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RISANKIZUMAB OUTPERFORMED USTEKINUMAB FOR STEROID-FREE CLINICAL AND BIOCHEMICAL REMISSION IN REAL-WORLD PATIENTS WITH CROHN’S DISEASE AFTER TUMOUR NECROSIS FACTOR ANTAGONIST EXPOSURE: A MULTICENTRE BAYESIAN ANALYSIS - REAL-SEQUENCE (AN IG-IBD STUDY)

Affiliations

1 Humanitas University, Pieve Emanuele, Italy

2 A.O.U. Citta della Salute e della Scienza di Torino, Torino, Italy

3 IRCCS Policlinico Gemelli, Roma, Italy

4 Division of Hepatogastroenterology, University of Campania "Luigi Vanvitelli", Naples, Italy

5 Gastroenterologia Universitaria L'Aquila, L'Aquila, Italy

6 Policlinico Universitario di Monserrato Cagliari, Cagliari, Italy

7 Fondazione IRCCS San Gerardo Dei Tintori, Monza, Italy

8 IRCCS Sacro Cuore Don Calabria Negrar, Negrar di Valpolicella, Italy

9 Ospedale San Bortolo ULSS8 Berica, Vicenza, Italy

10 Ospedale San Paolo ASST Santi Paolo e Carlo, Milano, Italy

11 Ospedale di Rho, Milano, Italy

12 University of Padua, Division of Gastroenterology, Padua, Italy

13 Ospedale Cannizzaro, Catania, Italy

14 Ospedale Manzoni, Milano, Italy

15 Department Of Medicine, University Of Padova, Treviso, Italy

16 Ente Ospedaliero Galliera, Genova, Italy

17 Policlinico di Bari, Bari, Italy

18 Ospedale Valduce, Como, Italy

19 Policlinico San Martino, Genova, Italy

20 Nuovo Ospedale dei Castelli, Ariccia, Italy

21 Osepdale di Taranto, Taranto, Italy

22 Department of Gastroenterology Universita di Ancona, Ancona, Italy

23 UOS Endoscopia Digestiva ASL Toscana Nord Ovest Pontedera, Pontedera, Italy

24 Humanitas Research Hospital, Rozzano, Italy

25 Fondazione Policlinico Universitario "A. Gemelli", IRCCS, Roma, Italy

26 University of Turin, Turin, Italy

27 IBD Center, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy

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Abstract

Introduction

The SEQUENCE trial showed the superiority of risankizumab (RZB) over ustekinumab (UST) in anti-TNF-experienced patients with Crohn's disease (CD). Whether this advantage translates to real-world practice remains uncertain.

Aims & Methods

We aimed to validate RZB superiority in a large real-world cohort, leveraging a Bayesian framework to integrate prior trial evidence with observational data. We performed a multicentre retrospective cohort study including anti-TNF-experienced CD patients initiating RZB or UST across 23 Italian centres. The primary endpoint was 6-month cumulative probability of steroid-free clinical remission (SFCR), defined as PRO-2 abdominal pain ≤1, stool frequency ≤1.5, and no corticosteroids use within the preceding 3 months. As a secondary endpoint, biochemical SFCR was defined as SFCR plus FCP <250 µg/g or CRP <5 mg/L (FCP prioritised when both available). A Bayesian Cox model was fitted on IPTW-weighted data, incorporating prior evidence from the SEQUENCE trial. The prior distribution for the treatment effect was centered on the clinical remission benefit observed in SEQUENCE (HR~1.5 in favour of RZB), with a conservative variance reflecting the open-label design and the difference in endpoint definition between the trial and the present study. Frequentist IPTW-Cox and a double-robust estimator (IPTW + multivariable Cox) served as sensitivity analyses.

