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EFFICACY OF OBEFAZIMOD IN ABTECT PHASE 3 INDUCTION TRIALS: RESULTS OF 8-WEEK THERAPY IN SUBSETS OF PATIENTS WITH AND WITHOUT PRIOR INADEQUATE RESPONSE TO ADVANCED THERAPIES

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EFFICACY OF OBEFAZIMOD IN ABTECT PHASE 3 INDUCTION TRIALS: RESULTS OF 8-WEEK THERAPY IN SUBSETS OF PATIENTS WITH AND WITHOUT PRIOR INADEQUATE RESPONSE TO ADVANCED THERAPIES

Silvio Danese 1, Bruce E. Sands 2, Laurent Peyrin-Biroulet 3, Marla C. Dubinsky 4, Britta Siegmund 5, Raja Atreya 6, Tadakazu Hisamatsu 7, Herbert Tilg 8, Alessandro Armuzzi 9, Xavier Treton 10, Filip Baert 11, Ursula Seidler 12, Fabio Cataldi 13, Douglas Jacobstein 13, Christopher Rabbat 13, Kejia Shan 13, George DuVall 14, Parambir Dulai 15, David T. Rubin 16, Severine Vermeire 17

Affiliations

1 Vita-Salute San Raffaele University - IRCCS San Raffaele Scientific Institute, Milan, Italy

2 Icahn School of Medicine at Mount Sinai, New York, United States

3 Nancy University Hospital, Vandoeuvre-les-Nancy, France

4 Mount Sinai Kravis Children’s Hospital, New York City, United States

5 Charité - Universitätsmedizin Berlin, Berlin, Germany

6 University Erlangen-Nuremberg, Erlangen, Germany

7 Kyorin University School of Medicine, Tokyo, Japan

8 Innsbruck Medical University - Department of Medicine, Innsbruck Medical University; Innsbruck/AT, Innsbruck, Austria

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

10 Groupe Hospitalier Prive Ambroise Pare – Hartmann - Institut des MICI, Neuilly sur Seine, France

11 Az Delta, Roeselare, Belgium

12 Medizinische Hochschule Klinik f. Gastroenterlogie, Hannover, Germany

13 Abivax, Paris, France

14 Tyler Research Institute, Tyler, United States

15 Feinberg School of Medicine Northwestern University, Chicago, United States

16 University of Chicago Medicine, Chicago, United States

17 University Hospital Leuven, Leuven, Belgium

Summary

AI Generated

Obefazimod 50 mg once daily demonstrated statistically significant clinical remission at week 8 in patients with moderate-to-severe ulcerative colitis regardless of prior advanced therapy exposure in the pooled ABTECT-1 and ABTECT-2 Phase 3 trials.

In the pooled analysis, obefazimod 50 mg achieved clinical remission in 13.3% of advanced therapy-exposed patients versus 3.4% with placebo (difference 10.1%, p=0.0009) and in 27.7% of advanced therapy-naive patients versus 5.3% with placebo (difference 22.4%, p<0.0001).
Clinical response was achieved in 55.8% of advanced therapy-exposed patients on obefazimod 50 mg versus 20.9% on placebo (difference 34.9%, p<0.0001) and in 68.0% of advanced therapy-naive patients versus 39.6% on placebo (difference 28.2%, p<0.0001).
Obefazimod 50 mg showed consistent clinical response across all lines of therapy including patients with 4 or more advanced therapy failures and those who had failed JAK inhibitors.
In advanced therapy-exposed patients, obefazimod 50 mg outperformed the 25 mg dose across efficacy measures, while both doses performed similarly in advanced therapy-naive patients.
Obefazimod was well tolerated with a safety profile similar to previous studies across both dose levels and placebo.

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Abstract

Introduction

Obefazimod (Obe), an oral, once-daily (QD), small molecule which enhances expression of microRNA-124 was studied in patients (pts) with moderately to severely active ulcerative colitis (UC) in Phase 2 studies [1-3]. Here we present efficacy endpoints at week 8 for pts with and without prior inadequate response to advanced therapies (AT-IR-Yes, AT-IR-No) from ABTECT-1 [NCT05507203] and ABTECT-2 [NCT05507216] Phase 3 trials.

Aims & Methods

The multicenter, randomized, double-blind, placebo-controlled ABTECT trials enrolled pts with moderate-to-severe UC (modified Mayo score, MMS≥ 5, with rectal bleeding sub-score (RBS) ≥ 1 and centrally read endoscopic score >2) who had inadequate response, loss of response, or intolerance to at least one prior therapy (no upper limit), including corticosteroids, immunosuppressants, biologics, S1P receptor modulators and/or JAK inhibitors (JAKi). Pts were randomized 2:1:1 to Obe 50 mg QD (Obe-50), Obe 25 mg QD (Obe-25) or placebo (PBO) for 8 weeks. Clinical remission per MMS and other efficacy measures (clinical response, endoscopic improvement, symptomatic remission, histo-endoscopic mucosal improvement) were analysed among AT-IR-Yes and AT-IR-No pts; all p-values are nominal.

Results

Among pts who participated in ABTECT-1, ABTECT-2, and the pooled analysis, 45.3% (288/636), 49.4% (314/636), and 47.3% (602/1272) were AT-IR-Yes, respectively; 54.7% (348/636), 50.6% (322/636), 52.7% (670/1272) were AT-IR-No. In ABTECT-1, ABTECT-2, and pooled, a higher proportion of the AT-IR-Yes subgroup receiving Obe-50 achieved all efficacy measures relative to PBO including clinical remission (Obe-50-PBO difference: ABTECT-1 12.7%, p=0.0039; ABTECT-2 7.6%, p=0.0652, pooled 10.1%, p=0.0009). In the AT-IR-Yes subgroup, the difference from PBO across all efficacy measures was lower for pts receiving Obe-25 relative to Obe-50 (Table). In the AT-IR-No subgroup, larger proportions achieved all efficacy measures relative to PBO including clinical remission (Obe-50-PBO difference: ABTECT-1 25.0%, p<0.0001; ABTECT-2 19.4%, p=0.0004; pooled 22.4%, p<0.0001). In the AT-IR-No subgroup, Obe-50 and Obe-25 performed similarly in the pooled analysis across efficacy measures. In the subset of pts who failed JAKi, higher proportion of pts receiving Obe-50 or Obe-25 achieved clinical response vs. PBO. The difference from PBO in clinical response for Obe-25 and Obe-50 was similar across lines of treatment, from AT-IR-No through 4+ AT-IRs (Table). Obe was well tolerated with a safety profile similar to previous studies.

