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

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dc.contributor.authorGhosh, Subrata
dc.contributor.authorSanchez Gonzalez, Yuri
dc.contributor.authorZhou, Wen
dc.contributor.authorClark, Ryan
dc.contributor.authorXie, Wangang
dc.contributor.authorLouis, Edouard
dc.contributor.authorLoftus, Edward V. Jr.
dc.contributor.authorPanes, Julian
dc.contributor.authorDanese, Silvio
dc.contributor.funderAbbVieen
dc.date.accessioned2021-07-05T08:59:41Z
dc.date.available2021-07-05T08:59:41Z
dc.date.issued2021-06-09
dc.date.updated2021-07-05T08:47:24Z
dc.description.abstractBowel urgency and abdominal pain are impactful, yet underappreciated 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 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 to 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 to placebo. These symptoms also correlate to clinical and HRQOL outcomes, supporting their use to monitor disease severity and other treatment outcomes.en
dc.description.statusPeer revieweden
dc.description.versionAccepted Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationGhosh, S., Sanchez Gonzalez, Y., Zhou, W., Clark, R., Xie, W., Louis, E., Loftus, E. V. Jr., Panes, J. and Danese, S. (2021) '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', Journal of Crohn's and Colitis. doi: 10.1093/ecco-jcc/jjab099en
dc.identifier.doi10.1093/ecco-jcc/jjab099en
dc.identifier.issn1876-4479
dc.identifier.issn1873-9946
dc.identifier.journaltitleJournal of Crohn's and Colitisen
dc.identifier.urihttps://hdl.handle.net/10468/11533
dc.language.isoenen
dc.publisherOxford University Pressen
dc.rights© 2021, the Authors. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited.en
dc.subjectAbdominal painen
dc.subjectBowel urgencyen
dc.subjectUpadacitiniben
dc.titleUpadacitinib treatment improves symptoms of bowel urgency and abdominal pain, and correlates with quality of life improvements in patients with moderate to severe ulcerative colitisen
dc.typeArticle (peer-reviewed)en
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