Mepolizumab real-world effectiveness in severe asthma with an eosinophilic phenotype and overlapping severe allergic asthma.

Background: Some patients with severe asthma have overlapping allergic and eosinophilic phenotypes and may be eligible for anti-eosinophilic or anti-IgE biologics.

Objective: This post hoc sub-analysis assessed real-world mepolizumab effectiveness in patients with overlapping allergic and eosinophilic phenotypes, using 1-year data from the international, prospective REALITI-A study.

Methods: The clinically significant asthma exacerbation (CSE) rate was assessed 1 year prior to (pre-treatment) and following (follow-up) mepolizumab treatment, stratified by baseline total IgE levels (tIgE; <60, 60-<190, 190-<550, and ≥550 kU/L), atopic status (yes/no/unknown), prior omalizumab use (yes/no), geographic baseline omalizumab eligibility (eligible/non-eligible), and baseline tIgE level and blood eosinophil count (BEC) threshold combinations (<81 or ≥81 kU/L and <300 or ≥300 cells/µL).

Chronic rhinosinusitis with nasal polyps (CRSwNP) symptom verbal response scales: content validity testing for use in adults with CRSwNP.

Background: PRO measures of symptoms in clinical trials have historically utilized visual and numerical scales but verbal descriptors may make it easier for patients to clearly differentiate between response options. This study assessed content validity and meaningful change in five verbal response scales (VRSs) used to assess chronic rhinosinusitis with nasal polyp (CRSwNP) symptom severity.

Methodology: This qualitative, semi-structured interview study recruited adults from the US, Germany, and China with confirmed moderate-to-severe CRSwNP.

Uncovering the spectrum of healthcare resource utilization and costs across moderate to severe asthma: high-cost subgroups and impact of biologics.

Objectives: The healthcare burden of moderate asthma is not as well studied as severe asthma. This study used 2019 US claims data to characterize patients in Global Initiative for Asthma (GINA) steps 3 to 5 (moderate to severe) during the first 90 days of 2019.

Methods: Patient characteristics, healthcare resource utilization and costs were described for all patients and GINA groups.

Sub-Optimal Disease Control and Low Blood Eosinophil Testing Frequency in Chinese Adult Patients with Asthma Receiving GINA Step 4/5 Treatment: A Real-World Study.

Purpose: To inform effective management strategies for severe asthma in China, this study aimed to comprehensively characterize clinical characteristics, treatment patterns, disease control status, and healthcare resource utilization among patients on GINA Step 4/5 therapies by analyzing data from the Adelphi Asthma Disease Specific Program conducted in China.

Patients And Methods: All information was retrieved from medical records or collected from physicians and patients on the survey date (August-December 2018); no follow-up was conducted. Results were summarized descriptively for patients on GINA Step 4/5 therapies, who were pooled from a consecutive sample (comprising three or more consecutive patients with physician-diagnosed asthma from each participating physician) and an oversample (comprising the next two patients with physician-perceived severe asthma from each participating physician).

Disease Burden, Treatment Patterns and Asthma Control in Adult Patients with Asthma in China: A Real-World Study.

Purpose: To inform better asthma management in China, this study aimed to comprehensively investigate clinical characteristics, treatment patterns, asthma control status, exacerbations, and humanistic burden among adult patients seeking hospital-based asthma care by analyzing data from Adelphi Asthma Disease Specific Program conducted in China.

Patients And Methods: All information was collected on survey date (August-December 2018) from medical records, physicians, or patients, without follow-up being conducted. Results are summarized descriptively for the overall population as well as subgroups defined by GINA 2018 treatment step.

Burden of eosinophilic granulomatosis with polyangiitis in Europe.

Background And Aims: Real-world evidence characterising the burden of eosinophilic granulomatosis with polyangiitis (EGPA) in Europe is limited. The aim of this study was to characterise patients in a large European EGPA cohort.

Methods: This retrospective, non-interventional, longitudinal study (GSK ID: 214661) recruited cross-specialty physicians from France, Germany, Italy, Spain and the UK to conduct medical chart reviews for patients with a physician-confirmed diagnosis of EGPA.

Real-world safety and effectiveness of mepolizumab for patients with eosinophilic granulomatosis with polyangiitis in Japan: A 48-week interim analysis of the MARS study.

Objectives: The objective of the study is to assess real-world, long-term safety/effectiveness of mepolizumab for eosinophilic granulomatosis with polyangiitis (EGPA) in Japan.

Methods: The Mepolizumab long-term study to Assess Real-world Safety and effectiveness of EGPA in Japan (MARS) (GSK ID: 213684/NCT04551989) is an ongoing 96-week study of patients with EGPA who received four-weekly mepolizumab 300 mg subcutaneously for ≥96 weeks before study entry (baseline) and continued treatment. This interim analysis included safety from baseline to Week 48 (observation period) and clinical outcomes before mepolizumab and during the observation period.

Mepolizumab in Patients With Severe Asthma and Comorbidities: 1-Year REALITI-A Analysis.

Background: Severe asthma is complex; comorbidities may influence disease outcomes.

Objective: To assess mepolizumab effectiveness in patients with severe asthma and comorbidities.

Methods: REALITI-A was a 2-year international, prospective study enrolling adults with asthma newly prescribed mepolizumab (100 mg subcutaneously) at physician's discretion.

The economic impact of asthma on private healthcare system in Brazil: Economic impact of asthma in Brazil.

To assess healthcare resource utilization and costs of patients with asthma in Brazilian Supplementary Healthcare System, focusing on hospitalization data. Retrospective cohort study, using data from an administrative database of a private company (Orizon). Patients aged ≥ 12 years with at least one record of emergency visit/hospitalization in the database with the ICD-10 J45 between January/2010 and June/2015 were included and followed until June/2016, death or inactivation of health plan.