Table: Efficacy of obefazimod at week 8 in pts with and without prior inadequate response* to AT– ABTECT-1, ABTECT-2 and pooled studies

ABTECT-1^a
AT-IR-Yes

ABTECT-1^a
AT-IR-No

ABTECT-2^a
AT-IR-Yes

ABTECT-2^a
AT-IR-No

Pooled ABTECT trials^a
AT-IR-Yes

Pooled ABTECT trials^a
AT-IR-No

Efficacy Endpoints
at week 8, % (n)

PBO
(N=69)

Obe-25
(N=70)

Obe-50
(N=149)

PBO
(N=89)

Obe-25
(N=90)

Obe-50
(N=169)

PBO
(N=79)

Obe-25
(N=76)

Obe-50
(N=159)

PBO
(N=80)

Obe-25
(N=83)

Obe-50
(N=159)

PBO
(N=148)

Obe-25
(N=146)

Obe-50
(N=308)

PBO
(N=169)

Obe-25
(N=173)

Obe-50
(N=328)

Clinical remission
Placebo adjusted Δ%
p-value

1.4 (1)

8.6 (6)
7.1
p=0.0556

14.1 (21)
12.7
p=0.0039

3.4 (3)

35.6 (32)
32.4
p<0.0001

28.4 (48)
25.0
p<0.0001

5.1 (4)

5.3 (4)
0.7
p=0.8529

12.6 (20)
7.6
p=0.0652

7.5 (6)

16.9 (14)
9.5
p=0.0659

27.0 (43)
19.4
p=0.0004

3.4 (5)

6.8 (10)
3.5
p=0.1728

13.3 (41)
10.1
p=0.0009

5.3 (9)

26.6 (46)
21.3
p<0.0001

27.7 (91)
22.4
p<0.0001

Endoscopic improvement
Placebo adjusted Δ%
p-value

4.3 (3)

14.3 (10)
9.9
p=0.0457

22.1 (33)
17.8
p=0.0011

6.7 (6)

55.6 (50)
48.9
p<0.0001

43.2 (73)
36.4
p<0.0001

8.9 (7)

11.8 (9)
3.5
p=0.4675

26.4 (42)
17.7
p=0.0015

11.3 (9)

31.3 (26)
20.3
p=0.0016

44.7 (71)
33.1
p<0.0001

6.8 (10)

13.0 (19)
6.4
p=0.0687

24.4 (75)
17.8
p<0.0001

8.9 (15)

43.9 (76)
34.9
p<0.0001

43.9 (144)
34.9
p<0.0001

Symptomatic remission
Placebo adjusted Δ%
p-value

10.1 (7)

27.1 (19)
17.0
p=0.0108

34.9 (52)
25.0
p=0.0001

23.6(21)

54.4 (49)
31.0
p<0.0001

46.7 (79)
23.2
p=0.0003

15.2 (12)

26.3 (20)
11.3
p=0.0841

37.1 (59)
21.7
p=0.0006

28.8 (23)

39.8 (33)
11.0
p=0.1430

43.4 (69)
14.2
p=0.0329

12.8 (19)

26.7 (39)
13.8
p=0.0031

36.0 (111)
23.4
p<0.0001

26.0 (44)

47.4 (82)
21.3
p<0.0001

45.1 (148)
19.2
p<0.0001

HEMI
Placebo adjusted Δ%
p-value

1.4 (1)

5.7 (4)
4.3
p=0.1803

12.8 (19)
11.3
p=0.0073

4.5 (4)

37.8 (34)
33.4
p<0.0001

32.0 (54)
27.5
p<0.0001

6.3 (5)

7.9 (6)
1.8
p=0.6596

17.0 (27)
11.0
p=0.0197

8.8 (7)

18.1 (15)
9.3
p=0.0805

30.8 (49)
21.8
p=0.0002

4.1 (6)

6.8 (10)
2.9
p=0.2785

14.9 (46)
11.1
p=0.0005

6.5 (11)

28.3 (49)
21.7
p<0.0001

31.4 (103)
24.7
p<0.0001

Clinical response
Placebo adjusted Δ%
p-value

21.7(15)

52.9 (37)
31.2
p=0.0002

54.4 (81)
32.5
p<0.0001

33.7(30)

75.6 (68)
41.8
p<0.0001

66.9 (113)
33.2
p<0.0001

20.3 (16)

40.8 (31)
21.0
p=0.0043

57.2 (91)
36.8
p<0.0001

46.3 (37)

65.1 (54)
18.8
p=0.0165

69.2 (110)
22.2
p=0.0008

20.9 (31)

46.6 (68)
25.6
p<0.0001

55.8 (172)
34.9
p<0.0001

39.6 (67)

70.5 (122)
30.7
p<0.0001

68.0 (223)
28.2
p<0.0001

NRI is used for subjects with missing outcome at Week 8 and subjects reporting any IE prior to Week 8.
% Difference is for Obe minus placebo and is based on estimated common risk difference using the Mantel-Haenszel weights adjusting for the randomization stratification factors: inadequate response to advanced therapies (yes/no), baseline oral corticosteroids usage (yes/no), and region (Japan/rest of world) [ABTECT-2 only]. p-values are two sided.
a: all p-values are nominal
Clinical remission: stool frequency sub-score (SFS) ≤1, rectal bleeding sub-score (RBS) = 0 and endoscopic sub-score ≤1; Clinical response: decrease from baseline in the MMS ≥ 2 points and ≥30% from baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1; Endoscopic improvement: endoscopic sub-score ≤1; Symptomatic remission: RBS=0, SFS <1; Histo-endoscopic mucosal improvement (HEMI): combination of histologic improvement (Geboes histologic score ≤3.1) and endoscopic improvement (endoscopy sub-score ≤1)
*: inadequate response = lack of response, loss of response, or intolerance to advanced therapies.
**: N1, N2 = total number of pts in the respective subset ; JAKi: Janus kinase inhibitor

Clinical response, %
AT-IR pts w/JAK failure
(n/N1**)
Placebo adjusted Δ%
p-value

AT-IR pts w/ 1 AT failure
(n/N2**)
Placebo adjusted Δ%
p-value

AT-IR pts w/ 2 AT failures
(n/N2**)
Placebo adjusted Δ%
p-value

AT-IR pts w/ 3 AT failures
(n/N2**)
Placebo adjusted Δ%
p-value

AT-IR pts w/ 4+ AT failures
(n/N2**)
Placebo adjusted Δ%
p-value

20.0
(7/35)

24.2
(15/62)

20.6
(7/34)

14.3
(4/28)

20.8
(5/24)

47.1
(16/34)
27.0
p=0.0196

53.3
(24/45)
30.5
p=0.0018

48.9
(22/45)
28.6
p=0.0114

42.4
(14/33)
27.3
p=0.0297

34.8
(8/23)
14.4
p=0.2968

54.5
(30/55)
34.4
p=0.0017

50.7
(76/150)
25.3
p=0.0008

67.2
(43/64)
45.5
p<0.0001

61.5
(32/52)
46.3
p<0.0001

50.0
(21/42)
28.7
p=0.0242

Conclusion

Among AT-IR-Yes and AT-IR-No subgroups, improvements in clinical, endoscopic, symptomatic and combined endoscopic-histologic measures were observed in pts treated with Obe at week 8 relative to PBO in ABTECT-1, ABTECT-2, and in the pooled analysis. Improvements vs. PBO in clinical response were observed in a pooled analysis in AT-IR-Yes JAKi-IR pts and across lines of therapy up to 4+ AT-IR.

