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Bringing light into new treatment targets: the role of histology and molecular healing in UC (Eli Lilly and Company) (Complete Session)

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Bringing light into new treatment targets: the role of histology and molecular healing in UC (Eli Lilly and Company) (Complete Session)

Fernando Magro 1, Laurent Peyrin-Biroulet 2, Alissa Walsh 3

1 Centro Hospitalar São João, Amadora, Portugal

2 Inserm U1256, Nancy University Hospital, Vandoeuvre-les-Nancy, France

3 Oxford University Hospitals, Oxford, United Kingdom

Publisher

Eli Lilly

Event

UEG Week Copenhagen 2023

Session

Bringing light into new treatment targets: the role of histology and molecular healing in UC (Eli Lilly and Company)

Published

2023

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Which measures are important to prevent complication of IBD

Elena Sonnenberg 1

1 Charité – Universitätsmedizin Berlin, Berlin, Germany

Event

UEG Week Berlin 2025

Topics

IBD Nurses

Session

IBD nurses: All around the gut

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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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

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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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Organisation of an IBD centre

Federica Furfaro 1

1 Department of Biomedical and Clinical Sciences, L. Sacco University Hospital, Milan, Milano, Italy

Event

UEG Week Copenhagen 2023

Topics

IBD Nurses Standards & Guidelines

Session

IBD nurses: All around the gut

Published

2023

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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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The metabolic nature of inflammatory bowel diseases: From mechanistic insights to precision nutrition

Timon Adolph 1

1 Univ.-Klinik für Innere Medizin / Univ.-Klinik für Innere Medizin I, Innsbruck, Austria

Event

UEG Week Copenhagen 2023

Topics

IBD Mechanisms & Personalised Medicine

Session

Prediction of response in IBD

Published

2023

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