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EFFECT OF RISANKIZUMAB TREATMENT ON EXTRAINTESTINAL MANIFESTATIONS (EIMS) IN PATIENTS WITH MODERATE TO SEVERE CROHN’S DISEASE (CD): RESULTS FROM THE ADVANCE, MOTIVATE AND FORTIFY STUDIES

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Introduction

Up to 50% of patients (pts) with inflammatory bowel disease have one or more extraintestinal manifestations (EIMs), which are independent risk factors for poor quality of life and greater disability.¹ Here, we evaluated EIM resolution in patients (pts) with moderate to severe Crohn’s disease (CD) who received risankizumab (RZB), an anti-IL-23p19 monoclonal antibody, versus (vs) placebo (PBO) during the ADVANCE and MOTIVATE induction and FORTIFY maintenance studies.^2,3

Aims & Methods

In this post-hoc analysis of pooled data from ADVANCE and MOTIVATE, data collected from an EIM form, used by investigators to record the presence of 16 pre-specified EIMs (yes/no), were examined. EIM presence at induction baseline (BL), resolution (see Table footnote for definition) at wk 12 with intravenous (IV) RZB 600 mg vs PBO in ADVANCE+MOTIVATE, and maintained resolution at FORTIFY wk 52 among pts treated with subcutaneous (SC) RZB 180 mg or 360 mg vs PBO (withdrew RZB) were assessed.³ Statistical analysis methods are provided in Table footnotes. Nominal P-values for pairwise treatment comparisons are shown.

Results

Previously, EIM resolution at wk 12 in pts with EIMs at BL was evaluated as a ranked secondary endpoint in ADVANCE and MOTIVATE.² A greater proportion of pts achieved EIM resolution at wk 12 with IV RZB 600 mg vs PBO in ADVANCE (38.1% vs 20.5%, nominal P-value = 0.02), but not MOTIVATE (29.5% vs 23.7%, nominal P-value = 0.38). In this pooled analysis, at BL, 323 EIMs were reported for 240 pts in the IV RZB 600 mg arm, and 221 EIMs were reported for 161 pts in the PBO arm; approximately 45% of pts in each arm had ≥1 EIM at BL. The most frequently reported EIMs at BL were peripheral arthropathy (IV RZB 600 mg, 64% [103/161]; PBO, 70.4% [169/240]), anaemia (IV RZB 600 mg, 36% [58/161]; PBO, 28.8% [69/240]), and axial arthropathy (IV RZB 600 mg, 16.1% [26/161]; PBO, 19.2% [46/240]). Together, these EIMs accounted for most reported EIMs across the IV RZB 600 mg (87.9% [284/323]) and PBO (84.6% [187/221]) arms; the incidence of other EIMs were too low for clinically meaningful interpretation (see Table footnotes). A greater proportion of pts achieved resolution of any EIM at wk 12 vs PBO (P = 0.031) with IV RZB 600 mg (Table). A significantly greater proportion of pts with anaemia or axial arthropathy, but not peripheral arthropathy, at BL achieved resolution of the respective EIM at wk 12 with IV RZB 600 mg vs PBO (anaemia: RZB 600 mg, 26/69 [37.4%]; PBO, 13/58 [22.4%]; adjusted (adj) difference 14.4%, P = 0.049; axial arthropathy: RZB 600 mg, 23/46 [50%]; PBO, 8/26 [30.8%]; adj difference 22.6%, P = 0.042; peripheral arthropathy: RZB 600 mg, 67/169 [39.8%]; PBO, 32/103 [31.2%]; adj difference 6.8%, P = 0.236). With SC RZB 360 mg compared to PBO, a greater proportion of pts with EIMs at BL achieved resolution of EIMs at wk 52 (P = 0.005), and a greater proportion of pts who achieved resolution of any EIM at wk 12 maintained resolution at wk 52 (P=0.014) (Table).

