UEGJournal Abstracts 2021 - 565

IBD
& Dohme, Norgine, Pfizer, Robarts Clinical Trials, Roche, Sanofi, Shire,
Takeda, UCB, Vifor Pharma
UF, JA are employees of and may hold stock in Biogen.
MFL received Consultancy and/or speaker fees from: AbbVie, Amgen,
Biogen, Ferring, Janssen, Mayoly Spindler, Merck Sharp & Dohme, Pfizer,
Takeda, Tillots Pharma.
MF received consultancy and/or speaker fees from: AbbVie, Biogen, Boehringer
Ingelheim, CTMA, Ferring, Gilead, Hospira, Janssen, Lilly, Merck
Sharp & Dohme, Pfizer, Takeda, Tillots, Celgene.
FC received speaker fees from Abbvie, Astra, Biocodex, Biogen, Ferring,
Janssen, MSD, Pfizer, Pileje, Takeda, Tillotts; and is a member of advisory
boards for Amgen, Arena, BMS, Celltrion, Enterome, Ferring, Janssen,
Medtronic, Pfizer, Pharmacosmos, Roche, and Tillotts.
Biogen International GmbH funded and sponsored this study. Authors had
full editorial control and provided final approval of all content.
P0489
A MATCHING-ADJUSTED INDIRECT COMPARISON OF MAINTENANCE
ORAL FILGOTINIB VERSUS INTRAVENOUS VEDOLIZUMAB FOR
MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS
X. Lu1, M.-J. Wang2, E. Gray3, Y. Xin3, Z.-Y. Zhou3
J.O. Lindsay5
1
Galapagos NV, Paris, France, 2
, V. Jairath4
,
States, 3Analysis Group, Inc., London, United Kingdom, 4
University Schulich School of Medicine, London, ON, Canada, 5
Analysis Group, Inc., Boston, United
Western
The
Royal London Hospital, Barts Health NHS Trust, London, United
Kingdom
Contact E-Mail Address: james.lindsay8@nhs.net
Introduction: Vedolizumab is a licensed advanced therapy for patients
with moderately to severely active ulcerative colitis (UC) and can be used
as first line biologic agent or after failure of anti-tumor necrosis factor
(TNF) agents. Filgotinib is a once-daily oral Janus kinase 1 (JAK1) preferential
inhibitor under clinical development that has demonstrated efficacy
and tolerability in moderately to severely active UC.
However, the comparative efficacy of vedolizumab and filgotinib has not
been studied. In the absence of head-to-head trials, indirect treatment
comparison methods such as matching-adjusted indirect comparisons
(MAIC) that adjust for cross-trial differences in patient characteristics, can
be used to assess the relative efficacy of filgotinib vs. vedolizumab.
Aims & Methods: MAIC was used to assess the comparative efficacy of oral,
once-daily, filgotinib 200mg vs. intravenous (IV) vedolizumab 300mg every
8 weeks (Q8W) in patients with moderately to severely active UC who
received maintenance therapy. Anchored MAIC were performed using individual
patient data (IPD) from the phase 2b/3 randomized, placebo-controlled
SELECTION trial (NCT02914522) for filgotinib 200mg and the published
aggregate data from the phase 3 randomized, placebo-controlled
GEMINI 1 trial (NCT00783718) for vedolizumab 300mg Q8W IV.
In both trials, patients who received active treatment during the induction
phase and achieved clinical response at the end of the induction period,
were reassigned to active treatment or placebo in the maintenance phase.
IPD of patients in the SELECTION maintenance phase were weighted to
exactly match average baseline characteristics at induction reported in
GEMINI 1, separately for the active treatment and placebo arms: sex, age,
weight, smoking status, total Mayo score, duration of UC, history of biologic
failure, and concomitant systemic corticosteroid use.
Comparisons of efficacy outcomes (i.e., clinical remission, endoscopic improvement
and sustained clinical remission) at the end of maintenance
were conducted separately for biologic-naïve and biologic-experienced
subgroups.
