Rishi J Desai

Rishi J Desai
Brigham and Women's Hospital | BWH · Division of Pharmacoepidemiology and Pharmacoeconomics

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206
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Publications

Publications (206)
Article
Background : The effect of sodium glucose cotransporter 2 inhibitors (SGLT2i) on the total (first and recurrent) burden of cardiovascular (CV) hospitalizations, including hospitalization for heart failure, myocardial infarction, and stroke, is poorly understood. Objective : To assess the effect of empagliflozin, an SGLT2i, on total CV hospitalizat...
Article
Background Hydroxychloroquine is often used as a first-line treatment of rheumatoid arthritis despite limited evidence on its cardiovascular risk. Objectives We conducted a cardiovascular safety evaluation comparing hydroxychloroquine to methotrexate among patients with rheumatoid arthritis. Methods Using Medicare data (2008-2016), we identified...
Article
Objective We aimed to use setting-appropriate comparisons to estimate effects of different gastrointestinal (GI) prophylaxis pharmacotherapies for patients hospitalized with COVID-19 and setting-inappropriate comparisons to illustrate how improper design choices could result in biased results. Study Design and Setting We identified 3,804 hospitali...
Article
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)...
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Background: Sacubitril/valsartan is strongly supported in guidelines for the management of heart failure, but suboptimal adherence and treatment non-persistence may limit the population-level benefit that this therapy might otherwise offer. Methods: We identified a cohort of Medicare beneficiaries (2014-2017) initiating sacubitril/valsartan afte...
Article
Increasing availability of electronic health databases capturing real-world experiences with medical products has garnered much interest in their use for pharmacoepidemiologic and pharmacovigilance studies. The traditional practice of having numerous groups use single databases to accomplish similar tasks and address common questions about medical...
Article
Introduction: Results from "ORAL Surveillance" safety trial have indicated an increased risk of malignancy with tofacitinib when compared with tumor necrosis factor inhibitors (TNFI). We further examined this safety concern in rheumatoid arthritis (RA) patients in the real-world setting. Methods: Using U.S. insurance claims data from Optum Clinf...
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Importance: Cytokine signaling, including tumor necrosis factor (TNF) and interleukin (IL)-6, through the Janus-kinase (JAK)-signal transducer and activator of transcription pathway, was hypothesized to attenuate the risk of Alzheimer disease and related dementia (ADRD) in the Drug Repurposing for Effective Alzheimer Medicines (DREAM) initiative b...
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Objective: While infliximab combined to thiopurines is more effective than infliximab monotherapy in patients with Crohn's disease (CD) and UC, the impact of adding thiopurines to vedolizumab remains controversial. We emulated two target trials comparing the effectiveness of combination therapy versus vedolizumab monotherapy in CD and UC. Design:...
Article
Background The impact of TOPCAT trial publication on spironolactone initiation and subsequent hospitalizations for hyperkalemia among patients with heart failure with preserved ejection fraction (HFpEF) has not been empirically evaluated. Methods We designed a cohort study using US Medicare fee-for-service data. Annual cohorts of patients with HFp...
Article
Objectives Recent results from ‘ORAL Surveillance’ trial have raised concerns regarding the cardiovascular safety of tofacitinib in patients with rheumatoid arthritis (RA). We further examined this safety concern in the real-world setting. Methods We created two cohorts of patients with RA initiating treatment with tofacitinib or tumour necrosis f...
Article
Objectives: To characterise the incidence rate of skin cancer associated with methotrexate and hydroxychloroquine in older adults with rheumatoid arthritis (RA). Methods: RA patients aged ≥65 years who initiated methotrexate or hydroxychloroquine as their first disease modifying antirheumatic drugs (DMARDs). The primary outcome was new occurrenc...
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The Sentinel System is a major component of the United States Food and Drug Administration’s (FDA) approach to active medical product safety surveillance. While Sentinel has historically relied on large quantities of health insurance claims data, leveraging longitudinal electronic health records (EHRs) that contain more detailed clinical informatio...
