Publications by authors named "Theresa Hunter"

Objective: To describe bDMARD initiators by biologic experience among ankylosing spondylitis (AS) patients and change in disease activity and patient-reported outcomes (PROs) in real-world US patients.

Methods: We included patients ≥18 years with AS based on physician diagnosis enrolled between 3/2013 and 11/2019 in the CorEvitas Psoriatic Arthritis (PSA)/Spondyloarthritis Registry (NCT02530268). Patients concurrently diagnosed with PSA were excluded.

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Objective: Although dosing regimens of targeted therapies (TT) for ulcerative colitis (UC) and Crohn's disease (CD) are guided by market authorizations and clinical guidelines, little is known about clinical guideline adherence or outcomes in patients receiving escalated doses of TT due to lack of response. This real-world study explored the prevalence of dose escalation and compared outcomes between patients receiving standard and escalated TT doses.

Methods: Data were from the 2020-2021 Adelphi Disease Specific Programme for inflammatory bowel disease, a cross-sectional survey of gastroenterologists and their UC and CD patients across five European countries and the US.

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Purpose: Bowel urgency (BU) is an important symptom of Crohn's disease (CD), however there is no patient-reported outcome (PRO) scale validated in this population to assess BU severity. Here we evaluated the content validity and psychometric properties of the Urgency Numeric Rating Scale (NRS).

Method: Qualitative interviews were conducted with moderate-to-severe CD participants to confirm importance and relevance of BU in this population, cognitively debrief the Urgency NRS, and explore score interpretation and CD remission.

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  • The study focused on understanding the impact of fatigue on patients with moderate-to-severe Crohn's disease (CD) and evaluated the effectiveness of the FACIT-F fatigue measurement tool.
  • It involved qualitative interviews to gather patient experiences and a two-week diary study assessing the FACIT-F's performance, reliability, and validity.
  • Results showed that fatigue significantly affects daily life for most participants, and the FACIT-F was generally well-received and reliable, with some noted limitations in certain items.
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  • 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.
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Neoantigens are peptides derived from non-synonymous mutations presented by human leukocyte antigens (HLAs), which are recognized by antitumour T cells. The large HLA allele diversity and limiting clinical samples have restricted the study of the landscape of neoantigen-targeted T cell responses in patients over their treatment course. Here we applied recently developed technologies to capture neoantigen-specific T cells from blood and tumours from patients with metastatic melanoma with or without response to anti-programmed death receptor 1 (PD-1) immunotherapy.

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Background: To assess disease activity, steroid-free remission, and other clinical outcome assessments among pediatric patients with ulcerative colitis (UC) and Crohn's disease (CD) in the ImproveCareNow (ICN) registry.

Methods: Patients aged 2-17 years diagnosed with UC or CD between June 1, 2013 and December 31, 2019 were enrolled if they initiated a biologic after enrollment in the ICN registry and completed at least 12 months follow-up after first maintenance dose. Baseline (at biologic initiation) demographics were summarized using descriptive statistics.

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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.
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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).

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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.

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  • T cell receptors (TCRs) are crucial for T cells to detect cancer cell mutations, and researchers used a CRISPR-Cas9 method to edit TCR genes in a clinical trial setting.
  • Sixteen patients with advanced solid cancers received personalized T cell therapies featuring engineered neoTCRs, with most participants experiencing either stable disease or disease progression.
  • The study confirmed that it is feasible to create multiple engineered TCRs, showing the safety and effectiveness of infusing gene-edited T cells that can successfully target tumors.
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  • - The Urgency Numeric Rating Scale (NRS) is a new tool created to measure bowel urgency severity in patients with ulcerative colitis, and its reliability and validity were thoroughly tested during a clinical trial involving over 1,160 participants.
  • - Results showed that participants reported lower urgency scores (better outcomes) after treatment, with high consistency in results across different testing periods and good correlations with established measures of disease severity.
  • - The study confirmed that the Urgency NRS is effective in differentiating levels of urgency based on different patient conditions and is responsive to positive treatment changes, indicating it's a useful outcome measure for future research and patient care.
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  • The study aimed to analyze treatment patterns and dosing of biologics in pediatric patients (ages 2-17) with ulcerative colitis (UC) or Crohn's disease (CD) over a period of 3 years using the ImproveCareNow registry data.* -
  • In patients with UC, corticosteroid and 5-ASA use decreased over time, while 6-MP/AZA and anti-TNFs increased; for CD, corticosteroid use also decreased, with an increase in methotrexate and anti-TNFs.* -
  • The study found that while corticosteroids were commonly used at the start, anti-TNFs were the most prevalent biologics, but the doses reported were significantly higher
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Objectives: To evaluate a dermatologist-centred screening tool followed by a structured rheumatological examination including MRI of sacroiliac joints and spine for the recognition of psoriatic arthritis with axial involvement (axPsA).

