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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Supplementary Data
Date
2021-06-09
Authors
Ghosh, Subrata
Sanchez Gonzalez, Yuri
Zhou, Wen
Clark, Ryan
Xie, Wangang
Louis, Edouard
Loftus, Edward V. Jr.
Panes, Julian
Danese, Silvio
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Publisher
Oxford University Press
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Abstract
Bowel 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 45Â 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.
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Keywords
Abdominal pain , Bowel urgency , Upadacitinib
Citation
Ghosh, 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/jjab099
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© 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.