UEGJournal Abstracts 2021 - 570

IBD
IBD patients would be investigated by relevant clinical investigation, assessing
the impact of spa treatment on the composition of the intestinal
microbiota and determining the relations between patients' improvement
and rebalancing the intestinal microbiota.
Disclosure: Nothing to disclose.
P0496
A 12-WEEK TAILORED PHYSICAL TRAINING PROGRAM INCLUDING
DIETARY ADVICE IN CHILDREN WITH INFLAMMATORY BOWEL DISEASE:
A RANDOMIZED CROSSOVER TRIAL
L.E. Scheffers1
G. Dielemans3
1
, L.E. van den Berg1
, A. Ploeg4
, W.A Helbing5
, M.W Pijnenburg2
, J.C Escher1
, E. Utens3
Erasmus MC - Sophia Children's Hospital, Paediatric
Gastroenterology, Rotterdam, Netherlands, 2
,
Erasmus MC - Sophia
Children's Hospital, Paediatric Respiratory Medicine, Rotterdam,
Netherlands, 3
Erasmus MC - Sophia Children's Hospital, Child
and Adolescent Psychiatry/Psychology, Rotterdam, Netherlands,
4
Erasmus MC - Sophia Children's Hospital, Center for Lysosomal
and Metabolic Disease, Rotterdam, Netherlands, 5
Erasmus MC
- Sophia Children's Hospital, Paediatric Cardiology, Rotterdam,
Netherlands
Contact E-Mail Address: l.scheffers@erasmusmc.nl
Introduction: Inflammatory Bowel Disease (IBD) is a chronic inflammatory
disease of the gastrointestinal tract. Recently, physical activity has
been suggested to improve quality of life and course of disease in adult
IBD patients.
Aims & Methods: The aim of this study was to examine physical functioning
in paediatric and adolescent IBD patients and to investigate the effects
of a tailored 12-week lifestyle intervention including a physical training
program. This study is a randomized crossover trial, including a 12-week
intervention and 12 week control period. All measurements were conducted
at baseline, after the control period, and after the 12-week lifestyle
intervention. The endpoints were (1) Disease activity: measured by PCDAI/
PUCAI and fecal calprotectin. Clinical remission was defined as PCDAI/
PUCAI scores <10. (2) Exercise capacity: PeakVO2 measured by maximal
cardiopulmonary exercise test, (3) Physical activity levels: measured by
actigraph, (4) Endurance: walked distance on 6-minute walking test, (5)
Quality of life: measured by IMPACT-III questionnaire and the child health
questionnaire, (6) Fatigue: measured by the PedsQol Multi Fatigue Scale.
The tailored 12-week lifestyle intervention was designed based on the
baseline measurements, and consisted of 3 supervised strenuous physical
training sessions a week and healthy diet advice in accordance with
measured total energy expenditure.
Results: Sixteen paediatric IBD patients (median age 15 [9 - 17]) were
included, 13 patients successfully completed the training program, 2
patients are still participating. At baseline 3 out of 13 patients were in
clinical remission. Patients had reduced exercise capacity (76.8%±17.7%
of predicted PeakVO2), and reduced physical activity levels as shown by
80.3%±7.4% of measured time being spent in sedentary activity. PCDAI/
PUCAI scores decreased significantly (13.8±11.7 vs. 3.65±4.5, P=0.002).
