Min Yang

Analysis Group

Background: Knowledge of treatment assignment may affect patient-reported outcomes (PROs), which is of concern in oncology, where open-label trials are common. This study measured the magnitude of open-label bias by comparing PROs for similar patient groups in oncology trials with different degrees of concealment. Methods: Individual patient dat...

Background Recurrence of Clostridioides difficile infection (rCDI) is common - up to 35% of patients may recur. RBX2660 is a microbiota restoration therapy to reduce rCDI. Here we report 8 weeks HRQL results using the Clostridioides difficile Health-related Quality-of-Life Questionnaire (Cdiff32), a disease-specific instrument, from PUNCH CD3 (a ra...

Purpose: Multiple biologics are available for moderate to severe asthma. Given the important relationship between patient engagement in healthcare decision-making and health outcomes, patient preference is an increasingly important consideration. This study elicited patients' preferences for attributes of biologic therapies for moderate to severe...

Introduction/aims: Hereditary transthyretin-mediated amyloidosis with polyneuropathy (hATTR-PN) progressively affects patients' functionality and compromises health-related quality of life (HRQL). The aim of this study was to quantify the projected long-term treatment effects of inotersen versus placebo on HRQL measures. Methods: The inotersen p...

Introduction: To examine the prevalence rates of biosimilar discontinuation and switchback to the originator tumor necrosis factor alpha (TNF) inhibitors following non-medical switch (NMS) in patients. Methods: Real-world studies reporting biosimilar discontinuation and switchback rates following NMS published between January 2012 and August 201...

Introduction/aims: Hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN) is a genetic condition associated with significant morbidity and mortality. We aimed to identify patient subgroups exhibiting the greatest health-related quality of life [HRQL] benefit from inotersen treatment. Methods: We examined data from the inotersen phas...

Introduction: The recent advent of disease-modifying therapies (DMTs) has dramatically changed the treatment landscape of spinal muscular atrophy (SMA), and the multifaceted impact of this advancement has not been assessed thoroughly in the growing body of literature. We sought to summarize the literature on the natural history of SMA and the impa...

Importance Clinical trial populations may not reflect clinical practice: knowledge generated in other settings can inform clinical decision-making. Objective To evaluate self-reported disease control and quality of life after initiating dupilumab treatment in patients with atopic dermatitis (AD) in the the clinical setting. Design, Setting, and P...

Objective: The aim of this study was to evaluate the impact of adherence to adalimumab on all-cause work loss, HRU, and direct medical and indirect costs over 2 years using real-world data. Methods: This was a retrospective cohort study using a large, United States administrative claims database. Adult patients treated with adalimumab were group...

IntroductionWe evaluated the real-world healthcare resource utilization (HRU) and costs among patients with high-grade non-muscle invasive bladder cancer (HG-NMIBC) following Bacillus Calmette-Guérin (BCG) therapy.Methods Patients aged ≥ 65 years diagnosed with HG-NMIBC between 2008 and 2015 who received adequate BCG induction and were identified i...

Importance Demonstrating the value of therapies from a patient’s perspective is increasingly important for patient-centered care. Objective To compare patient-reported outcomes (PROs) with risankizumab vs ustekinumab and placebo in psoriasis symptoms, health-related quality of life (HRQL), and mental health among patients with moderate to severe p...

Context Currently, there is no standard of care for patients with non–muscle-invasive bladder cancer (NMIBC) who recur despite bacillus Calmette-Guerin (BCG) therapy. Although radical cystectomy is recommended, many patients decline to undergo or are ineligible to receive it. Multiple agents are being investigated for use in this patient population...

453 Background: For patients with high-grade (HG) non-muscle invasive bladder cancer (NMIBC) who recur after Bacillus Calmette-Guérin (BCG) therapy, treatment options other than radical cystectomy have been limited. This study examined real-world utilization and outcomes of current bladder preservation therapies (BPT) after BCG treatment. Methods:...

