Validation of serostatus of rheumatoid arthritis using ICD-10 codes in administrative claims data.

Purpose: To determine the accuracy of International Classification of Diseases- Tenth Revision (ICD-10) diagnosis codes for rheumatoid arthritis (RA) serostatus using a U.S. claims database (Optum Clinformatics Data Mart, Optum) and to compare the results to a previous validation study performed in IBM Marketscan Research Database (sensitivity 73%, positive predictive value, PPV, 84%).

Real-world patient characteristics and use of disease-modifying anti-rheumatic drugs in patients with rheumatoid arthritis: a cross-national study.

Introduction: Rheumatoid arthritis (RA) is associated with significant morbidity and economic burden. This study aimed to compare baseline characteristics and patterns of anti-inflammatory drug use and disease-modifying anti-rheumatic drug (DMARD) use among patients with RA in Southern Italy versus the United States.

Method: Using Caserta Local Health Unit (Italy) and Optum's de-identified Clinformatics® Data Mart (United States) claims databases, patients with ≥ 2 diagnosis codes for RA during the study period (Caserta: 2010-2018; Optum: 2010-2019) were identified.

Predictors of Treatment Change Among Patients with Rheumatoid Arthritis Treated with TNF Inhibitors as First-Line Biologic Agent in the USA: A Cohort Study from Longitudinal Electronic Health Records.

Background: Previous observational studies utilizing administrative claims data have largely been unable to consider clinical factors that may be related to patterns of drug use among patients with rheumatoid arthritis (RA).

Objective: To understand predictors of treatment changes following initiation of a tumor necrosis factor inhibitor (TNFi) using nation-wide electronic health record (EHR) data in the USA.

Methods: The Optum Immunology Condition EHR data (01/01/2011-09/30/2019) was used to identify a population of adult patients with RA initiating a TNFi as the first line biologic disease-modifying anti-rheumatic drug (DMARD).

Patient characteristics associated with use of TNF vs interleukin inhibitors as first-line biologic treatment for psoriatic arthritis.

Previous studies have examined treatment patterns among patients who use tumor necrosis factor (TNF) inhibitors for psoriatic arthritis (PsA). However, little data exist for a comparison between the TNF inhibitor treatment pattern and that of newly available biologics such as interleukin (IL)-12/23 or 17 inhibitors in the United States. To (a) examine patient characteristics and their association with initiation of TNF inhibitors vs IL-12/23 or 17 inhibitors among PsA patients and (2) compare treatment persistence of PsA patients who initiated TNF inhibitors vs IL-12/23 or 17 inhibitors as first-line biologic treatment in a real-world setting in the United States.

Secular Trends in the Pharmacologic Treatment of Osteoporosis and Malignancy-Related Bone Disease from 2009 to 2020.

Background: New bone-directed therapies, including denosumab, abaloparatide, and romosozumab, emerged during the past decade, and recent trends in use of these therapies are unknown.

Objective: To examine temporal trends in bone-directed therapies.

Design: An open cohort study in a US commercial insurance database, January 2009 to March 2020.

Development and Validation of a Pediatric Comorbidity Index.

Comorbidity scores are widely used to help address confounding bias in nonrandomized studies conducted within health-care databases, but existing scores were developed to predict all-cause mortality in adults and might not be appropriate for use in pediatric studies. We developed and validated a pediatric comorbidity index, using health-care utilization data from the tenth revision of the International Classification of Diseases. Within the MarketScan database of US commercial claims data, pediatric patients (aged ≤18 years) continuously enrolled between October 1, 2015, and September 30, 2017, were identified.

Safety and Effectiveness of Dabigatran and Other Direct Oral Anticoagulants Compared With Warfarin in Patients With Atrial Fibrillation.

The study objective was to evaluate the safety and effectiveness of dabigatran and other direct oral anticoagulants (DOACs) compared with warfarin among patients with nonvalvular atrial fibrillation using a prospective monitoring program. We implemented a cohort design with propensity score matching to compare initiators of DOACs and warfarin between 2010 and 2015 in two US healthcare databases. Proportional hazards regression was used to estimate hazard ratios (HRs) for stroke and major bleeding.

Association of Opioid Overdose With Opioid Prescriptions to Family Members.

Importance: Prescription opioid misuse is a public health problem that leads to overdose. Although existing interventions focus on limiting prescribing to patients at high risk, individuals may still access prescription opioids dispensed to family members.

Objective: To determine whether opioid prescriptions to family members were associated with overdose for individuals who themselves did not have an opioid prescription.

Claims Data Studies of Direct Oral Anticoagulants Can Achieve Balance in Important Clinical Parameters Only Observable in Electronic Health Records.

Claims databases provide information on the effects of direct oral anticoagulants (DOACs) as used in routine care but may not contain important data on clinical characteristics, which may be captured in electronic health records (EHRs). Within a US claims database, we identified patients initiating a DOAC or warfarin between October 2010 and December 2014. Propensity score (PS) matching, 1:1, was used to balance 78 claims-defined baseline characteristics.

Changes in Outpatient Use of Antibiotics by Adults in the United States, 2006-2015.

Introduction: Numerous initiatives over the past decade have targeted the problem of antibiotic overuse in the US; however, the cumulative impact of such initiatives upon recent patterns of use is not known.

Objectives: The aims of this study were to (1) describe general trends in outpatient antibiotic use among adults over the period 2006-2015; and (2) identify rapid shifts in use during this time period as potential indicators for key events.

Methods: This was an observational study set in the ambulatory setting.

The effect of federal and state off-label marketing investigations on drug prescribing: The case of olanzapine.

