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OBEFAZIMOD IN PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS: EFFICACY AND SAFETY ANALYSIS FROM THE 96-WEEK OPEN-LABEL MAINTENANCE PHASE 2B STUDY

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Introduction

Obefazimod is an oral small molecule that modulates inflammation by upregulating a specific anti-inflammatory micro-RNA (miR-124). Obefazimod has demonstrated safety and efficacy in patients with moderate-to-severe ulcerative colitis (UC) in the randomized, placebo-controlled, phase 2b induction study (1). This analysis presents data at week 96 after subjects enrolled in the open-label (OL) maintenance study.

Aims & Methods

Patients received placebo or obefazimod 25mg, 50mg or 100mg once daily (od) during the 16-week induction Phase 2b and, irrespective of their clinical response, could enter the optional OL 96-week maintenance study with obefazimod 50mg od. A total of 217 patients were enrolled into this study from January 13, 2020 onwards. Patients were followed monthly for safety and efficacy. Non-responder imputation (NRI) was used for missing efficacy data.

Results

Of 222 patients who completed the phase 2b induction study, 217 (97.7%) were enrolled in the OL maintenance study. 30/217 (13.8%) subjects dropped out prior to week 48, 6 subjects did not qualify the second year of treatment (non-responders) and 17/181 (9.4%) subjects dropped out between week 48 and week 96. All dropouts were considered as treatment failures for this analysis. 164 subjects completed the second year of treatment. Main efficacy results are presented in the Table below.

Criteria	Definition	All patients (NRI) N=217
Clinical remission	MMS : stool frequency sub-score ≤1, RBS = 0 and endoscopic sub-score ≤1	52.5%
Endoscopic improvement	Endoscopic sub-score ≤1	59.0%
Endoscopic remission	Endoscopic sub-score = 0	35.9%
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	70.5%

MMS: Modified Mayo score ; NRI: Non-responder imputation ; RBS: rectal bleeding sub-score
Among the 168 patients with no clinical remission after week 16 induction, 81 (48.2 %) achieved de novo clinical remission at week 96 of the OL maintenance study. Among the 49 patients with clinical remission after induction, 33 (67.3 %) maintained remission at week 96.
In total, 149 /217 subjects (68.7 %) reported at least one treatment emergent adverse events (TEAE) over 2 years of treatment. TEAEs leading to study discontinuation were reported in 17 subjects (7.8 %) and serious adverse events (SAEs) were reported in 18 subjects (8.3 %). The most frequent TEAEs (≥ 5 %) were COVID-19 (14.3 %), headache (11.5%), ulcerative colitis (7.8 %) and nasopharyngitis (6.9 %). No new safety risks were identified over these 96 weeks.

Conclusion

Results from this 96-week analysis of the OL maintenance Phase 2b study confirmed long-term efficacy of obefazimod 50 mg od, with durable clinical remission, as well as a favorable long-term safety profile.

References

Vermeire S, Sands B, Tilg H et al. ABX464 (obefazimod) for moderate-to-severe, active ulcerative Colitis: a phase 2b, double-blind, randomised, placebo-controlled induction trial and 48 week, open-label extension. Lancet Gastroenterol Hepatol 2022, 7 (11): 1024-1035

Disclosure

Bruce E Sands reports consulting fees from Abbvie, Alimentiv , Amgen, Arena Pharmaceuticals, Artugen Therapeutics, Astra Zeneca, Boehringer Ingelheim, Boston Pharmaceuticals, Calibr, Celgene, Celltrion, ClostraBio, Equillium, Enthera, Evommune, Fresenius Kabi, Galapagos, Genentech (Roche), Gilead Sciences, GlaxoSmithKline, Gossamer Bio, Index Pharmaceuticals, Innovation Pharmaceuticals, Inotrem, Kaleido, Kallyope, Merck, Morphic Therapeutics, MRM Health, Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonist Therapeutics, Q32 Bio, Sun Pharma, Surrozen, Target RWE,Teva, TLL Pharmaceutical, Ventyx Biosciences; consulting and speaking fees from Abivax; consulting and speaking fees and other support from Lilly; research grants, consulting and speaking fees and other support from Bristol Myers Squibb, Janssen, Pfizer, Takeda; research grants and consulting fees from Theravance Biopharma; and stock options from Ventyx Biopharma.
Séverine Vermeire has received grants from AbbVie, J&J, Pfizer, Takeda and Galapagos; Séverine Vermeire has received consulting and/or speaking fees from: 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.

OBEFAZIMOD IN PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS: EFFICACY AND SAFETY ANALYSIS FROM THE 96-WEEK OPEN-LABEL MAINTENANCE PHASE 2B STUDY

Severine Vermeire 1, Josianne Nitcheu 2, Paul GINESTE 2, Sheldon Sloan 2, Hartmut Ehrlich 2, Bruce E. Sands 3

1 University Hospitals Leuven, Leuven, Belgium

2 Abivax, Paris, France

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

Event

UEG Week Copenhagen 2023

Topics

Endoscopy Histopathology IBD

Submission format

Abstract

Session

The new kids on the block for IBD: Part 1

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

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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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.