References

Vermeire S, et al. J Crohns Colitis. 2023; 17: 1689-1697
Vermeire S, et al. The Lancet Gastroenterology & Hepatology. 2022; 7: 1024-1035.
Vermeire S, et al. J Crohns Colitis. 2025 ; 19 : jjaf074

Disclosure

Authors reports following potential conflicts of interest:
BES: Abbvie, Abivax, Adiso Therapeutics, Agomab, Alimentiv, Amgen, AnaptysBio, Arena Pharmaceuticals, Artugen Therapeutics, Astra Zeneca, Biolojic Design, Biora Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Equillium, Enthera, Enveda Biosciences, Evommune, Ferring, Fzata, Galapagos, Genentech (Roche), Gilead Sciences, GlaxoSmithKline, Gossamer Bio, Imhotex, Index Pharmaceuticals, Innovation Pharmaceuticals, Kaleido, Kallyope, Lilly, Merck & Co., Microba, Microbiotica, Mitsubishi Tanabe, Mobius Care, Morphic Therapeutics, MRM Health, Nexus Therapeutics, Nimbus Discovery, Odyssey Therapeutics, OSE Immunotherapeutics, Janssen, Palisade Bio, Pfizer, Protagonist Therapeutics, Q32 Bio, Rasayana Therapeutics, Recludix Therapeutics, Reistone Biopharma, Sanofi, Sorriso Therapeutics, Spyre Therapeutics, Takeda, Target RWE,Teva, TLL Pharmaceutical, Tr1X, Trex Bio, Union Therapeutics, Ventyx Biosciences.
SV: AbbVie, Abivax, AbolerIS Pharma, AgomAb, Alimentiv, Arena Pharmaceuticals, AstraZeneca, Avaxia, BMS, Boehringer Ingelheim, Celgene, CVasThera, Cytoki Pharma, Dr Falk Pharma, Ferring, Galapagos, Genentech-Roche, Gilead, GSK, Hospira, Imidomics, Janssen, J&J, Lilly, Materia Prima, MiroBio, Morphic, MrMHealth, Mundipharma, MSD, Pfizer, Prodigest, Progenity, Prometheus, Robarts Clinical Trials, Second Genome, Shire, Surrozen, Takeda, Theravance, Tillots Pharma AG, Zealand Pharma.
LPB: Abbvie, Abivax, Adacyte, Alimentiv, Amgen, Applied Molecular Transport, Arena, Banook, Biogen, BMS, Celltrion, Connect Biopharm, Cytoki Pharma, Enthera, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, Gossamer Bio, GSK, IAC Image Analysis, Index Pharmaceuticals, Inotrem, Janssen, Lilly, Medac, Mopac, Morphic, MSD, Nordic Pharma, Novartis, Oncodesign Precision Medicine, ONO Pharma, OSE Immunotherapeuthics, Pandion Therapeuthics, Par' Immune, Pfizer, Prometheus, Protagonist, Roche, Samsung, Sandoz, Sanofi, Satisfay, Takeda, Telavant, Theravance, Thermo Fischer, Tigenix, Tillots, Viatris, Vectivbio, Ventyx, Ysopia.
SD: AbbVie, Ferring, Hospira, Johnson & Johnson, Merck, MSD, Takeda, Mundipharma, Pfizer Inc, Tigenix, UCB Pharma, Vifor, Biogen, Celgene, Allergan, Celltrion, Sandoz, Boehringer Ingelheim.
PSD: Abbvie, Abivax, Adiso, Alimentiv, Bristol Meyer Squibb, Celltrion, Genentech, Geneoscopy, Janssen, Pfizer, Takeda.
MD: Abbvie, Abivax, Arena Pharmaceuticals, Astra Zeneca, Boehringer Ingelheim International GmbH, Bristol-Meyer Squibb, Eli Lilly and Company, F. Hoffmann-La Roche Ltd, Genentech Inc, Gilead, Janssen Pharmaceuticals, Merck, Pfizer Inc, Prometheus Biosciences, Takeda Pharmaceuticals.
HT: Abbvie, Abivax, Dr Falk Pharma, ferring, Galapagos, Microbiotica, MSD, Pfizer, Takeda.
BS: AbbVie, Abivax, Boehringer Ingelheim, Bristol Myers Squibb, Dr. Falk Pharma, Eli Lilly, Endpoint Health, Falk, Galapagos, Gilead, Janssen, Landos, Materia Prima, PredictImmune, Pfizer, and Takeda; AlfaSigma, CED Service GmbH, MSD, Ferring, Galapagos, Tr1x bio
TH: Mitsubishi Tanabe Pharma Corporation, EA pharma Co. Ltd., AbbVie GK, JIMRO Co. Ltd., Zeria Pharmaceutical Co. Ltd., Kyorin Pharmaceutical Co. Ltd., Nippon Kayaku Co. Ltd., Takeda Pharmaceutical Co. Ltd., Pfizer Inc., Mochida Pharmaceutical Co. Ltd., Boston Scientific Corporation, Kissei Pharmaceutical Co. Ltd, Janssen Pharmaceutical K.K., Pfizer Inc., Eli Lilly, Gilead Sciences, Bristol Myers Squibb, Abivax.
XT: Celltrion, AbbVie, Johnson & Johnson, Lilly, Takeda, Alpha Sigma, Dr. Falk, Abivax, Biogen, Fresenius Kabi, MSD, Pfizer, Tillotts, and Thabor Therapeutics.
RA:AbbVie, Abivax, AstraZeneca, Bristol-Myers Squibb, Celltrion Healthcare, Galapagos, Johnson&Johnson, Lilly, MSD, Pfizer, and Takeda Pharma.
US: AbbVie, Abivax, Amgen, Galapagos, Janssen, Eli Lilly, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Gilead Sciences, Pfizer, Roche, Takeda Pharmaceuticals
AA: AbbVie, Abivax, AG Pharma, Alfa Sigma, Astra Zeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celltrion, Eli-Lilly, Enthera, Ferring, Galapagos, Gilead, Giuliani, Janssen, Lionhealth, MSD, Nestlé, Novartis, Pfizer, Protagonist Therapeutics, Roche, Samsung Bioepis, Sanofi, Sandoz, Takeda, Teva Pharmaceuticals, Tillots Pharma
FB: AbbVie, Amgen, Eurogenerics, J&J, Arena Pharmaceuticals, Celltrion, Ferring, Galapagos, Janssen, Merck Sharp & Dohme, Pfizer Inc, Takeda, Celgene, Fresenius Kabi, Sandoz
DTR: Abbvie, Abivax SA, Altrubio, Athos Therapeutics, Inc, Bristol-Myers Squibb, Celltrion, Connect BioPharma, Eli Lilly & Co., Genentech (Roche) Inc., Iterative Health, Janssen Pharmaceuticals, Johnson & Johnson, Merck & Co., Odyssey Therapeutics, Pfizer, Sanofi, Spyre, Takeda Pharmaceuticals, Vedanta Biosciences, and Ventyx.