In the past decade, the federal government has frequently investigated and prosecuted pharmaceutical manufacturers for illegal promotion of drugs for indications not approved by the Food and Drug Administration (FDA) ("off-label" uses). State governments can choose to coordinate with the federal investigation, or pursue their own independent state investigations. One of the largest-ever off-label prosecutions relates to the atypical antipsychotic drug olanzapine (Zyprexa).

Fracture Risk After Bariatric Surgery: Roux-en-Y Gastric Bypass Versus Adjustable Gastric Banding.

The long-term consequences of bariatric surgery on fracture risk are unclear but are likely to vary by procedure type. In physiologic studies, Roux-en-Y gastric bypass (RYGB) and adjustable gastric banding (AGB) have differential effects on rates of bone loss. Therefore, our objective was to compare fracture risk in obese adults after RYGB and AGB procedures.

Effect of Combination Therapy on Adherence Among US Patients Initiating Therapy for Hypertension: a Cohort Study.

Background: New trial evidence suggests that many patients may require more aggressive pharmacologic management to achieve lower blood pressure goals. Especially when first initiating anti-hypertensive treatment, it is unknown whether starting patients on multiple medications may be better for long-term adherence and persistence compared with starting one medication.

Objective: To examine contemporary patterns of anti-hypertensive therapy initiation and compare long-term adherence and persistence among patients initiating fixed-dose combinations and single anti-hypertensive therapies.

Comparative effectiveness and safety of thalidomide and lenalidomide in patients with multiple myeloma in the United States of America: A population-based cohort study.

Background: The comparative effectiveness of thalidomide and lenalidomide in the treatment of multiple myeloma has not been established. We conducted an observational cohort study of multiple myeloma patients receiving either thalidomide or lenalidomide in routine care in the United States of America to assess their comparative survival and rates of peripheral neuropathy.

Methods: Myeloma patients were identified and followed using administrative claims data from a large national health insurance provider (UnitedHealth).

Comparative Safety and Effectiveness of Denosumab Versus Zoledronic Acid in Patients With Osteoporosis: A Cohort Study.

Limited head-to-head comparative safety and effectiveness data exist between denosumab and zoledronic acid in real-world healthcare. We aimed to examine the safety and effectiveness of denosumab compared to zoledronic acid with regard to risk of serious infection and cardiovascular disease (CVD) and osteoporotic fracture. We conducted a cohort study using claims data (2009-2013) from a US commercial insurance plan database.

Association of Industry Payments to Physicians With the Prescribing of Brand-name Statins in Massachusetts.

Importance: Pharmaceutical industry payments to physicians may affect prescribing practices and increase costs if more expensive medications are prescribed.

Objective: Determine the association between industry payments to physicians and the prescribing of brand-name as compared with generic statins for lowering cholesterol.

Design, Setting, And Participants: Cross-sectional linkage of the Part D Medicare prescriptions claims data with the Massachusetts physicians payment database including all licensed Massachusetts physicians who wrote prescriptions for statins paid for under the Medicare drug benefit in 2011.

Did FDA Decisionmaking Affect Anti-Psychotic Drug Prescribing in Children?: A Time-Trend Analysis.

Background: Following Food and Drug Administration (FDA) approval, many drugs are prescribed for non-FDA-approved ("off-label") uses. If substantial evidence supports the efficacy and safety of off-label indications, manufacturers can pursue formal FDA approval through supplemental new drug applications (sNDAs). We evaluated the effect of FDA determinations on pediatric sNDAs for antipsychotic drugs on prescribing of these products in children.

Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naïve women.

Background: The incidence of opioid-related death in women has increased 5-fold over the past decade. For many women, their initial opioid exposure will occur in the setting of routine medical care. Approximately 1 in 3 deliveries in the United States is by cesarean, and opioids are commonly prescribed for postsurgical pain management.

Availability and utilization of cardiovascular fixed-dose combination drugs in the United States.

Background: Solid clinical evidence supports the effectiveness and safety of multiple drugs in treating diabetes, dyslipidemia, and hypertension, and numerous fixed-dose combination products (FDCs) containing such drugs have been developed for patients with more severe forms of these diseases. We sought to evaluate the extent to which utilization of treatment combinations for these conditions corresponded to the availability of FDCs.

Methods: Using claims data from a large national commercial insurer, we identified 2 cohorts of patients: those who filled multiple single-agent drugs to treat diabetes, dyslipidemia, and hypertension in 2012, and those who used FDCs containing these products during the same period.

Patterns of health care utilization related to initiation of amitriptyline, duloxetine, gabapentin, or pregabalin in fibromyalgia.

Introduction: Several pharmacologic treatments are available for fibromyalgia, but little is known about the comparative effectiveness of these treatments on health care utilization.

Methods: Using US commercial insurance claims data (covering 2007 to 2009), we conducted a cohort study to examine the comparative effectiveness of amitriptyline, duloxetine, gabapentin, and pregabalin on health care utilization in patients with fibromyalgia. We measured patients' medication adherence using the proportion of days covered (PDC) and estimated multivariable rate ratios (RRs) for outpatient visits, prescriptions, hospitalization, and emergency department (ED) visits in propensity score (PS)-matched cohorts.

Clinical characteristics and medication uses among fibromyalgia patients newly prescribed amitriptyline, duloxetine, gabapentin, or pregabalin.

Objective: Fibromyalgia is a common chronic pain disorder with unclear etiology. No definitive treatment is available for fibromyalgia, and treatment with antidepressants or antiepileptics is often used for symptom management.

Methods: Using US health care utilization data, a large population-based cohort study was conducted to describe clinical characteristics and medication use patterns in patients diagnosed with fibromyalgia who newly started amitriptyline, duloxetine, gabapentin, or pregabalin.