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

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

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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Introduction

Vedolizumab (VDZ), a monoclonal antibody therapy approved for moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD) in China in 2020¹has a unique, gut-selective, anti-lymphocyte trafficking (GSALT) mechanism of action.² However, there is limited data on VDZ's real-world effectiveness and safety in Chinese IBD patients.³ Interim results from the VALUE study that enrolled patients with UC have been published^3,4 and final results are reported here.

Aims & Methods

VALUE (NCT04872491), a multicenter, single-arm, prospective, observational study evaluated the safety and effectiveness of VDZ in adult Chinese patients with IBD (N = 500) over 72 weeks. Clinical response, clinical remission, and endoscopic remission were assessed at Weeks 14, 30, and 54. Partial Mayo and Mayo endoscopic subscores at baseline and Weeks 14, 30, and 54 were calculated. Clinical response was defined as ≥2-point reduction in Partial Mayo Clinic score and ≥25% decrease from baseline score accompanied with ≥1-point decrease in the rectal bleeding or absolute rectal bleeding subscore ≤1. Clinical remission was defined as Partial Mayo Clinic score ≤2 with no subscore >1, endoscopic remission as Mayo endoscopic subscore ≤1, and complete endoscopic remission as Mayo endoscopic subscore 0. Safety results and CD patients’ data are presented in separate VALUE abstracts (IDs: AS-UEG-2025-01329 and AS-UEG-2025-01324).

Results

Among 409 UC patients enrolled in the final analysis, 91.9% (376/409) were included in the effectiveness analysis set. Mean age (±standard deviation [SD]) of patients was 46.3 (±15.1) years, and 59.4% (n=243) were male. At baseline, 30.8% (126/409) of patients had moderate UC, and 29.8% (122/409) had severe UC. The median duration of UC was 2.5 years, concomitant steroids were prescribed in 18.9% (71/376). Mean (±SD) partial Mayo score was 5.1 (2.1) at baseline, which declined to 1.7 (1.7), 1.5 (1.7) and 1.3 (1.5) by Weeks 14, 30 and 54, respectively, post-VDZ treatment. Patients achieving clinical response, clinical remission, endoscopic remission, and complete endoscopic remission were 76.9% (220/286), 71.1% (207/291), 63.6% (35/55), and 21.8% (12/55) at Week 14; 78.1% (193/247), 76.3% (190/249), 63.6% (28/44), and 27.3% (12/44) at Week 30; and 80.3% (155/193), 83.3% (165/198), 71.4% (20/28), and 50.0% (14/28) at Week 54, respectively. Patients with moderate and severe UC; biologic naïve patients and patients with prior exposure to biologics at baseline also achieved clinical response, clinical remission, and endoscopic remission (Table). Compared with baseline, mean (±SD) reduction of C-reactive protein (mg/L) at Weeks 14, 30, and 54 were 7.8 (20.2), 6.5 (22.2), and 3.4 (24.8), respectively; mean (±SD) reduction of fecal calprotectin (mu g/g) was 42.7 (150.7) at Week 14 and 212.6 (480.1) at Week 30. The proportion of patients achieving clinical remission without steroid use by Week 14 was 37.7% (23/61), which increased to 60.6% (20/33) by Week 54.

Data are presented as % (n/N). N, number of patients having clinical response/remission/endoscopic remission data. n, number of patients achieving clinical response/remission and endoscopic remission data.
	Moderate UC			Severe UC
	Clinical response	Clinical remission	Endoscopic remission	Clinical response	Clinical remission	Endoscopic remission
Week 14	89.8 (79/88)	65.9 (58/88)	57.1 (12/21)	90.0 (72/80)	63.8 (51/80)	56.3 (9/16)
Week 30	87.7 (64/73)	69.9 (51/73)	30.8 (4/13)	91.2 (62/68)	66.2 (45/68)	90.9 (10/11)
Week 54	92.2 (59/64)	81.3 (52/64)	62.5 (5/8)	88.5 (46/52)	73.1 (38/52)	60.0 (3/5)
	Biologic-exposed UC: 10.9% (41/376)			Biologic-naïve UC: 89.1% (335/376)
Week 14	69.0 (20/29)	66.7 (20/30)	16.7 (1/6)	77.8 (200/257)	71.7 (187/261)	69.4 (34/49)
Week 30	74.2 (23/31)	71.0 (22/31)	83.3 (5/6)	78.7 (170/216)	77.1 (168/218)	60.5 (23/38)
Week 54	60.0 (15/25)	81.5 (22/27)	83.3 (5/6)	83.3 (140/168)	83.6 (143/171)	68.2 (15/22)

Conclusion

This study indicated that VDZ demonstrated a good effectiveness profile in Chinese UC patients in the real-world setting.

References

Yan J et al., Medicine (Baltimore). 2024; 103: e38759.
Soler D et al. J Pharmacol Exp Ther. 2009; 330: 864-875.
Baili C et al. Am J Gastroenterol. 2023; 118: S213-S214.
Yan C et al. Am J Gastroenterol. 2023; 119: S894-S895.

Disclosure

This study was funded by Takeda (China) International Trading Co. Ltd. Xiuli Zuo, Ye Chen, and Yingchao Li have no conflicts of interest. Lifei Gu and Fang Zhou are Takeda employees and hold Takeda stock options. Minhu Chen received speaker honorariums from Takeda China, AstraZeneca China, Xian Janssen, and Eisai China.
Medical writing support for the development of this abstract under the direction of the authors was provided by Vibhuti Singh, Ph.D., of Cactus Life Sciences (part of Cactus Communications), funded by Takeda (China) International Trading Co., Ltd.