Event

UEG Week Berlin 2025

Topics

Endoscopy IBD Mechanisms & Personalised Medicine

Submission format

Late-Breaking Abstract

Session

Hot off the press: IBD treatment

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Remo Panaccione

UEG Presentation

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INFLAMMAGEING AND RISK OF DIGESTIVE SYSTEM DISEASES: A LARGE COHORT STUDY BASED ON THE UK BIOBANK

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INFLAMMAGEING AND RISK OF DIGESTIVE SYSTEM DISEASES: A LARGE COHORT STUDY BASED ON THE UK BIOBANK

Weixiang Guan 1, Yan Qin 2, Yajie Zhang 3, Weihong Sha 3, Hao Chen 1

Affiliations

1 Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou 510080, China, Guangzhou, China|||South China University of Technology, Guangzhou, China

2 The First Affiliated Hospital of Guangzhou Medical University, Guangzhouchi, China

3 Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou 510080, China, Guangzhou, China

Summary

AI Generated

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Abstract

Introduction

Chronic low-grade inflammation, known as inflammageing, has been implicated in the pathogenesis of various digestive diseases. However, large-scale systematic evaluations of the association between inflammageing biomarker profiles and digestive system disorders remain scarce. Understanding these associations may have important implications for early detection and intervention strategies.

Aims & Methods

Leveraging the multidimensional data from the UK Biobank, this study aimed to investigate the longitudinal relationships between circulating inflammatory markers and major digestive diseases. A total of 45,475 participants were included, with inflammageing levels calculated as the average of standardized values of four circulating inflammatory markers: TNF, IL1RN, IL18, and IL6.
Digestive disease outcomes were identified from hospital records (HES) and death registries, covering 25 major diagnoses, including gastroesophageal reflux disease (GERD), inflammatory bowel disease (IBD), and non-alcoholic fatty liver disease (NAFLD). Cox proportional hazards models were used to estimate hazard ratios (HRs), adjusting for age, sex, BMI, smoking, and other potential confounders.
In addition, Mendelian randomization (MR) analysis was conducted using GWAS data derived from inflammageing scores to evaluate potential causal effects on digestive outcomes. Mediation and subgroup analyses were performed to explore possible mediating factors.

Results

In the Cox regression analysis, 22 out of 25 digestive outcomes showed significant associations with baseline inflammageing levels (Bonferroni-corrected P < 0.05), with HRs ranging from 1.2 to 2.4.
Mediation analysis identified neutrophil counts and LDL-C as important mediators in these associations, suggesting potential biological pathways linking inflammageing to digestive disease development.

Conclusion

Elevated baseline inflammageing levels were significantly associated with a wide spectrum of digestive system diseases. The findings highlight a potential mechanistic role of systemic inflammation in digestive disease pathogenesis. The use of inflammageing-related biomarkers may aid in early identification of high-risk individuals, offering opportunities for early prevention and targeted interventions.

Event

UEG Week Berlin 2025

Topics

IBD Mechanisms & Personalised Medicine Small Intestine & Nutrition Radiology & Imaging

Submission format

Abstract

Session

IBD: What about the environment?

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Remo Panaccione

UEG Presentation

Share via Email Share on Facebook Share on X Share on LinkedIn Share on Bluesky

EFFICACY AND SAFETY OF RISANKIZUMAB AFTER 4 YEARS OF TREATMENT IN PATIENTS WITH MODERATE TO SEVERE CROHN'S DISEASE: RESULTS FROM THE FORTIFY OPEN-LABEL LONG-TERM EXTENSION

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EFFICACY AND SAFETY OF RISANKIZUMAB AFTER 4 YEARS OF TREATMENT IN PATIENTS WITH MODERATE TO SEVERE CROHN'S DISEASE: RESULTS FROM THE FORTIFY OPEN-LABEL LONG-TERM EXTENSION

Marc Ferrante 1, Remo Panaccione 2, Jean-Frédéric Colombel 3, Marla C. Dubinsky 4, Tadakazu Hisamatsu 5, James O. Lindsay 6, Alex Song 7, Yi Yao 7, Yang Yang 7, Javier Zambrano 7, Fernando Aponte 7, Rachel Duan 7, Geert R. D'Haens 8

Affiliations

1 University Hospitals Leuven, Leuven, Belgium

2 University of Calgary, Calgary, Canada

3 Icahn School of Medicine at Mount Sinai, Usa, United States

4 Mount Sinai Hospital, Mount Sinai, New York City, United States

5 Kyorin University School of Medicine, Tokyo, Japan

6 Digestive Disorders Clinical Academic Unit, Barts and the London School of Medicine, London, United Kingdom

7 AbbVie, North Chicago, United States

8 AMC Amsterdam Inflammatory Bowel Disease Centre - Academic Medical Center, AMC Amsterdam Inflammator, Amsterdam, Netherlands

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Abstract

Introduction

Risankizumab (RZB) is a highly specific humanized monoclonal antibody that targets the p19 subunit of interleukin-23 and was designed to have low immunogenicity and high bioavailability, allowing for less-frequent dosing, although the clinical implications of these modifications have not been studied. The FORTIFY maintenance open label extension (OLE) is an ongoing phase 3 substudy evaluating the long-term efficacy and safety of RZB in pts with moderate to severe Crohn’s disease (CD). Here, we report interim efficacy and safety results from the FORTIFY OLE following up to 4 years (yrs) of RZB treatment.

Aims & Methods

The FORTIFY (NCT03105102) OLE enrolled pts who completed 52 weeks (wks) of RZB maintenance.^1,2 Pts received subcutaneous (SC) RZB 180mg every 8wks (Q8w) starting at wk56, except for pts who received rescue therapy prior to or during the OLE; these pts received SC RZB 360mg Q8w (see Table footnote for rescue therapy details). Pooled data (180mg+360mg) were analyzed through wk144 of the OLE (wk200 of cumulative RZB treatment) using as observed (AO) and modified nonresponder imputation (mNRI, pts were considered nonresponders for visits after premature discontinuation of RZB due to the primary reason of lack of efficacy or adverse event limited to Crohn’s disease only, as well as initiation of rescue, while other missing data were handled by multiple imputation [MI]) methods (‘All Patients [No Rescue or Prior to Rescue]’ group in Table). For pts who received rescue therapy, only their data obtained prior to receiving rescue were included in the aforementioned AO and mNRI analyses (‘All Patients [No Rescue]’ group in Table). Data from pts on the day of or after rescue were analyzed separately and reported AO starting at the initiation of rescue (defined as the last nonmissing value prior to or on initiation of rescue) and every 24 wks post-rescue (‘Rescue’ group in Table). Safety was evaluated in all pts receiving any RZB treatment in the OLE. Treatment-emergent adverse events (TEAEs) reported on/after the first dose in the OLE were summarized (cutoff date: 30DEC2024).

