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Randomized Controlled Trial
. 2021 Dec 18;15(12):2022-2030.
doi: 10.1093/ecco-jcc/jjab099.

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

Subrata Ghosh  1 , Yuri Sanchez Gonzalez  2 , Wen Zhou  3 , Ryan Clark  2 , Wangang Xie  4 , Edouard Louis  5 , Edward V Loftus  6 , Julian Panes  7 , Silvio Danese  8
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Randomized Controlled Trial

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

Subrata Ghosh et al. J Crohns Colitis. .

V体育2025版 - Abstract

Background and aims: 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. VSports手机版.

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]. V体育安卓版.

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 V体育ios版. 015]. At Week 8, moderate correlations were found between bowel urgency or abdominal pain and most clinical and HRQOL outcomes. .

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 VSports最新版本. .

Keywords: Abdominal pain; bowel urgency; upadacitinib V体育平台登录. .

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Figures

Figure 1.
Figure 1.
Percentage of patients reporting no bowel urgency over time with upadacitinib. *p ≤ 0.05, **p ≤ 0.01, ***p ≤ 0.001 compared with placebo. NRI, ITT population. ITT, intent-to-treat; NRI, non-responder imputation.
Figure 2.
Figure 2.
Improvements in abdominal pain with upadacitinib. A. Percentage of patients reporting an abdominal pain score of 0 from Weeks 2 to 8. B. Reduction in mean abdominal pain from Weeks 2 to 8. *p ≤ 0.05, **p ≤ 0.01, ***p ≤ 0.001 compared with placebo. Panel A is analysed NRI. Panel B is analysed LOCF ITT population. ITT, intent-to-treat; LOCF, last observation carried forward; NRI, non-responder imputation.
Figure 3.
Figure 3.
Association of bowel urgency with clinical outcomes and HRQOL measures. A. Bowel urgency severity in patients who attained clinical remission per adapted Mayo score at Week 8. B. Burden associated with bowel urgency based on HRQOL measures at baseline. Adapted Mayo score defined as stool frequency subscore ≤ 1, RBS of 0, and endoscopic subscore ≤ 1. *p ≤ 0.05, **p ≤ 0.01, using Mann–Whitney U test for patients between groups [panel A] or with any bowel urgency vs no bowel urgency [panel B]. Observed data. ITT population. HRQOL, health-related quality of life; IBDQ, Inflammatory Bowel Disease Questionnaire; ITT, intent-to-treat; MCS, Mental Component Summary; PCS, Physical Component Summary; RBS, rectal bleeding subscore; SF-36, 36-Item Short Form Health Survey.
Figure 4.
Figure 4.
Association of abdominal pain with clinical outcomes and HRQOL measures. A. Abdominal pain severity in patients who attained clinical remission per adapted Mayo score at Week 8. B. Burden associated with abdominal pain based on HRQOL measures at baseline. *p ≤ 0.01, **p ≤ 0.001 using Mann–Whitney U test for patients between groups [panel A] or with abdominal pain vs no pain [panel B]. ITT population. Observed data. HRQOL, health-related quality of life; IBDQ, Inflammatory Bowel Disease Questionnaire; ITT, intent-to-treat; MCS, Mental Component Summary; PCS, Physical Component Summary; SF-36, 36-Item Short Form Health Survey.
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VSports - References

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