CLINICAL EFFECTIVENESS OF VEDOLIZUMAB IN CHINESE PATIENTS WITH ULCERATIVE COLITIS: FINAL RESULTS FROM THE VALUE, A MULTICENTER PROSPECTIVE STUDY

Xiuli Zuo 1, Ye Chen 2, Yingchao Li 3, Lifei Gu 4, Fang Zhou 4, Minhu Chen 5

1 Qilu Hospital of Shandong University, Jinan, China

2 Integrated Clinical Microecology Center, Shenzhen Hospital, Southern Medical University, Shenzhen, China

3 The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China

4 Takeda Pharmaceutical Company, Shanghai, China

5 The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

IBD (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Introduction

Mirikizumab (MIRI), a p19-directed antibody against interleukin-23, demonstrated improvements in fatigue, abdominal pain (AP) and stool frequency (SF) at Week (W) 12 and W52 in the VIVID-1 clinical trial.¹

Aims & Methods

The aim of this analysis is to show the effect of MIRI on fatigue, AP, SF and achievement of clinical remission by Patient-Reported Outcome (PRO; SF ≤3 and AP ≤1 and neither worse than baseline) in the VIVID-2 open-label extension study through W104. This analysis includes data from primary analysis set in patients with Crohn’s disease (CD) randomised to the MIRI treatment arm in VIVID-1 who achieved endoscopic response (≥50% reduction from baseline in Simple endoscopic score for CD) at W52 and continued the MIRI subcutaneous dosing (300 mg) in VIVID-2. Change from VIVID-1 baseline was measured for continuous endpoints. Endpoints included fatigue measured using FACIT-Fatigue (measured as change from baseline, and clinically-meaningful improvement of ≥6-points among patients with baseline ≤46), AP improvement (measured as change from baseline, and achievement of ≤1 among patients with baseline >1), SF improvement (measured as change from baseline, and achievement of ≤3 among patients with baseline >3) and clinical remission by PRO, assessed at W64 and 104. Missing data were handled using observed case (OC) and modified non-responder imputation (mNRI) for response rates, while using modified baseline observation carried forward (mBOCF) for change from baseline. Response rates were presented as unadjusted proportions with 2-sided 95% confidence intervals using the Rubin's Rules (mNRI). ANCOVA models were used for continuous variables, adjusting for baseline values and intervention group.

Results

Fatigue mean (standard error [SE]) change from baseline was 10.7 (0.56) at W64; 9.4 (0.59) at W104, (observed response, n [%]: 152 [67.6%] at W64; 136 [64.8%] at W104; Table). AP improved (mean [SE] change: −1.5 [0.04] at W64; −1.6 [0.05] at W104), with response rates increasing from 174 (77.3%) to 161 (84.7%). SF showed sustained improvement (mean [SE] change: −4.3 [0.14] at W64; −4.3 [0.16] at W104), with response rates reaching 155 (89.6%) at W104 (Table). Similar rates of achievement of clinical remission by PRO were observed (178 [73.6%] at W64; 165 [80.1%] at W104) (Table).

Table: Improvement in fatigue, abdominal pain, stool frequency and achievement of clinical remission by PRO up to Week 104

	FACIT-Fatigue (N=251)		Abdominal pain (N=251)		Stool frequency (N=251)		Clinical remission by PRO (N=251)
	Week 64	Week 104	Week 64	Week 104	Week 64	Week 104	Week 64	Week 104
Change from baseline^a(mBOCF), LSM (SE)	10.7 (0.56)	9.4 (0.59)	−1.5 (0.04)	−1.6 (0.05)	−4.3 (0.14)	−4.3 (0.16)	NA	NA
Response (observed)^b, n (%) (95% CI)	152 (67.6) (61.2–73.3)	136 (64.8) (58.1–70.9)	174 (77.3) (71.4–82.3)	161 (84.7) (78.9–89.2)	175 (86.6) (81.3–90.6)	155 (89.6) (84.2–93.3)	178 (73.6) (67.7–78.7)	165 (80.1) (74.1–85.0)
Response^b (mNRI), % (95% CI)	67.1 (61.0–73.3)	60.8 (54.4–67.2)	76.7 (71.2–82.2)	79.2 (73.7–84.7)	85.8 (80.9–90.6)	84.0 (78.8–89.2)	72.6 (66.9–78.2)	75.0 (69.4–80.7)

CI, confidence interval; LSM, least squares mean; mBOCF, modified baseline observation carried forward; mNRI, modified non-responder imputation; n, no of patients; NA, not applicable; PRO, Patient-Reported Outcome; SE, standard error
^aBaseline of VIVID-1 study
^bFACIT-Fatigue: ≥6-point improvement for baseline score ≤46; Abdominal pain: achievement of ≤1 for baseline score >1; Stool frequency: achievement of ≤3 for baseline score >3; Clinical remission by PRO: SF ≤3 and AP ≤1 and neither worse than baseline

Conclusion

MIRI sustained improvement in fatigue, AP, SF and clinical remission by PRO through 104 weeks of continuous treatment. These consistent findings support the long-term treatment with MIRI to address key symptoms of CD.

