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Bowel urgency (BU), the sudden or immediate need for a bowel movement, is one of the most bothersome symptoms experienced by patients with ulcerative colitis (UC) or Crohn's disease (CD), considerably diminishing quality of life (QoL) 1. BU typically coincides with active disease and is associated with an increased risk of colectomy, corticosteroid use and hospitalisation 2. However, persistent BU has also been reported by a subset of patients with UC absent signs of active disease 3. Despite its importance to patients, BU has been historically sidelined in clinical studies, often buried within composite symptom scores. Focused attention on BU as a distinct therapeutic target has led to inconsistent, yet growing, availability of data on treatment efficacy specifically addressing this symptom. Patel et al. 4 have provided a systematic review and meta-analysis on the efficacy of advanced therapies on BU in IBD within the randomised controlled trial (RCT) setting. While 44 studies were identified, the meta-analysis itself pooled data from 11 of these trials—specifically those that assessed BU as a discrete variable—absence or presence. This pooled analysis shows that anti-interleukin (IL)-23p19 agents (guselkumab, mirikizumab, risankizumab) and the JAK inhibitor upadacitinib are effective in inducing and maintaining BU remission—namely BU absence—compared to placebo, with risk ratios of 1.8 and 2.1, respectively. The review finding, while welcomed, starkly exposes a major historical divide in our evidence. The inability to include pivotal therapies like anti-tumour necrosis factor (TNF), anti-integrin and anti-IL-12/23 agents reflects a prior deficiency in including more patient-centric metrics into regulatory and clinical efficacy assessments. We have no RCT level data on BU for our most-used advanced therapies. This evidence gap is most pronounced in CD and extends even to the newest advanced therapies, where available data are two RCTs for a single mechanism of action. This highlights a profound lapse in therapeutic evaluation concerning a patient cohort in which urgency, while less frequently reported than in UC, is a highly bothersome and life-altering symptom. The meta-analysis had to rely on studies that reported BU as a simple dichotomous variable. This binary metric, while allowing for a pooled analysis, lacks the granularity to detect partial yet clinically meaningful improvements, such as a patient moving from severe to mild urgency. It obscures our ability to detect more subtle, yet vital, differences in the absolute and relative efficacy across different therapeutic classes. Therefore, real-world evidence (RWE) from observational studies remains fundamental 5, 6. Prospective RWE studies utilising validated scores are essential to capture clinically relevant degrees of improvement, enabling more nuanced comparisons of effectiveness of all available therapies. We urge adoption of a holistic approach that actively inquires about, measures and targets BU. Focusing on patients' priorities, alongside objective disease activity metrics, is paramount to maximise QoL for every patient with IBD. Raja Atreya: conceptualization, writing – original draft, writing – review and editing. Daniele Noviello: conceptualization, writing – original draft, writing – review and editing. The authors have nothing to report. The authors have nothing to report. D.N. acknowledges ‘The Italian Ministry of Education and Research (MUR): Dipartimenti di Eccellenza Program 2023-2027 -Dept. of Pathophysiology and Transplantation, University of Milan’ and PNC ‘Hub Life Science- Diagnostica Avanzata (HLS-DA), PNC-E3- 2022-23683266- CUP: C43C22001630001’ for the support. R.A. acknowledges DFG-SFB/TRR241 Project IBDome, KFO5024 B04, which is funded by the German Research Council (DFG). D.N. reports unrestricted research grants from Pfizer, consulting fees from Dr. Falk and AbbVie and lecturer fees from Ferring, Sandoz, Alfasigma. R.A. has served as a speaker, consultant, or received research grants from AbbVie, Abivax, AlfaSigma, Amgen, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, CED Service GmbH, Celltrion Healthcare, Falk Foundation, Galapagos, Gilead, InDex Pharmaceuticals, Johnson&Johnson, Lilly, MSD Sharp & Dohme, Pfizer, Pandion Therapeutics, Roche Pharma, Takeda Pharma, Viatris. This article is linked to Patel et al. papers. To view these articles, visit https://doi.org/10.1111/apt.70446 and https://doi.org/10.1111/apt.70494. Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.
Noviello et al. (Sun,) studied this question.