Article
Introduction: The medication burden of patients with end-stage renal disease (ESRD) on hemodialysis, a patient population with a high comorbidity burden and complex care requirements, is among the highest of any of the chronic diseases. The goal of this study was to describe the medication burden and prescribing patterns in a contemporary cohort o...
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Importance Fewer than half of US adults receive the influenza vaccine each year; many cite concerns about side effects, which occur infrequently. By contrast, the recombinant zoster vaccine causes systemic side effects in a large proportion of patients. Objective To determine whether concurrent administration of the influenza and zoster vaccines w...
Article
Little is known about the impact of dose, duration and timing of prenatal prescription opioid exposure on the risk of neonatal opioid withdrawal syndrome (NOWS). Using a cohort of 18,869 pre-pregnancy chronic opioid users nested in the 2000-2014 Medicaid Analytic eXtract, we assessed average opioid dosage within bi-weekly gestational age intervals,...
Article
Aims : Patients with rheumatoid arthritis (RA) have an increased risk of venous thromboembolism (VTE), likely related to underlying inflammation. We examined VTE risk associated with two commonly used immunomodulators in RA patients, methotrexate and hydroxychloroquine. Methods and Results : Using U.S. Medicare claims data (2008-2017), we identifi...
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Purpose understand the validity of real-world evidence (RWE) studies in ulcerative colitis (UC), we emulated the SUCCESS randomized controlled trial (RCT) on the effectiveness of infliximab plus thiopurines, using U.S. and French healthcare insurance claims data. Methods The SUCCESS trial showed improved remission with infliximab plus thiopurines...
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Objective: The objective of this study was to compare the incidence rate of nonvertebral osteoporotic fractures (NVFs) in patients with rheumatoid arthritis (RA) initiating one of the nine biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs). Methods: We analyzed claims data from Optum (2008 to March 2019), Medicare,...
Article
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.DesignAn open cohort study in a US commercial insurance database, January 2009 to March 2020.Participants...
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Background Ejection fraction (EF) is an important prognostic factor in heart failure (HF), but administrative claims databases lack information on EF. We previously developed a model to predict EF class from Medicare claims. Here, we evaluated the performance of this model in an external validation sample of commercial insurance enrollees. Methods...
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Objective To evaluate the effectiveness of angiotensin receptor-neprilysin inhibitor (ARNI) versus renin-angiotensin system (RAS) blockade alone in older adults with heart failure with reduced ejection fraction (HFrEF). Methods We conducted a cohort study using US Medicare fee-for-service claims data (2014–2017). Patients with HFrEF ≥65 years were...
Article
Objective To compare the risk of serious infections requiring hospitalization in patients with psoriasis (PsO) or psoriatic arthritis (PsA) initiating ustekinumab versus other biologics or apremilast. Methods In this multi‐database cohort study, we identified patients with PsO/PsA who initiated adalimumab, apremilast, certolizumab, etanercept, gol...
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Importance List prices set by manufacturers for brand-name prescription drugs in the US have been increasing faster than inflation, although confidential manufacturer rebates offset some of these increases. Most commercially insured patients pay at least some out-of-pocket costs for prescription drugs, and higher patient spending is associated with...
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Multiple new osteoporosis therapies, including some with novel mechanisms of action, have been introduced in the past decade. However, little is known about temporal trends in prescribing these new medications. Using claims data from the Clinformatics Data Mart (Optum, Inc.), we determined the number of enrolled individuals over age 50 who were pre...
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Real‐world evidence (RWE) on the effectiveness of treatments in Crohn’s disease (CD) derived from clinical practice data will help fill many evidence gaps left by randomized controlled trials (RCTs). Emulating RCTs with healthcare database studies may calibrate RWE studies in CD. We aimed to emulate the SONIC trial on the effectiveness of inflixima...
Article
Objective To evaluate the risk of venous thromboembolism (VTE) with tofacitinib compared to tumor necrosis factor inhibitors (TNFIs) in patients with rheumatoid arthritis (RA). Methods RA patients initiating tofacitinib or a TNFI without use of any biologic or tofacitinib any time prior were identified from IBM ‘MarketScan’ (2012-2018), Medicare (...
