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Introduction

The Epi-IBD cohort is a prospective European population-based cohort of 1,390 patients diagnosed in 2010 and 2011 with inflammatory bowel disease (IBD) according to Copenhagen criteria in centres from Eastern and Western European countries.

Aims & Methods

The study aims at describing differences in incidence, treatment strategies, disease course and prognosis of ulcerative colitis (UC) Eastern and Western Europe. UC patients were followed prospectively from the time of diagnosis until December 31^st, 2020, death, emigration or loss of follow-up. Clinical data on surgery, hospitalizations and medical treatment were captured throughout the follow-up period and entered in a validated web-database, www.epi-ibd.org. Associations between colectomy and covariates were analysed by multivariate Cox regression analyses.

Results

A total of 816 UC patients aged ≥15 years from 21 centres in 5 Eastern and 11 Western European countries were included. Overall, 51 (6%) patients underwent colectomy. A total of 190 (23%) patients were hospitalized at least once for their UC. Cancer was diagnosed in 28 (3%) patients, including 4 colorectal cancers. The use of medical therapy was comparable across Eastern and Western European centres (Table 1).

During follow-up, 121 out of 776 (16%) patients with limited UC (proctitis or left-sided colitis) progressed to extensive colitis. The median time to progression was 21 (IQR: 8-48) months from diagnosis. No patients from Eastern Europe were exposed to biological therapy prior to change in disease extent, compared to 6 out of 98 patients (6%) from Western Europe.

Multivariate Cox regression analysis showed no difference in risk of colectomy according to European region (Eastern vs. Western Europe, HR: 1.05, 95%CI: 0.48-2.29). Early intervention with biologicals (within 6 months) was associated with higher risk of colectomy (HR: 3.06, 95% CI: 1.23-7.58), and so was early introduction of immunomodulators (HR: 2.35, 95%CI: 1.16-4.76). Progression in disease extent to extensive colitis was significantly associated with higher risk of surgery (HR: 5.30, 95% CI: 2.36-11.90) and similarly extensive colitis at diagnosis compared to proctitis (HR: 3.48, 95% CI: 1.12-10.82).

Conclusion

After 10 years of follow up in this European multicentre study, only 6% percent had a colectomy performed. Despite the widespread use of immunomodulators and biologicals, 16% of patients with limited disease extent progressed to extensive colitis which was associated with higher risk of surgery. The need for early introduction of biological therapy and immunomodulators might predict risk of surgery.

Table 1	Eastern Europe	Western Europe
No treatment	0 (0%)	47 (7%)
5-aminosalicylic acid	140 (100%)	617 (91%)
Steroids	63 (45%)	355 (53%)
Immunomodulators	36 (26%)	209 (31%)
Biological therapy	17 (12%)	96 (14%)

DISEASE COURSE OF ULCERATIVE COLITIS DURING THE FIRST TEN YEARS FOLLOWING DIAGNOSIS IN A PROSPECTIVE EUROPEAN POPULATION-BASED INCEPTION COHORT – THE EPI-IBD COHORT

Mads Damsgaard Wewer 1, Riina Salupere 2, Hendrika Adriana Linda Kievit 3, Kari Rubek Nielsen 4, Jóngerð Midjord 4, Viktor Domislovic 5, Zeljko Krznaric 5, Natalia Pedersen 6, jens kjeldsen 7, Carl Eriksson 8, Jonas Halfvarson 8, Alison Talbot 9, Shaji Sebastian 9, Eugen-Adrian Goldis 10, Ravi Misra 11, Naila Arebi 11, Tuire Meri Ilus 12, Pia Oksanen 13, Anders Neumann 14, Vibeke Andersen 15, Alexandros Skamnelos 16, Konstantinos H. Katsanos 16, Iulian Negru 17, Svetlana Turcan 17, Bernard Borg 18, Pierre Ellul 18, Juozas Kupcinskas 19, Gediminas Kiudelis 19, Clara Yzet 20, Mathurin Fumery 20, Ioannis Kaimakliotis 21, Greta Lorenzon 22, Renata D'Incà 22, Vicente Hernandez Ramirez 23, Alberto Fernández Villaverde 24, Ebbe Langholz 25, Pia Munkholm 26, Johan Burisch 1