Results

We included 404 patients (UST, n=287, RZB, n=117; Table 1). After IPTW, all covariates were balanced, with standardized mean differences <0.1. The cumulative probability of SFCR at 6 months was 52.5% (95% CI 44.8-59.2) for UST and 71.7% (95% CI 56.8-81.5) for RZB. Bayesian analysis yielded a posterior HR of 1.71 (95% CrI 1.49-1.95), with a posterior probability of RZB superiority >99% (P[superiority]>0.99). Results were robust to prior specification, including under a non-informative prior (HR 1.70, 95% CrI 1.49-1.95). Frequentist IPTW-Cox analysis confirmed these findings (HR 1.77, 95% CI 1.24-2.52, p=0.002), as did the double-robust estimator (aHR 2.08, 95% CI 1.52-2.85, p<0.001). For the biochemical SFCR endpoint, RZB demonstrated an even stronger advantage (Bayesian HR 1.94, 95% CrI 1.64-2.29; P(superiority)>0.99; IPTW-Cox: HR 2.00, 95% CI 1.39-2.89, p=0.0002). Independent predictors of lower SFCR were higher baseline stool frequency (aHR 0.82, 95% CI 0.75-0.90) and baseline steroid use (aHR 0.45, 95% CI 0.26-0.78).

Table 1. Patients’ baseline characteristics

Variable	UST (n=287)	RZB (n=117)	p
Age, years, median (IQR)	50.5 (36–60)	46.0 (34–60)	0.265
Sex, M/F, $n$ (%)	159/128 (55.4%/44.6%)	76/41 (64.7%/35.3%)	0.107
Location: L1/L2/L3, $n$ (%)	115/31/141 (40.2%/10.8%/49.0%)	34/14/69 (29.4%/11.8%/58.8%)	0.117
Behaviour: B1/B2/B3, $n$ (%)	100/131/56 (34.8%/45.5%/19.6%)	48/50/19 (40.8%/42.9%/16.3%)	0.554
Steroids at baseline, $n$ (%)	84 (29.4%)	25 (21.2%)	0.150
Stool frequency, median (IQR)	3.0 (1.0–5.0)	2.0 (0.0–4.0)	<0.001
Abdominal pain score, median (IQR)	1.0 (0–2)	1.0 (0–1)	0.466
CRP, mg/L, median (IQR)	18.0 (7.0–77.0)	28.0 (6.5–84.0)	0.334
FCP, µg/g, median (IQR)	258 (107–654)	380 (141–1000)	0.108

Conclusion

In this large, real-world cohort of anti-TNF-experienced patients with CD, RZB was associated with a significantly higher probability of achieving SFCR at 6 months than UST, corroborating the findings from the SEQUENCE trial and supporting their external validity of randomized evidence in an unselected clinical population. By combining IPTW with a Bayesian framework formally incorporating RCT evidence as prior knowledge, this study provides methodologically rigorous real-world validation, supporting the positioning of RZB over UST in anti-TNF-experienced CD patients in clinical practice.

Disclosure

GP received consultancy fees from Abbvie and Janssen. CB received lecture fees and served as a consultant for Takeda, MSD, Ferring, Abbvie, Galapagos and Janssen.
AA has received consulting and/or advisory board fees from AbbVie, Abivax, Alfa Sigma, Astra Zeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celltrion, Eli-Lilly, Enthera, Ferring, Galapagos, Gilead, Giuliani, Janssen, Lionhealth, MSD, Nestlé, Pfizer, Protagonist Therapeutics, Roche, Sanofi, Samsung Bioepis, Sandoz, Takeda, Teva Pharmaceuticals, Tillots Pharma; lecture and/or speaker bureau fees from AbbVie, AG Pharma, Alfa Sigma, Biogen, Bristol-Myers Squibb, Eli-Lilly, Ferring, Galapagos, Gilead, Janssen, Lionhealth, MSD, Novartis, Pfizer, Roche, Sandoz, Samsung Bioepis, Takeda, Teva Pharmaceuticals; and research grants from MSD, Pfizer, Takeda and Biogen.
The remaining authors declare no competing interests.

Conference

UEG Week Barcelona 2026

Topics

IBD

Submission format

Abstract

Session

Therapeutics in IBD: Real-world experience (II) (Posters)

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

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EFFECTIVENESS AND SAFETY OF RISANKIZUMAB IN CROHN’S DISEASE AFTER FAILURE OF A FIRST LINE OF ADVANCED THERAPY: A LONG-TERM, REAL-LIFE STUDY

Antonio Tursi

RISANKIZUMAB OUTPERFORMED USTEKINUMAB FOR STEROID-FREE CLINICAL AND BIOCHEMICAL REMISSION IN REAL-WORLD PATIENTS WITH CROHN’S DISEASE AFTER TUMOUR NECROSIS FACTOR ANTAGONIST EXPOSURE: A MULTICENTRE BAYESIAN ANALYSIS - REAL-SEQUENCE (AN IG-IBD STUDY)