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Objective To evaluate the risk of first trimester exposure to prescription opioids for major congenital malformations, previously reported to be associated with such exposure. Design Population based cohort study. Setting Nationwide sample of publicly and commercially insured pregnant women linked to their liveborn infants, nested in the Medicaid...
Article
Objective We aimed to investigate the prevalence, incidence and cause-specific mortality of RA-associated interstitial lung disease (RA-ILD) among older US patients with RA. Methods We performed a nationwide cohort study using Medicare claims data (parts A, B and D for 2008–2017). RA was identified with a validated algorithm using RA diagnosis cod...
Article
Objective To develop a claims‐based model to predict persistent high‐dose opioid use amongst patients undergoing total knee replacement (TKR). Methods Using Medicare claims (2010‐2014), we identified patients ≥65 years who underwent TKR with no history of high‐dose opioid use (>25 mean morphine equivalents (MME)/day) in the year prior. We used gro...
Article
Purpose To evaluate chronic opioid utilization patterns during pregnancy using nationwide data from publicly and commercially insured women. Methods Pregnancy cohorts were identified using data from the Medicaid Analytic eXtract 2008–2014 and the IBM Health MarketScan Research Database 2008–2015. Opioid dispensing was evaluated using claims from f...
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Background: Regulators are evaluating the use of non-interventional real-world evidence (RWE) studies to assess the effectiveness of medical products. The RCT-DUPLICATE initiative uses a structured process to design RWE studies emulating randomized controlled trials (RCTs) and compare results. Here, we report findings of the first 10 trial emulatio...
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Background and aims The risk of serious infections associated with vedolizumab in patients with inflammatory bowel disease (IBD) is uncertain. We assessed the risk of serious infections associated with use of vedolizumab versus anti-TNF in patients with IBD, according to IBD subtype and previous exposure to anti-TNF. Methods Based on two U.S. nati...
Article
Background Vaginal delivery is the most common reason for hospitalization in the United States and approximately 30% of women fill an opioid prescription after vaginal delivery, making this a common source of opioid exposure in women of reproductive age. Objective(s) To evaluate the effect of receiving an opioid prescription after vaginal delivery...
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Objectives Bone marrow transplantation (BMT) is currently the only curative therapy available for patients with sickle cell disease (SCD), but clinical outcomes in routine care are not well understood. We describe the rates of vaso‐occlusive crises (VOCs), transplant complications, and mortality in SCD patients after BMT. Methods A cohort study of...
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Drug discovery for disease-modifying therapies for Alzheimer's disease and related dementias (ADRD) based on the traditional paradigm of experimental animal models has been disappointing. We describe the rationale and design of the Drug Repurposing for Effective Alzheimer's Medicines (DREAM) study, an innovative multidisciplinary alternative to tra...
Article
Background Population-level data spanning different countries describing oral and parenteral treatment in pregnant women with inflammatory bowel disease (IBD) are scarce. We studied treatment with sulfasalazine/5-aminosalicylates, corticosteroids, thiopurines/immunomodulators, and tumor necrosis factor (TNF)-inhibitors in the United States (Optum C...
Preprint
Full-text available
BACKGROUND Ejection fraction (EF) is an important prognostic factor in heart failure (HF), but administrative claims databases lack information on EF. We previously developed a model to predict EF class from Medicare claims. Here, we evaluated the performance of this model in an external validation sample of commercial insurance enrollees. METHOD...
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To add to the limited existing evidence on clinical outcomes and healthcare use in sickle cell disease (SCD) among beneficiaries of the US Medicaid program, we conducted a cohort study using nationwide Medicaid claims data (2000–2013). Patients were included based on HbSS SCD diagnosis and followed until Medicaid disenrollment, death, bone marrow t...
