UEGJournal Abstracts 2021 - 571

IBD
study. Comparing UPA with placebo, approximately 80−81% versus 44%
of patients had an IBDQ response while 61−62% versus 23−28% achieved
IBDQ remission at Week 8 (P<0.001).
Conclusion: Induction treatment with UPA 45 mg achieved significant
improvements in a broad range of HRQOL aspects at 8-weeks from
baseline for patients with moderately to severely active UC, including IBD
and UC symptoms, physical and mental functioning, work productivity,
and general well-being.
LS mean
change from
baseline at
Week 8a
IBDQ total
score
EQ-5D-5L
WPAI-WTM/
IWW,%
WPAI-OWI/
AI,%
SF-36 PCS/
MCS
UC-SQ
IBDQ
response/
remission,%b
a
PBO (N=154)
U-ACHIEVE
UPA
(N=319)
21.7
N=125
0.045
N=125
4.6/−7.2
N=70/N=65
−4.5/−9.0
N=70/N=125
2.28/2.40
N=125/N=125
−7.5
N=124
44.2/23.4
N=154/N=154
55.3
N=292
0.142
N=291
−8.9/−23.5
N=180/N=166
−26.7/−27.3
N=180/N=291
7.37/8.33
N=291/N=291
−18.5
N=287
80.7/61.1
N=319/N=319
0.097*
−13.4*/
−16.4*
−22.2*/
−18.3*
5.09*/
5.93*
−10.9*
36.9*/
37.7*
Difference
33.7*
PBO
(N=174)
21.1
N=156
0.048
N=155
−9.3/−10.9
N=89/N=82
−14.1/−10.5
N=89/N=155
2.88/2.75
N=156/N=156
−7.7
N=155
43.7/28.2
N=174/N=174
U-ACCOMPLISH
UPA
(N=341)
52.2
N=315
0.125
N=312
−9.1/−26.8
N=166/N=148
−27.3/−26.4
N=166/N=313
7.59/7.30
N=313/N=313
−18.5
N=312
79.5/62.2
N=341/N=341
0.077*
0.2/
−15.9*
−13.2*/
−15.9*
4.71*/
4.56*
−10.7*
36.4*/
33.9*
Estimates
calculated using a mixed-effect model for repeat measures analysis with adjustment for
baseline, treatment, visit, treatment by visit interaction, baseline corticosteroid use, Adaptive Mayo
Score, and bio-IR status. Baseline values for PBO and UPA differed by >5% in U-ACHIEVE for EQ5D-5L
(5.3%), WPAI-WTM (6.9%), and WPAI-IWW (5.5%), and in U-ACCOMPLISH for WPAI-WTM
(19.3%), WPAI-IWW (11.2%), WPAI-OWI (12.5%), and WPAI-AI (12.3%).
b
Percentage of patients at Week 8 achieving outcome based on synthesized results from NonResponder
Imputation incorporating Multiple Imputation for missing data due to COVID-19 (NRI-C).
Difference was estimated according to the Cochran-Mantel-Haenszel test adjusted for baseline
corticosteroid use, Adaptive Mayo Score, and bio-IR status while handling missing data using NRI-C
method. *P<0.001.
AI, activity impairment; Bio-IR, biologic-agent inadequate response; EQ-5D-5L, European Quality of
Life-5 Dimensions 5 Levels; HRQOL, health-related quality of life; IBDQ, Inflammatory Bowel Disease
Questionnaire, IWW, impairment while working; LS, least squares; MCS, Mental Component Summary;
OWI, overall work impairment; PBO, placebo; PCS, Physical Component Summary; SF-36, Short Form
36; UC-SQ, Ulcerative Colitis Symptoms Questionnaire; UPA, upadacitinib; WPAI, Work Productivity
and Impairment; WTM, work time missed.
Table
Disclosure: Funding statement: Financial support for the study was provided
by AbbVie. AbbVie participated in interpretation of data, review, and
approval of the abstract. All authors contributed to development of the
abstract and maintained control over final content. No honoraria or payments
were made for authorship.
Medical writing services, provided by Alan Saltzman, PhD, CMPP, of Fishawack
Facilitate Ltd, part of Fishawack Health, were funded by AbbVie.
Disclosures:
Julian Panes received financial support for research from AbbVie and Pfizer;
received lecture fee(s) from AbbVie, Ferring, Janssen, Takeda; and received
consultancy fees from AbbVie, Arena Pharmaceuticals, Boehringer
Ingelheim, Celltrion, Ferring, Genentech, Janssen, MSD, Origo, Pandion,
Pfizer, Robarts, Roche, Takeda, Theravance, and Wassermann.