1 Hvidovre University Hospital, Hvidovre, Denmark|||Hvidovre Unversity Hospital, Hvidovre, Denmark

2 Tartu University Hospital, Tartu, Estonia

3 Herning central Hospital, Herning, Denmark

4 National Hospital of the Faroe Islands, Torshavn, Faroe Islands

5 University Hospital Centre Zagreb, Zagreb, Croatia

6 Slagelse Regional Hospital, Slagelse, Denmark

7 Odense University Hospital, Odense, Denmark

8 Örebro University, Örebro, Sweden

9 Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom

10 University of Medicine ‘Victor Babes’, Timisoara, Romania

11 St. Marks Hospital, London, United Kingdom

12 Tampere University Hospital, Tampere, Finland

13 Tampere University, Tampere, Finland|||Tampere University Hospital, Tampere, Finland

14 Viborg Hospital, Viborg, Denmark

15 University Hospital of Southern Denmark, Aabenraa, Denmark|||University of Southern Denmark, Odense, Denmark|||University of Southern Denmark, Odense, Denmark

16 University Hospital and University of Ioannina, Ioannina, Greece

17 Nicolae Testemitanu State University of Medicine and Pharmacy of Moldova, Chisinau, Moldova, Republic of

18 Mater Dei Hospital, Bugibba, Malta

19 Lithuanian University of Health Sciences, Kaunas, Lithuania

20 Amiens University Hospital, Amiens, France

21 American Gastroenterology Center, Nicosia, Cyprus

22 University of Padua, Padua, Italy

23 Xerencia Xestion Integrada de Vigo, SERGAS, Vigo, Spain|||Galicia Sur Health Research Institute (IIS Galicia Sur), SERGAS-UVIGO, VigoSpain, Spain

24 Ribera-POVISA Hospital, Vigo, Spain

25 University Hospital Copenhagen – Herlev Hospital, Herlev, Denmark

26 University Hospital Copenhagen – North Zealand Hospital, Hillerød, Denmark

Conference

UEG Week Copenhagen 2023

Topics

IBD

Submission format

Abstract

Session

Disease burden of IBD (Posters)

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

UEG Presentation

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POSTOPERATIVE RECURRENCE IN CROHN'S DISEASE: COMPARING PROACTIVE VERSUS REACTIVE MANAGEMENT STRATEGIES AFTER ILEOCECAL RESECTION - A MULTICENTER RETROSPECTIVE STUDY

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Introduction

Postoperative recurrence is common in Crohn's disease following ileocecal resection, with varying management strategies employed. This study aimed to compare the efficacy of prophylactic approach (starting thiopurines or biological therapy within 6 months from the surgery) versus reactive one (starting biological therapy after evidence of disease reactivation) in preventing postoperative recurrence.

Aims & Methods

This retrospective, multicenter study included 895 adult patients who underwent ileocecal resection for Crohn's disease across 13 Italian centers (prophylactic strategy: n=196; reactive strategy: n=699). Patients were classified as high-risk (≥1 risk factor: active smoking, prior intestinal resection, penetrating disease, perianal disease, or large resection ≥50 cm) or low-risk. The primary outcome was endoscopic recurrence (Rutgeerts' score ≥i2a) at 6-12 months post-surgery. Secondary outcomes included clinical, biochemical, and radiological recurrence at various time points, as well as long-term outcomes including need for repeat surgery.

