Andre B. Araujo

Erectile Dysfunction as a Marker for Cardiovascular Disease Diagnosis and Intervention: A Cost Analysis

INTRODUCTIONnErectile dysfunction (ED) is a risk factor for cardiovascular disease (CVD). We examine the costs of screening men with ED for CVD risk factors and the cost savings of treating these at risk men.nnnAIMnThis study aims to evaluate the effect of screening men presenting with ED for CVD risk factors and to determine the cost effectiveness of this screening protocol.nnnMETHODSnThe known incidence and prevalence of ED and CVD, the rate of undiagnosed CVD, and the effects of CVD treatment were used to model the change in prevalence of acute CVD events and ED as a function of the number of men with ED and CVD. The cost savings associated with reduction in acute cardiovascular (CV) events and ED prevalence was estimated over 20 years.nnnMAIN OUTCOME MEASURESnAcute CVD event rate reduction and associated cost savings were modeled over 20 years.nnnRESULTSnThe relative risk of ED in men with CVD is 1.47 and the coprevalence of both ED and CVD was estimated at 1,991,520 men. Approximately 44% of men with CVD risk factors are unaware of their risk. If all men presenting with ED were screened for CVD, 5.8 million men with previously unknown CVD risk factors would be identified over 20 years, costing

Prevalence of rheumatoid arthritis in the United States adult population in healthcare claims databases, 2004–2014

2.7 billion to screen. Assuming a 20% decrease in CV events as a result of screening and treatment, 1.1 million cardiovascular events would be avoided, saving

Incretin-mimetic therapies and pancreatic disease: a review of observational data.

21.3 billion over 20 years. Similarly, 1.1 million cases of ED would be treated, saving

Racial/Ethnic and Socioeconomic Differences in Bone Loss Among Men

9.7 billion. Together, the reduction in acute CVD and ED treatment cost would save

Characteristics and Medication Use of Psoriasis Patients Who May or May Not Qualify for Randomized Controlled Trials

28.5 billion over 20 years.nnnCONCLUSIONSnScreening for CVD in men presenting with ED can be a cost-effective intervention for secondary prevention of both CVD and, over the longer term, ED.

Treatment Patterns of Newly Diagnosed Rheumatoid Arthritis Patients from a Commercially Insured Population

This study aimed to determine the prevalence of rheumatoid arthritis in the United States (US) adult insured population from 2004 to 2014. This was an observational, retrospective, cross-sectional study based on US administrative health insurance claims databases (Truven Health MarketScan® Research database and IMS PharMetrics Plus database). Trends in RA prevalence focusing on the 10-year period covering January 1, 2004–December 31, 2014 were analyzed using a validated algorithm for the identification of RA. Prevalence rates in the databases were determined and age- and gender-adjusted rates were projected to the US population in 2014. Analysis of data from the two databases indicated that the RA prevalence rate in commercially insured adult US population ranged from 0.41 to 0.54% from 2004 to 2014. The prevalence varied substantially by gender and age in each year and increased gradually across the years for most subgroups. In 2014, out of 31,316,902 adult patients with continuous enrollment in the Truven Health MarketScan® Research database, 157,634 (0.50%) patients met our criteria for RA. Similarly, out of 35,083,356 adult patients in the IMS PharMetrics Plus database, 139,300 (0.50%) patients met our criteria for RA. In 2014, the overall age-adjusted prevalence of RA ranged from 0.53 to 0.55% (0.29–0.31% for males and 0.73–0.78% for females). The prevalence of RA in the US appeared to increase during the period from 2004 to 2014, affecting a conservative estimate of 1.28–1.36 million adults in 2014.