Background: The Atopic Dermatitis Control Tool (ADCT©) is a brief patient self-administered instrument designed and validated to assess atopic dermatitis (AD) control; six AD symptoms and impacts are evaluated over the past week, including overall severity of symptoms, days with intense episodes of itching, intensity of bother, problem with sleep,...

Background: The Atopic Dermatitis Control Tool (ADCT©) is a brief patient self-administered instrument designed and validated to assess atopic dermatitis (AD) control; six AD symptoms and impacts are evaluated over the past week, including overall severity of symptoms, days with intense episodes of itching, intensity of bother, problem with sleep,...

Background: The Atopic Dermatitis Control Tool (ADCT©) is a brief patient self-administered instrument designed and validated to assess atopic dermatitis (AD) control; six AD symptoms and impacts are evaluated over the past week, including overall severity of symptoms, days with intense episodes of itching, intensity of bother, problem with sleep,...

Background: The Atopic Dermatitis Control Tool (ADCT©) is a brief patient self-administered instrument designed and validated to assess atopic dermatitis (AD) control; six AD symptoms and impacts are evaluated over the past week, including overall severity of symptoms, days with intense episodes of itching, intensity of bother, problem with sleep,...

Background: The Atopic Dermatitis Control Tool (ADCT©) is a brief patient self-administered instrument designed and validated to assess atopic dermatitis (AD) control; six AD symptoms and impacts are evaluated over the past week, including overall severity of symptoms, days with intense episodes of itching, intensity of bother, problem with sleep,...

Introduction The new direct acting antiviral (DAA) therapies are able to effectively treat chronic hepatitis C (CHC). This study elicited the preferences of CHC patients for treatment attributes of new DAAs. Methods An online discrete choice experiment survey was designed to collect data from adult CHC patients in the USA, UK, France, Germany, Spa...

Introduction A systematic literature review was conducted to review and summarize the economic impact of non-medical switching (NMS) from biologic originators to their biosimilars (i.e., switching a patient’s medication for reasons irrelevant to the patient’s health). Methods English publications reporting healthcare resource utilization (HRU) or...

Background Biologic therapies have considerably improved clinical management of autoimmune diseases. Over the past few years, several biosimilars have been introduced in Europe for these conditions. Limited information is available evaluating the impact of switching stable patients from originators to their respective biosimilars in clinical practi...

Background To optimise clinical outcomes of biologics for autoimmune conditions, continued treatment of the same agent is critical, particularly for stable patients. The introduction of biosimilars to originator biologics has prompted non-medical switching (NMS) which may interrupt treatment consistency. This study examined prevalence rates of bios...

Background: Preference valuations of health status are essential in health technology and economic appraisal. This study estimated utilities for treatment-related health states of acute myeloid leukemia (AML) and disutilities of severe adverse events (SAEs) using a representative sample of adults from the general population in the United States (U...

Objectives: To estimate short-term costs associated with non-medical switch (NMS) from originator biologics to biosimilars among stable patients with autoimmune conditions in rheumatology, gastroenterology, and dermatology from a US provider's and third-party payer's perspective. Methods: An economic model was constructed to estimate switching c...

Background As biosimilars are approved and commercialised for rheumatic diseases, patients may be switched from originator biologic treatment to biosimilars due to perceived cost savings between the two biologic products. However, in the short term, non-medical switching (NMS) may require additional patient education, office visits, lab/imaging tes...

Background Biosimilars, often priced at a discounted rate of originator biologics, may prompt switching patients from originator biologics to biosimilars for non-medical reasons. However, other relevant costs (e.g., non-medical switching (NMS) program setup, costs of concomitant therapies, additional healthcare resource utilisation [HRU]) associate...

Background A Patient Support Program (PSP) offered by AbbVie to adalimumab-treated patients assists them with issues pertaining to medication costs, nurse support, injection training, pen disposal, and medication reminders. A number of studies have reported the benefit of enrollment in this PSP from different perspectives, including clinical, patie...