Results

The prophylactic biologic therapy group demonstrated significantly lower rates of endoscopic recurrence at 6-12 months compared to the reactive approach (51.54% vs. 64.83%, p=0.007). After adjusting for confounders, including age at surgery and previous biologic exposure, a reactive approach was associated with increased odds of endoscopic recurrence (OR 1.893, 95% CI: 1.225-2.926, p=0.004). The prophylactic strategy also showed lower rates of clinical recurrence (23.08% vs. 36.36%, p=0.002), biochemical recurrence (33.81% vs. 48.89%, p=0.004), and severe endoscopic recurrence (22.31% vs. 32.55%, p=0.028) at 6-12 months. In high-risk patients with a single risk factor, prophylaxis significantly reduced endoscopic recurrence (49.06% vs. 65.75%, p=0.033) and surgical recurrence (2.56% vs. 11.58%, p=0.017). For patients with multiple risk factors, benefits were mainly observed in clinical (29.87% vs. 45.77%, p=0.022) and biochemical recurrence (37.88% vs. 56.32%, p=0.024). In low-risk patients, prophylaxis primarily reduced severe endoscopic recurrence (10.52% vs. 34.48%, p=0.037), but not other outcomes. However, these benefits diminished over time, with no significant differences in all outcomes at 15-36 months or in long-term surgical recurrence rates as compared to patients undergoing the reactive approach in all groups (p=0.438). No significant difference was observed between the two approaches regarding the need for endoscopic dilation during follow-up (p=0.301).

Table 1: Differences in outcomes at 6-12 months between a proactive and reactive strategy approach. Abbreviations: CD: Crohn's Disease, FC: Fecal Calprotectin, HBI: Harvey-Bradshaw Index

Characteristic	Proactive strategy	Reactive strategy	p-value
	n=352	n=543
Early biochemical recurrence ~3 months (FC ≥ 150 μg/g, n, %))	21 (42.9)	37 (60.7)	0.063
Clinical recurrence ~6–12 months (HBI ≥5, n, %))	57 (24.3)	134 (38.1)	<0.001
Biochemical recurrence ~6–12 months (FC ≥ 150 μg/g), n (%)	65 (35.9)	114 (50.0)	0.004
Endoscopic recurrence ~6–12 months (SES-CD ≥3 or Rutgeerts ≥2), n (%)	111 (56.1)	203 (64.9)	0.047
Severe endoscopic recurrence ~6–12 months (SES-CD ≥16 or Rutgeerts ≥3), n (%)	49 (24.7)	104 (33.2)	0.041
Radiological recurrence ~6–12 months (n, %)	70 (49.0)	122 (52.8)	0.468
Any CD complication ~6–12 months (n, %)	29 (8.2)	46 (8.5)	0.902

Conclusion

A prophylactic strategy significantly reduces short-term postoperative recurrence in Crohn's disease patients following ileocecal resection, with particular benefit in high-risk patients with a single risk factor. However, the protective effects appear to diminish over time. Further research is needed to refine predictive models and validate interventions targeting high-risk populations for sustained benefits.

POSTOPERATIVE RECURRENCE IN CROHN'S DISEASE: COMPARING PROACTIVE VERSUS REACTIVE MANAGEMENT STRATEGIES AFTER ILEOCECAL RESECTION - A MULTICENTER RETROSPECTIVE STUDY

Luisa Bertin 1, Benedetta Masoni 2, Silvia Ferretti 2, Alessandro Armuzzi 2, Cristina Bezzio 2, Miriana Zanconato 1, Gianluca Semprucci 1, Davide Giuseppe Ribaldone 3, Adele Capello 3, Giorgia Bodini 4, ANDREA PASTA 4, Francesco Calabrese 4, Linda Ceccarelli 5, Francesco Costa 5, Lorenzo Bertani 6, Marco Marino 7, Luca Navarria 7, Gianluca Benevento 8, Renato Sablich 8, Marta Ascolani 9, Andrea Buda 10, Gaia Riguccio 10, Nicoletta Merlini 11, Elisabetta Dal Pont 12, Daniele Canova 13, Edoardo Vincenzo Savarino 1, Fabiana Zingone 1