Methods: This was a prospective multicentre study. Adult patients with a confirmed diagnosis of psoriasis who had chronic back pain (≥3 months), onset <45 years and had not been treated with any biologic or targeted synthetic disease-modifying antirheumatic drug in the 12 weeks before screening were referred to a specialised rheumatology clinic.

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Objective: This study aimed to assess treatment patterns and frequency of inadequate response associated with advanced therapy initiation among patients with ankylosing spondylitis (AS) and psoriatic arthritis (PsA) in the USA.

Methods: Adult patients with AS or PsA who initiated advanced therapy were identified from the HealthCore Integrated Research Database®. Inadequate response to advanced therapies (tumour necrosis factor inhibitors [TNFi] and non-TNFi biologics) was identified using a claims-based algorithm.

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Objectives: Assess baseline characteristics and treatment response to ixekizumab (IXE) categorised by sex in patients with radiographic axial spondyloarthritis (r-axSpA) and non-radiographic axSpA (nr-axSpA) up to 52 weeks.

Methods: Data were analysed from three randomised controlled trials of IXE through 52 weeks. Patients fulfilled ASAS classification criteria for r-axSpA or nr-axSpA and were randomised to receive 80 mg subcutaneous administration of IXE every 2 weeks (Q2W) or 4 weeks (Q4W), or placebo (16 weeks COAST-V/W; 52 weeks COAST-X).

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Introduction: The aim of this study was to characterize employment, work productivity, and biologic disease-modifying anti-rheumatic drug (bDMARD) treatment in a predominantly female population of axial spondyloarthritis (axSpA) patients in a real-world setting.

Methods: This was a cross-sectional study of axSpA participants within the ArthritisPower registry. Outcomes were assessed with surveys (Work Productivity and Activity Impairment [WPAI], Bath Ankylosing Spondylitis Disease Activity Index [BASDAI], and Patient-Reported Outcomes Measurement Information System instruments) and compared between subgroups (employed vs.

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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.
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Introduction: There is limited information regarding treatment experience of patients with axial spondyloarthritis/ankylosing spondylitis (axSpA/AS) receiving biological disease-modifying antirheumatic drugs (bDMARDs). Here we characterize patient experiences and perspectives, including satisfaction among those currently treated with bDMARD therapy for axSpA/AS. We also assess the use of supplemental medication during perceived wear-off between doses.

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Objective: Aims were to 1) to characterize patient decision-making with treatment for axial spondyloarthritis (axSpA) and 2) to explore relationships among decision-making, treatment satisfaction, and biologic disease modifying antirheumatic drugs (bDMARDs).

Methods: ArthritisPower participants with physician-diagnosed axSpA were invited to complete an online survey about their treatment and their most recent physician visit. Analysis compared treatment decision by satisfaction and bDMARD status.

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Background: Patients with non-radiographic axial spondyloarthritis experience negative impacts on sleep, work productivity, and activity impairment. Ixekizumab, a monoclonal antibody selectively targeting interleukin-17A, has shown efficacy in treating the signs and symptoms of non-radiographic axial spondyloarthritis. This analysis evaluated the effect of ixekizumab treatment on sleep, work productivity, and activity impairment in patients with non-radiographic axial spondyloarthritis.

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Background: This analysis assessed improvements in patients with radiographic axial spondyloarthritis (r-axSpA) treated with ixekizumab in the Assessment of Spondyloarthritis International Society (ASAS) treatment response domains and additional patient-reported outcomes at 1 year of treatment.

Methods: COAST-V and COAST-W were 52-week, phase 3, randomized controlled trials evaluating the efficacy and safety of ixekizumab in biologic disease-modifying antirheumatic drug (bDMARD)-naïve and tumor necrosis factor inhibitor (TNFi)-experienced patients with radiographic spondyloarthritis, respectively. Patients were treated with 80-mg ixekizumab either every 2 weeks or every 4 weeks.

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Objectives: Little is known with certainty about the natural history of spinal disease progression in ankylosing spondylitis (AS). Our objective was to discover if there were distinct patterns of change in vertebral involvement over time and to study associated clinical factors.

Methods: Data were analysed from the Prospective Study of Outcomes in Ankylosing Spondylitis (PSOAS) observational cohort.

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Objective: We compared pain medication use in patients with ankylosing spondylitis (AS), psoriatic arthritis (PsA), and rheumatoid arthritis (RA) versus matched control over 2 years; a subgroup analysis assessed changes in pain medication use in patients who initiated a biologic during 12 months before and after.

Methods: This was a retrospective observational cohort study using an administrative claims database. Newly diagnosed adult patients with AS, PsA, or RA identified between 1/1/2014 and 7/31/2017 were included.

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  • 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.
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