Real-World Treatment and Outcomes in ALK-Rearranged NSCLC: Results From a Large U.S.-Based Database.

Introduction: rearranged advanced NSCLC (aNSCLC) represents 4% of all NSCLCs, and multiple ALK-targeted therapies (ALK-inhibitors) are now available for use. Little is known about changes in treatment patterns, or how prognostic factors and sequence of therapy may impact overall survival in the real-world setting. We aim to describe initial and subsequent treatments used, survival outcomes, prognostic factors, and the impact of treatment on overall survival in the largest (N = 739) real-world cohort of patients with ALK+ aNSCLC reported in the literature.

Use of natriuretic peptides and echocardiography for diagnosing heart failure.

Aims: International guidelines have recommended the use of echocardiography and natriuretic peptides (NP) testing in the diagnostic evaluation of heart failure (HF) for more than 10 years. However, real-world utilization of these diagnostic tests in the US is not known. We sought to assess contemporary trends in echocardiography and NP testing for diagnosing HF in the US.

TNFi Cycling Versus Changing Mechanism of Action in TNFi-Experienced Patients: Result of the Corrona CERTAIN Comparative Effectiveness Study.

Objective: Comparative effectiveness research can inform treatment decisions regarding the choice of biologics for rheumatoid arthritis (RA). The objective of this study is to compare the efficacy of tumor necrosis factor inhibitors (TNFis) and non-TNFis (nTNFis) in real-world patients with RA and past TNFi experience.

Methods: Comparative Effectiveness Registry to study Therapies for Arthritis and Inflammatory Conditions (CERTAIN) was nested within the United States Corrona registry.

Real evidence to assess clinical testing interference risk (REACTIR): A strategy using real world data to assess the prevalence of interfering substances in patients undergoing clinical laboratory testing.

Introduction: Laboratory test interferences can cause spurious test results and patient harm. Knowing the frequency of various interfering substances in patient populations likely to be tested with a particular laboratory assay may inform test development, test utilization and strategies to mitigate interference risk.

Methods: We developed REACTIR (Real Evidence to Assess Clinical Testing Interference Risk), an approach using real world data to assess the prevalence of various interfering substances in patients tested with a particular type of assay.

Clinical Impact of Adherence to NCCN Guidelines for Biomarker Testing and First-Line Treatment in Advanced Non-Small Cell Lung Cancer (aNSCLC) Using Real-World Electronic Health Record Data.

Introduction: Although clinical guidelines are broadly available, the relationship between adherence and outcomes is not well studied. This study aimed to assess the association between adherence to National Comprehensive Cancer Network (NCCN) guidelines and clinical outcomes for adult patients with advanced non-small-cell lung cancer (aNSCLC).

Methods: This was a retrospective cohort study of adult patients with aNSCLC (stages IIIB, IIIC, and IV) from a de-identified real-world database.

Value of Precision Medicine in Advanced Non-Small Cell Lung Cancer: Real-World Outcomes Associated with the Use of Companion Diagnostics.

Background: Companion diagnostic (CDx) testing for patients with advanced non-small cell lung cancer (aNSCLC) identifies patients more likely to benefit from biomarker-driven treatments.

Methods: Patients with nonsquamous cell (non-Sq) aNSCLC from the Flatiron Health database (diagnosed January 1, 2011-May 31, 2018) who had CDx testing were compared with those who had no reported evidence of testing. The association between CDx testing and overall survival was evaluated by unadjusted and adjusted Cox proportional hazards regression models.

ISPOR, the FDA, and the Evolving Regulatory Science of Medical Device Products.

The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is a key venue for members from private industry, government, and academia to collaborate and share advances in regulatory, clinical, and reimbursement science for drugs, devices, and diagnostics. In parallel, the US Food and Drug Administration (FDA) "is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable." In 2012, the Medical Device Innovation Consortium (MDIC) was formed as a public-private partnership bringing together government, industry, and nonprofit organizations to advance approaches that promote patient access to safe, innovative medical technologies.

Long-Term Safety of Rituximab in Rheumatoid Arthritis: Analysis From the SUNSTONE Registry.

Objective: To evaluate the long-term safety of rituximab in an observational cohort of patients with rheumatoid arthritis (RA) who had an inadequate response to ≥ 1 antitumor necrosis factor therapies in the United States (SUNSTONE Registry).

Methods: In this prospective, observational cohort study, patients received rituximab according to their physician's standard practice and were evaluated at standard-of-care follow-up visits at least every 6 months. The primary outcome was the incidence of protocol-defined significant infections.