1 University of Padova, Padova, Italy

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

3 University of Turin, Turin, Italy

4 Policlinico San Martino, Genova, Italy

5 AOU Pisa, Pisa, Italy

6 University of Pisa, Pisa, Italy

7 Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy

8 Ospedale S.Maria degli Angeli, Pordenone, Italy

9 Ospedale Ca'Foncello, Treviso, Italy

10 Ospedale di Santa Maria del Prato di Feltre, Feltre, Italy

11 Ospedale Vittorio Emanuele III, Montecchio, Italy

12 Ospedale San Martino di Belluno, Belluno, Italy

13 San Bortolo Hospital, Vicenza, Italy

Event

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

Predicting clinical outcomes in IBD

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Presentation

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Summary: The Crohn´s disease journey

Manuel Barreiro de Acosta 1

1 Health Research Institute of Santiago de Compostela (IDIS), Santiago de Compostela, Spain

Event

UEG Postgraduate Teaching Programme Berlin 2025

Topics

IBD Surgery

Session

The Crohn´s disease journey

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Introduction

‘Biologic therapies’ are the mainstay treatment for moderate to severe Inflammatory Bowel Disease (IBD), resulting in fewer hospitalisations, adequate treatment response and mucosal healing. ^[1] Adalimumab, Golimumab, Ustekinumab & Risankizumab are administered subcutaneously (SC), Infliximab and Vedolizumab are administered intravenously (IV), and have additionally been available SC since 2020. SC Infliximab was used during the pandemic to limit exposure to hospitals & reduce risk of Covid-19, ^[2] as well as for convenience.

Aims & Methods

We explore patient’s views of IV and SC administered treatments via a paper-based survey for those patients who were on IV treatment when attending for infusions, and a telephone survey on patients with IBD who have been on SC treatment.

Results

IV survey

122 completed the survey.
50/122 (41.0%) were on Vedolizumab (41.0%), 64 (52.5%) Infliximab, 8 (6.6%) others / didn’t specify.
25/120 (20.8%) had been on IV therapy for 2-6 months, 17 (14.2%) for 7-12 months, 29 (24.2%) for 1-3 years, 21 (17.5%) for 3-5 years, 21 (17.5%) for >5 years.
107/120 (89.2%) rated treatments as easy, 13 (10.8%) intermediate, 0 difficult.
25/112 (22.3%) were previously on SC injections. Of this group: 15/24 (60.0%) favoured the IV route, 9 (36.0%) favoured the SC route.
4/15 who favoured the IV route “did not like to inject themselves” or “found it difficult”. 3/15 preferred IV route as they were being monitored.
104/110 (94.5%) attended all scheduled blood tests, 4 (3.6%) attended most of them
106/109 (97.2%) attended all OP appointments, 2 (1.8%) attend most
91/111 (82.0%) had no concerns, 10 (9.0%) had concerns over side effects (SE)
31/104 (29.8%) reported SE.
6/29 (20.7%) stated SE not affected their quality of life (QoL), 12 (41.4%) little impact QoL, 10 (34.5%) moderate impact, 1 (3.4%) severe impact.
96/105 (91.4%) would recommend IV route