References

Ferrante, MarcTron, Emiliano, et al. The Lancet. 404 (10470):2423-2436.

Disclosure

PB: Received financial support for research from AbbVie, EG; lecture fees from AbbVie, AMC ICP, Amgen, Bristol Myers Squibb, Celltrion, Dr Falk Benelux, EG, Galapagos, Globalport, Lilly, Medtalks, Materia Prima, Pentax, Springer Media; served on an advisory board for AbbVie, Bristol Meyers Squibb, CIRC, Galapagos, Janssen, Lilly, Pentax, PSI-CRO, Roche, Takeda, Tetrameros. AA: Consultant for Geneoscopy; received research support from Takeda. AV, GY and JW: Employee and shareholder of Eli Lilly and Company. NL: Consultant for Eli Lilly and Company. JRA: Consultant for Janssen, Pfizer, Abbvie, Vedanta, Geneteche, Seres Therapeutics, Ferring, GSK, Merck, Bristol Myer Squibb, Roivant, Celltrion, and TRXBio, Xencor, Shattuck Labs; Speaker for Abbvie, Janssen. MC: Provided educational activities for AbbVie, China Medical System, IPSEN, Janssen, and Takeda; served on an advisory board for Boehringer Ingelheim and Janssen; and has support for clinical research from Janssen and Takeda.

MIRIKIZUMAB SUSTAINS IMPROVEMENT IN FATIGUE, ABDOMINAL PAIN, AND STOOL FREQUENCY FOLLOWING 104 WEEKS OF CONTINUOUS TREATMENT FOR CROHN’S DISEASE: RESULTS FROM THE VIVID-2 OPEN-LABEL EXTENSION STUDY

Peter Bossuyt 1, Ashwin Ananthakrishnan 2, Aisha Vadhariya 3, Na Lu 4, Guanglei Yu 3, Jianmin Wu 3, Jessica Allegretti 5, Minhu Chen 6

1 Imelda GI Clinical Research Centre, Bonheiden, Belgium

2 Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, United States

3 Eli Lilly and Company, Indianapolis, United States

4 Precision Statistics Consulting Inc, Woodbury, United States

5 Division of Gastroenterology, Hepatology and Endoscopy, Department of Medicine, Brigham & Women's Hospital, Boston, United States

6 The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

Patient-reported outcome and quality of life in IBD (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Green endoscopy: Step by step to a paper free endoscopy unit

Konstantinos Triantafyllou 1

1 Attikon University General Hospital, Athens, Greece

Event

UEG Week Berlin 2025

Topics

Nurses

Session

Green endoscopy: What makes sense?

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Introduction

Despite the benefits of available therapies for Crohn’s disease (CD), many patients (pts) lose treatment response over time, highlighting the need for options with sustained effectiveness.^1-3 Part 2 of the SEQUENCE trial is an open-label extension (OLE) study that evaluates the long-term efficacy and safety of the interleukin-23 p19 inhibitor risankizumab (RZB) in pts with moderate to severe CD and prior anti-TNF failure. Here, we evaluated the durability of clinical remission, quality of life (QoL), and inflammatory biomarker outcomes in RZB-treated pts through week (wk) 100 of SEQUENCE.

Aims & Methods

In SEQUENCE (NCT04524611), pts randomised to the RZB arm during Part 1 who completed the wk48 visit continued to receive open-label 360mg subcutaneous RZB maintenance dose every 8 wks starting at wk52 (baseline of Part 2).⁴ We assessed the proportion of pts achieving clinical remission (per CD activity index [CDAI] and stool frequency/abdominal pain score [SF/APS]) and Inflammatory Bowel Disease Questionnaire (IBDQ) remission at wks 8, 24, 52, 76, and 100. Additionally, pts with elevated high-sensitivity C-reactive protein (hs-CRP; > 5 mg/L) or faecal calprotectin (FCP; > 250 µg/g) at baseline were assessed for normalization of hs-CRP or FCP at wks 8, 24, 52, 76, and 100. We also assessed the proportion of pts who achieved these endpoints at wk100 among pts who also achieved that endpoint previously at either wk8 or at wk52. Data were assessed for all intent-to-treat pts using As Observed (AO) and per Non Responder imputation (NRI). Safety was not assessed in this post hoc analysis, although previously reported.⁵

Results

Of the 224 pts who entered SEQUENCE Part 2, the proportion of pts who achieved clinical remission (per AO data) increased from wk8 to wk52, and remained stable up to wk100 (CDAI: 48.0% [n/N=96/200] at wk8, 75.3% [168/223] at wk52, and 84.4% [141/167] at wk100; SF/APS: 44.0% [88/200] at wk8, 71.2% [158/222] at wk52, and 74.7% [124/166] at wk100) (Table). Similar trends were observed (per AO data) for IBDQ remission (41.5% [88/212] at wk8, 62.1% [139/224] at wk52, and 65.3% [126/193] at wk100), normalisation of hs-CRP (38.8% [54/139] at wk8, 53.1% [76/143] at wk52, and 62.0% [80/129] at wk100), and normalisation of FCP (34.6% [46/133] at wk8, 56.9% [87/153] at wk52, and 60.0% [75/125] at wk100). Most pts who achieved clinical remission at wk8 remained in remission at wk100, and the same was observed for patients in remission at both wk52 and wk100 (AO data; respectively, CDAI: 96.1% [73/76] and 91.1% [123/135]; SF/APS: 90.1% [64/71] and 86.8% [112/129]). A durable effect was also observed from wk8 to wk100 and from wk52 to wk100 in the majority of RZB-treated pts across all other endpoints (AO data; respectively, IBDQ remission: 91.5% [65/71] and 85.7% [102/119]); normalisation of hs-CRP: 80.0% [40/50] and 81.2% [56/69]; normalisation of FCP: 81.1% [30/37] and 85.1% [57/67]). Similar results to AO data were observed per NRI data (Table).