Results

A total of 1112 pts (excluding 36 pts who received RZB rescue at entry to OLE) received ≥1 dose of RZB 180mg or 360mg in the OLE. Efficacy rates (per mNRI analysis) were stable from OLE wk0 to wk144 for clinical remission per stool frequency/abdominal pain score (SF/APS, 64.5% to 75.8%) and per CD Activity Index (CDAI, 68.6% to 82.8%), endoscopic response (55.1% to 73.8%), and endoscopic remission (39.0% to 58.8%) (Table). Pts who received rescue therapy in the OLE demonstrated clinical and endoscopic improvements over time. The profiles of TEAEs and AEs of special interest were consistent with the known safety profile of RZB.^3,4

Week in OLE^a	All Patients (No Rescue or Prior to Rescue), Pooled^b		Initiation of Rescue (Week 0) and Every 24 Weeks Post-Rescue^e	Rescue^c, Pooled^d
Week in OLE^a	AO n/N (%) [95% CI]	mNRI n/N (%) [95% CI]		AO n/N (%) [95% CI]
SF/APS Clinical Remission^f Week 0 Week 24 Week 48 Week 72 Week 96 Week 120 Week 144 CDAI Clinical Remission^g Week 0 Week 24 Week 48 Week 72 Week 96 Week 120 Week 144 Endoscopic Response^h Week 0 Week 96 Endoscopic Remissionⁱ Week 0 Week 96	717/1112 (64.5) [61.7, 67.3] 665/1000 (66.5) [63.6, 69.4] 587/844 (69.5) [66.4, 72.7] 574/798 (71.9) [68.8, 75.0] 523/723 (72.3) [69.1, 75.6] 494/669 (73.8) [70.5, 77.2] 483/637 (75.8) [72.5, 79.1] 763/1112 (68.6) [65.9, 71.3] 693/933 (74.3) [71.5, 77.1] 609/797 (76.4) [73.5, 79.4] 591/755 (78.3) [75.3, 81.2] 547/689 (79.4) [76.4, 82.4] 503/628 (80.1) [77.0, 83.2] 496/599 (82.8) [79.8, 85.8] 588/1068 (55.1) [52.1, 58.0] 573/776 (73.8) [70.7, 76.9] 417/1068 (39.0) [36.1, 42.0] 456/776 (58.8) [55.3, 62.2]	717/1112 (64.5) [61.7, 67.3] 707/1112 (63.6) [60.7, 66.5] 667/1112 (60.0) [57.0, 63.0] 651/1112 (58.5) [55.5, 61.5] 624/1112 (56.1) [53.0, 59.1] 599/1112 (53.8) [50.7, 57.0] 605/1112 (54.4) [51.2, 57.5] 763/1112 (68.6) [65.9, 71.3] 783/1112 (70.4) [67.6, 73.2] 745/1112 (67.0) [64.0, 70.0] 729/1112 (65.5) [62.5, 68.5] 701/1112 (63.0) [60.0, 66.0] 675/1112 (60.7) [57.5, 63.9] 689/1112 (62.0) [58.9, 65.1] 602/1112 (54.1) [51.2, 57.1] 648/1112 (58.3) [55.2, 61.4] 419/1112 (37.7) [34.8, 40.5] 491/1112 (44.2) [41.0, 47.4]	SF/APS Clinical Remission^f At initiation of rescue 24 weeks post-rescue 48 weeks post-rescue 72 weeks post-rescue 96 weeks post-rescue 120 weeks post-rescue 144 weeks post-rescue CDAI Clinical Remission^g At initiation of rescue Week 24 post-rescue Week 48 post-rescue Week 72 post-rescue Week 96 post-rescue Week 120 post-rescue Week 144 post-rescue Endoscopic Response^h At initiation of rescue Week 96 post-rescue Endoscopic Remissionⁱ At initiation of rescue Week 96 post-rescue	3/278 (1.1) [0.4, 3.1] 101/251 (40.2) [34.4, 46.4] 98/185 (53.0) [45.8, 60.0] 74/154 (48.1) [40.3, 55.9] 65/125 (52.0) [43.3, 60.6] 50/92 (54.3) [44.2, 64.1] 38/64 (59.4) [47.1, 70.5] 39/278 (14.0) [10.4, 18.6] 108/226 (47.8) [41.4, 54.3] 99/164 (60.4) [52.7, 67.5] 80/138 (58.0) [49.6, 65.9] 69/111 (62.2) [52.9, 70.6] 55/80 (68.8) [57.9, 77.8] 39/54 (72.2) [59.1, 82.4] 95/265 (35.8) [30.3, 41.8] 102/189 (54.0) [46.9, 60.9] 46/265 (17.4) [13.3, 22.4] 68/189 (36.0) [29.5, 43.0]
Adverse Events Events (E/100PYs)	(N=1112) (PYs=3160.2)		(N=278) (PYs=543.9)
All TEAEs Investigator-defined drug-related AE Severe AE Serious AE AEs leading to study drug discontinuation Death Adverse Events of Special Interest^j Adjudicated MACE Adjudicated anaphylactic reaction Serious infections Opportunistic infections excluding tuberculosis and herpes zoster Herpes zoster Malignant tumors Non-melanoma skin cancer Malignancies excluding NMSC Hypersensitivity Hepatic events Injection site reactions	5067 (160.3) 610 (19.3) 263 (8.3) 385 (12.2) 47 (1.5) 3 (<0.1) 5 (0.2) 0 68 (2.2) 5 (0.2) 22 (0.7) 23 (0.7) 8 (0.3) 15 (0.5) 142 (4.5) 83 (2.6) 141 (4.5)		1187 (218.2) 114 (21.0) 86 (15.8) 109 (20.0) 25 (4.6) 0 2 (0.4) 0 12 (2.2) 4 (0.7) 5 (0.9) 5 (0.9) 2 (0.4) 3 (0.6) 22 (4.0) 24 (4.4) 17 (3.1)
AO, as observed; AE, adverse event; APS, abdominal pain score; CDAI, Crohn’s disease activity index; E, events; OLE, open-label extension; NMSC, nonmelanoma skin cancer; mNRI, modified nonresponder imputation; Q8w, every 8 weeks; MACE, major adverse cardiovascular event; PY, patient years; RZB, risankizumab; SC, subcutaneous; SES-CD, simple endoscopic score for Crohn’s disease; SF, stool frequency; TEAE, treatment-emergent AE; Wk, week. The study population included all patients who received at least one dose of study drug in the FORTIFY OLE. For AO analysis, data were used as is, except for data collected on or after rescue, which were excluded. For mNRI, patients were categorized as nonresponders for visits after premature discontinuation of study drug due to the primary reason of lack of efficacy and initiation of rescue therapy while other missing data were handled by multiple imputation. Patients who received rescue before receiving RZB 180 mg/360 mg treatment at week 0 of the OLE were not included in efficacy analysis. For patients who received rescue during the OLE, data on or after receiving risankizumab rescue therapy are presented as observed. ^aFor patients not receiving rescue, the week denotes the week of the OLE. ^bData for the 180mg + 360mg RZB treatment groups were pooled. Data through wk144 of the OLE were included in the analysis, unless the patient received rescue, in which case only data obtained prior to rescue were included. Data on or after initiation of rescue were excluded from this analysis and are shown in the far-right column (“Rescue, Pooled”). ^cRescue therapy consisted of a single 1200mg intravenous RZB dose, then 360mg SC Q8w, and was given in the case of inadequate response (as determined by increased symptoms plus an objective marker of inflammation). ^dRescue data was pooled, meaning patients may have received either 180mg or 360mg RZB prior to rescue. ^eInitiation of rescue was the last non-missing value prior to or on the initiation of risankizumab rescue therapy in the FORTIFY OLE. Subsequent timepoints are defined as the number of weeks post-rescue. ^fSF/APS clinical remission is defined as average daily SF ≤ 2.8 and not worse than baseline of the induction study and average daily AP score ≤ 1 and not worse than baseline of the induction study. ^gCDAI clinical remission is defined as CDAI < 150. ^hEndoscopic response is defined as decrease in SES-CD > 50% from baseline of the induction study (or for patients with isolated ileal disease and a baseline SES-CD = 4, at least a 2-point reduction from baseline of the induction study). ⁱEndoscopic remission is defined as SES-CD ≤ 4 and at least a 2-point reduction versus baseline of the induction study and no subscore > 1 in any individual variable ^jThere were no events of active tuberculosis or serious hypersensitivity.