SC survey

106/113 (93.8%) completed the survey..
54/106 patients were on Adalimumab (50.9%), 24 (22.6%) Ustekinumab, 13 (12.2%) Vedolizumab , 13 (12.3%) Infliximab, 2 (1.9%) Golimumab
10/106 (9.4%) for 1-6 months, 21 (19.8%) for 6-12 months, 33 (31.1%) for 1-3yrs, 21 (19.8%) for 3-5 years and 20 (18.9%) for >5 years.
89/106 (83.9%) rated treatment administration as easy, 10 (9.4%) intermediate, 2 (1.9%) difficult
59/106 (55.7%) were previously on IV infusions. Of this group: 43/59 (72.9%) favoured the SC route, 8 (13.6%) favoured IV, and 8 (13.6%) no preference.
24/43 who favoured who favoured SC route stated ‘convenient”, “easy”, “not have to attend hospital” as reasons.
86/106 (81.1%) attended all scheduled blood tests, 5 (4.7%) attended most of them,
102/106 (96.2%) attended all OP appointments, 3 (2.8%) attend most,
68/106 (64.2%) had no concerns, 21 (19.81%) concerned about fewer face to face episodes
40/106 (37.7%) reported SE. 8 (20%) skin reactions
11/40 (27.5%) stated SE not affected their quality of life (QoL), 14 (35%) little impact QoL, 9 (22.5%) moderate impact, 6 (15%) severe impact.
87/106 (82.1%) recommend SC route

Conclusion

The survey found that both IV and SC treatments were easy to administer for the vast majority (89.2% & 84.9%), For patients on SC therapy who previously had IV infusions, 75.6% preferred SC as “convenient”, “easy” and “no (need to attend) hospital”. For patients on IV therapy who previously had SC, 60.0% preferred IV as “did not ned to self inject / found it difficult”, and “preferred monitoring”. Overall there are high levels of satisfaction with 91.4% of patients on IV treatment, and 82.1% of patients on SC treatment recommend their current route of administration.

References

E J Mao, G S Hazlewood, G G Kaplan, L Peyrin-Biroulet, and A N Ananthakrishnan, Systematic review with meta-analysis: comparative efficacy of immunosuppressants and biologics for reducing hospitalisation and surgery in Crohn's disease and ulcerative colitis. Aliment Pharmacol Ther, 45: 3-13. https://doi.org/10.1111/apt.13847
P J Smith, L Critchley, D Storey, et al, Efficacy and Safety of Elective Switching from Intravenous to Subcutaneous Infliximab [CT-P13]: A Multicentre Cohort Study, Journal of Crohn's and Colitis, Volume 16, Issue 9, September 2022, Pages 1436-46. https://doi.org/10.1093/ecco-jcc/jjac053

PATIENT REPORTED ATTITUDES TO INTRAVENOUS AND SUBCUTANEOUS ADMINISTERED THERAPIES FOR INFLAMMATORY BOWEL DISEASE

Nora Hollos 1, Lauren Ellis 1, Ajay Verma 1

1 Kettering General Hospital, Kettering, United Kingdom

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

IBD (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Presentation

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ASSOCIATION OF BASELINE IL-23 PATHWAY-ASSOCIATED GENE EXPRESSION WITH RISANKIZUMAB-INDUCED CLINICAL REMISSION AND ENDOSCOPIC RESPONSE AT WEEK 12 IN CROHN’S DISEASE PATIENTS

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Introduction

Interleukin (IL)-23 is a key driver in the pathogenesis of Crohn’s disease (CD). IL-23 is a heterodimer, consisting of p19 and p40 subunits encoded by IL-23A and -23R, respectively. Signaling through the IL-23 receptor complex leads to the transcription of effector cytokine genes, including IL-17A, -17F and -22. Risankizumab (RZB), a monoclonal antibody with specificity for IL-23p19 has demonstrated safety and efficacy for the treatment of CD.^1,2 Here we investigate if baseline (BL) IL-23 pathway gene expression (IL-17A, -17F, -22, -23R, and -23A) in CD patients (pts) is associated with clinical remission and endoscopic response at week (wk) 12 of induction in patients treated with RZB (see Table footnote for endpoint definitions).

