A Linked Electronic Medical Record-Claims Analysis of the Clinical and Economic Outcomes of Patients Coded for Erosive Esophagitis in the United States.

Introduction: Erosive esophagitis (EE) is a severe form of gastroesophageal reflux disease commonly treated with proton pump inhibitors (PPIs). The aim of this retrospective, observational cohort study was to describe the characteristics and healthcare burden of patients with EE.

Methods: We identified adults in the USA with an EE diagnosis between January  1, 2016 and February 28, 2019 in a linked dataset containing electronic health records (EHR) from the Veradigm Network EHR and claims data from Komodo Health.

Healthcare costs among patients with newly diagnosed infection in the United States: a linked claims-EHR study.

Aims: The study objectives were to 1) characterize the cost drivers of patients with (HP) and 2) estimate HP-related cost savings following lab-confirmed HP eradication with US guideline-recommended treatment compared to failed eradication.

Methods: We identified adults newly diagnosed with HP between 1/1/2016-12/31/2019 in the Veradigm Electronic Health Record Database linked to claims data (earliest HP diagnosis = index date). For the overall costs analysis, we required patients to have data available for ≥12 months before and after the index date.

Development and validation of a psoriasis treatment acceptability measure through group concept mapping.

Background: Psoriasis is a common autoimmune dermatologic condition which has a pronounced negative impact on patient quality of life and disease burden. Currently, there are a number of treatments available for psoriasis, with differences in efficacy, mechanism of action, mode of administration, adverse effects, and tolerability. However, a reliable, validated patient-reported instrument to address patient expectations and of psoriasis treatment has not been developed.

Brief communication: global temporal trends in the efficacy of clarithromycin-based regimens for the treatment of infection.

Background: eradication rates achieved with clarithromycin-based triple therapies are declining due to antibiotic resistance, but data regarding temporal changes in efficacy with these eradication therapies are scarce.

Objective: To evaluate the efficacy of clarithromycin-based triple eradication regimens over time.

Design: A comprehensive literature review and time-trend analysis.

Real-world outcomes associated with vonoprazan-based proton pump inhibitor-based therapy for infection in Japan.

Background: Japanese guidelines recommend triple therapy with vonoprazan or a proton pump inhibitor (PPI) in combination with antibiotics to treat () infection. While studies have shown improved eradication rates and reduced costs with vonoprazan PPIs, there is little data describing healthcare resource use (HCRU) and treatment patterns.

Objectives: To compare patients treated with a vonoprazan-based or PPI-based regimen for infection in Japan in terms of their characteristics, HCRU, healthcare costs, clinical outcomes, and treatment patterns.

Diagnosis and treatment patterns among patients with newly diagnosed Helicobacter pylori infection in the United States 2016-2019.

Approximately 36% of the United States (US) population is infected with Helicobacter pylori (HP), a known major risk factor for peptic ulcer disease and gastric cancer. HP eradication reduces the rate of complications; however, the benefits are undermined by rising rates of HP eradication treatment failure. This real-world observational cohort analysis aims to describe HP diagnostic and treatment patterns among insured patients in the US.

Induction and maintenance of healing in erosive esophagitis in the United States.

Introduction: Erosive esophagitis (EE) occurs when refluxate from the stomach causes T-lymphocyte infiltration of the esophageal mucosa, resulting in mucosal breaks. Currently, therapy with proton-pump inhibitors (PPIs) is the standard treatment for EE in the United States, but few comprehensive reviews exist on the efficacy of PPIs in US populations. Here, we present the most contemporary, thorough analysis of PPI efficacy rates, and identify and characterize patient subgroups at risk for poor healing outcomes.

Patient journey in erosive oesophagitis: real-world perspectives from US physicians and patients.

Objective: Management of erosive oesophagitis (EE) remains suboptimal, with many patients experiencing incomplete healing, ongoing symptoms, and relapse despite proton pump inhibitor (PPI) treatment. The Study of Acid-Related Disorders investigated patient burden of individuals with EE in a real-world setting.

Design: US gastroenterologists (GIs) or family physicians (FPs)/general practitioners (GPs) treating patients with EE completed a physician survey and enrolled up to four patients with EE for a patient survey, with prespecified data extracted from medical records.

