Introduction
Bowel urgency (BU) is the sudden or immediate need to have a bowel movement. Although it is a common symptom in ulcerative colitis (UC), its burden is poorly known. We aimed to assess the overall burden of UC patients with BU.
Aims & Methods
The THEFAR study is a non-interventional, cross-sectional and multicenter study carried out in France between July and December 2022 including adult patients with UC treated with biologics/targeted-synthetic drugs. Clinical and therapeutic management data were collected by gastroenterologists using a e-CRF. Quality of life, disability and work impairment (WPAI:UC) were collected using patient-self completion questionnaires. BU was defined as a UNRS (0-10 Urgency Numeric Rating Scale) >1, BU remission as a URNS ≤1 and incontinence as a Wexner score ≥5. Descriptive statistics and bivariate analyses were performed. Continuous variables were summarized with mean values and SDs using the Student’s t-test or Wilcoxon test. Categorical variables were expressed as proportions and compared using the Pearson's Chi-Squared test or Fischer's exact test.
Results
Of the 293 patients enrolled at 41 sites, the median (IQR) age was 42.0 (31.0-55.0) years with a median (IQR) disease duration of 6.0 (3.0-11.0) years. 64.2% were employed. Respectively, 45 (15,4%), 117 (39.9%) and 131 (44.7%) had proctitis, left-side colitis and pancolitis. 38.9% had active disease (partial Mayo score ≥2) and 53.6% experienced flares over the past year. Overall, 144 (49.1%) of patients were treated with TNF-inhibitors, 99 (33.8%) with vedolizumab, 35 (11.9%) with ustekinumab, and 13 (4.4%) with tofacitinib with a median treatment duration of 1.0 year (0.0 - 3.0). Of the 291 patients who answered patient-self completion questionnaires, 57.0% had BU [median (IQR) UNRS: 2 (0.0-6.0)] and 78.3% had fecal incontinence [median (IQR) Wexner score: 8.0 (5.0-11.0)] with 14.7% wearing pads at least once a month. Overall, half of patients (52.3%) had both BU and fecal incontinence. A significantly higher proportion of patients had active disease with BU (57.2%) compared to those with BU remission (15.2%) (p<0.0001). Patients with BU had twice more months flaring over the past year (2.3 vs 1.0 month, p<0.0001) and a significantly higher proportion of patients with BU (45.8% vs 14.4%, p<0.0001) received steroids over the past year. Rates of BU were similar regardless of disease location (p=0.74), UC treatment (all UC treatments p>0.05) or line of therapy (p=0.27). Median (IQR) Wexner score was almost twice higher in patients with BU [10.0 (8.0-13.0) vs 6.0 (0.0-8.0), p<0.0001]. QoL was significantly impacted in patients with BU with lower mean (SD) EQ-5D-5L utility [0.846 (0.186) vs 0.943 (0.099), p<0.0001] and Visual Analogue Scale (VAS) scores [66.2 (18.2) vs 82.1 (14.5), p<0.0001]. There was a significantly higher proportion of patients with moderate to severe disability (IBD-DISK score ≥40) in patients with BU (53.7% vs 16.9%, p<0.0001) and BU was significantly associated with the IBD-DISK (r=0.52447, p<0.0001). Mean (SD) absenteeism [11.5% (25.4) vs 3.9% (12.5), p=0.0013], overall work impairment [35.7% (29.4) vs 11.3% (18.9), p<0.0001] and activity impairment [33.0% (27.0) vs 7.9% (13.7), p<0.0001] were significantly higher in patients with BU.
Conclusion
Despite advances in UC therapies, more than one in two patients treated with biologics/targeted-synthetic drugs experience BU. Patients with BU have a high symptom burden, disability and impaired quality of life and work productivity. These findings highlight that the control of BU remains an unmet medical need in UC patients.
Disclosure
AbbVie, Ferring, Janssen, MSD, Takeda, Pfizer, Celgene, Biogen, Amgen, Boehringer Ingelheim, Lilly, Hospira et Celltrion