Endpoint, n/N (%) [95% CI]^a	AO^b	NRI^c
CDAI clinical remission^d Week 8 Week 24 Week 52^e Week 76 Week 100 Week 100 among pts who achieved at Week 8 Week 100 among pts who achieved at Week 52 SF/APS clinical remission^f Week 8 Week 24 Week 52^e Week 76 Week 100 Week 100 among pts who achieved at Week 8 Week 100 among pts who achieved at Week 52 IBDQ remission^g Week 8 Week 24 Week 52^e Week 76 Week 100 Week 100 among pts who achieved at Week 8 Week 100 among pts who achieved at Week 52 Normalisation of hs-CRP^h Week 8 Week 24 Week 52^e Week 76 Week 100 Week 100 among pts who achieved at Week 8 Week 100 among pts who achieved at Week 52 Normalisation of FCPⁱ Week 8 Week 24 Week 52^e Week 76 Week 100 Week 100 among pts who achieved at Week 8 Week 100 among pts who achieved at Week 52	96/200 (48.0) [41.1, 54.9] 148/199 (74.4) [68.3, 80.4] 168/223 (75.3) [69.7, 81.0] 140/168 (83.3) [77.7, 89.0] 141/167 (84.4) [78.9, 89.9] 73/76 (96.1) [91.7, 100.0] 123/135 (91.1) [86.3, 95.9] 88/200 (44.0) [37.1, 50.9] 135/198 (68.2) [61.7, 74.7] 158/222 (71.2) [65.2, 77.1] 125/167 (74.9) [68.3, 81.4] 124/166 (74.7) [68.1, 81.3] 64/71 (90.1) [83.2, 97.1] 112/129 (86.8) [81.0, 92.7] 88/212 (41.5) [34.9, 48.1] 129/212 (60.8) [54.3, 67.4] 139/224 (62.1) [55.7, 68.4] 135/201 (67.2) [60.7, 73.7] 126/193 (65.3) [58.6, 72.0] 65/71 (91.5) [85.1, 98.0] 102/119 (85.7) [79.4, 92.0] 54/139 (38.8) [30.7, 47.0] 68/139 (48.9) [40.6, 57.2] 76/143 (53.1) [45.0, 61.3] 82/139 (59.0) [50.8, 67.2] 80/129 (62.0) [53.6, 70.4] 40/50 (80.0) [68.9, 91.1] 56/69 (81.2) [71.9, 90.4] 46/133 (34.6) [26.5, 42.7] 64/129 (49.6) [41.0, 58.2] 87/153 (56.9) [49.0, 64.7] 71/130 (54.6) [46.1, 63.2] 75/125 (60.0) [51.4, 68.6] 30/37 (81.1) [68.5, 93.7] 57/67 (85.1) [76.5, 93.6]	94/224 (42.0) [35.5, 48.4] 145/224 (64.7) [58.5, 71.0] 168/224 (75.0) [69.3, 80.7] 136/224 (60.7) [54.3, 67.1] 134/224 (59.8) [53.4, 66.2] 70/94 (74.5) [65.7, 83.3] 117/168 (69.6) [62.7, 76.6] 88/224 (39.3) [32.9, 45.7] 133/224 (59.4) [52.9, 65.8] 158/224 (70.5) [64.6, 76.5] 121/224 (54.0) [47.5, 60.5] 117/224 (52.2) [45.7, 58.8] 61/88 (69.3) [59.7, 79.0] 107/158 (67.7) [60.4, 75.0] 86/224 (38.4) [32.0, 44.8] 126/224 (56.3) [49.8, 62.7] 139/224 (62.1) [55.7, 68.4] 133/224 (59.4) [52.9, 65.8] 122/224 (54.5) [47.9, 61.0] 62/86 (72.1) [62.6, 81.6] 99/139 (71.2) [63.7, 78.7] 54/143 (37.8) [29.8, 45.7] 67/143 (46.9) [38.7, 55.0] 76/143 (53.1) [45.0, 61.3] 80/143 (55.9) [47.8, 64.1] 77/143 (53.8) [45.7, 62.0] 40/54 (74.1) [62.4, 85.8] 53/76 (69.7) [59.4, 80.1] 46/153 (30.1) [22.8, 37.3] 64/153 (41.8) [34.0, 49.6] 87/153 (56.9) [49.0, 64.7] 71/153 (46.4) [38.5, 54.3] 73/153 (47.7) [39.8, 55.6] 29/46 (63.0) [49.1, 77.0] 56/87 (64.4) [54.3, 74.4]
Table. Achievement of Endpoints Over Time and at Week 100 in Patients Who Achieved Endpoints at Weeks 8 and 52. Abbreviations: AO, as observed, CDAI, Crohn’s Disease Activity Index; FCP, faecal calprotectin; hs-CRP; high-sensitivity C-reactive protein; IBDQ; Inflammatory Bowel Disease Questionnaire; NRI, nonresponder imputation; OLE, open-label extension; pt, patient; SF/APS, stool frequency/abdominal pain score. The study population includes all intent-to-treat patients who received at least one dose of study drug in the SEQUENCE OLE. ^aConstruction of CIs for response rate is based on the normal approximation to the binomial distribution. ^bFor the AO analysis, data were used as is; 16 patients received at least one dose of rescue therapy during Part 2. ^cOnly patients with 2-year matured data or those who discontinued the study early are included in the NRI analysis. Pts were categorised as non-responders for visits with missing assessments, visits after premature discontinuation of study, and visits after initiation of rescue therapy (if applicable). ^dCDAI clinical remission: CDAI < 150. ^eValues for wk52 represent the most recent non-missing assessment prior to the start of Part 2. ^fSF/APS clinical remission: Average daily SF ≤ 2.8 and not worse than baseline value and average daily APS ≤ 1 and not worse than baseline value. ^gIBDQ remission is defined as IBDQ total score ≥ 170 points. ^hC-reactive protein (hs-CRP) ≤ 5 mg/L. ⁱFCP ≤ 250 µg/g.