Aims & Methods

RNA-sequencing was performed to examine IL-23 pathway gene expression at BL in intestinal biopsy samples (n=280) obtained from pts (n=160) in the 600 mg intravenous (IV) RZB arms of the ADVANCE and MOTIVATE induction studies.¹ Biopsies were taken from the site of active disease (colon [n=146] and/or ileum [n=134]). A linear model based differential expression was conducted between response and non-response using the co-primary endpoints of SF/APS clinical remission and endoscopic response at induction wk 12. Data were normalized using trimmed mean of M-values and log2 counts per million. P-values were adjusted using Benjamini-Hochberg method of multiple testing correction. Comparisons were performed between endoscopic responders or clinical remitters (R) and endoscopic non-responders or clinical non-remitters (NR) in all pts. Analyses were stratified by disease location and/or prior biologic response status.

Results

In the total cohort, IL-23A gene expression was higher at BL in clinical R versus (vs) NR (p=0.03) (see Table for results). However, this difference was only significant in patients with prior bio-failure (p=0.03). Additionally, no difference was observed in IL-23 pathway gene expression between endoscopic R vs NR. When stratifying by disease location, higher BL expression of IL-17A, -17F, -22 and -23A were observed in patients with colonic disease in clinical R vs NR with (p<0.05). This difference was observed in both bio-failure and non-bio-failure patients (p<0.05). No difference was observed between endoscopic R vs NR. In pts with ileal disease, no differences in IL-23 pathway gene expression were observed between clinical R versus NR. Higher BL expression of IL-17A and -17F, and lower BL expression of IL-23R, were demonstrated in endoscopic R vs NR at wk 12 (p<0.05). However this difference was only significant in bio-failure patients.

Conclusion

Endpoint	Patient Subgroups	Baseline Gene Expression NR vs R Adjusted P-value (p<0.05 denoted in bold)
Endpoint	Patient Subgroups	IL-17A	IL-17F	IL-22	IL-23R	IL-23A
Clinical Remission at Week 12^a	All Patients N=160 (62 R, 98 NR) Colonic Disease N=146 (56 R, 90 NR) Ileal Disease N=134 (47 R, 87 NR) Prior Bio-Failure N=113 (37 R, 76 NR) Without Prior Bio-Failure N=47 (25 R, 22 NR) Colonic Disease + Prior Bio-Failure N=101 (33 R, 68 NR) Colonic Disease + Without Prior Bio-Failure N=45 (23 R, 22 NR) Ileal Disease + Prior Bio-Failure N=94 (26 R, 68 NR) Ileal Disease + Without Prior Bio-Failure N=40 (21 R, 19 NR)	0.40 0.04 0.21 0.11 0.79 0.048 0.51 0.99 0.26	0.5 0.04 0.94 0.10 0.82 0.06 0.50 0.70 0.73	0.17 0.03 0.78 0.26 0.30 0.04 0.41 0.68 0.52	0.95 0.84 0.65 0.23 0.30 0.25 0.45 0.77 0.44	0.03 0.002 0.92 0.03 0.73 0.005 0.44 0.71 0.65
Endoscopic Response At Week 12^b	All Patients N=160 (69 R, 91 NR) Colonic Disease N=146 (37 R, 109 NR) Ileal Disease N=134 (35 R, 99 NR) Prior Bio-Failure N=113 (23 R, 90 NR) Without Prior Bio-Failure N=47 (19 R, 28 NR) Colonic Disease + Prior Bio-Failure N=101 (20 R, 81 NR) Colonic Disease + Without Prior Bio-Failure N=45 (17 R, 28 NR) Ileal Disease + Prior Bio-Failure N=94 (18 R, 76 NR) Ileal Disease + Without Prior Bio-Failure, N=40 (17 R, 23 NR)	0.83 0.08 0.01 0.77 0.65 0.10 0.57 0.049 0.19	0.45 0.44 0.049 0.35 0.98 0.49 0.85 0.02 0.9	0.44 0.06 0.42 0.48 0.53 0.09 0.43 0.49 0.90	0.44 0.06 0.42 0.48 0.53 0.09 0.43 0.49 0.90	0.79 0.07 0.10 0.84 1.00 0.09 0.71 0.14 0.63
^aAverage daily SF ≤ 2.8 and not worse than BL AND average daily AP score ≤ 1 and not worse than BL; ^bDecrease in SES-CD > 50% from BL (or for subjects with isolated ileal disease and a BL SES-CD of 4, at least a 2 point reduction from BL), as scored by central reviewer