Conclusion

Endpoint	Induction, week 12			Maintenance, week 52
Endpoint	PBO IV	RZB 600 mg IV	Adjusted difference (%) RZB 600 mg IV vs PBO IV, P-value	Withdrawal (PBO SC)	RZB 180 mg SC	Adjusted difference (%) RZB 180 mg SC vs withdrawal (PBO SC), P-value	RZB 360 mg SC	Adjusted difference (%) RZB 360 mg SC vs withdrawal (PBO SC), P-value
Proportion of patients with any EIMs at induction BL, % (n/N)	44.5% (161/362)	45.5% (240/527)		48.7% (80/164)	45.9% (72/157)		48.9% (69/141)
Proportion of patients with resolution of EIMs at week 12 or week 52 in patients with any EIMs at induction BL, % (n/N)	22.5% (36/161)	34.5% (83/240)	9.6%, P=0.031	36.3% (29/80)	41.7% (30/72)	7.5% P=0.283	52.2% (36/69)	20.7%, P=0.005
Proportion of patients with maintenance of resolution of EIMs at FORTIFY week 52 in patients with EIMs at induction BL and who met resolution of EIMs at week 0 of the maintenance period, % (n/N)				45% (18/40)	45.9% (17/37)	3.1%, P=0.764	71.9% (23/32)	25.4%, P=0.014
BL, baseline; EIM, extraintestinal manifestation; PBO, placebo; RZB, risankizumab. EIM resolution was derived by summarizing the binary Yes/No responses from the 16 component questions in the EIM form. Additional EIMs captured on EIM form, along with their prevalence in the population at induction BL (600 mg RZB IV, N=240; PBO IV, N=161), are as follows (n [%]): oral aphthous ulcers, 600 mg RZB IV; 20 (8.3); PBO IV, 17 (10.6), erythema nodosum, 600 mg RZB IV, 7 (2.9); PBO IV, 7 (4.3), nephrolithiasis, 600 mg RZB IV, 7 (2.9); PBO IV, 0, uveitis 600 mg RZB IV, 1 (0.4); PBO IV, 2 (1.2), primary sclerosing cholangitis, 600 mg RZB IV, 1 (0.4); PBO IV, 2 (1.2), chronic obstructive pulmonary disease, 600 mg RZB IV, 0; PBO IV, 1 (0.6), venous thromboembolism 600 mg RZB IV, 1 ( 0.4); PBO IV, 1 ( 0.6), pyoderma gangrenosum, 600 mg RZB IV, 1 (0.4); PBO IV, 1 (0.6), iritis, 600 mg RZB IV, 0; PBO IV, 1 (0.6), Sweet's syndrome, 600 mg RZB IV, 1 (0.4); PBO IV, 1 (0.6), autoimmune hepatitis, 600 mg RZB IV, 0; PBO IV, 0, bronchiectasis, 600 mg RZB IV, 0; PBO IV, 1 (0.6), episcleritis, 600 mg RZB IV, 0; PBO IV, 0. Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used for efficacy analyses. Treatment differences between each RZB dose and PBO were calculated using a normal approximation to the binomial distribution. P-values for pairwise treatment comparisons were provided within each subgroup category based on the Cochran-Mantel-Haenszel test adjusted for study (ADVANCE, MOTIVATE) and strata (number of prior biologics failed (0, 1, >1) and baseline steroid use [Yes, No]).

Among CD pts with EIMs at BL, induction treatment with IV RZB 600 mg led to resolution of EIMs, in particular anaemia and axial arthropathy, while maintenance treatment with SC RZB 360 mg was effective in sustaining EIM resolution through wk 52

References

1. Marinelli C, et al. Gastroenterology Research and Practice. 2019 Aug 21;2019:1–10.
2. D’Haens G, et al. The Lancet. 2022 May;399(10340):2015–30.
3. Ferrante M, et al. The Lancet. 2022 May;399(10340):2031–46.

