Upadacitinib Treatment Improves Symptoms of Bowel Urgency and Abdominal Pain, and Correlates With Quality of Life Improvements in Patients With Moderate to Severe Ulcerative Colitis.
Abdominal Pain
Adolescent
Adult
Aged
Colitis, Ulcerative
/ drug therapy
Fecal Incontinence
Female
Gastrointestinal Agents
/ administration & dosage
Heterocyclic Compounds, 3-Ring
/ administration & dosage
Humans
Male
Middle Aged
Quality of Life
Severity of Illness Index
Surveys and Questionnaires
Treatment Outcome
Young Adult
Abdominal pain
bowel urgency
upadacitinib
Journal
Journal of Crohn's & colitis
ISSN: 1876-4479
Titre abrégé: J Crohns Colitis
Pays: England
ID NLM: 101318676
Informations de publication
Date de publication:
18 Dec 2021
18 Dec 2021
Historique:
pubmed:
10
6
2021
medline:
29
1
2022
entrez:
9
6
2021
Statut:
ppublish
Résumé
Bowel urgency and abdominal pain are impactful, yet under-appreciated ulcerative colitis symptoms and not commonly assessed in clinical trials. We evaluated how these symptoms may improve with upadacitinib treatment and correlate with clinical and health-related quality of life [HRQOL] outcomes in the phase 2b U-ACHIEVE study. Patients aged 18-75 years, with moderately to severely active ulcerative colitis, were randomised to receive placebo or upadacitinib (7.5, 15, 30, or 45 mg once daily [QD]). Bowel urgency and abdominal pain were evaluated at baseline and Weeks 2, 4, 6, and 8. Week 8 correlations were evaluated between bowel urgency/abdominal pain with clinical [Mayo subscores and high-sensitivity C-reactive protein and faecal calprotectin measurements] and HRQOL outcomes [Inflammatory Bowel Disease Questionnaire and 36-Item Short Form Health Survey scores]. A greater proportion of patients [n = 250] reported no bowel urgency and less abdominal pain with upadacitinib treatment compared with placebo, with improvements observed as early as 2 weeks. At Week 8, patients receiving the 45-mg QD dose had the greatest improvements versus placebo, with 46% reporting no bowel urgency [vs 9%; p ≤ 0.001] and 38% reporting no abdominal pain [vs 13%; p = 0.015]. At Week 8, moderate correlations were found between bowel urgency or abdominal pain and most clinical and HRQOL outcomes. Induction treatment with upadacitinib demonstrated significant reductions in bowel urgency and abdominal pain compared with placebo. These symptoms also correlate to clinical and HRQOL outcomes, supporting their use to monitor disease severity and other treatment outcomes.
Sections du résumé
BACKGROUND AND AIMS
OBJECTIVE
Bowel urgency and abdominal pain are impactful, yet under-appreciated ulcerative colitis symptoms and not commonly assessed in clinical trials. We evaluated how these symptoms may improve with upadacitinib treatment and correlate with clinical and health-related quality of life [HRQOL] outcomes in the phase 2b U-ACHIEVE study.
METHODS
METHODS
Patients aged 18-75 years, with moderately to severely active ulcerative colitis, were randomised to receive placebo or upadacitinib (7.5, 15, 30, or 45 mg once daily [QD]). Bowel urgency and abdominal pain were evaluated at baseline and Weeks 2, 4, 6, and 8. Week 8 correlations were evaluated between bowel urgency/abdominal pain with clinical [Mayo subscores and high-sensitivity C-reactive protein and faecal calprotectin measurements] and HRQOL outcomes [Inflammatory Bowel Disease Questionnaire and 36-Item Short Form Health Survey scores].
RESULTS
RESULTS
A greater proportion of patients [n = 250] reported no bowel urgency and less abdominal pain with upadacitinib treatment compared with placebo, with improvements observed as early as 2 weeks. At Week 8, patients receiving the 45-mg QD dose had the greatest improvements versus placebo, with 46% reporting no bowel urgency [vs 9%; p ≤ 0.001] and 38% reporting no abdominal pain [vs 13%; p = 0.015]. At Week 8, moderate correlations were found between bowel urgency or abdominal pain and most clinical and HRQOL outcomes.
