UEG Journal Abstracts 2023 - 128

(27.2% [13.1-41.3]; P<0.001 vs 21.0% [8.2-33.8]; P=0.003), endoscopic improvement
(28.7% [15.7-41.7]; P<0.001 vs 13.4% [5.2-21.7]; P=0.008), and
mucosal healing (18.0% [8.1-27.9]; P=0.003 vs 5.4% [0.5-10.2]; P=0.09).
Moderate disease (MES=2)
C1: PBO
(n=64)
Clinical remission,a
n (%)
Clinical response,b
n (%)
Endoscopic
improvement,c
n (%)
Mucosal healing,d
n (%)
7 (10.9)
C1: OZA
(n=138)
C2: OZA
(n=94)
49 (35.5) 38 (40.4)
Severe disease (MES=3)
C1: PBO
(n=73)
2 (2.7)
C1: OZA
(n=149)
17 (11.4)
C2: OZA
(n=98)
18 (18.4)
20 (31.3) 83 (60.1) 64 (68.1) 18 (24.7) 69 (46.3) 54 (55.1)
13 (20.3) 68 (49.3) 48 (51.1)
5 (7.8)
36 (26.1) 23 (24.5)
Pts with missing data were considered nonresponders.
a
4 (5.5)
1 (1.4)
29 (19.5) 23 (23.5)
10 (6.7)
6 (6.1)
Clinical remission: RBS=0, SFS ≤1 point (and a decrease of ≥1 point from baseline SFS), and
MES ≤1 point. b
Endoscopic improvement: MES ≤1 point. d
Mucosal healing: MES ≤1 point
and Geboes index score <2.0.
OZA vs PBO efficacy at W10 in advanced therapy-naive pts by baseline
endoscopic disease activity.
Conclusion: Pts with inadequate disease control while on conventional
therapies were better controlled with OZA treatment than those who
continued conventional treatments. Pts with moderate disease achieved
greater benefit and responded more rapidly than those with severe disease.
OZA is an effective oral advanced therapy option for pts suboptimally
controlled on conventional therapies, especially those with moderate
disease.
Disclosure: This study was funded by Bristol Myers Squibb, Princeton, NJ,
USA.
PI: received lecture fees from AbbVie, Bristol Myers Squibb, Celgene, Celltrion,
Dr. Falk Pharma, Ferring, Galapagos, Gilead, Janssen, MSD, Pfizer,
Sandoz, Sapphire Medical, Shire, Takeda, Tillotts, and Warner Chilcott;
received financial support for research from Celltrion, MSD, Pfizer, and
Takeda; received advisory fees from AbbVie, Arena, Boehringer Ingelheim,
Bristol Myers Squibb, Celgene, Celltrion, Eli Lilly, Genentech, Gilead, Hospira,
Janssen, MSD, Pfizer, Pharmacosmos, Prometheus Biosciences,
Roche, Samsung Bioepis, Sandoz, Takeda, TopiVert, VH2, Vifor, and Warner
Chilcott.
MDL: received research funding from Pfizer and Takeda; consulted for AbbVie,
Bristol Myers Squibb, Calibr, Eli Lilly, Genentech, Janssen, Pfizer, Prometheus,
Roche, Salix, Takeda, Target RWE, and Theravance.
BS: consulted for AbbVie, Arena, Boehringer Ingelheim, Bristol Myers
Squibb, Celgene, Falk Pharma, Galapagos, Janssen, Lilly, Pfizer, Prometheus,
and Takeda; received speaker fees from AbbVie, CED Service
GmbH, Falk Pharma, Ferring, Janssen, Novartis, Pfizer, and Takeda.
GD: served as an advisor for AbbVie, Agomab Therapeutics, Alimentiv, Applied
Molecular Therapeutics, AstraZeneca, Boehringer Ingelheim, Bristol
Myers Squibb, Celltrion, Cytoki, Eli Lilly, Exeliom Biosciences, Ferring,
Galapagos, GlaxoSmithKline, Gossamer Bio, Immunic, Johnson & Johnson,
Pfizer, Polpharma, ProciseDx, Progenity, Prometheus Biosciences,
Prometheus Laboratories, Protagonist Therapeutics, Seres, Takeda, Tillotts,
and Versant; and received speaker fees from AbbVie, Bristol Myers
Squibb, Eli Lilly, Galapagos, Johnson & Johnson, Pfizer, Takeda, and Tillotts.
IB:
received consulting fees from AbbVie, Amgen, Arena, Biogen, Bristol
Myers Squibb, Celltrion, Ferring, Galapagos, Janssen, Pfizer, Shire, and
Takeda; received speaker fees from AbbVie, Amgen, Arena, Biogen, Bristol
Myers Squibb, Celgene, Celltrion, Ferring, Galapagos, Janssen, Mylan,
Pfizer, Shire, and Takeda.
