J Crohns Colitis. 2021 Dec 18;15(12):2022-2030.doi: 10.1093/ecco-jcc/jjab099.

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

Author information

¹College of Medicine and Health, University College Cork, Cork, Ireland.

²Department of Health Economics and Outcomes Research, AbbVie Inc., North Chicago, IL, USA.

³Department of Clinical Development, AbbVie Inc., North Chicago, IL, USA.

⁴Department of Data and Statistical Sciences, AbbVie Inc., North Chicago, IL, USA.

⁵Department of Gastroenterology, University Hospital CHU of Liège, Liège, Belgium.

⁶Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, MN, USA.

⁷Department of Gastroenterology, Hospital Clinic Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.

⁸Department of Gastroenterology, Istituto Clinico Humanitas, Milan, Italy.

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.

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: 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: 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.