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Real-World Effectiveness of Advanced Therapies on Bowel Urgency in Patients With Crohn’s Disease in the United States
AIBD 2023
Background:
Bowel urgency, the sudden or immediate need to have a bowel movement, affects over 70% of patients with Crohn’s disease (CD) and is shown to be strongly correlated with clinical disease activity. However, limited research has described the effects of different advanced therapies on bowel urgency. This study assessed the real-world effectiveness of advanced therapies on bowel urgency in patients with CD at study enrollment, 6-month, and 12-month visits through quarterly patient-reported surveys.
Methods:
This observational study used data from the Study of a Prospective Adult Research Cohort with Inflammatory Bowel Disease (SPARC IBD) in the United States from November 2016 to March 2022. The study included adult patients (age ≥ 18 years) with CD who had completed the bowel urgency questionnaire and stayed on advanced therapies during enrollment, 6-month, and/or 12-month follow-up visits. Advanced therapies included tumor necrosis factor inhibitors (TNFi; adalimumab, infliximab, golimumab, and certolizumab) and non-TNFi (ustekinumab, tofacitinib, and vedolizumab). Patients self-reported their bowel urgency severity on a scale of 0 (none) to 4 (severe). The proportions of patients who experienced bowel urgency at enrollment, 6-month, and 12-month visits were summarized by advanced therapy classes (TNFi vs non-TNFi), individual therapies, and bowel urgency severity (i.e., none, mild, and moderate to severe) using descriptive statistics.
Results:
Of the 532 patients in this study, 332 received TNFi (females: 56.9%; mean age: 41.4 years) and 200 received non-TNFi (females: 64.5%; mean age: 42.2 years) at enrollment. In the TNFi group, 29.5%, 28.7%, and 20.3% of patients reported moderate to severe bowel urgency at enrollment, 6-, and 12-month visits, respectively. In the non-TNFi group, numerically higher proportion of patients reported moderate to severe bowel urgency at 6-month (41.0%) and 12-month visits (39.2%) compared with those at enrollment (36.0%). In the ustekinumab-treated group, a numerically higher proportion of patients reported moderate to severe bowel urgency at 12-month visit compared with those at enrollment (41.0% vs 35.8%, respectively). A nearly equal proportion of patients reported moderate to severe bowel urgency at enrollment and 12-month visits in the vedolizumab-treated group (37.2% vs 37.5%, respectively). In the TNFi group, 21.3% of patients reported worsening of bowel urgency severity from enrollment to 6-month and 21.7% from enrollment to 12-month visits; whereas 20.1% and 17.9% reported improvement of bowel urgency from enrollment to 6- and 12-month visits, respectively. In the non-TNFi group, patients who reported worsening of bowel urgency severity from enrollment was 19.9% at 6-month and 19.4% at 12-month visits; whereas 17.3% and 22.3% of patients reported improvement at 6- and 12-month from enrollment, respectively.
Conclusions:
Despite treatment with advanced therapy for 1 year, nearly one third of total patients continued to suffer from moderate to severe bowel urgency. Approximately 20% of patients reported worsening and 20% reported improvement in bowel urgency severity from enrollment to the follow-up visits. Novel therapies focusing on bowel urgency and other patient-reported outcomes are needed to address the unmet need of patients with CD.