Minimal differences in BL expression of IL-23 pathway genes were detected in the total cohort between clinical R vs NR and endoscopic R vs NR. Significant differences in BL expression of several IL-23 pathway genes were identified between clinical R and NR in pts with colonic disease. Shared and unique IL-23 pathway genes were significantly altered in pts with ileal disease between endoscopic R vs NR. However, these differences are unlikely to be clinically meaningful or predictive of response to RZB.

References

1. D’Haens G, Panaccione R, Baert F, Bossuyt P, Colombel JF, Danese S, et al. Risankizumab as induction therapy for Crohn’s disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. The Lancet. 2022 May;399(10340):2015–30.
2. Ferrante M, Panaccione R, Baert F, Bossuyt P, Colombel JF, Danese S, 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. The Lancet. 2022 May;399(10340):2031–46.

Disclosure

James Lindsay: Consultant and an advisory board participant for AbbVie, Atlantic Healthcare, Bristol-Myers Squibb, Celgene, Celltrion, Eli Lilly, Ferring Pharmaceuticals, Galapagos, Gilead, GSK, Janssen, MSD, Napp, Pfizer, Shire, Takeda, and Vifor Pharma; has received speaker fees and sponsorship for academic meetings from AbbVie, Ferring Pharmaceuticals, Janssen, MSD, Napp, Norgine, Pfizer, Shire, Tillotts Pharma, and Takeda; and has received investigator-led research grants from AbbVie, Gilead, Pfizer, Shire and Takeda.
Bram Verstockt: Research support from AbbVie, Biora Therapeutics, Landos, Pfizer, Sossei Heptares and Takeda. -Speaker’s fees from Abbvie, Biogen, Bristol Myers Squibb, Celltrion, Chiesi, Falk, Ferring, Galapagos, Janssen, MSD, Pfizer, R-Biopharm, Takeda, Truvion and Viatris. Consultancy fees from Abbvie, Alimentiv, Applied Strategic, Atheneum, Biora Therapeutics, Bristol Myers Squibb, Galapagos, Guidepont, Mylan, Inotrem, Ipsos, Janssen, Pfizer, Progenity, Sandoz, Sosei Heptares, Takeda, Tillots Pharma and Viatris.
Jean Frederic Colombel: Research grants from AbbVie, Janssen Pharmaceuticals and Takeda; receiving payment for lectures from AbbVie, Amgen, Allergan, Inc. Ferring Pharmaceuticals, Shire, and Takeda; consulting fees from AbbVie, Amgen, Arena Pharmaceuticals, Boehringer Ingelheim, BMS, Celgene Corporation, Eli Lilly, Ferring Pharmaceuticals, Galmed Research, Genentech, Glaxo Smith Kline, Janssen Pharmaceuticals, Kaleido Biosciences, Imedex, Immunic, Iterative Scopes, Merck, Microbia, Novartis, PBM Capital, Pfizer, Protagonist Therapeutics, Sanofi,Takeda, TiGenix, Vifor; and hold stock options in Intestinal Biotech Development
Valerie Pivorunas, Naim Al Mahi, Nizar Smaoui, F. Stephen Laroux, Kristina Kligys Kori Wallace, and Heath Guay are AbbVie employees and may own AbbVie stock and/or options.