CONCLUSIONS
CONCLUSIONS
Induction treatment with upadacitinib demonstrated significant reductions in bowel urgency and abdominal pain compared with placebo. These symptoms also correlate to clinical and HRQOL outcomes, supporting their use to monitor disease severity and other treatment outcomes.
Identifiants
pubmed: 34107013
pii: 6295522
doi: 10.1093/ecco-jcc/jjab099
pmc: PMC8684481
doi:
Substances chimiques
Gastrointestinal Agents
0
Heterocyclic Compounds, 3-Ring
0
upadacitinib
4RA0KN46E0
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
2022-2030Subventions
Organisme : AbbVie Inc.
Informations de copyright
© The Author(s) 2021. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation.
Références
J Crohns Colitis. 2020 Jul 29;:
pubmed: 32722760
Gastroenterology. 2020 Apr;158(5):1450-1461
pubmed: 31945371
Dig Dis. 2019;37(4):266-283
pubmed: 30726845
Gastroenterology. 1994 Feb;106(2):287-96
pubmed: 8299896
Lancet. 2017 Apr 29;389(10080):1756-1770
pubmed: 27914657
Arthritis Rheumatol. 2016 Dec;68(12):2857-2866
pubmed: 27390150
Inflamm Intest Dis. 2020 Feb;5(1):27-35
pubmed: 32232052
Ann Rheum Dis. 2017 Jun;76(6):998-1008
pubmed: 27993829
Gastroenterology. 2020 Jun;158(8):2123-2138.e8
pubmed: 32044319
BMC Res Notes. 2017 Sep 25;10(1):491
pubmed: 28946891
Med Care. 1992 Jun;30(6):473-83
pubmed: 1593914
J Crohns Colitis. 2019 Apr 26;13(5):555-563
pubmed: 30476099
Clin Gastroenterol Hepatol. 2014 Sep;12(9):1485-93.e2
pubmed: 24480677
Inflamm Bowel Dis. 2013 Sep;19(10):2207-14
pubmed: 23929261
BMC Gastroenterol. 2012 Aug 15;12:108
pubmed: 22894661
Patient. 2020 Jun;13(3):317-325
pubmed: 31997116
N Engl J Med. 2017 May 4;376(18):1723-1736
pubmed: 28467869
Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9
pubmed: 11124729
Arthritis Rheumatol. 2016 Dec;68(12):2867-2877
pubmed: 27389975
Gut. 2005 Jun;54(6):782-8
pubmed: 15888785
Lancet. 2012 Nov 3;380(9853):1606-19
pubmed: 22914296
Am J Gastroenterol. 2019 Mar;114(3):384-413
pubmed: 30840605
Am J Gastroenterol. 2010 Mar;105(3):501-23; quiz 524
pubmed: 20068560
BMC Gastroenterol. 2019 Oct 15;19(1):166
pubmed: 31615445
Gastroenterology. 2020 Jun;158(8):2139-2149.e14
pubmed: 32092309
J Rheumatol. 2014 May;41(5):837-52
pubmed: 24692527
J Gastroenterol Hepatol. 2017 Nov;32(11):1818-1824
pubmed: 28370253
Gut. 2017 Jun;66(6):1049-1059
pubmed: 28209624
Eur J Gastroenterol Hepatol. 2015 Jul;27(7):804-12
pubmed: 25933126
Health Qual Life Outcomes. 2008 Sep 20;6:69
pubmed: 18803870
J Crohns Colitis. 2013 Dec;7(11):890-900
pubmed: 23269224
Inflamm Bowel Dis. 2009 Apr;15(4):581-8
pubmed: 19067414
Lancet. 2018 Dec 23;390(10114):2769-2778
pubmed: 29050646
Ann Rheum Dis. 2017 Jun;76(6):1009-1019
pubmed: 27993828
Inflamm Bowel Dis. 2008 Dec;14(12):1660-6
pubmed: 18623174