Conclusion

Pts with moderately to severely active CD receiving RZB demonstrated durable clinical remission, IBDQ remission, and inflammatory biomarker reductions through wk100 in the SEQUENCE OLE. Notably, most pts who achieved efficacy endpoints early maintained effectiveness during continued RZB treatment.

References

Colombel JF, et al. Gastroenterology. 2007;132:52–65.
Hanauer SB, et al. Lancet. 2002;359:1541–9.
Turner D, et al. Gastroenterology. 2021;160:1570–83.
Peyrin-Biroulet L, et al. N Engl J Med. 2024;391:213–23.

Disclosure

Raja Atreya has served as a speaker, or consultant, or received research grants from AbbVie, Abivax, AlfaSigma, AstraZeneca, Bristol Myers Squibb, CED Service, Celltrion Healthcare, Dr Falk, Galapagos, Johnson & Johnson, Eli Lilly, MSD Sharp & Dohme, Pfizer, Takeda Pharma.
James O. Lindsay has served as a consultant and an advisory board participant for AbbVie, Astra Zeneca, Bristol Myers Squibb, , Celltrion, Eli Lilly, Engytix, Ferring Pharmaceuticals, Galapagos, Gilead, GSK, Janssen, MSD, Pfizer, Takeda, and Vifor Pharma; has received speaker fees and sponsorship for academic meetings from AbbVie, Ferring Pharmaceuticals, Janssen, MSD, Pfizer, Tillotts Pharma, and Takeda; and has received investigator-led research grants from AbbVie, Gilead, Pfizer, and Takeda.
Marc Ferrante has received 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, Merck Sharp and Dohme, MRM Health, Pfizer, Takeda, and ThermoFisher; and speakers’ fees from AbbVie, Biogen, Boehringer Ingelheim, Dr Falk Pharma, Ferring, Janssen-Cilag, Merck Sharp and Dohme, Pfizer, Takeda, Truvion Healthcare, and Viatris.
Britta Siegmund has received consulting fees from AbbVie, Abivax, Boehringer Ingelheim, BMS, Dr Falk, Endpoint Health, Galapagos, Gilead, Janssen, Landos, Lilly, Pfizer, and Takeda, and speaker’s fees from AbbVie, AlfaSigma, BMS, CED Service, Dr Falk, Ferring, Galapagos, Janssen, Lilly, MSD, Pfizer, and Takeda.
Qian Cao has served as a steering committee adviser for Bristol Myers Squibb Company, and Janssen Research Development, LLC; and has received research grants from Takeda and Johnson & Johnson.
Stijn van Haaren, Jameson Crowley, Toni Anschutz, and Andrew Garrison are full-time employees of AbbVie and may own AbbVie stock or stock options.
Marla Dubinsky has received consulting and advisory fees from AbbVie, Abivax, Astra Zeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Eli Lilly, Genentech, Gilead, GSK, Janssen, Johnson and Johnson, Merck, Pfizer, Prometheus Labs, Prometheus Biosciences, Sanofi, Spyre and Takeda
Funding: AbbVie funded this trial and participated in the trial design, research, analysis, data collection, interpretation of data, and the review and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. AbbVie and the authors thank the patients, study sites, and investigators who participated in this clinical trial. Medical writing support was provided by Mahesh Chemudupati, PhD of AbbVie. Editorial support was provided by Amy Kuang, PhD of AbbVie.