Background Endoscopy is commonly used for diagnosis and management of patients with inflammatory bowel disease (IBD); however, it is costly, invasive and has known risks of complications. Faecal calprotectin (FC) is a non-invasive biomarker of intestinal inflammation and is highly correlated with endoscopic disease activity. The use of FC testing i...

Objectives To compare outcomes between adalimumab and etanercept in the treatment of moderate to severe plaque psoriasis. Methods Study groups included patients randomized to adalimumab or placebo (REVEAL and CHAMPION trials) and those randomized to etanercept or placebo (M10-114 and M10-315 trials). Week 12 outcomes were compared between patients...

Objectives: We assessed the level of maintained effectiveness and associated healthcare costs in stabilised rheumatoid arthritis (RA) patients who reduced doses of adalimumab or etanercept. Methods: Eligible patients were identified from a U.S. commercial insurance database using the following criteria: adults with ≥2 RA diagnoses; effectively t...

Background: Adalimumab (ADA) and infliximab (INF) are approved for treating patients with ulcerative colitis (UC) who have failed conventional therapy. Research comparing the effectiveness of these therapies following induction is limited. We compared the real-world effectiveness of initiating ADA versus INF among patients in the early weeks of tre...

Background The OuTcomes Associated with taPering biologics among patiEnts with Rheumatoid arthritis (TAPER) is a retrospective chart review study to assess real-world implication of Taiwan policy on tapering/withdrawing biologics in stable rheumatoid arthritis (RA) patients.¹ Objectives To assess RA flare rates before and after anti-TNF dose taper...

Background The OuTcomes Associated with taPering biologics among patiEnts with Rheumatoid arthritis (TAPER) study is a multicenter retrospective chart review to assess real-world implication of the Taiwan National Health Insurance Administration policy on tapering and withdrawing biologics in stable rheumatoid arthritis (RA) patients. Objectives T...

Background: Patient-reported outcome (PRO) measures have been used to assess treatment benefit in a variety of therapeutic areas and are now becoming increasingly important in aesthetic research. Objectives: The objective of the current study was to develop and validate a new PRO measure (Eyelash Satisfaction Questionnaire [ESQ]) to assess satis...

Background Ankylosing spondylitis (AS), a chronic rheumatic disease predominantly involving the axial skeleton, can substantially impact work productivity in employed patients, resulting in economic costs to employers and society.1,2 Objectives To assess salary growth, an integrated measure of work performance, in employed patients with AS treated...

Objective To assess direct and indirect healthcare resource utilization and costs of privately insured US employees with ulcerative colitis (UC) from a societal perspective. Research design and methods Employees aged 18–64 with ≥2 UC diagnoses and no more than one diagnosis of Crohn’s disease (CD) were identified from a large, de-identified, priva...

The primary driver of healthcare costs for patients with community-acquired pneumonia (CAP) is hospital length of stay (LOS). Unfortunately, hospital LOS comparisons are difficult to make from Phase III CAP trials due to their structured designs and pre-specified treatment durations. However, an opportunity still exists to draw inferences about pot...

Background The Headache Impact Test (HIT)-6 was developed and has been validated in patients with various types of headache. The objective of this study was to report the psychometric properties of the HIT-6 among patients with chronic migraine.Methods Data came from two international, multicenter, randomized, double-blind, placebo-controlled clini...

Objective: Cushing's disease (CD) can significantly impair patients' health-related quality of life (HRQOL). This study investigated the treatment effectiveness of pasireotide on HRQOL of CD patients, and assessed the relationships between HRQOL and urinary free cortisol (UFC) and CD-related signs and symptoms. Design: In this phase III, randomi...

Background: While hospital length of stay (LOS) comparisons are difficult to make from Phase III CAP trials, an opportunity exists to draw inferences about potential LOS differences between treatments using surrogate dates for hospital discharge. Criteria of discharging a hospitalized CAP patient are well described in the literature and consistent...