Alessandro Armuzzi

EVALUATION OF CROHN’S DISEASE ACTIVITY DURING RISANKIZUMAB MAINTENANCE USING THE BUSS SCORE: A MULTICENTER REAL-WORLD STUDY FROM THE AN-IBD NETWORK

Mariabeatrice Rita Daniela Principi

PREVALENCE OF USUAL CLINICAL TRIALS EXCLUSION CRITERIA AND IMPACT ON TREATMENTS EFFECTIVENESS IN A REAL-WORLD EVIDENCE COHORT

Anthony Buisson

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Alina Tariq

AIRIS-CROHN: REMISSION, PERSISTENCE AND SAFETY OF RISANKIZUMAB IN CROHN’S DISEASE IN REAL-WORLD PRACTICE

Federico Argüelles-Arias

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PREVALENCE OF USUAL CLINICAL TRIALS EXCLUSION CRITERIA AND IMPACT ON TREATMENTS EFFECTIVENESS IN A REAL-WORLD EVIDENCE COHORT

Marianne Hupé 1, Guillaume Le Cosquer 2, Gilles Boschetti 3, Maria Nachury 4, Mathurin Fumery 5, Bruno Pereira 6, Anthony Buisson 6

Affiliations

1 Grenoble University Hospital, Grenoble, France

2 CHU Toulouse, Toulouse, France

3 Lyon-Sud Hospital, Pierre-Benite, France

4 CHRU Lille, Courbevoie Cedex, France

5 Amiens University Hospital, Amiens, France

6 CHU Estaing Clermont-Ferrand, Clermont-ferrand, France

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Abstract

Introduction

Population of patients with CD enrolled in clinical trials did not really represent the whole CD population owing to stringent inclusion/exclusion criteria, slowing the speed of recruitment down and limiting the generalization of the results from randomized controlled trials to real-life practice.

Aims & Methods

From this real-world evidence study, we assessed the percentage of patients who would not been eligible to be enrolled in a randomized controlled trials according to the usual inclusion/exclusion criteria as well as the weight of each individual criteria and its potential impact on treatment efficacy.
In this multicenter international retrospective study, we analyzed all consecutive adult patients (≥ 18 years-old) starting an advanced therapy (2021-2024) for CD with available except for situations such as prevention of endoscopic postoperative recurrence, definitive ostomy or total colectomy, or isolated perianal CD.
Outcomes were prevalence of usual clinical trials exclusion criteria and steroid-free clinical remission at week 12 according to PRO-2 (stool frequency ≤ 3 and abdominal pain subscore ≤ 1).

Results

Overall, 535 patients with CD have been included (53.8% female, 32.1% active smokers, 28.5% prior bowel resection, median CD duration 24.4 months [19.3-33.9], 41.3% with isolated ileal CD, 13.1% with isolated colonic CD and, 23.7% and 27.3% with B2 end B3 phenotypes, respectively). Most of these patients started with anti-TNF (n=212), vedolizumab (n=40), Ustekinumab (n=151), Risankizumab (n=89), or upadacitinib (n=72).
CFREM was achieved in 62.1% at week 12.
The prevalence of each usual clinical trials exclusion criteria and their association with CFREM at week 12 are given in the table.
The most limiting exclusion criteria were moderate-to-severe symptoms (41.4%, 222/535), concomitant immune-mediated inflammatory disease (IMID) (18.5%, 99/535) as well as capping the number of advanced therapies (13.6%, 73/535) or therapeutic classes (14.6%, 78/535).
The only factors impacting CFREM at W12 were prior exposure to at least 4 advanced therapies (49.1% vs 64.1%, p = 0.026), prior exposure to at least 3 therapeutic classes (148.3% vs 64.4%, p =0.017) and absence to moderate-to-severe symptoms according to PRO-2 (81.1% vs 47.6%, p < 0.001).