DURABLE EFFICACY OF RISANKIZUMAB THROUGH WEEK 100 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE: A POST HOC ANALYSIS FROM PART 2 OF THE SEQUENCE TRIAL

Raja Atreya 1, James O. Lindsay 2, Marc Ferrante 3, Britta Siegmund 4, Qian Cao 5, Stijn Van Haaren 6, Jameson Crowley 6, Toni Anschutz 6, Andrew Garrison 6, Marla C. Dubinsky 7

1 Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany

2 Centre for Immunobiology, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom

3 University Hospitals Leuven, Leuven, Belgium

4 Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany|||Campus Benjamin Franklin, Berlin, Germany

5 Sir Run Run Shaw Hospital, College of Medicine Zhejiang University, Hangzhou, China

6 AbbVie Inc, North Chicago, IL, United States

7 Susan and Leonard Feinstein IBD Center, Icahn School of Medicine at Mount Sinai, New York, NY, United States

Conference

UEG Week Berlin 2025

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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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Introduction

The STRIDE-II consensus on the management of Crohn’s disease (CD) highlights the importance of achieving multiple treatment targets, including clinical remission, normalisation of the inflammatory biomarkers high-sensitivity C-reactive protein (hs-CRP) and fecal calprotectin (FCP), and quality of life (QoL) improvements.¹ In this post hoc analysis of the SEQUENCE open-label extension (OLE), we assessed inflammatory biomarker reductions and improvements in clinical and QoL outcomes (alone or in combination) in patients (pts) with moderately to severely active CD treated with risankizumab (RZB), an interleukin-23 p19 inhibitor.

Aims & Methods

In Part 2 of SEQUENCE (NCT04524611), pts randomised to the RZB arm during Part 1 and who completed the week (wk) 48 visit were eligible to continue receiving open-label 360mg subcutaneous RZB maintenance dose every 8 wks.² This analysis included all patients who completed wk100 of RZB treatment or who discontinued treatment prior to wk100 in Part 2 (cutoff date: July 11, 2024). Pts with elevated hs-CRP (> 5 mg/L) or FCP (> 250 mg/kg) at induction baseline were assessed for achievement of normalised hs-CRP or FCP alone or in combination with clinical remission per CD activity index (CDAI) or per stool frequency/abdominal pain score (SF/APS), or with inflammatory bowel disease questionnaire (IBDQ) remission (endpoints defined in Table footnote) at wks 52 (OLE baseline), 76, and 100. Data were assessed for all intent-to-treat pts using as observed (AO) regardless of rescue therapy and nonresponder imputation (NRI). Safety was previously reported and not assessed in this post hoc analysis.³

Results

Of the 224 pts who entered SEQUENCE Part 2, 184 pts had elevated hs-CRP or FCP levels at induction baseline and were included in this analysis. The majority of these pts achieved normalisation of hs-CRP or FCP (per AO data) at wk52 (77.7%) and continued to show improvement at wks 76 and 100 (83.9% and 86.6%, respectively) (Table). Most of these pts also achieved both normalised hs-CRP or FCP and clinical remission simultaneously at wks 52, 76, and 100 per CDAI (AO data: 60.9%, 66.2%, and 71.0%, respectively) and per SF/APS (AO data: 55.2%, 60.2%, and 62.9%, respectively). The proportion of pts who achieved normalisation of hs-CRP or FCP and IBDQ remission increased from wk52 through wk100 (AO data; wk52: 50.0%, wk76: 54.9%, wk100: 57.1%). NRI data for all endpoints are summarized in the Table.

Endpoint, n/N (%) [95% CI]^a	AO^b	NRI^c
Normalisation of hs-CRP^d or FCP^e Week 52 Week 76 Week 100 Normalisation of hs-CRP or FCP and CDAI clinical remission^f Week 52 Week 76 Week 100 Normalisation of hs-CRP or FCP and SF/APS clinical remission^g Week 52 Week 76 Week 100 Normalisation of hs-CRP or FCP and IBDQ remission^h Week 52 Week 76 Week 100	143/184 (77.7) [71.7, 83.7] 141/168 (83.9) [78.4, 89.5] 136/157 (86.6) [81.3, 91.9] 112/184 (60.9) [53.8, 67.9] 88/133 (66.2) [58.1, 74.2] 93/131 (71.0) [63.2, 78.8] 101/183 (55.2) [48.0, 62.4] 80/133 (60.2) [51.8, 68.5] 83/132 (62.9) [54.6, 71.1] 92/184 (50.0) [42.8, 57.2] 89/162 (54.9) [47.3, 62.6] 88/154 (57.1) [49.3, 65.0]	143/184 (77.7) [71.7, 83.7] 140/184 (76.1) [69.9, 82.3] 130/184 (70.7) [64.1, 77.2] 112/184 (60.9) [53.8, 67.9] 86/184 (46.7) [39.5, 53.9] 89/184 (48.4) [41.1, 55.6] 101/184 (54.9) [47.7, 62.1] 78/184 (42.4) [35.3, 49.5] 79/184 (42.9) [35.8, 50.1] 92/184 (50.0) [42.8, 57.2] 88/184 (47.8) [40.6, 55.0] 85/184 (46.2) [39.0, 53.4]
Table. Achievement of Endpoints in Patients With Elevated hs-CRP or Elevated FCP at Baseline. Abbreviations: AO, as observed; CDAI, Crohn’s Disease Activity Index; FCP, fecal calprotectin; hs-CRP; high-sensitivity C-reactive protein; IBDQ, Inflammatory Bowel Disease Questionnaire; NRI, nonresponder imputation; SF/APS, stool frequency/abdominal pain score. The study population includes all intent-to-treat patients who received at least one dose of study drug in the SEQUENCE OLE. ^aConstruction of CIs for response rate is based on the normal approximation to the binomial distribution. ^b16 patients received at least one dose of rescue therapy during Part 2. ^cOnly patients with 2-year matured data or those who discontinued the study before the cutoff date (n = 26) are included in the NRI analysis. Pts were categorised as nonresponders for visits with missing assessments, visits after premature discontinuation of study, and visits after initiation of rescue therapy (if applicable). ^dC-reactive protein (hs-CRP) ≤ 5 mg/L. ^eFCP ≤ 250 mg/kg. ^fCDAI clinical remission: CDAI < 150. ^gSF/APS clinical remission: Average daily SF ≤ 2.8 and not worse than baseline value and average daily APS ≤ 1 and not worse than baseline value. ^hIBDQ remission is defined as IBDQ total score ≥170 points.