Vol. 9 | October 2021
P0490
SIMPLIFIED RULES TO IDENTIFY BIO-NAÏVE PATIENTS WITH CROHN'S
DISEASE WITH HIGHER LIKELIHOOD OF CLINICAL REMISSION WHEN
INITIATING VEDOLIZUMAB VERSUS ANTI-TNFΑ THERAPIES: ANALYSIS OF
EVOLVE STUDY DATA
G.J. Mantzaris1, A. Yarur2, S. Wang3, S. Adsul4
A. Guerin7, E. Billmyer7
1
, P. Kamble5
, H. Nguyen7, B. Bressler8
Evangelismos Hospital, 1st Dept. of Gastroenterology, Athens,
Greece, 2
Takeda,
Takeda Pharmaceuticals Inc., Global
Medical College of Wisconsin, Milwaukee, United States,
3Takeda Pharmaceuticals International Co., Global Outcomes
Research & Epidemiology, Cambridge, United States, 4
Zurich, Switzerland, 5
Evidence and Outcomes-Gastroenterology, Cambridge, United
States, 6
Takeda, Cambridge, United States, 7
Analysis Group,
Boston, United States, 8University of British Columbia, Vancouver,
Canada
Contact E-Mail Address: gjmantzaris@gmail.com
Introduction: Previously, we identified subsets of biologic-naïve patients
(pts) with Crohn's disease (CD) from the EVOLVE study who had higher
rates of clinical remission (CR) when initiating vedolizumab (VDZ) vs antiTNFα
treatment, using prediction models based on multiple baseline
characteristics.1,2
To aid use in practice, we investigated whether these
subsets could be identified using simpler rules based on fewer baseline
characteristics.
Aims & Methods: Using data from EVOLVE, we used recursive partitioning
and regression tree (RPART) classification to predict membership in the
previously identified higher CR subsets for VDZ. CR was defined as meeting
any of the conditions in the following algorithm: 1) Crohn's Disease
Activity Index (CDAI) score < 150; or 2) if CDAI was unknown, Harvey-Bradshaw
Index (HBI) ≤4 points; or 3) if HBI was unknown, modified HBI (mHBI)
≤4 points; or 4) if mHBI was unknown, remission status in medical chart
recorded as 'in remission'. The RPART algorithm repeatedly splits data,
based on baseline predictors (demographics, prior treatments, clinical
565
, M. Luo6
,
Results: All patients who received filgotinib 200mg (n=202) or placebo
(n=99) in the SELECTION maintenance phase were matched to patients
who received vedolizumab IV (n=122) or placebo (n=126) in the GEMINI
1 maintenance phase. The effective sample sizes of filgotinib and its placebo
arm were 106 and 55, respectively, after matching. Among biologicnaïve
patients, there were no significant differences between filgotinib
and vedolizumab IV in terms of the odds of clinical remission (odds ratio
[OR]=2.2 [95% CI: 0.8, 6.4]), endoscopic improvement (OR=1.3 [0.5, 3.3]), or
sustained clinical remission (OR=2.1 [0.6, 7.9]) at the end of maintenance
phase. For biologic-experienced patients, the differences in the odds of
clinical remission (OR=2.4 [0.3, 21.6]), endoscopic improvement (OR=0.5
[0.1, 2.8]), and sustained clinical remission (OR=1.7 [0.1, 34.5]) between
filgotinib and vedolizumab IV at the end of maintenance phase were also
not statistically significant.
Conclusion: In a matching-adjusted indirect comparison of filgotinib vs.
vedolizumab during the maintenance phase, filgotinib showed similar
efficacy outcomes compared with vedolizumab, regardless of history of
biologic treatment, among patients with moderately or severely active
UC. The subgroup comparisons based on history of biologic treatment for
efficacy outcomes are limited by small sample sizes and should be confirmed
by further research.
Disclosure: The study was funded by Galapagos NV. XL is an employee of
Galapagos NV; VJ and JOL received honoraria from Galapagos NV; MJW,
EG, YX, and JZY are employees of Analysis Group, Inc., which received
funding from Galapagos NV.

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