Potassium-Competitive Acid Blocker and Proton Pump Inhibitor-Based Regimens for First-Line Eradication: A Network Meta-Analysis.

Background And Aims: Effective acid suppression is a crucial component of () eradication regimens. Approved treatments include dual, triple, and quadruple therapies composed of certain antibiotics in combination with proton pump inhibitors (PPIs). Vonoprazan, a potassium-competitive acid blocker, provides more potent and durable acid suppression than PPIs.

infection treatment in the United States: clinical consequences and costs of eradication treatment failure.

Introduction: (Hp) is causal in benign and malignant gastrointestinal diseases. Accordingly, current guidelines recommend Hp eradication in patients with active infection. Unfortunately, treatment failure is common, exposing patients to complications associated with persistent Hp infection and consequences of repeated treatment, including promotion of antibiotic resistance.

Study of Acid-related Disorders: Real-world Physician and Patient Perspectives on Burden of Infection.

Background And Aims: eradication rates have declined as antibiotic resistance rates have increased. In addition, adherence to treatment guidelines is suboptimal. It is therefore important that contemporary, real-world evidence of diagnostic and treatment patterns is explored and compared with evidence-based guidelines.

Switch rates and total cost associated with apremilast and biologics in biologic-naive patients with psoriatic arthritis.

Real-world treatment data for psoriatic arthritis are limited. We evaluated switch rates, adherence, and costs for patients initiating apremilast versus tumor necrosis factor inhibitor (TNFi) and interleukin inhibitor (ILi) among biologic-naive psoriatic arthritis patients. This retrospective analysis used IBM MarketScan claims data to assess treatment switches, adherence and costs.

Postinfusion monitoring costs by site of care for patients with relapsed/refractory large B-cell lymphoma receiving third- or later-line treatment with lisocabtagene maraleucel in the TRANSCEND NHL 001 and OUTREACH trials.

This retrospective study estimated postinfusion health care resource utilization (HCRU) by site of care among 303 patients with relapsed/refractory large B-cell lymphoma who received third- or later-line treatment with lisocabtagene maraleucel (liso-cel) in the TRANSCEND NHL 001 and OUTREACH trials. Inpatients ( = 256) had higher rates of hospitalization versus outpatients ( = 47; >99% vs 62%), by definition, and higher rates of tocilizumab use for cytokine release syndrome and/or neurological events (22% vs 9%). Rates of intensive care unit admission, corticosteroid use, vasopressor use, hemodialysis, and intubation were generally low and similar between groups.

Cytokine release syndrome and neurological event costs in lisocabtagene maraleucel-treated patients in the TRANSCEND NHL 001 trial.

Chimeric antigen receptor (CAR) T-cell therapies have demonstrated high response rates in patients with relapsed/refractory large B-cell lymphoma (LBCL); however, these therapies are associated with 2 CAR T cell-specific potentially severe adverse events (AEs): cytokine release syndrome (CRS) and neurological events (NEs). This study estimated the management costs associated with CRS/NEs among patients with relapsed/refractory LBCL using data from the pivotal TRANSCEND NHL 001 trial of lisocabtagene maraleucel, an investigational CD19-directed defined composition CAR T-cell product with a 4-1BB costimulation domain administered at equal target doses of CD8+ and CD4+ CAR+ T cells. This retrospective analysis of patients from TRANSCEND with prospectively identified CRS and/or NE episodes examined relevant trial-observed health care resource utilization (HCRU) associated with toxicity management based on the severity of the event from the health care system perspective.

Real-world treatment patterns, healthcare use and costs in triple-class exposed relapsed and refractory multiple myeloma patients in the USA.

To estimate treatment patterns and healthcare costs among triple-class exposed relapsed and refractory multiple myeloma (RRMM) patients. Eligible patients had ≥1 line of therapy (LOT) each of proteasome inhibitors, immunomodulatory drugs and daratumumab in December 2015-September 2018 and received a new LOT.  A total of 154 patients were included with a median follow-up of 6.

Treatment Patterns and Relapses Among Newly Treated Multiple Sclerosis Patients From a Retrospective Claims Analysis.