AJ, HW, and MTO: employees and/or shareholders of Bristol Myers Squibb.
128
S. Danese1, M. Lukáš2
A. Shashi5
, D. Lindner6
, M. Volfova3
, S. Jones6
, G. Rydzewska-Wyszkowska4
, S. Vermeire7
1University Vita-Salute, San Raffaele, Milan, Italy, 2
,
IBD Clinical and
Research Centre, ISCARE Clinical Centre, Prague, Czech Republic,
3
Department
of Gastroenterology, Central Clinical Hospital of The Ministry
of Interior and Administration of Warsaw, Warsaw, Poland,
5
Takeda, Cambridge, United States, 6
7
Department of Hepatogastroenterology, Institute for Clinical and
Experimental Medicine, Prague, Czech Republic, 4
Takeda, Zurich, Switzerland,
Department of Gastroenterology and Hepatology, University
Hospitals Leuven, Leuven, Belgium
Contact E-Mail Address: sdanese@hotmail.com
Introduction: Vedolizumab (VDZ) is a gut-selective humanised monoclonal
anti-α4
Clinical response: decrease from baseline in the 3-component Mayo score (sum
of RBS, SFS, and MES) of ≥2 points and ≥35% and a reduction of ≥1 point in RBS or absolute
RBS of ≤1 point. c
OP134
VEDOLIZUMAB LONG-TERM TREATMENT PERSISTENCE AND SAFETY
- RESULTS FROM A MULTINATIONAL EXTENDED ACCESS PROGRAMME
STUDY
DCW: received research funding from AbbVie, Bristol Myers Squibb, Genentech,
Janssen, Pfizer/Arena, and Takeda; consulted for AbbVie, Bristol
Myers Squibb, Eli Lilly, Janssen, Pfizer, and Takeda; received speaker fees
from AbbVie, Bristol Myers Squibb, Janssen, and Takeda.
DTR: received grant support from Takeda; consulted for AbbVie, AltruBio,
Aslan Pharmaceuticals, Athos Therapeutics, Bellatrix Pharmaceuticals,
Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Chronicles, ClostraBio,
Connect BioPharma, EcoR1, Eli Lilly, Genentech/Roche, Gilead Sciences,
Iterative Health, Janssen, Kaleido Biosciences, Pfizer, Prometheus
Biosciences, Reistone, Seres Therapeutics, Syneos, Takeda, Target RWE,
and Trellus Health.
β7 integrin antibody for treatment of ulcerative colitis (UC) and
Crohn's disease (CD). The GEMINI Long-Term Safety (LTS) study demonstrated
the durable efficacy and safety of vedolizumab for inflammatory
bowel disease (IBD) treatment. Patients experiencing clinical benefit from
vedolizumab in GEMINI LTS (NCT00790933) or VERSIFY (NCT02425111)
studies could continue treatment in the vedolizumab extended access
programme (XAP).
Aims & Methods: The XAP study was a phase 3b/4, prospective, open-label,
multinational, interventional study (NCT02743806)1,2
conducted from
Aug 2016 to Jan 2023 to investigate long-term treatment persistence and
safety of vedolizumab 300mg IV every 4 weeks (Q4W) or every 8 weeks
(Q8W) in adults with UC or CD.
Results: The study enrolled 331 patients (UC=142; CD=189) including 20
rolling over from VERSIFY and 311 patients from GEMINI LTS. Patients
treated with vedolizumab in the XAP study had either dose frequency
reduction Q4W to Q8W or were maintained on their current Q8W or Q4W
dosing; 297 patients started the XAP study on Q8W dosing, of which 295
received at least one dose of vedolizumab in XAP.
At XAP study baseline, mean (SD) disease duration was 13.9 (6.8) and 13.2
(6.8) yrs for patients with UC and CD, respectively; most patients were in
clinical remission (Table 1).
In total, 283/295 patients (95.9%) were persistent on Q8W dosing for ≥6
months without relapse (UC: 129/132 [97.7%] and CD: 154/163 [94.5%]).
Median (range) duration of vedolizumab treatment in the XAP study was
UC: 3.8 (0-6) and CD: 4.2 (0-6) yrs.
Only 27 patients (9.2%) were re-escalated from Q8W to Q4W dosing during
the study (UC: 11/132 [8.3%] and CD: 16/163 [9.8%]); median (range) duration
from last dose in the qualifying study to dose escalation in XAP was
1.5 (0.6-3.0) and 1.2 (0.2-5.2) yrs for UC and CD groups, respectively; the
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