作者
Millie D. Long,Theresa M. Hunter,Angela Dobes,Laura Weisbein,Xian Zhang,Wenli Chen,Richard Moses
摘要
Introduction: In patients with Crohn’s disease (CD), clinical trials often focus on disease activity measures such as abdominal pain and stool frequency. Patients with CD frequently experience bowel urgency (BU), yet less is known about the prevalence of BU and its association with quality of life (QoL) in real-world CD populations. Methods: In this cross-sectional study from the nationwide inflammatory bowel disease (IBD) Partners cohort, BU was measured utilizing the validated 11-point Urgency Numeric Rating Scale (NRS)1. This was categorized into “no or minimal” BU (Urgency NRS=0-1) vs. BU (Urgency NRS=2-10). Remission was measured utilizing the Short CD Activity Index (sCDAI). QoL measures included Patient Reported Outcome Measurement Information System (PROMIS) measures of depression, anxiety, pain interference, sleep disturbance, fatigue, and social satisfaction via T-scores. Bivariate analyses were utilized to compare categorical variables by urgency. Correlations were performed utilizing Pearson and Spearman rank as appropriate. Results: Among 1533 patients with CD, 58% reported BU. Rates of BU were higher among patients with active disease as compared to those with remission (87% vs. 48%, P< 0.001). Other factors significantly associated with BU included higher body mass index (BMI), longer disease duration, prior hospitalization, prior surgery, and corticosteroid use (P< 0.05 for all) (Table 1). Patients with BU had significantly higher rates of depression (25% vs. 13%, P< 0.001), anxiety (39% vs. 21%, P< 0.001), pain (38% vs. 14%, P< 0.001), sleep disturbance (27% vs. 14%, P< 0.001), fatigue (47% vs. 24%, P< 0.001) and worse social satisfaction (46% vs. 23%, P< 0.001; Figure 1). In a sub-analysis of those in remission, BU continued to be significantly associated with anxiety, pain, fatigue, and worse social satisfaction (p≤0.001 for all). BU was moderately correlated with disease activity (r=0.52) and weakly correlated with PROMIS measures (r=0.23-0.34). Conclusion: Bowel urgency is common in this real-world Crohn’s disease population, with profound effects on important quality of life measures. Factors associated with more severe disease, such as prior surgery, hospitalization and longer disease duration are also associated with bowel urgency in Crohn’s disease. Bowel urgency is moderately associated with disease activity.Figure 1.: Associations between bowel urgency and PROMIS measures in the CD population. N, Total number of patients; n, number of patients in the subgroups; PROMIS, Patient-Reported Outcome Measurement Information System; CD, Crohn’s Disease. PROS measured by PROMIS T-scores, dichotomized at ≥55 or ≤45 for each measure as appropriate. Bowel urgency was measured via 11 point validated scale, 0-1=No or minimal bowel urgency, 2-10= bowel urgency. P-value was measured by chi-square test. Table 1. - Characteristics of the Crohn’s Disease Population by Presence of Bowel Urgency Characteristic No or minimal bowel urgency (0-1)a N=650 Bowel urgency (2-10)N=883 P-valueb Age (years), mean (SD) 53.4 (16.1) 54.1 (15.5) 0.320 Female, n (%) 452 (70) 632 (73) 0.290 Education (>high school), n (%) 601 (92) 789 (89) 0.039 Race (%) Caucasian 592 (91) 789 (89) 0.196 African American 11 (2) 10 (1) Other 47 (7) 84 (10) Current smoking (yes), n (%) 11 (2) 29 (3) 0.053 BMI, mean (SD) 25.3 (4.9) 26.8 (6.3) < 0.001 Disease duration (years), mean (SD) 23.7 (13.7) 25.7 (14.1) 0.003 Ever GI surgery (yes), n (%) 311 (48) 540 (61) < 0.001 Ever GI hospitalization (yes), n (%) 417 (64) 649 (73) < 0.001 Number hospitalizations, mean (SD) 3.1 (2.3) 3.9 (2.6) < 0.001 Current medications, n (%) Anti-TNFs 246 (38) 311 (35) 0.258 Vedolizumab 64 (10) 98 (11) 0.450 Ustekinumab/Risankizumab 108 (17) 168 (19) 0.242 Tofacitinib/Upadacitinib 2 (0) 3 (0) 0.918 Immunomodulatorsc 118 (18) 152 (17) 0.601 Corticosteroids 24 (4) 80 (9) < 0.001 5-ASA 98 (15) 136 (15) 0.894 Remission (yes), n (%) 599 (92) 544 (62) < 0.001 ASA, aminosalicylic acid; GI, gastrointestinal; N, total number of patients; TNF, tumor necrosis factor.aUrgency was measured using 11-point validated Urgency NRS, 0-1=No or minimal bowel urgency, 2-10=bowel urgency; bChi-square test was used to compare minimal urgency vs urgency for each of the variables; cImmunomodulators included thiopurine or methotrexate. Reference 1 Dubinsky MC, et al. J Patient Rep Outcomes.6, 114 (2022).