Unmet Needs in Real-World Advanced Therapy-Naïve and -Experienced Patients with Moderately to Severely Active Ulcerative Colitis in the United States.

INTRODUCTION: Despite availability of advanced therapies (ATs) for ulcerative colitis (UC), many patients fail to respond to treatment. This study examined real-world clinical and humanistic outcomes associated with current treatments in patients with UC. METHODS: This cross-sectional study used US data from the Adelphi Real World Disease Specific Programme for inflammatory bowel disease from before (2017-2018) and during the COVID-19 pandemic (2020-2021). Physicians (gastroenterologists) seeing > 5 patients/month reported patients' disease characteristics, current symptoms and treatments, and reasons for treatment choices for their next seven consecutive patients aged ≥ 18 years with moderately to severely active UC before current treatment. Patients were asked to complete the EQ-5D-5L health-related quality of life (HRQoL) measure. ATs included tumor necrosis factor inhibitors (TNFis), integrin receptor antagonists, interleukin-12/23 antagonists, and Janus kinase inhibitors. Patients were classified as AT-naïve or AT-experienced based on current treatment received for ≥ 8 weeks and further classified as responders or non-responders based on symptoms, disease flare status, and remission. Descriptive analyses are presented. RESULTS: The 2017-2018 cohort included 92 physicians and 539 patients (208 [38.6%] AT-experienced). The 2020-2021 cohort included 73 physicians and 448 patients (349 [77.9%] AT-experienced). TNFis were the most common ATs. In 2017-2018, 195 (58.9%) AT-naïve and 113 (54.3%) AT-experienced patients were non-responders; in 2020-2021 this was 57 (57.6%) and 182 (52.1%). Efficacy and induction of remission were physicians' most common reasons for AT choice. Dislike of injections/infusions was the most common reason for eligible patients not receiving biologic therapy. Numerically, non-responders (both AT-naïve and AT-experienced) had more symptoms, overall pain and fatigue, and lower HRQoL scores than responders. CONCLUSIONS: Before (2017-2018) and during the pandemic (2020-2021), over half of patients with UC did not respond to AT. Non-responders carried a high burden of disease. Alternative therapies are urgently needed to treat UC.

Burden of Fatigue Among Patients with Ulcerative Colitis and Crohn's Disease: Results from a Global Survey of Patients and Gastroenterologists.

INTRODUCTION: To assess the prevalence of fatigue and its association with disease activity and patient-reported outcomes among patients with ulcerative colitis (UC) or Crohn's disease (CD). METHODS: Data from a cross-sectional survey conducted with gastroenterologists and their consulting adult patients with UC or CD were analyzed. Data were collected via gastroenterologist-completed patient record forms and patient-self completion forms. Patient demographics, clinical characteristics, disease activity and medication use were reported by the gastroenterologist, while current symptoms (fatigue, rectal urgency, abdominal pain, sleep disturbance), work productivity and the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) were reported by the patient. Logistic regression models were used to identify measures associated with fatigue and expressed as odds ratio (OR) with 95% confidence interval. p < 0.05 was considered statistically significant. RESULTS: A total of 1057 patients with UC and 1228 patients with CD were included in this analysis. Fatigue was reported in 22.6% of UC and 26.0% of patients with CD. Higher proportion of patients with UC and fatigue had moderate/severe disease activity (p = 0.0001), had a higher Mayo score (5.0 vs. 4.0, p < 0.0001) and were unemployed (5.6% vs. 3.9%, p = 0.0149) compared to those without fatigue. In patients with CD reporting fatigue, a higher proportion were female (55.9% vs. 48.2%, p = 0.0193), were unemployed (5.8% vs. 4.9%, p = 0.0069), had moderate/severe disease (p < 0.0001) and had a higher mean Crohn's Disease Activity Index score (145.0 vs. 96.2, p < 0.0001) than patients without fatigue. Patients with UC and fatigue had higher mean level of pain (p < 0.0001) and sleep disturbance (p < 0.0001), whereas patients with CD and fatigue had lower SIBDQ scores (p < 0.0001) and greater work impairment (p = 0.0015) than patients without fatigue. Abdominal pain (OR: 2.01, p = 0.001) and use of immunomodulators (OR: 1.69, p = 0.006) increased the odds of having fatigue in patients with UC. In patients with CD, abdominal pain (OR: 2.29, p < 0.001) and use of biologics or biosimilars (OR: 2.02, p = 0.003) increased the odds of having fatigue. CONCLUSION: Fatigue is a common symptom among patients with UC or CD that is associated with higher levels of disease activity and decreased work productivity and is driven by various factors. A multidisciplinary approach may be needed to manage fatigue.