Conclusion

Durable clinical and endoscopic efficacy was observed in pts with moderate to severe CD who completed up to 4 yrs of RZB maintenance therapy in the FORTIFY OLE. Pts who received rescue therapy in the OLE also showed clinical and endoscopic improvements by wk144. No new safety risks for RZB were identified, supporting its long-term use in treating CD.

References

1. Ferrante M, et al. J Crohns Colitis. 2021;15(12):2001-2010.
2. Ferrante M, et al. Lancet. 2022; 399(10340):2031–46.
3. Papp KA, et al. J. Am. Acad. Dermatol. 2023; 89(6):1149–58.
4. Ferrante M, et al. J Crohns Colitis. 2024;18(Supplement_1):i168–70.

Disclosure

Marc Ferrante
Research grants from AbbVie, EG Pharma, Janssen, Pfizer, Takeda and Viatris. Consultancy fees from AbbVie, AgomAb Therapeutics, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Janssen-Cilag, MRM Health, Merck Sharp and Dohme, Pfizer, Takeda and ThermoFisher. Speakers’ fees from AbbVie, Biogen, Boehringer Ingelheim, Dr Falk Pharma, Ferring, Janssen-Cilag, Merck Sharp and Dohme, Pfizer, Takeda, Truvion Healthcare and Viatris
Remo Panaccione
Consulting fees from AbbVie, Abbott, Alimentiv, Amgen, Arena, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Celltrion, Cosmos Pharmaceuticals, Eisai, Elan, Ferring, Galapagos, Genentech, Gilead Sciences, GlaxoSmithKline, Janssen, Lilly, Merck, Mylan, Oppilan Pharma, Pandion Pharma, Pfizer, Progenity, Protagonist Therapeutics, Roche, Sandoz, Satisfai Health, Schering-Plough, Shire, Sublimity Therapeutics, Theravance, UCB, and Takeda; speaker fees from AbbVie, Arena, Celgene, Ferring, Gilead Sciences, Janssen, Lilly, Merck, Pfizer, Roche, Sandoz, Shire, and Takeda; and research/educational support from AbbVie, Ferring, Janssen, Pfizer, and Takeda. He has served on an advisory board for AbbVie, Amgen, Arena, Bristol Myers Squibb, Celgene, Celltrion, Ferring, Galapagos, Genentech, Gilead Sciences, GlaxoSmithKline, Janssen, Lilly, Merck, Mylan, Oppilan Pharma, Pandion Pharma, Pfizer, Sandoz, Shire, Sublimity Therapeutics, Takeda, and Theravance
Jean-Frederic Colombel
Research grants from AbbVie, Janssen Pharmaceuticals, and Takeda; payment for lectures from AbbVie, Allergan, Amgen, Ferring Pharmaceuticals, Shire, and Takeda; consulting fees from AbbVie, Amgen, Arena Pharmaceuticals, Boehringer Ingelheim, Bristol Myers Squibb, Celgene Corporation, Ferring Pharmaceuticals, Galmed Research, Genentech, GlaxoSmithKline, Imedex, Immunic, Iterative Scopes, Janssen Pharmaceuticals, Kaleido Biosciences, Lilly, Merck, Microbia, Novartis, PBM Capital, Pfizer, Protagonist Therapeutics, Sanofi, Takeda, TiGenix, and Vifor; and holds stock options in Intestinal Biotech Development.
Marla Dubinsky
Consulting fees from AbbVie, Arena, Bristol Myers Squibb, Celgene, Eli Lilly, Genentech, Gilead, Janssen, Pfizer, Prometheus Labs, and Takeda; and is founder and a shareholder of Trellus Health
Tadakazu Hisamatsu
Grant support from AbbVie, Daiichi-Sankyo, EA Pharma Co, Ltd. JIMRO, Mitsubishi Tanabe Pharma Corporation, Mochida Pharmaceutical Co., Ltd., Nippon Kayaku Co., Ltd., Pfizer Inc., Takeda Pharmaceutical Co., Ltd. Consulting fees from EA Pharma Co, Ltd., Janssen Research & Development, LLC., Gilead Sciences, Eli Lilly, Bristol Myers Squibb. Lecture fees from AbbVie, EA Pharma Co, Ltd, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceutical Co., Ltd., Mochida Pharmaceutical Co., Ltd., Kissei Pharmaceutical Co, Ltd.
James O. 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.
Geert D’Haens
Consultant for AbbVie, AgomAb, AstraZeneca, AM Pharma, AMT, Bristol Myers Squibb, Boehringer Ingelheim, Celltrion, Eli Lilly, Exeliom Biosciences, Exo Biologics, Galapagos, Index Pharmaceuticals,, GSK, Pfizer, Immunic, J&J, Origo, Polpharma, Procise Diagnostics, Prometheus Laboratories, Prometheus Biosciences, Progenity, Protagonist and Ventyx; and has received speakers bureau fees from AbbVie, Arena Pharmaceuticals, Galapagos, Gilead, Pfizer, Bristol Myers Squibb, and Takeda

Alexandra Song, Yi Yao, Yang Yang, Javier Zambrano, Fernando Aponte, and W. Rachel Duan are full-time employees of AbbVie and may own AbbVie stock or options.

