Publications by authors named "April N Naegeli"
Article Synopsis
- The study investigates the prevalence of fatigue in patients with Crohn's disease (CD) and ulcerative colitis (UC), finding that 47.7% of CD patients and 40.9% of UC patients report experiencing fatigue.
- Fatigue is linked with various factors such as disease activity, abdominal pain, bowel issues, and depressive symptoms in CD, while in UC, it correlates with moderate to severe disease activity and similar depressive symptoms.
- The findings highlight that fatigue is a significant issue for patients with CD or UC, suggesting a need for better management of fatigue alongside other disease symptoms.
Background: Bowel urgency is a highly burdensome symptom among patients with inflammatory bowel disease (IBD).
Objectives: To assess changes in severity of bowel urgency and identify predictors of worsening or improvement among patients with Crohn's disease (CD) and ulcerative colitis (UC) at 6 months from their enrollment visit.
Methods: Data from patients in the Study of a Prospective Adult Research Cohort with IBD were analyzed.
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.
Background: Understanding the demographic and clinical characteristics of patients with Inflammatory Bowel Disease (IBD) who are likely to experience poor disease outcomes may allow early interventions that can improve health outcomes.
Objectives: To describe demographic and clinical characteristics of patients with ulcerative colitis (UC) and Crohn's disease (CD) with the presence of at least one Suboptimal Healthcare Interaction (SOHI) event, which can inform the development of a model to predict SOHI in members with IBD based on insurance claims, with the goal of offering these patients some additional intervention.
Methods: We identified commercially insured individuals with IBD between 01 January 2019 and 31 December 2019 using Optum Labs' administrative claims database.
Article Synopsis
- Fecal urgency, a symptom of Ulcerative Colitis (UC), was studied to understand its association with patient characteristics and treatment changes among 400 patients in the CorEvitas Inflammatory Bowel Disease Registry.
- The study classified patients into four groups based on their urgency status at enrollment and after 6 months, finding that those with persistent or changing urgency reported more comorbidities and had worse overall health outcomes.
- Results indicated that patients experiencing urgency were more likely to change treatments within the 6-month follow-up, suggesting urgency may indicate inadequate therapy and negatively impacts quality of life.
Article Synopsis
- Mirikizumab, a targeted monoclonal antibody for ulcerative colitis (UC), showed effectiveness in improving health-related quality of life (HRQoL) during a Phase 2 study.
- The study utilized the Inflammatory Bowel Disease Questionnaire (IBDQ) and Short Form Health Survey (SF-36) to measure HRQoL, finding significant improvements in various mirikizumab dosage groups compared to placebo after 12 weeks.
- Improvements in HRQoL were linked to achieving clinical response and remission, with long-term benefits observed up to 52 weeks, particularly through reduction in rectal bleeding symptoms.
Background: Early initiation of biologics in moderate-to-severe Crohn's disease (CD) may significantly alter disease progression, resulting in better patient outcomes. Limited real-world data exist on the impact of early biologic use in patients with CD in the United States.
Aims: We aimed to characterize biologic initiation and subsequent healthcare resource utilization (HCRU) in adults with recently diagnosed CD.
Background: The purpose of this analysis was to assess the frequency of inadequate response over 1 year from advanced therapy initiation among patients with Crohn's disease (CD) or ulcerative colitis (UC) in the United States using a claims-based algorithm. Factors associated with inadequate response were also analyzed.
Methods: This study utilized claims data of adult patients from the HealthCore Integrated Research Database (HIRD) from January 01, 2016 to August 31, 2019.
Article Synopsis
- Bowel urgency is a common issue for patients with ulcerative colitis (UC) and negatively impacts their quality of life (QoL).
- In a clinical trial, the drug Mirikizumab was found to significantly reduce bowel urgency in patients with moderate-to-severe UC over a 12-week period.
- Patients without bowel urgency showed notable improvements in quality of life and clinical outcomes, suggesting that managing bowel urgency could be key in treating UC effectively.
Background: To evaluate disease burden and patient-reported outcomes (PROs) of ulcerative colitis (UC) patients at enrollment into CorEvitas' Inflammatory Bowel Disease Registry by therapy class.
Methods: Between May 3, 2017 and September 3, 2019, 773 UC registry patients were categorized by therapy class at enrollment: patients on 5-aminosalicylic acids (5-ASAs) only ( = 290), and patients on biologics/Janus kinase inhibitors (JAKi) alone or in combination with 5-ASAs or immunosuppressant therapies (BIO/JAKi) ( = 315). To quantify between group differences, the mean/proportional differences and corresponding 95% CIs were calculated.
Background: Patient-reported outcome measures are needed to assess the impact of treatments for COVID-19 on symptoms. The ACTIV-2 COVID-19 Symptom Diary (ACSD) is being used in the ongoing Accelerating COVID-19 Therapeutic Interventions and Vaccines-2 (ACTIV-2) platform clinical trial. The purpose of the current study was to conduct qualitative interviews to assess content validity of the ACSD.
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- The study focuses on understanding how patients with ulcerative colitis (UC) experience bowel urgency, a key symptom, and evaluates the effectiveness of the Urgency Numeric Rating Scale (NRS) in capturing this experience.
- Interviews with 20 adults with moderately to severely active UC revealed that urgency is a significant concern, with various definitions of disease remission and symptom severity among participants.