Impact of rituximab on patient-reported outcomes in patients with rheumatoid arthritis from the US Corrona Registry.

To evaluate the impact of rituximab on patient-reported outcomes (PROs) in a US-based observational cohort of patients with rheumatoid arthritis (RA). Patients with active RA, prior exposure to ≥1 tumor necrosis factor inhibitor (TNFi) and who newly initiated rituximab were identified. Changes in PROs were assessed 1 year after rituximab initiation.

Concomitant Use of Statins in Tocilizumab-Treated Patients with Rheumatoid Arthritis: A Post Hoc Analysis.

Introduction: Patients with rheumatoid arthritis (RA) have decreased survival because of increased cardiovascular risk compared with the general population, and treatment with tocilizumab (TCZ) has been shown to increase lipid levels; however, the relationship between lipids and cardiovascular risk is unknown. This post hoc analysis expanded on previously reported 24-week results by characterizing statin use and subsequent changes in lipid parameters in patients with RA treated with intravenous or subcutaneous TCZ (TCZ-IV or TCZ-SC) over 2 years of treatment.

Methods: Data were collected from patients with moderate to severe active RA who received ≥1 dose of the study drug in seven international, randomized, double-blind, controlled phase 3 and 4 clinical trials of TCZ-IV or TCZ-SC.

Dosing of Intravenous Tocilizumab in a Real-World Setting of Rheumatoid Arthritis: Analyses from the Corrona Registry.

Introduction: In the United States, the recommended starting dose of intravenous tocilizumab (TCZ) is 4 mg/kg every 4 weeks, with an increase to 8 mg/kg based on clinical response for patients with moderate to severe rheumatoid arthritis; however, data on how TCZ dose is escalated in real life are missing. The objective of this analysis was to describe patterns of early intravenous TCZ dose escalation in a real-world setting using data from the Corrona registry.

Methods: All patients enrolled in the comparative effectiveness substudy (CERTAIN) nested within Corrona who initiated TCZ and completed 3- and 6-month study visits were eligible for inclusion.

Risk of Infection Associated With Subsequent Biologic Agent Use After Rituximab: Results From a National Rheumatoid Arthritis Patient Registry.

Objective: To assess whether the time between the last rituximab infusion and initiation of a different biologic agent influenced infection risk in patients with rheumatoid arthritis (RA).

Methods: Patients with RA who newly initiated rituximab within the Consortium of Rheumatology Researchers of North America registry were included if they switched to a nonrituximab biologic agent and had ≥1 followup visit within 12 months of switching. Patients were categorized by duration of time between their last rituximab infusion and initiation of a subsequent biologic agent (≤5 months, 6-11 months, and ≥12 months).

Comparative effectiveness and safety of rituximab versus subsequent anti-tumor necrosis factor therapy in patients with rheumatoid arthritis with prior exposure to anti-tumor necrosis factor therapies in the United States Corrona registry.

Introduction: Patients with active rheumatoid arthritis (RA) despite anti-tumor necrosis factor(anti-TNF)agent treatment can switch to either a subsequent anti-TNF agent or a biologic with an alternative mechanism of action, such as rituximab; however, there are limited data available to help physicians decide between these 2 strategies. The objective of this analysis was to examine the effectiveness and safety of rituximab versus a subsequent anti-TNF agent in anti-TNF-experienced patients with RA using clinical practice data from the Corrona registry.

Methods: Rituximab-naive patients from the Corrona registry with prior exposure to ≥1 anti-TNF agent who initiated rituximab or anti-TNF agents (2/28/2006-10/31/2012) were included.

Characteristics Associated with Biologic Monotherapy Use in Biologic-Naive Patients with Rheumatoid Arthritis in a US Registry Population.

Introduction: The aim of this study was to describe factors associated with initiating a biologic as monotherapy vs in combination with a conventional disease-modifying antirheumatic drug (DMARD) in biologic-naive patients with rheumatoid arthritis (RA) enrolled in the Corrona registry.

Methods: First biologic initiations were classified as monotherapy (Bio MT) or combination therapy (Bio CMB). Baseline demographic and clinical characteristics were evaluated.

Effectiveness of Rituximab for the Treatment of Rheumatoid Arthritis in Patients with Prior Exposure to Anti-TNF: Results from the CORRONA Registry.

Objective: To characterize the real-world effectiveness of rituximab (RTX) in patients with rheumatoid arthritis.

Methods: Clinical effectiveness at 12 months was assessed in patients who were prescribed RTX based on the Clinical Disease Activity Index (CDAI). Change in CDAI was calculated (CDAI at 12 mos minus at initiation).

