, Ana Maria Trapero-Martínez 10, Francisco Jesús Mata Perdigón 11, Ana Bejarano García 12, Teresa Valdes-Delgado 13

Affiliations

1 Santa Ana Hospital, Motril, Granada, Granada, Spain

2 Hospital Regional de Málaga, Málaga, Spain

3 Hospital Clínico San Cecilio, Granada, Spain

4 Hospital Costa del Sol, Marbella, Spain

5 Hosp. Universitario Virgen De Las Nieves, Granada, Spain

6 Huv macarena, Sevilla, Spain

7 Hospital Virgen de la Victoria, Málaga, Spain

8 Hospital Torrecárdenas, Almería, Spain

9 Hospital Universitario Reina Sofia, Cordoba, Spain

10 Hospital Universitario de Jaén, Jaén, Spain

11 Hospital de Puerto Real, Puerto Real, Cádiz, Spain

12 Hospital Juan Ramón Jiménez, Huelva, Spain

13 Hospital Universitario Virgen Macarena, Seville, Spain

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Abstract

Introduction

There is limited real-world evidence regarding the effectiveness and safety of risankizumab in patients with Crohn’s disease. This multicenter observational study aimed to evaluate the clinical outcomes of risankizumab in Crohn’s disease across several hospitals in Andalusia.

Aims & Methods

Clinical and biochemical data were ambvispectively collected from 160 patients who started risankizumab therapy at ten centers participating in the AIRIS-Crohn registry. Clinical remission (CR) was defined as a Harvey-Bradshaw Index (HBI) score below 5. Combined clinical and biochemical remission (CBR) required HBI <5, C-reactive protein (CRP) <5 mg/L, and fecal calprotectin <250 μg/g. Steroid-free remission (SFR) was defined as HBI <5 with no corticosteroid use from week 12 onward. Outcomes were assessed at weeks 12 and 24.

Results

A total of 160 patients were included, with a mean age of 50 years (range 19–84), and 48% were male. Ileal involvement was present in 49%, and upper gastrointestinal involvement in 6%. Extraintestinal manifestations were observed in 38%, and perianal disease in 56%. The average disease duration was 15 years, and 40% had a history of surgery. Patients had previously failed an average of 2.5 advanced therapies. At initiation, 3% were on immunomodulators and 30% on corticosteroids. At week 24, 89% remained on 360 mg every 8 weeks, 6% required dose intensification to every 6 weeks, and 5% to every 4 weeks.
At week 12, among 129 patients, 49% achieved CR (p<0.001) and 8% achieved CBR (p=0.041). At week 24, among 81 patients, 37% achieved CR (p<0.001), 3% achieved CBR (p=0.480), and 34% achieved SFR (p=0.007). The mean baseline HBI was 8, decreasing to 5.4 at week 12 and 6.1 at week 24 (p<0.001). Mean baseline fecal calprotectin was 1761 μg/g, decreasing to 1151 μg/g at week 12 and 1091 μg/g at week 24 (p<0.001). CRP levels also declined, though not significantly (from 12.9 mg/L at baseline to 8.4 mg/L at week 12 and 7.4 mg/L at week 24; p=0.407) (Table 1).
Patients with ≥2 prior advanced treatment failures showed significantly lower 6-month clinical remission (32.9% vs 64.3% in 1-failure group, p=0.029) and steroid-free remission rates (28.9% vs 64.3%, p=0.014).
Treatment discontinuation occurred in 12.5% of patients, primarily due to lack of response. Adverse events were reported in 5.6%, mainly cutaneous reactions, leading to discontinuation in five cases.

Table 1: Effectiveness Outcomes

Time	Baseline (n=160)	12 weeks (n=129)	6 months (n=81)	p¹
Harvey-Bradshaw Index (mean)	8.0	5.4 (<0.001)²	6.1 (<0.001)²	<0.001
CRP (mg/L, mean)	12.9	8.4	7.4	0.407
Calprotectin (μg/g, mean)	1760.6	1150.9 (<0.001)²	1090.8 (<0.001)²	<0.001
Clinical remission (%)	21.3%	48.5% (<0.001)³	37.4% (<0.001)³	-
Clinical-biochemical remission (%)	2.5%	7.7% (0.041)³	3.3% (0.480)³	-
Steroid-free remission (%)	-	25.4%	34.1% (0.007)³	-
Treatment discontinuation (n)	-	9	20	-

Notes:
¹ Friedman test for related samples (two-way ANOVA by ranks).
² Post-hoc pairwise comparisons using the Friedman test.
³ McNemar test for related samples.

Conclusion

Risankizumab demonstrated favorable effectiveness and safety in a cohort of highly refractory Crohn’s disease patients, with 88% maintaining therapy through follow-up. Composite remission rates remained low across all groups (<9%), highlighting the challenge of achieving combined clinical and biochemical targets in multirefractory CD. These results align with real-world evidence showing risankizumab maintains effectiveness in patients with multiple biologic failures, though response rates diminish with increasing treatment refractoriness.

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

Real-world evidence of Crohn's disease (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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	n T0	n T1	n T2	T0 vs T1	p	T0 vs T2	p	T1 vs T2	p
EREFS ± SD	292	259	136	3±2 vs 2±1	<0.0001	3±2 vs 1±1	<0.0001	2±1 vs 1±1	0.1
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Distal Esophagus Eosinophilic peak ± SD	292	259	136	40±38 vs 5±12	<0.0001	40±38 vs 5±13	<0.0001	5±12 vs 5±13	1
Mid Esophagus Eosinophilic peak ± SD	292	259	136	31±38 vs 3±12	<0.0001	31±38 vs 3±13	<0.0001	3±12 vs 3±13	1
Proximal Esophagus Eosinophilic peak ± SD	292	259	136	28±30 vs 3±11	<0.0001	28±30 vs 1±5	<0.0001	3±11 vs 1±5	0.04
DSQ ± SD	195	172	137	30±23 vs 6±12	<0.0001	30±23 vs 4±10	<0.0001	6±12 vs 4±10	0.1
HRQoL ± SD	191	162	135	112±37 vs 153±30	<0.0001	112±37 vs 153±28	<0.0001	153±30 vs 153±28	1

Table 1. Overview of the remission rates at W24 between surgery-naïve and surgery-experienced patients
	CSF clinical remission	Clinical remission	Biochemical remission	Combined remission
Total	34/62 54.8%	39/62 62.9%	17/55 30.9%	17/43 39.5%
Surgery-naïve	15/23 65.2%	17/23 73.9%	6/21 28.6%	6/16 37.5%
Surgery-experienced	19/37 51.3%	22/37 59.5%	11/32 34.8%	11/24 45.8%

Measure	Sensitivity	Specificity	AUC	p-value	95% CI
	Endoscopic Activity
TAS (MUC) (≥8.5)	67.6%	60.9%	0.67	<0.001	0.59-0.76
TPUS (MUC) (≥8)	86%	62.3%	0.78	<0.001	0.70-0.86
EUS (MUC) (≥8)	81.7%	81.2%	0.94	<0.001	0.85-0.95
	Histologic activity
TAS (MUC) (>8.6)	62.8%	66%	0.64	0.005	0.54-0.74
TPUS (MUC) (≥9.7)	59.3%	79.6%	0.70	<0.001	0.61-0.79
EUS (MUC) (>7)	83.7%	81.5%	0.87	<0.001	0.81-0.93

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