Article
Introduction Administrative claims do not contain ejection fraction (EF) information for heart failure (HF) patients. To address this limitation, we recently developed a claims-based model to classify HF patients into reduced EF (rEF) or preserved EF (pEF) using 35 predictors. Purpose To report distribution of key patient characteristics and rates...
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Introduction With increasing rates of opioid overdoses in the US, a surveillance tool to identify high-risk patients may help facilitate early intervention. Objective To develop an algorithm to predict overdose using routinely-collected healthcare databases. Methods Within a US commercial claims database (2011–2015), patients with ≥1 opioid presc...
Article
Gout is the most common inflammatory arthritis affecting nearly 4% of adults (9.2 millions) in the U.S. Initiation of urate‐lowering therapy (ULT) is strongly recommended for all patients with tophaceous gout, radiographic damage, or frequent gout flares. While allopurinol is the first‐line ULT, some patients do not tolerate or adequately respond t...
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Background Administrative claims do not contain ejection fraction information for heart failure patients. We recently developed and validated a claims-based model to predict ejection fraction subtype. Methods Heart failure patients aged 65 or above from US Medicare fee-for-service claims were identified using diagnoses recorded during a 6-month ba...
Article
Background: Hydroxychloroquine (HCQ) is generally considered safe in pregnancy for the treatment of rheumatic conditions, but studies have been too small to evaluate teratogenicity. Quantifying the risk of congenital malformations associated with early pregnancy exposure to HCQ is important both in the context of its ongoing use for rheumatologica...
Article
Objective: Certain antihyperglycemic therapies modify cardiovascular and kidney outcomes among patients with type 2 diabetes, but early uptake in practice appears restricted to particular demographics. We examine the association of Medicaid expansion with use of and expenditures related to antihyperglycemic therapies among Medicaid beneficiaries....
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Background: Despite the widespread use, only sparse information is available on the safety of gabapentin during pregnancy. We sought to evaluate the association between gabapentin exposure during pregnancy and risk of adverse neonatal and maternal outcomes. Methods and findings: Using the United States Medicaid Analytic eXtract (MAX) dataset, we...
Article
Background The bias implications of outcome misclassification arising from imperfect capture of mortality in claims‐based studies are not well understood. Methods and Results We identified 2 cohorts of patients: (1) type 2 diabetes mellitus (n=8.6 million), and (2) heart failure (n=3.1 million), from Medicare claims (2012–2016). Within the 2 cohor...
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Background Inflammatory bowel disease (IBD) patients may develop anterior uveitis. Methods An observational cohort of IBD patients followed new users of (1) tumor necrosis factor inhibitor versus nonbiologic agents or (2) adalimumab versus infliximab until occurrence of anterior uveitis or treatment change/discontinuation. Cox-proportional hazards...
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Background: The differential impact of various demographic characteristics and comorbid conditions on development of heart failure (HF) with preserved (pEF) and reduced ejection fraction (rEF) is not well studied among the elderly. Methods: Using Medicare claims data linked to electronic health records, we conducted an observational cohort study...
Article
The comparative safety of frequently used second-line agents to treat type 2 diabetes (T2D) with respect to the risk of venous thromboembolism (VTE) in routine care is unknown. It has been hypothesized that the diuretic effect of SGLT2 inhibitors (SGLT2i) may have an unintended impact on VTE risk by increasing blood viscosity. Using Optum Clinforma...
Article
Background: Certain antihyperglycemic therapies modify CV disease courses in DM, but their uptake in practice appears limited among low-income adults. Methods: We employed a difference-in-difference (DiD) design to study the association between Medicaid Expansion and non-insulin antihyperglycemic prescriptions. We used 2012-2017 National and State...
Article
Background Patients undergoing total knee replacement (TKR) are at increased risk of persistent opioid use and dependence Objectives To identify patients with persistent high-dose opioid use after TKR using group-based trajectory models (GBTM) and determine predictors of persistent high-dose opioid users using pre-TKR patient characteristics Meth...