Fecal calprotectin decreased significantly over the exercise period (400
[18-3089] vs. 128 [20-2704], P=0.041). All patients but one had no changes
in medical regimens before or during the lifestyle intervention that could
have influenced disease activity. After the 12-week lifestyle intervention
period, 9 out of 13 patients were in clinical remission. Maximum walked
distance increased significantly (503±69 vs. 540±77 meters, P=0.001), although
PeakVO2
and percentage of time spent in moderate-to-vigorous activity
did not. Patients improved on overall quality of life measured by the
Impact-III (+2.4 points, p=0.017). The Child Health Questionnaire showed a
570
P0497
UPADACITINIB TREATMENT IMPROVES HEALTH-RELATED QUALITY
OF LIFE AMONG PATIENTS WITH MODERATELY TO SEVERELY ACTIVE
ULCERATIVE COLITIS: RESULTS FROM THE PHASE 3 INDUCTION
STUDIES U-ACHIEVE AND U-ACCOMPLISH
J. Panes1, E. Loftus Jr.2
Q. Zhou5
, D. Ilo5
, P. Higgins3, J. Lindsay4
, C. Phillips5
1Hospital Clinic Barcelona, Barcelona, Spain, 2
of Medicine, Rochester, United States, 3
Ann Arbor, United States, 4
Leuven, Leuven, Belgium
Contact E-Mail Address: JPANES@clinic.cat
Introduction: A relevant proportion of patients with ulcerative colitis (UC)
have reduced health-related quality of life (HRQOL). Upadacitinib (UPA), a
selective and reversible Janus kinase inhibitor, is currently being assessed
in patients with moderately to severely active UC in the Phase 3 multicenter,
randomized, double-blind U-ACHIEVE (NCT02819635) substudy 2
and U-ACCOMPLISH (NCT03653026) induction studies.
Aims & Methods: This study aims to assess the HRQOL benefits of induction
treatment with UPA. Eligible patients were 16-75 years of age with
a diagnosis of moderately to severely active UC, and with an inadequate
response, loss of response, or intolerance to aminosalicylates, corticosteroids,
immunosuppressive agents, and/or biologic therapies. Patients
were randomized 2:1 to receive UPA 45 mg once daily or placebo for 8
weeks. HRQOL outcomes evaluated were change from baseline to Week 8
in Inflammatory Bowel Disease Questionnaire (IBDQ), European Quality of
Life-5 Dimensions 5 Levels (EQ-5D-5L), Work Productivity and Impairment
Questionnaire (WPAI), Short Form 36, and Ulcerative Colitis Symptoms
Questionnaire (UC-SQ) scores, as well as the proportion of patients who
achieved IBDQ response (≥16-point IBDQ total point improvement from
baseline) and remission (IBDQ total score ≥170).
Results: A total of 154 and 319 patients received placebo and UPA, respectively,
in U-ACHIEVE; and 174 and 341 patients received the respective
treatments in U-ACCOMPLISH and were included in the Intent-to-Treat
population for statistical analysis (Table). Baseline values for the HRQOL
outcomes analyzed were similar between UPA and placebo groups in both
studies (<5% difference) for IBDQ, SF-36, and UC-SQ, with differences >5%
listed in the table footnote. When comparing UPA versus placebo at Week
8, significant improvements from baseline in HRQOL were achieved for all
outcomes in both studies (P<0.001), with the exception of WPAI-work time
missed in which significant benefit was only achieved in the U-ACHIEVE
UEG Journal | Abstract Book
, W. Zhou5
, Y. Sanchez Gonzalez5
,
, S. Vermeire6
Mayo Clinic College
University of Michigan,
Barts Health NHS Trust, Department
of Gastroenterology, The Royal London Hospital, London, United
Kingdom, 5
AbbVie Inc., Chicago, United States, 6
University Hospital
significant improvement on the child-reported physical functioning scale
and on 5 parent-reported scales of quality of life. Child-reported fatigue
measured by the PedsQol MFS did not improve significantly, parentsreported
fatigue did. No changes were found on mentioned outcomes
during the control period. The control period was extended by 3 months
due to the COVID-19 lockdown, which started right after baseline measurements
and lasted the entire study. The lockdown possibly affected normal
daytime activities of the patients during this study.
Conclusion: This study is the first to investigate the effects of a tailored
life-style intervention on disease activity, exercise capacity, physical activity,
endurance, quality of life and fatigue in paediatric IBD patients. This
study shows that a 12-week tailored physical training program including
diet advice is safe and beneficial for paediatric IBD patients, and may even
contribute to better control of inflammation.
Disclosure: Nothing to disclose.
UEGJournal Abstracts 2021

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