Disclosure

Subrata Ghosh: SG has received consulting fees from AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Gilead, Galapagos, Janssen, Pfizer, and Receptos; speaker fees from AbbVie, Falk Pharma, Pfizer, Ferring, Janssen, Shield, and Takeda
Marc Ferrante: Research grants from: AbbVie, Amgen, Biogen, EG, Janssen, Pfizer, Takeda and Viatris; Consultancy fees from: AbbVie, Agomab Therapeutics, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Janssen-Cilag, Medtronic, MSD, Pfizer, Regeneron, Samsung Bioepis, Sandoz, Takeda and ThermoFisher; Speakers’ fees from: AbbVie, Amgen, Biogen, Boehringer Ingelheim, Falk, Ferring, Janssen-Cilag, Lamepro, MSD, Pfizer, Sandoz, Takeda, Truvion Healthcare and Viatris
Britta Siegmund: Consultant for AbbVie, Arena, BI, BMS, Celgene, Falk, Galapagos, Janssen, Lilly, Pfizer, Prometheus, and Takeda; and received speaker’s fees from AbbVie, CED Service GmbH, Falk, Ferring, Janssen, Novartis, Pfizer, and Takeda
Takehiro Arai: Nothing to disclose
Walter Reinisch WR has served as a speaker for AbbVie, Celltrion, Falk Pharma GmbH, Ferring, Janssen, Galapagos Medice, MSD, Roche, Pfizer, Pharmacosmos, Shire, Takeda, Therakos, as a consultant for AbbVie, Amgen, AOP Orphan, Arena Pharmaceuticals, Astellas, Astra Zeneca, Bioclinica, Boehringer Ingelheim, Bristol Myers Squibb, Calyx, Celgene, Celltrion, Eli Lilly, Falk Pharma GmbH, Ferring, Galapagos, Gatehouse Bio Inc., Genentech, Gilead, Grünenthal, ICON, Index Pharma, Inova, Janssen, Landos Biopharma, Medahead, MedImmune, Microbiotica, Mitsubishi Tanabe Pharma Corporation, MSD, Novartis, OMass, Otsuka, Parexel, Periconsulting, Pharmacosmos, Pfizer, Protagonist, Provention, Quell Therapeutics, Sandoz, Seres Therapeutics, Setpointmedical, Sigmoid, Sublimity, Takeda, Teva Pharma, Therakos, Theravance, Zealand, as an advisory board member for AbbVie, Amgen, Astra Zeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Galapagos, Janssen, Mitsubishi Tanabe Pharma Corporation, MSD, Pharmacosmos, Pfizer, Sandoz, Takeda, and has received research funding from AbbVie, Janssen, MSD, Sandoz, Sanofi, Takeda.
David Hudesman Consultant: AbbVie, BMS, Fresenius Kabi, Janssen, Pfizer, Prometheus, Takeda, UCB
Research Support: Janssen and Pfizer
Edouard Louis: Research grant: Janssen, Pfizer, Ferring, Falk, AbbVie and Takeda; educational grant: AbbVie, Janssen, Fresenius-Kabi and Takeda; speaker fees: AbbVie, Falk, Ferring, Janssen, Pfizer, Galapagos, BMS and Takeda; advisory board: Abbvie, Celgene, Ferring, Janssen, BMS, Pfizer, and Takeda, Galapagos, Gilead, Arena, Eli Lilly; consultant: Abbvie
Naomi Martin, Joanne Rizzo,Kristina Kligys, Yafei Zhang, Javier Zambrano, and Jasmina Kalabic are AbbVie employees and may own AbbVie stock and/or options.

EFFECT OF RISANKIZUMAB TREATMENT ON EXTRAINTESTINAL MANIFESTATIONS (EIMS) IN PATIENTS WITH MODERATE TO SEVERE CROHN’S DISEASE (CD): RESULTS FROM THE ADVANCE, MOTIVATE AND FORTIFY STUDIES

Subrata Ghosh 1, Marc Ferrante 2, Britta Siegmund 3, Takehiro Arai 4, Walter Reinisch 5, Naomi Martin 6, Joanne Rizzo 6, Kristina Kligys 6, Yafei Zhang 6, Javier Zambrano 6, Jasmina Kalabic 7, David P. Hudesman 8, Edouard Louis 9

1 University College Cork, Birmingham, Ireland

2 University Hospitals Leuven, Leuven, Belgium

3 Charité - Universitätsmedizin Berlin, Berlin, Germany

4 Tokatsu‐Tsujinaka Hospital, Chiba, Japan

5 Medical University of Vienna, Wien, Austria

6 AbbVie, Inc, North Chicago, United States

7 AbbVie Deutschland GmbH Co. KG, Ludwigshafen am Rhein, Germany

8 Inflammatory Bowel Disease Center, New York, United States

9 CHU Liège and Liège University, Liège, Belgium

Event

UEG Week Copenhagen 2023

Topics

Endoscopy Histopathology IBD

Submission format

Abstract

Session

IL-23-Blockers in IBD: Part 2

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

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How to define the hot spots?