Edward V. Loftus Jr received financial support for research from AbbVie,
Takeda, Janssen, UCB, Amgen, Pfizer, Genentech, Gilead, Celgene,
Robarts Clinical Trials, Receptos, Bristol Myers Squibb, Theravance; and
received consultancy fees from AbbVie, Allergan, Boehringer Ingelheim,
Takeda, Janssen, UCB, Amgen, Pfizer, Eli Lilly, Celgene, Celltrion Healthcare,
Bristol Myers Squibb, Gilead, Genentech, Iterative Scopes, Ono Pharma,
Calibr, Arena, and Sun Pharma.
Peter D. R. Higgins has received consultancy fees from AbbVie, PRIME
Medical Education, UCB, Takeda, Amgen, Lilly, and Lycera and research
funding from Janssen, AbbVie, Pfizer, Lilly, UCB, Takeda, Janssen, Arena,
National Institutes of Health, and Crohn's and Colitis Foundation.
Vol. 9 | October 2021
P0498
IN CONTRAST TO ORAL IRON THERAPY, INTRAVENOUS IRON THERAPY
IS NEITHER INFLUENCED BY, NOR DOES IT EXACERBATE, SYSTEMIC
INFLAMMATION IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE
A. Aksan1,2
1
, A. Dignass3, O. Schröder4,2
, J. Stein5,2,4
, K. Farrag4,2
Institute of Nutritional Science, Justus-Liebig University
Giessen, Giessen, Germany, 2
Centre Rhein-Main, Frankfurt am Main, Germany, 3
Markuskrankenhaus, Frankfurt am Main, Germany, 4
Sachsenhausen, Frankfurt am Main, Germany, 5
Interdisciplinary Crohn Colitis
Agaplesion
DGD Kliniken
Institute of
Pharmaceutical Chemistry, Goethe University Frankfurt, Frankfurt
am Main, Germany
Contact E-Mail Address: ayseguel.aksan@ernaehrung.uni-giessen.de
Introduction: Iron deficiency anemia (IDA) is a common complication of
inflammatory bowel disease (IBD). ECCO guidelines recommend intravenous
(IV) supplementation of iron in patients with IBD.1
However, data on
efficacy and safety of high dose IV iron in IBD patients with systemic inflammation
are conflicting.
Aims & Methods: We aimed to assess body iron stores, hemoglobin (Hb)
and degree of inflammation in patients with IBD-associated IDA treated
with IV iron (ferric carboxymaltose; FCM). A prospective non-interventional
post-marketing study was performed in 101 centers in Germany. Anemia
and iron status were assessed by Hb, ferritin, transferrin saturation
(TSAT) and C-reactive protein (CRP). Response was defined as increase of
≥2g/dL or normalization of Hb level during a 16-wk observation period.
Results: 224 patients (127 Crohn's disease / 97 Ulcerative colitis; mean
age 39y) were included. Mean total dose of IV FCM over ca.12 weeks was
1,139mg (range: 100-4.800mg), 76.7% of doses being between 500mg and
2,000mg. Mean CRP levels decreased significantly, from 6.4 to 3.5mg/L,
indicating reduced inflammatory activity independent of baseline Hb.
Change in CRP level was statistically significant in patients with high disease
activity, patients who received 500-1,000mg iron, and those completing
therapy. Amelioration of inflammation as shown by CRP reduction was
confirmed by disease activity indices (CDAI/CAI). Patients in all CRP subgroups
showed increased Hb, ferritin and TSAT, but reduced CRP levels
(Table 1).
Conclusion: In our study, the effectiveness of high-dosed FCM therapy was
not influenced by systemic inflammatory activity in patients with IBD, nor
did it cause any exacerbation of inflammation.
References: 1. Dignass AU et al. European consensus on the diagnosis
and management of iron deficiency and anaemia in inflammatory bowel
diseases. J Crohns Colitis. 2015;9(3):211-22.
Disclosure: Aysegül Aksan: Consultancy fees and research support;
Immundiagnostik AG, Vifor Pharma.
Axel Dignass: Consultancy fees: Abbott, Amgen, Fresenius Kabi, Hexal,
571
Difference
31.2*
James
O. Lindsay has served as consultant and an advisory board participant
for AbbVie, Allergan (Warner Chilcott), Atlantic Healthcare, Bristol
Myers Squibb, Celgene, Celltrion, Ferring Pharmaceuticals, Gilead, GSK,
Janssen, Lilly, MSD, Napp, Pfizer, Shire, Takeda, and Vifor Pharma, has received
speaker fees and sponsorship for academic meetings from AbbVie,
Allergan (Warner Chilcott), 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.
Wen Zhou, Qing Zhou, Dapo Ilo, Charles Phillips, and Yuri Sanchez Gonzalez
are full-time employees of AbbVie and may hold AbbVie stock and/
or stock options.
Séverine Vermeire is a senior clinical investigator of the Research Foundation-Flanders
(FWO).
UEGJournal Abstracts 2021

Table of Contents for the Digital Edition of UEGJournal Abstracts 2021