The rheumatoid arthritis treat-to-target trial: a cluster randomized trial within the Corrona rheumatology network.

Background: The treat-to-target (T2T) approach to the care of patients with rheumatoid arthritis involves using validated metrics to measure disease activity, frequent follow-up visits for patients with moderate to high disease activity, and escalation of therapy when patients have inadequate therapeutic response as assessed by standard disease activity scores. The study described is a newly launched cluster-randomized behavioral intervention to assess the feasibility and effectiveness of the T2T approach in US rheumatology practices. It is designed to identify patient and provider barriers to implementing T2T management.

Technetium-99m bone scan and panoramic radiography in detection of bone invasion by oral carcinoma.

Objective: The correct extension of cancer in the bone usually remains undetected on static imaging which may lead to inadequate or over excision. The conventional radiography as well as other anatomical imaging modalities like computed tomography, magnetic resonance imaging often fails to detect functional changes in the bone. However, bone scinitigraphy is highly sensitive in detecting earlier changes in the bone but lack anatomical definition.

Bone scintigraphy and panoramic radiography in deciding the extent of bone resection in benign jaw lesions.

Objective: To find out the value of correlating radiographic and scintigraphic imaging for defining the extent and nature of benign jaw lesions (BJL).

Material And Methods: Twenty patients with histologically proven benign lesions of the jaws were investigated pre-operatively by panoramic radiography (PR) and bone scintigraphy (BS). To test the efficacy of combination of these two imaging modalities, their results were compared with intra-operative and histopathological findings.

Improvements in health-related quality of life after treatment with tocilizumab in patients with rheumatoid arthritis refractory to tumour necrosis factor inhibitors: results from the 24-week randomized controlled RADIATE study.

Objective: To investigate the effect of tocilizumab on patient-reported outcomes (PROs) in RA patients with inadequate responses to TNF inhibitors (TNFis).

Methods: In a Phase III randomized controlled trial, 489 patients received 4 or 8 mg/kg tocilizumab or placebo every 4 weeks plus MTX for 24 weeks. Mean changes from baseline over time and proportions of patients reporting improvements greater than or equal to minimum clinically important differences (MCIDs) in PROs were analyzed.

Factors associated with gastrointestinal perforation in a cohort of patients with rheumatoid arthritis.

Objective: To estimate the incidence and risk factors for gastrointestinal (GI) perforation among patients with rheumatoid arthritis (RA).

Methods: Claims from employer health insurance plans were used to identify RA patients and those hospitalized for upper or lower GI perforation. GI perforation cases were identified using both a sensitive and a specific definition.

Dyslipidemia and changes in lipid profiles associated with rheumatoid arthritis and initiation of anti-tumor necrosis factor therapy.

Objective: To investigate the frequency of lipid testing in clinical practice and to explore the relationship between rheumatoid arthritis (RA), dyslipidemia, and other cardiovascular (CV) risk factors with RA treatment.

Methods: Patients in this retrospective database study were ages ≥18 years and had ≥2 physician diagnoses for RA or osteoarthritis (OA; comparator group) between March 2004 and March 2008. Outcomes of interest included the percentage of RA and OA patients receiving lipid tests, lipid profiles (total cholesterol, low-density lipoprotein [LDL] cholesterol, and high-density lipoprotein [HDL] cholesterol) of RA versus OA patients, and lipid profiles of RA patients before and after initiation with a tumor necrosis factor (TNF) inhibitor.

Validation of ICD-9-CM codes to identify gastrointestinal perforation events in administrative claims data among hospitalized rheumatoid arthritis patients.

Purpose: To validate, using physician review of abstracted medical chart data as a gold standard, a claims-based algorithm developed to identify gastrointestinal (GI) perforation cases among rheumatoid arthritis (RA) patients.

Methods: Patients with established RA, aged 18 years or older with hospital admissions between January 2004 and September 2009, were selected from a large US-hospital-based database. An algorithm with International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes for GI perforation and combinations of GI-related diagnosis codes and Current Procedural Terminology (CPT-4) procedure codes for relevant GI surgeries was used to identify potential GI perforation cases.

Utilization of biologic agents in rheumatoid arthritis in the United States: analysis of prescribing patterns in 16,752 newly diagnosed patients and patients new to biologic therapy.

Background: Treatment of rheumatoid arthritis (RA) has shifted toward earlier and more aggressive therapy with tra- ditional disease-modifying antirheumatic drugs (DMARDs) and biologics. However, the extent to which these agents are used in current clinical practice in the United States (U.S.