Conclusion

In this post hoc analysis, pts with moderately to severely active CD demonstrated inflammatory biomarker normalisation with RZB treatment and continued improvement of inflammation up to wk100 in the SEQUENCE OLE. Notably, most pts simultaneously achieved normalisation of inflammatory biomarkers plus clinical or QoL outcomes through wk100 of RZB treatment.

References

Turner D, et al. Gastroenterology. 2021;160:1570–83.
Peyrin-Biroulet L, et al. N Engl J Med. 2024;391:213–23.
L Peyrin-Biroulet, et al. Journal of Crohn's and Colitis. 2025;19(Supplement_1):i1405–07.

Disclosure

Benjamin L. Cohen has received advisory board and consultancy fees from AbbVie, ALPCO, Celgene-Bristol Myers Squibb, Johnson & Johnson Innovative Medicine, Lilly, Pfizer, Sublimity Therapeutics, Takeda, TARGET RWE; DSMB: Emmes Biopharma Services LLC; speakers’ fees from AbbVie and Takeda.
Corey Siegel has served as a consultant for AbbVie, BMS, Boomerang, Buhlmann, Celltrion, Johnson & Johnson, Lilly, Napo Pharmaceuticals, Path Healthcare, Pfizer, Prometheus Biosciences & Labs, Sanofi, Takeda, and Trellus Health; received grants from AbbVie, Johson & Johnson, Pfizer, and Takeda; and is co-founder of MiTest Health, LLC, technology “System and Method of Communicating Predicted Medical Outcomes” licensed to Takeda; equity interest in Path Healthcare and Trellus Health
Alessandro Armuzzi has received consulting/advisory board fees from AbbVie, Alfa Sigma, Amgen, Arena, Biogen, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring, Galapagos, Gilead, Janssen, MSD, Mylan, Pfizer, Protagonist Therapeutics, Roche, Samsung Bioepis, Sandoz, Takeda, and Teva Pharmaceuticals; speaker’s fees from AbbVie, Alfa Sigma, Amgen, Arena, Biogen, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring, Galapagos, Gilead, Janssen, MSD, Novartis, Pfizer, Roche, Samsung Bioepis, Sandoz, Takeda, and Teva Pharmaceuticals; and research support from MSD, Takeda, Pfizer, and Biogen.
Fernando Aponte, Toni Anschutz, Andrew Garrison, Namita Joshi, and Javier Zambrano are full-time employees of AbbVie and may own AbbVie stock or stock options.
Laurent Peyrin-Biroulet has received personal fees from AbbVie, Adacyte, Alimentiv, Alma Bio Therapeutics, Amgen, Applied Molecular Transport, Arena, Biogen, BMS, Celltrion, CONNECT Biopharm, Cytoki Pharma, Enthera, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, Gossamer Bio, GSK, HAC-Pharma, IAG Image Analysis, Index Pharmaceuticals, Inotrem, Janssen, Lilly, Medac, Mopac, Morphic, MSD, Norgine, Nordic Pharma, Novartis, OM Pharma, ONO Pharma, OSE Immunotherapeutics, Pandion Therapeutics, Par’Immune, Pfizer, Prometheus, Protagonist, Roche, Sanofi, Sandoz, Takeda, Theravance, Thermo Fisher, Tigenix, Tillots, Viatris, Vifor, Ysopia, Abivax, Samsung, Ventyx, Roivant, and Vectivbio.

Funding
AbbVie funded this trial and participated in the trial design, research, analysis, data collection, interpretation of data, and the review and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. AbbVie and the authors thank the patients, study sites, and investigators who participated in this clinical trial. Medical writing support was provided by Mahesh Chemudupati, PhD of AbbVie. Editorial support was provided by Amy Kuang, PhD of AbbVie.

INFLAMMATORY BIOMARKER REDUCTIONS AND IMPROVEMENTS IN CLINICAL AND QUALITY OF LIFE OUTCOMES WITH RISANKIZUMAB THROUGH 100 WEEKS OF TREATMENT IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE: A POST HOC ANALYSIS FROM PART 2 OF THE SEQUENCE TR

Benjamin L. Cohen 1, Corey A Siegel 2, Alessandro Armuzzi 3, Fernando Aponte 4, Toni Anschutz 4, Andrew Garrison 4, Namita Joshi 4, Javier Zambrano 4, Laurent Peyrin-Biroulet 5

1 Cleveland Clinic Foundation, Cleveland, OH, United States

2 Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States

3 IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy

4 AbbVie Inc, North Chicago, IL, United States

5 INFINY Institute, INSERM NGERE, Centre Hospitalier Régional Universitaire de Nancy, Vandœuvre-lès-Nancy, France|||McGill University Health Centre, Montreal, Canada

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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