Examination of Patient-Reported Outcomes in Association with TNF-Inhibitor Treatment Response: Results from a US Observational Cohort Study

Abstract Background/objective: Signals from the FDA Adverse Event Reporting System (AERS) and pre-clinical and human pancreata obtained from organ donors have suggested that incretin-based therapies used to treat type 2 diabetes mellitus, such as glucagon-like peptide 1 (GLP-1) receptor agonists and dipeptidyl peptidase-4 (DPP-4) inhibitors, may increase the risk of acute pancreatitis (AP) and pancreatic cancer (PC). However, data from observational studies and randomized trials have been conflicting. We conducted a literature review to identify and summarize all observational data published assessing the pancreatic safety of incretins. Methods: Searches were conducted in MEDLINE via PubMed and Embase using the key terms for the time period of 1 January 2005, to 12 February 2014. A total of 180 articles were screened in abstract form and 49 were subsequently reviewed in full text for inclusion. Data from 12 articles are included in this report. Findings: Data from the FDA AERS database suggest increased risk of AP and PC with GLP-1 receptor agonist and DPP-4 inhibitor use. These findings are not supported by population-based observational studies for either AP or PC; however, studies assessing the relationship between PC and incretin-based therapies are limited. Conclusions: Current evidence is conflicting and inadequate to conclude whether use of incretin-based therapies increases the risk of AP and PC. Further studies, with the ability to provide long term follow-up, are needed.

Healthcare resource utilization and costs among psoriasis patients treated with biologics, overall and by disease severity

As men age, they lose bone and are susceptible to fracture. Despite having lower fracture rates than women, men have worse fractures than women do. Racial/ethnic and socioeconomic status (SES) disparities in fracture rates exist, yet data on rates of bone loss by race/ethnicity and SES among men are limited. We examined annualized percentage change in bone mineral density (%ΔBMD) at the hip (Nu2009=u2009681), spine (Nu2009=u2009663), and forearm (Nu2009=u2009636) during 7 years of follow‐up among men aged 30–79 years at baseline. Multivariable models tested whether race/ethnicity, income, or genetic ancestry predicted annualized %ΔBMD after controlling for an extensive set of covariates. Annualized %ΔBMD ranged from −0.65(0.04)% (femoral neck) to +0.26(0.03)% (1/3 distal radius), and changes were consistent across age groups with the exception of the ultradistal radius, where annualized declines increased with age. Neither self‐identified race/ethnicity nor genetic ancestry were associated with annualized %ΔBMD. In contrast, income was strongly associated (dose‐response) with annualized %ΔBMD at total hip (independent of confounders, self‐identified race/ethnicity, and genetic ancestry). Fully adjusted least‐square mean change in annualized %ΔBMD at the total hip were −0.24(0.12)% and −0.16(0.06)% steeper among men with low and moderate incomes, respectively, than among men with higher incomes (overall pu2009=u20090.0293). Results show a linear decline in bone that begins relatively early in life among men, that rates of bone loss do not vary with race/ethnicity (self‐identified or “objectively” measured), and that income plays an important role in relation to bone loss at the hip. These data suggest that fracture risk in men may be driven in part by income‐related differences in bone loss, but also, that the known higher fracture risk among white men is not the result of racial/ethnic differences in bone loss, but rather, early life exposures that lead to attainment of higher peak bone mass among minorities.

Treatment patterns among patients with psoriasis using a large national payer database in the United States: a retrospective study