Funding
AbbVie funded this study and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the abstract. All authors had access to relevant data and participated in the drafting, review, and approval of this abstract. No honoraria or payments were made for authorship. AbbVie and authors thank all the trial investigators and the patients who participated in this clinical trial.
Medical writing support was provided by Stephanie Parsons, PhD, an employee of AbbVie.

Event

UEG Week Berlin 2025

Topics

IBD Mechanisms & Personalised Medicine

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Abstract

Session

Clinical management of IBD

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Remo Panaccione

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How to boost your biology? Every day strategies to improve therapies and combinations

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How to boost your biology? Every day strategies to improve therapies and combinations

Britta Siegmund 1

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1 Charité - Universitätsmedizin Berlin, Berlin, Germany

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Abstract

Event

UEG Week Berlin 2025

Topics

IBD Mechanisms & Personalised Medicine Surgery

Session

How to optimise success in IBD treatment

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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INFLAMMAGEING AND RISK OF DIGESTIVE SYSTEM DISEASES: A LARGE COHORT STUDY BASED ON THE UK BIOBANK

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EFFICACY AND SAFETY OF RISANKIZUMAB AFTER 4 YEARS OF TREATMENT IN PATIENTS WITH MODERATE TO SEVERE CROHN'S DISEASE: RESULTS FROM THE FORTIFY OPEN-LABEL LONG-TERM EXTENSION

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Remo Panaccione

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Identifying disease trajectories by AI

Florian Tran 1

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1 University Medical Center Schleswig-holstein, Campus Kiel, Kiel, Germany

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Abstract

Event

UEG Week Berlin 2025

Topics

Histopathology IBD Nurses

Session

The art of making clinical research precise: AI – friend or foe?

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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INFLAMMAGEING AND RISK OF DIGESTIVE SYSTEM DISEASES: A LARGE COHORT STUDY BASED ON THE UK BIOBANK

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EFFICACY AND SAFETY OF RISANKIZUMAB AFTER 4 YEARS OF TREATMENT IN PATIENTS WITH MODERATE TO SEVERE CROHN'S DISEASE: RESULTS FROM THE FORTIFY OPEN-LABEL LONG-TERM EXTENSION

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UEG Presentation

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The pan-enteric assessment of IBD: Is this the future of mucosal healing?

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The pan-enteric assessment of IBD: Is this the future of mucosal healing?

Salvatore Oliva 1

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1 University Hospital Umberto, Sapienza University of Rome, Rome, Italy

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Abstract

Event

UEG Week Berlin 2025

Topics

IBD Mechanisms & Personalised Medicine Surgery

Session

How to optimise success in IBD treatment

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Remo Panaccione

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GUSELKUMAB MAINTENANCE DOSE REGIMENS IN PATIENTS WITH HIGH DISEASE ACTIVITY AND SEVERITY: SUBGROUP ANALYSIS OF PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE IN THE GALAXI PHASE 3 STUDIES

Anita Afzali 1, Tadakazu Hisamatsu 2, David T. Rubin 3, Natalie Terry 4, Rian Van Rampelbergh 5, Jacqueline Yee 6, Kitty Yuen Yi Wan 7, Zijiang Yang 8, Walter Reinisch 9, Bruce E. Sands 10, Silvio Danese 11, Remo Panaccione 12

Affiliations

1 University of Cincinnati College of Medicine, Cincinnati, United States

2 Kyorin University School of Medicine, Tokyo, Japan

3 University of Chicago Medicine, Chicago, United States

4 Johnson And Johnson, Philadelphia, United States

5 Johnson & Johnson, Beerse, Belgium

6 Johnson & Johnson, Bedminster, United States

7 Johnson & Johnson, Allschwil, Switzerland

8 Johnson & Johnson, Spring House, United States

9 Medical University of Vienna, Wien, Austria

10 Icahn School of Medicine at Mount Sinai, New York, United States

11 Vita-Salute San Raffaele University - IRCCS San Raffaele Scientific Institute, Milan, Italy

12 University of Calgary, Calgary, Canada

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Abstract

Introduction

Guselkumab (GUS) intravenous (IV) induction followed by subcutaneous (SC) maintenance with 200mg q4w or 100mg q8w was effective in the GALAXI 2 & 3 phase 3 treat-through studies of participants (pts) with moderately to severely active Crohn’s disease (CD), with similar efficacy between both maintenance doses in the overall study populations. Here, we evaluated the efficacy of maintenance doses in subgroups by baseline disease activity and severity and inflammatory burden at Week (Wk) 12 to determine if some pts may receive additional benefit from the higher maintenance dose.

Aims & Methods

Eligible pts had moderately to severely active CD (CDAI 220–450 and mean daily stool frequency score >3 or abdominal pain score >1), SES-CD ≥6 (≥4 for isolated ileal disease), and inadequate response or intolerance to oral corticosteroids, AZA, 6-MP, MTX, or biologics. Pts were randomly assigned to GUS 200mg IV at Wks 0, 4, and 8, followed by GUS SC 100mg q8w (N=286) or 200mg q4w (N=296). The studies also included placebo and ustekinumab arms, but this analysis focused on differences between GUS maintenance doses. Wk48 endpoints included clinical remission (CDAI <150) and endoscopic response (≥50% improvement in SES-CD or SES-CD ≤2). Analyses of subgroups by baseline disease activity (CDAI >300 or SES-CD >12), and inflammatory burden (CRP >5) or endoscopic response at Wk 12 were prespecified but not multiplicity controlled.

Results

In the pooled GALAXI 2 & 3 dataset, pts with baseline high disease activity (CDAI >300 or SES-CD >12) had numerically greater clinical and endoscopic outcomes at Wk 48 with 200mg q4w compared with 100mg q8w. Pts with baseline CDAI >300 had numerically greater percentages of clinical remission (200mg: 68.0% [83/122] vs 100mg: 55.1% [65/118], respectively) and endoscopic response (52.5% [64/122] vs 44.1% [52/118]) at Wk 48. Pts with baseline SES-CD >12 also had numerically greater percentages of these outcomes (clinical remission: 77.0% [94/122] vs 65.1% [82/126] and endoscopic response 67.2% [82/122] vs 58.7% [74/126]). Pts with baseline CDAI ≤300 or SES-CD ≤12 had similar Wk 48 outcomes for both maintenance doses. Pts with greater inflammatory burden (CRP >5mg/L) at Wk 12 or who were not in endoscopic response at Wk 12 also had numerically greater clinical and endoscopic outcomes at Wk 48 with 200mg compared with 100mg (Table). Pts with CRP ≤5mg/L or who were in endoscopic response at Wk 12 had similar clinical and endoscopic outcomes for both maintenance doses. Results for individual GALAXI 2 & 3 studies generally trended in the same direction for all subgroups.