Rectal Urgency Among Patients With Ulcerative Colitis or Crohn's Disease: Analyses from a Global Survey.

Background: Rectal urgency is a common but under-reported inflammatory bowel disease (IBD) symptom. The present study assessed the prevalence of rectal urgency and its association with disease activity and patient-reported outcomes (PROs) among patients with ulcerative colitis (UC) or Crohn's disease (CD) in a real-world setting. Methods: Data were drawn from the 2017-2018 Adelphi IBD Disease Specific Programme™, a multi-center, point-in-time survey of gastroenterologists and consulting adult patients with UC or CD in France, Germany, Italy, Spain, the United Kingdom, and the United States. Gastroenterologists completed patient record forms and patients completed self-reported forms. Analyses were conducted separately for patients with UC or CD. Patient demographics, clinical characteristics, disease activity, symptoms, and PROs were compared between patients with and without rectal urgency. Results: In total, 1057 patients with UC and 1228 patients with CD were included. Rectal urgency was reported in 20.2% of patients with UC and 16.4% with CD. Patients with rectal urgency were more likely to have moderate or severe disease (UC or CD: P < .0001), higher mean Mayo score (UC: P < .0001), higher mean Crohn's Disease Activity Index score (CD: P < .0001), lower Short IBD Questionnaire scores (UC or CD: P < .0001), and higher work impairment (UC: P < .0001; CD: P = .0001) than patients without rectal urgency. Conclusions: Rectal urgency is a common symptom associated with high disease activity, decreased work productivity, and worse quality of life. Further studies are needed to include rectal urgency assessment in routine clinical practice to better gauge disease activity in patients with UC or CD.

Work-Related Productivity Loss and Associated Indirect Costs in Patients With Crohn's Disease or Ulcerative Colitis in the United States.

Background: Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), affects an estimated 1.6 million US adults, and results in humanistic and economic burden even among mild patients, which grows with increasing disease activity. Methods: Gastroenterologists and their IBD patients provided real-world data via US IBD Disease Specific Programmes 2014-2018. Patients with physician- and patient-reported data completing a Work Productivity and Activity Impairment questionnaire were categorized by disease activity, defined using Crohn's Disease Activity Index (CD) and partial Mayo scores (UC), respectively. Associations of disease activity with patient-reported productivity loss and indirect costs were assessed. Results: The analyses included 281 patients with CD and 282 patients with UC. Mean ages were 40.0 and 40.5 years, and mean disease durations 7.1 and 5.4 years, for CD and UC, respectively. In CD, absenteeism (0.95%-14.6%), presenteeism (11.7%-44.9%), and overall work impairment (12.4%-51.0%) increased with increasing disease activity (all P < .0001). In UC, absenteeism (0.6%-11.9%), presenteeism (7.1%-37.1%), and overall work impairment (7.5%-41.9%) increased with increasing disease activity (all P < .0001). Annual indirect costs due to total work impairment increased with increasing disease activity (all P < .0001), from $7169/patient/year (remission) to $29 524/patient/year (moderately-to-severely active disease) in CD and $4348/patient/year (remission) to $24 283/patient/year (moderately-to-severely active disease) in UC. Conclusions: CD and UC patients experienced increased absenteeism, presenteeism, and overall work impairment with increasing disease activity, resulting in higher indirect costs. Treatments significantly reducing IBD disease activity could provide meaningful improvements in work productivity and associated costs.