Respiratory Infections PostersSESSION TYPE: Original Investigation PosterPRESENTED ON: Wednesday, October 30, 2013 at 01:30 PM - 02:30 PMPURPOSE: The study objective was to better quantify time to "readiness-to-discharge" among patients with CAP who received ceftaroline or ceftriaxone in the FOCUS trials. While hospital length of stay (LOS) compari...

Constipation is a common side effect of opioid therapy. Tapentadol immediate release (IR) was better tolerated than oxycodone IR in 2 clinical trials involving patients with low back or osteoarthritis pain. The objective of this study was to examine patient-reported bowel function during those trials. Bowel function was assessed during secondary po...

Purpose: Opioid treatment effectiveness may be best compared using definitions of treatment response, which combine measures assessing pain reduction and the occurrence of adverse events (AEs). This analysis of data from two phase III clinical trials was conducted to examine the pain relief and tolerability (PRT) balance of immediate release (IR)...

To provide evidence for the reliability and validity of the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ) for use in chronic migraine (CM) in adults. MSQ is one of the most frequently utilized disease-specific tools assessing impact of migraine on health-related quality of life (HRQL). However, evidence for its reliability and v...

Purpose The SF-36, a generic measure of 8 domains of health-related quality of life (HRQOL), has been widely used to examine HRQOL of end-stage renal disease (ESRD) patients undergoing hemodialysis (HD). The current study synthesizes existing literature to examine which SF-36 domains capture the largest burden in this patient population. Methods A...

Table S1. Characteristics and main findings of studies included in the analyses. Description: Microsoft Word table containing the following information for each of the 28 studies included in the analyses: study publication(s); study design; anti-tumor necrosis factor (anti-TNF) groups (anti-TNF naïve, first-, second- or third-time switchers and the...

The purpose of this study was to assess psychometric properties of the six-item Headache Impact Text (HIT-6™) across episodic and chronic migraine. Using a migraine screener and number of headache days per month (HDPM), participants from the National Survey of Headache Impact (NSHI) study and the HIT-6 validation study (HIT6-V) were selected for th...

The long-term treatment of rheumatoid arthritis (RA) most often involves a sequence of different therapies. The response to therapy, disease progression and detailed knowledge of the role of different therapies along treatment pathways are key aspects to help physicians identify the best treatment strategy. Thus, understanding the effectiveness of...

The Fatigue Impact Scale (FIS) has been used extensively to assess the impact of fatigue on health-related quality of life (HRQOL) in multiple sclerosis (MS). The objective of this study was to estimate the minimally important difference (MID) of the FIS to facilitate the interpretation of the scale in patients with MS. Data came from a cross-secti...

Premenstrual syndrome (PMS) is reported to affect between 13% and 31% of women. Between 3% and 8% of women are reported to meet criteria for the more severe form of PMS, premenstrual dysphoric disorder (PMDD). Although PMDD has received increased attention in recent years, the cost effectiveness of treatments for PMDD remains unknown. To evaluate t...

To link the Premenstrual Symptoms Impact Survey (PMSIS) scores to health-related quality of life (HRQOL) and sexual drive impact associated with premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD). Secondary data analysis was performed using the online survey study for PMSIS development. Women were sorted into 10 mutually exclusi...

To estimate the minimally important difference (MID) for the Insomnia Severity Index (ISI) by examining the association of score differences of the ISI with health-related outcomes including health-related quality of life, productivity, and fatigue. Data came from a randomized, placebo-controlled clinical trial evaluating the long-term efficacy of...

Objective: The aim of this study was to evaluate the comparability of ACT * scores from a telephone interview format ('Telephone') against the original paper-and-pencil format ('Paper'). * Asthma Control Test (ACT) is a registered trademark of QualityMetric Incorporated, Lincoln, RI, USA METHODS: This was a randomized, crossover design with subjec...

An antipsychotic utilization pattern has evolved substantially over the past 20 years or so due to the introduction of the second-generation antipsychotics (SGAs) and the increasing understanding of their adverse effect profile. To understand antipsychotic utilization trends (including monotherapy, antipsychotic switching, and combination therapy)...