Introduction

Despite increasing treatment opportunities for ulcerative colitis (UC), patients often suffer acute periods of increased disease severity. Since little is known regarding how healthcare resource utilization (HCRU) and drug dosing differ between flaring and non-flaring patients in a real-world clinical setting, we aimed to assess these differences.

Aims & Methods

Data were extracted from the Adelphi UC Disease Specific Programme, a point-in-time survey of gastroenterologists and patients conducted in France, Germany, Italy, Spain, the United Kingdom, and the United States from January 2020 - March 2021. Gastroenterologists provided clinical characteristics, treatment history and HCRU for their next 5-7 consulting UC patients with a history of moderate-severe disease. Patients were categorized based on whether they had experienced a flare in the last 12 months, and compared using Fisher’s exact, t-test and Mann-Whitney tests. Two subgroups were analysed separately to explore drug dosing patterns for flaring and non-flaring patients; those on targeted therapies (TT; biologics, Janus kinase inhibitors) who had been receiving their therapy for ≥12 months and those who were currently receiving corticosteroids.

Results

This study included 2,019 patients; 968 (47.9%) were reported by their gastroenterologist to have flared in the last 12 months, while 1,051 (52.1%) had no flares. While age and sex were similar across the patient subgroups, flaring patients had a shorter disease duration (p=0.05) and greater disease extension (p<0.01) than non-flaring patients (Table 1). Differences were seen across all HCRU measures with a greater number of consultations (7.2 vs 5.3), hospitalizations (0.4 vs 0.1), biopsies, endoscopies, stool and blood tests in the last 12 months for flaring patients compared to non-flaring patients (all p<0.01). A higher proportion of flaring patients had received corticosteroids in the last 12 months compared to non-flaring patients (39.4% vs 13.9%, p<0.01), and among those currently receiving corticosteroids, 9.9% of flaring patients had their corticosteroid dose escalated vs 5.6% of non-flaring patients (p=0.28). Of those patients receiving their current TT for ≥12 months, 25.7% of flaring patients had their TT dose escalated compared to 11.7% of non-flaring patients (p<0.01).

Table 1. Gastroenterologist-reported patient demographics, clinical characteristics, healthcare resource utilization, and treatment usage

Conclusion

Almost half of patients with UC in our cohort had experienced a flare within the last 12 months. These patients had greater HCRU, increased corticosteroid use, and those on TT were more likely to receive escalated drug doses, highlighting the need for additional treatment options to target disease control, entailing the potential for a reduced burden of flares on UC patients and healthcare systems.

Disclosure

This study was supported by Eli Lilly and Company.

Introduction

Upper gastrointestinal bleeding (UGIB) poses a significant threat in patients presenting to the emergency department, particularly in those with associated hemodynamic instability. Despite major advancements in medical and endoscopic therapeutic options, mortality rates have not shown a substantial decline over the years. This study aimed to assess clinical practice patterns in order to gain a clearer understanding of the pre-endoscopic assessment for patients with acute UGIB.

Aims & Methods

This study was an international online survey based on a prospective two-phase data collection approach, conducted between April 2023 and November 2023. The survey targeted practicing physicians actively involved in managing patients with UGIB. Data collection and management were performed through Research Electronic Data Capture (REDCap), an electronic data collection tool. The survey comprised four key domains: demographics and clinical practice, definitions of hemodynamic instability, pre-endoscopic assessment, and optimal timing of endoscopy, encompassing a total of 33 questions. The primary analysis provided a descriptive assessment of responses reported as proportions. Secondary analyses explored differences in responses based on years of clinical experience, practice setting, and the estimated annual number of UGIB cases encountered

Results

A total of 533 clinicians from 50 countries completed our survey. Among respondents, 54.6% work in university-based hospitals, and 67.7% reported managing over 100 UGIB patients annually. Regarding clinical experience, 55.7% have less than 10 years, with 44.3% with over 10 years of experience. Only 47.1% of respondents reported that their hospitals implement a triage system for UGIB patients. Additionally, 39.6% indicated that they do not use any risk stratification scores at the time of patient presentation. For initial fluid resuscitation, 0.9% saline (40.9%) and balanced crystalloid fluids (39.5%) were almost equally preferred. The rate of fluid resuscitation was reported to depend on the patient’s hemodynamic status by 40.2% of respondents. Most respondents indicated that hemodynamically unstable patients are primarily managed in the emergency department or intensive care unit. A total of 34.3% of respondents indicated that they do not routinely use prokinetics prior to endoscopy in UGIB patients, while 27.6% reported not commonly using them even in cases involving severe bleeding or known gastric emptying disorders. Proton pump inhibitors are administered prior to upper GI endoscopy in all cases by 70.4% of respondents, while vasoconstricting agents are used by 61% in cases of suspected variceal bleeding.

Conclusion

Our survey found considerable variability among respondents regarding the pre-endoscopic management of patients presenting with upper gastrointestinal hemorrhage. The overall adherence to international guidelines was low, which can potentially result in a significant negative impact on patient outcomes.

Introduction

Mirikizumab, a p19-directed interleukin-23 monoclonal antibody, is efficacious in inducing clinical response at Week(W) 12 and maintaining clinical remission through W52 in patients with moderately-to-severely active Crohn’s disease (CD) as shown in the phase 3 treat-through trial VIVID-1 (NCT03926130).¹ Here, we present analysis of maintenance outcomes through W52 for Patient-Reported Outcome (PRO) clinical responders and nonresponders at W12.

Aims & Methods

The analysis set includes patients randomized to mirikizumab at baseline, who did or did not achieve PRO clinical response at W12 after intravenous (IV) induction treatment (900 mg mirikizumab IV every 4 weeks [Q4W]) before entering subcutaneous (SC) maintenance treatment (300 mg mirikizumab SC Q4W). Descriptive statistics are used to summarize the data, applying nonresponder imputation for missing binary endpoints. As a treat-through study, no rerandomization was applied.

Results

From a total of 551 patients who entered SC maintenance treatment, baseline characteristics of age, duration of CD, and baseline Crohn’s Disease Activity Index (CDAI) were similar between W12 PRO responders (n=402, 73.0%) and W12 PRO nonresponders (n=149, 27.0%). PRO responders at W12 had a higher objective inflammatory burden at baseline (faecal calprotectin, c-reactive protein, and Simple Endoscopic Score-CD), whereas concomitant or prior medication usage was similar between the groups. For W12 PRO responders, SC mirikizumab treatment from W12 to W52 resulted in an increase in CDAI clinical remission from 52.2% to 65.4%, PRO clinical remission from 53.2% to 65.4%, and endoscopic response from 35.1% to 54.7%, respectively (Table 1). Among W12 PRO nonresponders, PRO response was achieved by 39.6% at W16, 45.6% at W20, 44.3% at W24, and 56.4% at W52 with continued mirikizumab SC treatment, while CDAI clinical remission and PRO clinical remission were achieved by 33.6% and 31.5% at W52, respectively. Endoscopic response increased from 30.2% at W12 to 40.3% at W52 among W12 PRO nonresponders (Table 1).

Conclusion

Subcutaneous mirikizumab maintenance treatment over 40 weeks leads to incremental and sustained improvements in rates of clinical and endoscopic response regardless of PRO clinical response status after induction. A substantial proportion of clinical nonresponders at W12 improved early during maintenance treatment suggesting continued treatment with mirikizumab can be beneficial and lead to long-term response.

References

1. Ferrante, Marc et al. Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn's disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat-through study. Lancet. 2024;404(10470):2423-2436. doi:10.1016/S0140-6736(24)01762-8