ASSOCIATION OF BASELINE IL-23 PATHWAY-ASSOCIATED GENE EXPRESSION WITH RISANKIZUMAB-INDUCED CLINICAL REMISSION AND ENDOSCOPIC RESPONSE AT WEEK 12 IN CROHN’S DISEASE PATIENTS

James O. Lindsay 1, Valerie Pivorunas 2, Naim Al Mahi 2, Nizar Smaoui 2, Stephen Laroux 2, Bram Verstockt 3, Kristina Kligys 2, Kori Wallace 2, Heath M. Guay 2, Jean-Frédéric Colombel 4

1 Queen Mary University of London, London, United Kingdom

2 AbbVie, Inc, North Chicago, United States

3 University Hospitals Leuven and KU Leuven, Translational Research in Gastrointestinal Disorders - IB, Leuven, Belgium

4 Icahn School of Medicine at Mount Sinai, USA, United States

Event

UEG Week Copenhagen 2023

Topics

Endoscopy IBD

Submission format

Abstract

Session

IL-23-Blockers in IBD: Part 1

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

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Introduction

Mirikizumab is a monoclonal antibody directed against the p19 subunit of interleukin (IL)-23 approved for the management of patients with moderate-to-severe ulcerative colitis (UC). Currently, there is no large study supporting the effectiveness of mirikizumab in UC in a real-life setting.

Aims & Methods

This study aims to evaluate the effectiveness and safety of mirikizumab in real-life setting. This was a retrospective multicenter cohort study of a prospectively collected database including adult patients with confirmed diagnosis of UC treated with mirikizumab according to clinical practice. Patients were enrolled in three third-level italian centers (San Raffaele Hospital, Humanitas Research Hospital, and Federico II Hospital) from June 2024 to February 2025. All patients with at least 3 months of follow-up after therapy initiation were eligible. The primary outcome was the clinical remission rate (defined as partial Mayo Score (pMS) < 2 with a rectal bleeding subscore of 0) at week 12. Secondary outcomes included changes in bowel urgency (measured by the Numeric Rating Scale (NRS) urgency score), changes in serum C-reactive protein (CRP) and fecal calprotectin (FC) levels from week 0 to 12, safety profile of mirikizumab during induction therapy.

Results

In total 100 patients (60% male, with median age 48.53 ± 15.36) with UC were included. Most patients had a left-sided colitis (55, 55%) or a pancolitis (41, 41%). Most patients (81, 81%) were already treated with at least one advanced therapy before starting mirikizumab (including 28 patients treated with ustekinumab, 28%). A fifth of patients (19, 19%) were exposed to ≥ 4 advanced therapies. A significant reduction in pMS was observed from baseline to week 12 (median [IQR]: 4.0 [1.75–6.0] vs. 2.0 [0.0–4.0]; Wilcoxon signed-rank test: W = 312, Z = -5.35, p < 0.00001, n = 69) with 48 (48%) patients reaching clinical remission at week 12. Moreover, a significant improvement in bowel urgency was observed from baseline to week 12 (t(98) = 6.58, p = 2.28×10⁻⁹), with a moderate-to-large effect size (g = 0.66). From baseline to week 12, both FC and CRP levels showed significant reductions following treatment (FC: V = 1153.00, p = 2.4×10⁻⁵, r = 0.67; CRP: V = 680.00, p = 0.03, r = 0.37). Effect sizes were large for FC and moderate for CRP with paired data from 53 and 47 patients being analyzed, respectively. In total, 39 patients (39%) underwent extended induction while 3 patients (3%) discontinued the drug at week 12. There were no adverse events leading to discontinuation or death. Two mild adverse events were reported (upper respiratory tract infection in 1 patient and pyrexia in 1 patients). No significant changes were observed in liver aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels over time (AST: χ²(2) = 0.21, p = 0.90, W = 0.005; ALT: χ²(2) = 3.73, p = 0.16, W = 0.08).

Conclusion

This is the largest study demonstrating the effectiveness and safety of mirikizumab in inducing clinical remission in patients with UC in a real-life setting. Patients treated with mirikizumab achieved a significant reduction in bowel urgency, FC and CRP levels. No statistically significant increase in liver toxicity was detected during the induction treatment.