BACKGROUNDnClinical trials impose exclusion criteria that may limit the generalizability of results.nnnOBJECTIVESnTo (a) determine the percentage of real-world patients who would qualify for psoriasis randomized controlled trials; (b) ascertain differences between moderate-to-severe psoriasis patients who would be eligible, ineligible, or potentially eligible for clinical trials; and (c) compare their biologic treatment patterns.nnnMETHODSnModerate-to-severe psoriasis patients were identified from the U.S. Department of Defense health care database from January 1, 2008, to October 31, 2013. Eligibility classification for psoriasis trials was based on common trial exclusion criteria involving medical conditions and recent treatment history. Patient characteristics and treatment patterns of 4 biologics (adalimumab, etanercept, infliximab, and ustekinumab) were compared between groups. Adherence was measured by medication possession ratio and persistence as continuous time on drug with ≤ 90-day gap between supply times.nnnRESULTSnAmong 16,284 qualifying psoriasis patients, 4,677 (28.7%) were medically ineligible, and 8,466 (52.0%) had ineligibility-related treatments that could be stopped prior to trial entry; the latter patients were considered potentially eligible for psoriasis trials. Common reasons for medical ineligibility included malignancies and hematologic disorders; treatment ineligibilities included use of topical corticosteroids and phototherapy. Medically ineligible patients were older and had more comorbidities, while potentially eligible patients were younger and healthier than trial-eligible patients. Most treatment patterns were similar across groups, except that, compared with the trial-eligible group, medically ineligible patients had greater adherence to infliximab and potentially trial-eligible patients had greater adherence and persistence to adalimumab.nnnCONCLUSIONSnThis large real-world study found that patients who may be ineligible for psoriasis trials differ in important respects (e.g., comorbidities, prior treatments) from their trial-eligible counterparts. Regardless of their differences at baseline, adherence, persistence, and switching of biologic medications are largely similar, with few differences noted among groups.nnnDISCLOSURESnFinancial support for this study was provided by Lilly USA. Wu has received research funding from AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Coherus Biosciences, Dermira, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Regeneron, Sandoz, and Sun Pharmaceutical Industries, and he is a consultant for AbbVie, Amgen, Celgene, Dermira, Eli Lilly, Pfizer, Regeneron, and Sun Pharmaceutical Industries. Malatestinic, Goldblum, Solotkin, Lin, Johnston, and Araujo are employees and/or stock owners of Lilly. Nordstrom, Kistler, and Fraeman are employees of Evidera, which received funding from Lilly to conduct this study. LCDR Hawley is a military service member. This work was prepared as part of her official duties. Title 17 U.S.C. 105 provides that copyright protection under this title is not available for any work of the United States Government. Title 17 U.S.C. 101 defines a U.S. government work as a work prepared by a military service member or employee of the U.S. government as part of that persons official duties. Research data were derived from an approved Naval Medical Center, Portsmouth, Virginia, institutional review board protocol. The views expressed in this work are those of the authors and do not necessarily reflect the official policy or position of the Department of the Navy, Department of Defense, or the U.S. government. Study concept and design were contributed by Malatestinic and Araujo, along with the other authors. Nordstrom, Kistler, Fraeman, and Sicignano collected the data, and data interpretation was performed by Wu, Lin, and Hawley, along with Malatestinic, Nordstrom, Solotkin, and Araujo. The manuscript was written by Johnston, Malatestinic, Kistler, Wu, and Araujo, along with Nordstrom, Goldblum, Solotkin, Hawley, and Sicignano, and revised by Goldblum, Solotkin, Malatestinic, and Araujo, along with Nordstrom, Wu, Fraeman, Johnston, Hawley, and Sicignano.

Treatment patterns, adherence, and persistence among psoriasis patients treated with biologics in a real-world setting, overall and by disease severity

IntroductionTo describe treatment patterns in newly diagnosed rheumatoid arthritis (RA) patients in a large, nationally representative managed-care database.MethodsNewly diagnosed RA patients were identified from 07/01/2006–08/31/2014. Patients had ≥ 1 RA diagnosis by a rheumatologist, or ≥ 2 non-rheumatologist RA diagnoses ≥ 30 days apart, or RA diagnosis followed by a disease-modifying antirheumatic drug (DMARD) prescription fill within 1 year. Patients were ≥ 18 years old at index (earliest date fulfilling diagnostic criteria) and had ≥ 6 and 12 months of pre- and post-index health plan enrollment, respectively. Patterns of DMARD treatment, including conventional synthetic DMARDs (csDMARD), tumor necrosis factor inhibitors (TNFi), non-TNFi, and Janus kinase inhibitors (JAKi), were captured during follow-up.ResultsOf the 63,101 RA patients identified, 73% were female; mean age was 57 years. During an average of 3.5 ± 2.1 years of follow-up, 45% of patients never received a DMARD, 52% received a csDMARD (94 ± 298 meanxa0±xa0SD days from index), 16% a TNFi (315 ± 448 days), 4% a non-TNFi (757 ± 660 days), and < 1% a JAKi. Among DMARD recipients, the most common treatment patterns were: receiving csDMARDs only (68%), adding a TNFi as second-line therapy after initiation of a csDMARD (12%), and receiving only a TNFi (6%) during follow-up. Among those not on DMARDs, the all-cause usage of an opioid was 56% and 19% had chronic opioid use (≥ 180 days supplied).ConclusionsDespite American College of Rheumatology recommendations for DMARD treatment of RA, nearly half of newly diagnosed RA patients received no DMARD therapy during follow-up. These data identify a treatment gap in RA management.FundingEli Lilly & Company.