- The findings suggest that the Urgency NRS is effective in measuring urgency levels, and even small changes in scores can indicate meaningful improvements in patients' daily lives.
Background: Although various treatments help reduce abdominal pain, real-world pain medication utilization among patients with Crohn's disease (CD) or ulcerative colitis (UC) receiving advanced therapies is poorly understood. The aim is to understand the utilization of pain medication 12 months before and after the initiation of advanced therapies among patients with newly diagnosed CD or UC.
Methods: This retrospective, observational cohort study used administrative medical and pharmacy claims data of patients with CD or UC from HealthCore Integrated Research Database (HIRD).
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.
Background: In the phase 2/3 BLAZE-1 trial, bamlanivimab and etesevimab together reduced coronavirus disease 2019 (COVID-19)-related hospitalizations and any-cause mortality in ambulatory patients. Herein, we assess the impact of bamlanivimab and etesevimab treatment on the severity and length of symptoms and health outcomes among patients at increased risk for severe COVID-19.
Methods: In the phase 3 portion of BLAZE-1 (NCT04427501), symptomatic patients with increased risk for severe COVID-19 were randomized (2:1) to a single infusion of 700 mg bamlanivimab and 1400 mg etesevimab or placebo.
Background: Bowel urgency, the sudden or immediate need to have a bowel movement, is a common, bothersome and disruptive symptom of ulcerative colitis (UC). UC treatment goals include control of urgency; however, it is not consistently assessed in UC clinical trials. The Urgency Numeric Rating Scale (NRS) is a new patient-reported measure to assess severity of bowel urgency in adults with UC developed in accordance with Food and Drug Administration guidelines.
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- This study explores the link between the severity of inflammatory bowel disease (IBD) and its impact on patients' quality of life, work productivity, healthcare use, and costs by using real-world data from the National Health and Wellness Survey (NHWS).
- It included 687 patients with self-reported IBD diagnoses, showing that a large majority had corresponding claims data to confirm their conditions.
- Results revealed that patients with moderate to severe IBD had significantly worse quality of life and higher costs compared to those with mild symptoms, highlighting the need for treatment approaches that consider both physical symptoms and patient well-being.
Article Synopsis
- Mirikizumab, a monoclonal antibody targeting interleukin 23p19, shows promise in treating moderate-to-severe Crohn's disease (CD), with demonstrated effectiveness in earlier studies on psoriasis and ulcerative colitis.
- In a study with 191 patients, those receiving mirikizumab had a significantly better endoscopic response at Week 12 compared to placebo, particularly at the 600 mg and 1000 mg doses.
- Safety profiles for mirikizumab were comparable to placebo, although there were higher rates of serious adverse events in certain nonrandomized groups, indicating the necessity for careful monitoring.
Article Synopsis
- This research explored how common fecal urgency is among patients with ulcerative colitis (UC) and Crohn's disease (CD) and its connection to IBD symptoms and well-being.
- The study found that a significant percentage of UC (59.5%) and CD (65.2%) patients experience mild to moderate-severe urgency, which correlates with increased bowel movements, rectal bleeding, and abdominal pain.
- Additionally, moderate-severe urgency was linked to reduced well-being in both UC and CD patients, indicating a strong relationship between urgency, active inflammation, and overall quality of life.
Background: Understanding ulcerative colitis disease activity assessed via the full, modified, or partial Mayo Score may help clinicians apply results from clinical trials to practice and facilitate interpretation of recent and older studies.
Methods: Mayo Score variables were assessed in a cross-sectional study of 2608 ulcerative colitis patients.
Results: Permutations of Mayo Scores were highly correlated, and models predicting the omitted variable from each permutation demonstrated significant agreement between predicted and observed values.
Article Synopsis
- The study focused on mirikizumab, an antibody targeting interleukin 23, and its effectiveness in treating moderate to severe ulcerative colitis after an initial 12-week trial period.
- In the extended open-label study, patients who initially did not respond to mirikizumab were given higher doses (600 mg or 1000 mg) for another 12 weeks.
- Results showed that around 50% of patients receiving 600 mg and 43.8% receiving 1000 mg achieved a clinical response, with some going on to a maintenance period with lower doses.
Background: Disease burden, a definition of remission, and symptoms that drive treatment seeking were explored in a Crohn's disease (CD) population.
Methods: A qualitative semistructured interview guide was developed, informed by published literature. Clinicians identified adolescents and adult patients with CD.
Article Synopsis
- * The study analyzed data from over 24,000 rheumatoid arthritis (RA) patients and nearly 10,000 ulcerative colitis (UC) patients to compare four different methods of calculating disease-related costs and HCRU.
- * The findings revealed that Method 4, which involves manual determination by clinicians, provides the closest estimate of costs, while simpler Method 1 may still suffice in some cases; the study highlights differences in approaches between RA and UC populations.
Background: Ulcerative colitis (UC) often first presents during adolescence and early adulthood. Primary symptoms of UC are well known, yet similarities and differences of disease experience in adults and adolescents are not well characterized.
Methods: To understand the health-related quality of life (HRQoL) and symptomatic experience of UC, in-depth interviews were conducted in the US with 21 adults (20-70 years) and 14 adolescents (12-17 years).
Article Synopsis
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