Type of criteria	Prevalence of patients in the RWE cohort	Association with CFREM at week 12 (Presence of criteria vs absence)	p-value
At least three prior bowel resection	3.1% (17/535)	No association	0.37
History of cancer (excluding non melanoma skin cancer)	3.7% (20/535)	No association	0.24
Primary sclerosing cholangitis	2.8% (15/535)	No association	0.44
Any concomitant IMID	18.5% (99/535)	No association	0.29
Active perianal CD	8.4% (45/535)	No association	0.75
Prior exposure to at least 4 advanced therapies	13.6% (73/535)	49.1% vs 64.1%	0.026
Prior exposure to at least 3 therapeutic classes	14.6% (78/535)	48.3% vs 64.4%	0.017
Non accessible lesions with usual ileocolonoscopy	8.2% (44/535)	No association	0.56
Absence to moderate-to-severe symptoms according to PRO-2	41.4% (222/535)	81.1% vs 47.6%	< 0.001

Conclusion

In this real-world evidence cohort of consecutive patients with CD starting an advanced therapy, more than half of them would have not been eligible for a clinical trial while most of inclusion criteria did not impact therapeutic efficacy except for symptoms and number of prior drug exposures, which could be taken into account by stratification. Our data advocated for less stringent inclusion/exclusion criteria in clinical trials to provide results closer to the rela-life practice.

Disclosure

•Consulting fees from: Abbvie, Amgen, Arena, Biogen, Celltrion Healthcare, Ferring, Galapagos/AlfaSigma, GutuCare/Resilience, Hikma, J&J, Lilly, Mylan, Nexbiome, Pileje, Pfizer, Roche, Sandoz, Takeda, Tillotts
•Lecturer for: Abbvie, Amgen, Biogen, Celltrion Healthcare, Ferring, Fresnius-Kabi, Galapagos/Alfa Sigma, Hikma, J&J, Lilly, Mayoli-Spindler, MSD, Pfizer, Roche, Sanofi-Aventis, Takeda, Tillotts, Vifor-Pharma
•Research fundings from: Abbvie, Celltrion Healthcare, Galapagos/AlfaSigma, J&J, Lessaffre, Lilly, Pfizer, ScientaLab,Takeda

Conference

UEG Week Barcelona 2026

Topics

IBD

Submission format

Abstract

Session

IBD (INCLUDING MICROSCOPIC COLITIS) (Posters)

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

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EFFECTIVENESS AND SAFETY OF RISANKIZUMAB IN CROHN’S DISEASE AFTER FAILURE OF A FIRST LINE OF ADVANCED THERAPY: A LONG-TERM, REAL-LIFE STUDY

Antonio Tursi

RISANKIZUMAB OUTPERFORMED USTEKINUMAB FOR STEROID-FREE CLINICAL AND BIOCHEMICAL REMISSION IN REAL-WORLD PATIENTS WITH CROHN’S DISEASE AFTER TUMOUR NECROSIS FACTOR ANTAGONIST EXPOSURE: A MULTICENTRE BAYESIAN ANALYSIS - REAL-SEQUENCE (AN IG-IBD STUDY)

Alessandro Armuzzi

EVALUATION OF CROHN’S DISEASE ACTIVITY DURING RISANKIZUMAB MAINTENANCE USING THE BUSS SCORE: A MULTICENTER REAL-WORLD STUDY FROM THE AN-IBD NETWORK

Mariabeatrice Rita Daniela Principi

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Anthony Buisson

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Alina Tariq

AIRIS-CROHN: REMISSION, PERSISTENCE AND SAFETY OF RISANKIZUMAB IN CROHN’S DISEASE IN REAL-WORLD PRACTICE

Federico Argüelles-Arias

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AIRIS-CROHN: REMISSION, PERSISTENCE AND SAFETY OF RISANKIZUMAB IN CROHN’S DISEASE IN REAL-WORLD PRACTICE

Affiliations

1 Hospital Clínico San Cecilio, Granada, Spain

2 Hospital Universitario Virgen Macarena, Seville, Spain

3 Hospital Regional Málaga, Málaga, Spain

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

5 Hospital Universitario Juan Ramón Jiménez, Huelva, Spain

6 Hospital Universitario Torrecárdenas, Almería, Spain

7 Hospital Universitario Virgen de la Victoria, Málaga, Spain

8 Hospital Universitario Costa del Sol, Málaga, Spain

9 Hospital Universitario de Jaén, Jaén, Spain

10 Hospital Santa Ana, Granada, Spain

11 Hospital Universitario Reina Sofia, Cordoba, Spain

12 Hospital Universitario de Puerto Real, Cádiz, Spain

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Abstract

Introduction

Risankizumab, a selective anti-interleukin-23 antibody, has shown efficacy in Crohn’s disease, but long-term real-world data in highly pre-treated patients remain limited. The AIRIS-Crohn study aimed to evaluate remission, treatment persistence and safety of risankizumab in a large multicenter real-world cohort.

