NEW YORK (Reuters Health) – Upadacitinib, an oral selective Janus kinase (JAK)-1 inhibitor, may reduce symptoms and improves quality of life in patients with ulcerative colitis (UC), according to a post hoc analysis of data from a clinical trial.
“Patients who suffer from ulcerative colitis not only are distressed by diarrhea and rectal bleeding, but also complain of abdominal pain and urgency,” said Dr. Subrata Ghosh of University College Cork, in Ireland.
“Generally, when specific therapies are tested in clinical trials, disease-assessment tools or patient-reported outcomes focus on diarrhea and rectal bleeding,” he told Reuters Health by email. “This is one of the first studies that formally assessed these debilitating symptoms in clinical trials of ulcerative colitis.”
In a paper in the Journal of Crohn’s and Colitis, Dr. Ghosh and colleagues note that current guidelines advocate using the Mayo score to define ulcerative colitis severity, which includes evaluating stool frequency, rectal bleeding, endoscopic findings and Physician Global Assessment.
To incorporate bowel urgency and abdominal pain, the researchers examined data from the phase-2b U-ACHIEVE trial. This involved analysis of outcome in an intent-to-treat population of 250 patients, who ranged in age from 18 to 75 years, had moderately to severely active ulcerative colitis and were randomized to receive from 7.5 to 45 mg of upadacitinib daily or placebo over the course of eight weeks.
A greater proportion of patients reported no bowel urgency and less abdominal pain with upadacitinib treatment than placebo, with significant improvements being observed at as early as two weeks.
Reductions in bowel urgency with upadacitinib were dose dependent: 19% of patients on the lowest dose reported no bowel urgency at eight weeks compared to 46% on the highest dose and 9% of placebo patients. Corresponding proportions for patients reporting no abdominal pain at eight weeks were 21%, 38% and 13%.
Dr. Ghosh and his colleagues note that “improvements with upadacitinib in bowel urgency and abdominal pain correlate with positive changes in various clinical outcomes, health-related quality of life measures, and biomarker levels, including those that are commonly used to measure disease severity in clinical trials.”
AbbVie, producers of upadacitinib (Rinvoq), sponsored the study. Dr. Ghosh reports financial ties to the company as do other authors, a number of whom are employees.
SOURCE: https://bit.ly/36o01ql Journal of Crohn’s and Colitis, online June 9, 2021.
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