Hypereosinophilic syndrome in Europe: Retrospective study of treatment patterns, clinical manifestations, and healthcare resource utilization.

Background: The burden of hypereosinophilic syndrome (HES) in Europe is not well characterized.

Objective: To evaluate real-world patient characteristics, treatment patterns, clinical manifestations, and healthcare resource utilization for patients with HES from France, Germany, Italy, Spain, and the United Kingdom.

Methods: In this retrospective, noninterventional study, data for patients with a physician-confirmed diagnosis of HES were abstracted from medical chart reviews.

Mepolizumab improves quality of life and reduces activity impairments in patients with CRSwNP.

Mepolizumab improves quality of life and reduces activity impairments in patients with CRSwNP.

Modeling the Health and Economic Burden of Chronic Obstructive Pulmonary Disease in China From 2020 to 2039: A Simulation Study.

Objectives: Despite a growing prevalence of respiratory diseases in recent decades in China, limited evidence is available on the health and economic burden of chronic obstructive pulmonary disease (COPD). We estimated the 20-year health and economic burden of COPD in China from 2020 to 2039.

Methods: We created a probabilistic dynamic open-cohort Markov model of COPD for the Chinese population aged ≥40 years.

REALITI-A Study: Real-World Oral Corticosteroid-Sparing Effect of Mepolizumab in Severe Asthma.

Background: Patients with severe asthma may require maintenance oral corticosteroids (mOCS) for disease control as well as systemic corticosteroid (SCS) bursts for clinically significant exacerbations. However, mOCS and SCS use are associated with adverse effects, which increases patient disease burden.

Objective: To assess the real-world corticosteroid-sparing effect of mepolizumab in patients with severe asthma.

Reduction in asthma exacerbation rate after mepolizumab treatment initiation in patients with severe asthma: A real-world database study in Japan.

Objective: To investigate the changes in asthma exacerbation, as well as in oral corticosteroid (OCS) use, exacerbation-related healthcare resource utilization (HRU), and healthcare costs before and after mepolizumab treatment initiation in patients with severe asthma who started treatment with mepolizumab in a real-world clinical setting in Japan.

Methods: A retrospective, observational, self-controlled study was conducted in Japan using a hospital-based administrative claims database. Patients who were diagnosed with asthma and who were new users of mepolizumab were included in the study.

Mepolizumab improves work productivity, activity limitation, symptoms, and rescue medication use in severe eosinophilic asthma.

Patients with severe eosinophilic asthma experience daily activity limitations and reduced productivity at work. Using anonymized individual patient-level data from two previously conducted randomized, double-blind, placebo-controlled studies (MENSA [GSK ID:115588/NCT01691521]; MUSCA [GSK ID:200862/NCT02281318]), we investigated the effect of mepolizumab on work productivity, activity limitation, symptoms, and rescue medication use. Patient-reported outcomes including Work Productivity and Activity Impairment-General Health (WPAI-GH) scores (impairment percentages, 0%-100%), global activity limitation (scale 1-4), and perceived change in activity limitation (Likert scale 1-7) since the start of the study were analyzed.

Real-life effectiveness of mepolizumab in severe asthma: a systematic literature review.

Objective: The efficacy and safety of mepolizumab in patients with severe eosinophilic asthma in randomized controlled trials is well established. Following approval of mepolizumab as add-on therapy for severe eosinophilic asthma in multiple regions worldwide, it is now important to determine its impact in real-world settings in which patients are not subject to stringent eligibility criteria. This systematic literature review assessed published evidence of clinical outcomes, safety, and healthcare resource use among patients with severe asthma receiving mepolizumab in real-world settings.

Value Assessment Frameworks in Latin America: "Il buono, il brutto e il cattivo".

Objectives: Using a taxonomy previously developed, we assessed the strengths and limitations of available value assessment frameworks (VAF) in Latin America.

Methods: Systematic review of peer-reviewed journals, gray literature review, and surveys to ISPOR Latin America Industry Committee members were done to identify and select current VAF. Once selected, independent reviewers, organized by pairs, assessed each framework's input, methodology, and outputs.

Automating Electronic Clinical Data Capture for Quality Improvement and Research: The CERTAIN Validation Project of Real World Evidence.

Background: The availability of high fidelity electronic health record (EHR) data is a hallmark of the learning health care system. Washington State's Surgical Care Outcomes and Assessment Program (SCOAP) is a network of hospitals participating in quality improvement (QI) registries wherein data are manually abstracted from EHRs. To create the Comparative Effectiveness Research and Translation Network (CERTAIN), we semi-automated SCOAP data abstraction using a centralized federated data model, created a central data repository (CDR), and assessed whether these data could be used as real world evidence for QI and research.

An indirect comparison of intravenous and subcutaneous belimumab efficacy in patients with SLE and high disease activity.

Aim: To compare the efficacy of intravenous (IV) and subcutaneous (SC) belimumab plus standard therapy in patients with active, autoantibody-positive systemic lupus erythematosus and high disease activity (HDA).

Patients & Methods: An indirect treatment comparison using patient-level data of patients with HDA from three belimumab IV Phase III randomized controlled trials (BLISS-52 [BEL110751]; BLISS-76 [BEL110752]; Northeast Asia study [BEL113750]) and one belimumab SC randomized controlled trial (BLISS-SC [BEL112341]).

Results: Similar efficacy results were identified between the belimumab formulations and greater improvements in efficacy endpoints were observed for both formulations compared with placebo.