Upadacitinib treatment exhibited significant reductions in bowel urgency and abdominal pain, which are impactful, yet commonly overlooked ulcerative colitis (UC) symptoms, according to research results published in Journal of Crohn’s and Colitis.
This post hoc analysis included 250 patients with moderately to severely active UC, aged 18 to 75 years, from the 8-week induction therapy portion of the U-ACHIEVE study (ClinicalTrials.gov Identifier: NCT02819635). During induction therapy, patients were randomized to receive placebo or upadacitinib at doses of 7.5, 15, 30, or 45 mg once daily.
Bowel urgency and abdominal pain symptoms were recorded daily by the patient via an electronic diary. Data from the most recent consecutive 3-day period within 10 days before each study visit were calculated for symptoms. Symptoms were collected and evaluated at baseline and at weeks 2, 4, 6, and 8.
At baseline, 83% of all patients reported bowel urgency over 3 days and 82% of patients experienced some level of abdominal pain. After 2 weeks, improvements in bowel urgency were observed in patients receiving upadacitinib. The greatest improvements were seen in patients receiving upadacitinib 45 mg once daily. By week 8, 46.4% of patients receiving upadacitinib 45 mg reported no bowel urgency compared with 8.7% of the placebo group (P ≤.001).
Patients who received upadacitinib reported lower abdominal pain scores as well, with differences observed as early as week 2. Among those who received upadacitinib 45 mg, 37.5 % of patients reported an abdominal pain score of 0 at week 8 (P =.015). Reductions in mean abdominal pain scores were significant for most upadacitinib doses over the course of the study (P ≤.01).
This study was limited by its design as a post-hoc analysis. While the data assessed were based on a previous study with a limited sample size, its positive findings warrant further evaluation in the form of an expanded, phase 3 trial.
Investigators concluded, “As patients treated with upadacitinib had superior [Inflammatory Bowel Disease Questionnaire] remission and response rates compared with those given placebo, these results indicate a potential [Health Related Quality of Life] benefit with symptom relief for patients with UC. These results support the further evaluation of upadacitinib for patients with moderate to severe UC in phase 3 trials.”
Disclosure: This clinical trial was supported by AbbVie Inc. Please see the original reference for a full list of authors’ disclosures.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Ghosh S, Sanchez Gonzalez Y, Zhou W, et al. 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. J Crohns Colitis. Published online June 9, 2021. doi: 10.1093/ecco-jcc/jjab099
This article originally appeared on Gastroenterology Advisor