Aims & Methods

We performed a multicenter, observational, ambispective study in adult patients with moderate-to-severe Crohn’s disease treated with risankizumab in 14 Andalusian hospitals. Clinical remission was defined as Harvey-Bradshaw Index <5; clinical-biochemical remission as Harvey-Bradshaw Index <5 with C-reactive protein <5 mg/L and faecal calprotectin <250 μg/g; and steroid-free remission as clinical remission without systemic corticosteroids from week 12 onwards. Outcomes were assessed at baseline, week 12, 6 months, 12 months and 18 months.

Results

A total of 312 patients initiated risankizumab; mean age was 50.5 years, mean disease duration 14.5 years, 36.9% had prior resective surgery and 26.5% perianal disease. Patients were highly pre-treated, with a mean of 2.5 prior advanced therapies; 84.0% had received ustekinumab, 66.0% adalimumab and 59.0% infliximab. Risankizumab induced rapid and sustained improvement in clinical activity and remission outcomes up to 18 months (Table 1). At 6 months, clinical remission was significantly higher in patients with one versus two or more prior biologics (68.0% vs 38.4%, p=0.005), while differences at later timepoints were not significant. Regarding safety, adverse events were mainly mild-to-moderate and occurred in approximately 7% of patients, including upper respiratory tract infections, cutaneous manifestations, transient liver enzyme elevations, neurological symptoms and alopecia. Treatment discontinuations reached 53 patients (17.0%) by 18 months, mostly due to lack or loss of response, with a smaller proportion related to adverse events or other causes.

Table 1. Effectiveness results at baseline, week 12, 6, 12 and 18 months

Timepoint	Baseline (n=307)	Week 12 (n=270)	6 Months (n=209)	12 Months (n=133)	18 Months (n=66)	p
Harvey-Bradshaw Index, median	8	4.5 (<0.001)	5 (<0.001)	5 (<0.001)	4 (<0.001)	<0.001
C-reactive protein mg/L, median	5.0	4.0 (>0.999)	4.0 (>0.999)	3.8 (0.418)	3.3 (0.159)	0.023
Faecal calprotectin μg/g, median	1102	800 (0.446)	659.5 (0.491)	530 (0.002)	688 (0.056)	0.004
Clinical remission (%)	16.9	48.7 (<0.001)	41.3 (<0.001)	37.4 (<0.001)	31.0 (0.009)	—
Clinical-biochemical remission (%)	4.2	10.0 (<0.001)	9.8 (0.003)	6.4 (0.180)	2.7 (>0.999)	—
Steroid-free remission (%)	—	44.1	36.0 (0.164)	27.5 (0.017)	17.7 (0.023)	—
Treatment discontinuation, n	—	19	38	50	53	—

Pairwise p values are shown in parentheses versus baseline; global p values correspond to Friedman or McNemar tests.

Conclusion

Risankizumab was effective in a large, highly pre-treated real-world Crohn’s disease cohort, achieving clinically meaningful remission and steroid-free remission with sustained benefit up to 18 months. Patients with fewer prior biologics achieved higher remission rates, particularly at 6 months. The safety profile was consistent with that reported in clinical trials.

Conference

UEG Week Barcelona 2026

Topics

IBD

Submission format

Abstract

Session

IBD (INCLUDING MICROSCOPIC COLITIS) (Posters)

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

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Alessandro Armuzzi

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Mariabeatrice Rita Daniela Principi

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Anthony Buisson

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Alina Tariq

AIRIS-CROHN: REMISSION, PERSISTENCE AND SAFETY OF RISANKIZUMAB IN CROHN’S DISEASE IN REAL-WORLD PRACTICE

Federico Argüelles-Arias

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