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Regulators wish to understand whether real‐world evidence (RWE) can be used for secondary indications of biologics. Using the secondary indication of adalimumab for ulcerative colitis (UC) as an example, we aimed to replicate the ULTRA‐2 RCT finding on the effectiveness of adalimumab in patients with UC using real world data analyses. Adalimumab, a...
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Background: To compare the risk of incident heart failure (HF) between initiators of hydrophilic and lipophilic statins. Methods: Using claims data for commercial health insurance program enrollees in the USA (2005-2014), we identified new initiators of hydrophilic or lipophilic statins. Follow-up for the primary outcome of incident HF began aft...
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Objective The objective of this study is to compare the risk of incident diabetes mellitus (DM) in patients with rheumatoid arthritis (RA) treated with biologic or targeted synthetic disease‐modifying antirheumatic drugs. Methods A new‐user observational cohort study was conducted using data from a US commercial (Truven MarketScan, 2005‐2016) clai...
Preprint
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Objective Using US claims data and the most up-to-date pharmacoepidemiological study design tools we aimed to investigate two safety signals for (1) macrolides and heart failure; and (2) non-steroidal anti-inflammatory drugs (NSAIDs) and pneumonia generated from a large-scale screening analysis using a self-controlled sequence symmetry design in Da...
Article
Background The risk of serious infection is a major concern when prescribing a disease-modifying antirheumatic drug (DMARD) for rheumatoid arthritis. Little evidence exists with regard to serious infection risk associated with tofacitinib, a targeted synthetic (ts)DMARD, compared with biologic DMARDs (bDMARDs) among patients with rheumatoid arthrit...
Article
Select biosimilars—versions of originator biologic drugs made by different manufacturers—have provided substantial cost savings in some European countries.(1) For example, Denmark obtained a 64% discount in a mandatory nationwide non‐medical switch from originator to biosimilar infliximab.(2) In the US, for systemic inflammatory conditions such as...
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Importance Accurate risk stratification of patients with heart failure (HF) is critical to deploy targeted interventions aimed at improving patients’ quality of life and outcomes. Objectives To compare machine learning approaches with traditional logistic regression in predicting key outcomes in patients with HF and evaluate the added value of aug...
Article
Angiotensin receptor blockers (ARBs) are one of the most common prescription drug classes, used by 5.8% of adults in the United States in 2011-2012 for treatment of hypertension, heart failure, and diabetic nephropathy.¹ Discovery of potentially carcinogenic nitrosamine impurities (N-nitrosodimethylamine, N-nitroso-N-diethylamine, and N-nitroso-N-m...
Article
The anticoagulant response to warfarin, a narrow therapeutic index drug, increases with age, which may make older patients susceptible to adverse outcomes resulting from small differences in bioavailability between generic and brand products. Using US Medicare claims linked to electronic medical records from two large hospitals in Boston, we design...
Poster
Introduction: There is limited contemporary evidence on clinical outcomes and healthcare use in sickle-cell disease (SCD) patients enrolled in US Medicaid. We aimed to provide contemporary estimates for rates of vaso-occlusive crises (VOC), mortality, and healthcare resource utilization (HRU) in SCD patients enrolled in US Medicaid. Methods: We con...
Poster
Introduction: Sickle cell disease (SCD) is a hereditary condition characterized by severe complications and repeated episodes of acute illness throughout life, leading to premature death. Blood and Marrow Transplantation (BMT) is the only available cure for this debilitating disorder; however, it remains infrequently used because of challenges in f...
Article
Background: Biologic agents may pose a potential risk for exacerbations of pulmonary comorbidities in rheumatoid arthritis (RA) patients. Methods: Using U.S. Medicare and Truven MarketScan databases, we identified three cohorts of RA patients with interstitial lung disease (ILD), chronic obstructive pulmonary disease (COPD), or asthma who initia...
Article
This report aims to provide methodological guidance to help practitioners select the most appropriate weighting method based on propensity scores for their analysis out of many available options (eg, inverse probability treatment weights, standardised mortality ratio weights, fine stratification weights, overlap weights, and matching weights), and...