Marjolijn Duijvestein 1

1 Radboudumc, Nijmegen, Netherlands

Event

UEG Week Berlin 2025

Topics

Endoscopy Nurses

Session

Is your GI-practice sustainable?

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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What can we learn from monogenic IBD

Alexo Muise 1

1 SickKids Research Institute, Toronto, Canada

Event

UEG Week Berlin 2025

Topics

IBD Mechanisms & Personalised Medicine

Session

The art of making clinical research precise: Predicting therapy response in IBD

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Poster

Standard Poster

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Introduction

In the southwest Netherlands, hospitals collaborate to provide high quality, uniform care for inflammatory bowel disease (IBD). To achieve this, a care pathway (CP) was implemented for treating IBD with biologics and small molecules (1). The CP consists of protocols addressing different stages in IBD treatment, such as initiation and switching of therapy, frequency and type of follow-up. This study assessed the adherence to the CP and identified barriers and facilitators to its implementation.

Aims & Methods

A mixed-methods study was conducted. Quantitative data was used to evaluate the adherence to different protocols of the CP and was collected retrospectively from electronic health records (EHRs) from December 2020 until March 2023. Surveys and semi-structured interviews were used to identify barriers and facilitators, using the Extended Normalisation Theory. Surveys were sent to all healthcare providers and interviews were conducted with gastroenterologists, IBD-nurses, healthcare assistants, and IT-personnel.

Results

A total of 299 patients were included. Adherence to the CP regarding the documentation of travel plans and vaccination status improved after implementing the CP (15% pre-implementation vs. 33% post-implementation), as well as written communication with general practitioners (31% vs. 83%) and body weight registration (12% vs. 50%). Among patients switching medication, 25% had a repeated screening for HIV, tuberculosis, and hepatitis B and C documented if prior tests were over a year old. Post-implementation, scheduling outpatient visits were more closely aligned with CP recommendations across CP protocols (57% vs. 100%), as did blood test ordering (10% vs. 44%). Disease activity scoring with validated questionnaires remained low (7% vs. 21%).  Adherence to registering medication adherence, current smoking status, and side effects during annual outpatient visits remained low (18% vs. 40%).
Of 85 surveys, 42 were completed, and 11 interviews were conducted. Facilitators were improving collaboration between healthcare providers and the potential to standardise care. Barriers included the complexity of the use in EHRs, difficulty for healthcare providers to change their current routine, and the heterogeneity of IBD.

Conclusion

A CP for the treatment of IBD with biologics and small molecules has been implemented to improve IBD care, however, adherence appears to be challenging, partially contributed to the difficulty healthcare providers experience in changing their behaviour. The gradual improvement indicates that increased familiarity with the CP may enhance adoption. Discrepancies between performed and documented tasks in EHRs may also contribute to lower adherence rates, which could be improved by audit and feedback sessions.

References

1. van Linschoten R, van Leeuwen N, Nieboer D, Birnie E, Scherpenzeel M, Verweij KE, et al. Value-based care pathway for inflammatory bowel disease: a protocol for the multicentre longitudinal non-randomised parallel cluster IBD Value study with baseline period. (2044-6055 (Electronic))

Disclosure

Drs. Visser received speaker fees from Lilly outside the submitted work. Prof. Dr. van der Woude reports grants from Pfizer and Janssen and personal fees from AbbVie and Celltrion outside the submitted work. Dr. van Noord reports personal fees from Janssen, Takeda, and Falk outside the submitted work. Dr. West reports personal fees from AbbVie, Janssen, and Pfizer outside the submitted work.