Purpose: Although all disease-modifying therapies (DMTs) reduce risk of relapse in multiple sclerosis (MS), many factors, including route of administration, influence selection of first-line DMT. Knowledge of real-world treatment patterns and effectiveness in reducing relapses across DMTs is important to understanding factors influencing this choice. This study sought to describe treatment patterns and relapses among newly treated adults with MS and by DMT route of administration (oral, injectable, and infusion).

Productivity Loss and Associated Costs Among Employed Patients Receiving Disease-Modifying Treatment for Multiple Sclerosis.

Objectives: The aim of this study was to examine the indirect burden of employed multiple sclerosis (MS) patients initiating disease-modifying therapies (DMTs) in the US.

Methods: DMT-treated MS patients (DMT users) and direct-matched controls without MS (1:3) were captured using the IBM MarketScan Commercial Claims and Encounters Database and the Health and Productivity Management Database between 1 January 2009 and 1 January 2017. DMT users were also stratified by route of administration.

Switch Rates and Total Cost of Care Associated with Apremilast and Biologic Therapies in Biologic-Naive Patients with Plaque Psoriasis.

Purpose: Compare treatment switching rates and costs among biologic-naive psoriasis patients initiating apremilast or biologics.

Methods: This retrospective claims analysis used IBM MarketScan Commercial and Medicare Supplemental databases to identify patients who initiated apremilast or a biologic (ie, tumor necrosis factor [TNF] or interleukin [IL] inhibitor) for psoriasis treatment between January 1, 2015, and December 31, 2016. A 1:1 propensity score matching was used to adjust for possible selection bias and maximize the number of patients available for analysis.

Real-world switch patterns and healthcare costs in biologic-naive psoriasis patients initiating apremilast or biologics.

Treatment switching and healthcare costs were compared among biologic-naive psoriasis patients initiating apremilast or biologics with ≥12 months pre-/post-index continuous enrollment in Optum Clinformatics™ Data Mart. After propensity score matching, switch rates (new therapy post-index) and days between index and switch were assessed. Total and per-patient per-month costs by service type were assessed.

Causal inference and adjustment for reference-arm risk in indirect treatment comparison meta-analysis.

To illustrate that bias associated with indirect treatment comparison and network meta-analyses can be reduced by adjusting for outcomes on common reference arms. Approaches to adjusting for reference-arm effects are presented within a causal inference framework. Bayesian and Frequentist approaches are applied to three real data examples.

Treatment Patterns Among Patients with Multiple Sclerosis Initiating Second-Line Disease-Modifying Therapy.

Objective: Disease-modifying therapies (DMTs) can reduce multiple sclerosis (MS) relapse rates; however, effectiveness of treatments may vary. It is important to understand real-world treatment patterns in the context of MS relapses. We describe MS relapses related to treatment patterns among patients who switch treatment after their first DMT.

Treatment Switch Patterns and Healthcare Costs in Biologic-Naive Patients with Psoriatic Arthritis.

Introduction: We compared treatment switch patterns and healthcare costs among biologic-naive patients with psoriatic arthritis (PsA) who initiated apremilast or biologics.

Methods: A 1:2 propensity score match was used to adjust administrative claims data for adults initiating apremilast or biologics from January 1, 2014, to September 30, 2016, for possible selection bias. Patients had at least 12 months of pre- and post-index continuous enrollment in the Optum Clinformatics™ Data Mart database.

Comparative safety and efficacy of ozanimod versus fingolimod for relapsing multiple sclerosis.

Ozanimod and fingolimod are sphingosine 1-phosphate receptor-modulating therapies for relapsing multiple sclerosis. Comparative effectiveness was assessed by matching adjusted indirect comparisons of safety and efficacy trial outcomes at first-dose cardiac monitoring, 1 year and 2 years. After adjustment, baseline characteristics were similar.

A criterion-based approach to systematic and transparent comparative effectiveness: a case study in psoriatic arthritis.

Indirect treatment comparisons are used when no direct comparison is available. Comparison networks should satisfy the transitivity assumption, that is, equal likelihood of treatment assignment for a given patient based on comparability of studies. Seven criteria were evaluated across 18 randomized controlled trials in psoriatic arthritis: inclusion/exclusion criteria, clinical trial design and follow-up, patient-level baseline characteristics, disease severity, prior therapies, concomitant and extended-trial treatment and placebo response differences.