Table. Week 48 Outcomes by CRP and Endoscopic Response Status at Week 12
Week 48 outcome by status at Week 12	Guselkumab 200 mg q4w (N=278)	Guselkumab 100 mg q8w (N=268)
CRP>5mg/L at Week 12	107/278 (38.5%)	85/268 (31.7%)
Clinical remission at Week 48	76/107 (71.0%)	46/85 (54.1%)
Endoscopic response at Week 48	54/107 (50.5%)	31/85 (36.5%)
Not in endoscopic response at Week 12	177/278 (63.7%)	156/268 (58.2%)
Clinical remission at Week 48	120/177 (67.8%)	97/156 (62.2%)
Endoscopic response at Week 48	79/177 (44.6%)	50/156 (32.1%)
Clinical remission was defined as CDAI score <150; endoscopic response was defined as ≥50% improvement from baseline in SES-CD or SES-CD ≤2

Conclusion

Pts with high clinical or endoscopic disease severity at baseline, greater inflammatory burden after induction, or who had not achieved endoscopic response after induction showed greater clinical and endoscopic outcomes at Wk 48 with GUS 200mg SC q4w compared with 100mg SC q8w.

Disclosure

AA: AbbVie, Bristol Myers Squibb/Celgene, DiaSorin, Eli Lilly, Gilead, IBD Horizons, Johnson & Johnson, Pfizer, Takeda, and TLL Pharmaceuticals
TH: grants from AbbVie GK, Boston Scientific Corporation, EA Pharma Co. Ltd., JIMRO Co. Ltd., Kissei Pharmaceutical Co. Ltd., Kyorin Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Corporation, Mochida Pharmaceutical Co. Ltd., Nippon Kayaku Co. Ltd., Pfizer Inc., Takeda Pharmaceutical Co. Ltd., and Zeria Pharmaceutical Co. Ltd.; consulting fees from AbbVie GK, Abivax, Bristol Myers Squibb, EA Pharma Co. Ltd., Gilead Sciences, Janssen Pharmaceutical K.K., Lilly, Mitsubishi Tanabe Pharma Corporation, and Pfizer Inc.; lecture fees from AbbVie GK, EA Pharma Co. Ltd., Janssen Pharmaceutical K.K., JIMRO Co., Kissei Pharmaceutical Co. Ltd., Kyorin Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Corporation, Mochida Pharmaceutical Co., Ltd., Pfizer Inc., and Takeda Pharmaceutical Co. Ltd.
DTR: consulting/speaker fees/advisory board for AbbVie, Altrubio, Apex, Avalo, Bristol Myers Squibb, Buhlmann Diagnostics, Celgene, Connect BioPharma, Intouch Group, Iterative Health, Johnson & Johnson, Lilly, Pfizer, Samsung Neurologica, and Takeda; Altrubio, Datos Health, and Iterative Health stock options; grants from Takeda; membership on Board of Directors of Cornerstones Health, Inc and Crohn’s & Colitis Foundation’s Board of Trustees.
NAT, RVR, JY, KYYW, and ZY: employees of and may own Johnson & Johnson stock.
WR: speaker for AbbVie, Celltrion, Ferring, Johnson & Johnson, Galapagos Medice, MSD, Roche, Pfizer, Sobi, Takeda; consultant for AbbVie, Amgen, AOP Orphan, Boehringer Ingelheim, Bristol Myers Squibb, Calyx, Celltrion, Eli Lilly, Galapagos, Gilead, Index Pharma, Johnson & Johnson, Medahead, Microbiotica, Pfizer, Takeda; advisory board member for AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Galapagos, Johnson & Johnson, Pfizer; funding from AbbVie, Johnson & Johnson, Sandoz, Sanofi, Takeda.
BES: consulting fees from AbbVie, Adiso Therapeutics, Agomab, Alimentiv, Amgen, AnaptysBio, Arena Pharmaceuticals, AstraZeneca, Biolojic Design, Biora Therapeutics, Boehringer Ingelheim, Boston Pharmaceuticals, Celltrion, Equillium, Enthera, Enveda Biosciences, Evommune, Ferring, Galapagos, Genentech (Roche), Gilead Sciences, GlaxoSmithKline, Gossamer Bio, Imhotex, Index Pharmaceuticals, Innovation Pharmaceuticals, Inotrem, Kaleido, Kallyope, Merck, Microba, Mirador Therapeutics, Mobius Care, Morphic Therapeutics, MRM Health, Nexus Therapeutics, Nimbus Discovery, Odyssey Therapeutics, Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonist Therapeutics, Q32 Bio, Rasayana Therapeutics, Recludix Therapeutics, Reistone Biopharma, Sanofi, Sorriso Pharmaceuticals, Spyre Therapeutics, Sun Pharma, Surrozen, Target RWE, Teva, TLL Pharmaceutical, Tr1X, Union Therapeutics, Ventyx Biosciences, and Vividion Therapeutics; consulting /speaking fees from Abivax; consulting/speaking fees/other support from Lilly; research grants/consulting/speaking fees/other support from Bristol Myers Squibb, Johnson & Johnson, Pfizer, and Takeda; stock/options from Ventyx Biopharma.
SD: consultancy fees from AbbVie, Alimentiv, Allergan, Amgen, AstraZeneca, Athos, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Enthera, Ferring, Gilead, Hospira, Inotrem, Johnson & Johnson, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity, Takeda, TiGenix, UCB, and Vifor; lecture fees from AbbVie, Amgen, Ferring, Gilead, Janssen, Mylan, Pfizer, and Takeda.
RP: consulting fees from Abbivax, Abbott, AbbVie, Alimentiv, Amgen, AnaptsyBio, Arena Pharmaceuticals, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion, Cosmos Pharmaceuticals, Eisai, Elan, Eli Lilly, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead Sciences, GlaxoSmithKline, JAMP Bio, Johnson & Johnson, Merck, Mylan, Novartis, Oppilan Pharma, Organon, Pandion Pharma, Pendopharm, Pfizer, Progenity, Prometheus Biosciences, Protagonist Therapeutics, Roche, Sandoz, Satisfai Health, Shire, Spyre Therapeutics, Sublimity Therapeutics, Takeda Pharmaceuticals, Theravance Biopharma, Trellus, Union Biopharma, Viatris, Ventyx, and UCB; speaker’s fees from AbbVie, Amgen, Arena Pharmaceuticals, Bristol-Myers Squibb, Celgene, Eli Lilly, Ferring, Fresenius Kabi, Gilead Sciences, Johnson & Johnson, Merck, Organon, Pfizer, Roche, Sandoz, Shire, and Takeda Pharmaceuticals; Advisory Boards for AbbVie, Alimentiv, Amgen, Arena Pharmaceuticals, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Ferring, Fresenius Kabi, Genentech, Gilead Sciences, Glaxo-Smith Kline, JAMP Bio, Johnson & Johnson, Merck, Mylan, Novartis, Oppilan Pharma, Organon, Pandion Pharma, Pfizer, Progenity, Protagonist Therapeutics, Roche, Sandoz, Shire, Sublimity Therapeutics, Takeda Pharmaceuticals, and Ventyx.

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

New treatments on the horizon for Crohn's disease (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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