Stephen Joseph Balevic

Journal Article CPT Pharmacometrics Syst Pharmacol · June 4, 2024 Pantoprazole is a proton pump inhibitor indicated for the treatment of gastroesophageal reflux disease, a condition that disproportionately affects children with obesity. Appropriately dosing pantoprazole in children with obesity requires understanding the ... Full text Link to item Cite

Indomethacin Pharmacokinetics and Pharmacodynamics in Pregnancies With Preterm Labor: The Need for Dose-Ranging Trials.

Journal Article J Clin Pharmacol · June 2024 The use of indomethacin to delay delivery in preterm labor (PTL) is widely accepted; however, the optimal dosage of indomethacin in pregnancy is unknown. Here, we perform population pharmacokinetic (PK) and pharmacodynamic (PD) analyses, characterize the p ... Full text Link to item Cite

Interpreting hydroxychloroquine blood levels for medication non-adherence: a pharmacokinetic study.

Journal Article Lupus Sci Med · April 30, 2024 OBJECTIVE: Characterise the relationship between hydroxychloroquine (HCQ) blood levels and the number of missed doses, accounting for dosage, dose timing and the large variability in pharmacokinetics (PK) between patients. METHODS: We externally validated ... Full text Link to item Cite

Opportunistic dried blood spot sampling validates and optimizes a pediatric population pharmacokinetic model of metronidazole.

Journal Article Antimicrob Agents Chemother · April 3, 2024 Pharmacokinetic models rarely undergo external validation in vulnerable populations such as critically ill infants, thereby limiting the accuracy, efficacy, and safety of model-informed dosing in real-world settings. Here, we describe an opportunistic appr ... Full text Link to item Cite

Infliximab Concentrations in Participants with Moderate to Severe COVID-19.

Journal Article J Clin Pharmacol · April 2024 Full text Link to item Cite

Abatacept Pharmacokinetics and Exposure Response in Patients Hospitalized With COVID-19: A Secondary Analysis of the ACTIV-1 IM Randomized Clinical Trial.

Journal Article JAMA Netw Open · April 1, 2024 IMPORTANCE: The pharmacokinetics of abatacept and the association between abatacept exposure and outcomes in patients with severe COVID-19 are unknown. OBJECTIVE: To characterize abatacept pharmacokinetics, relate drug exposure with clinical outcomes, and ... Full text Link to item Cite

Comparative Effectiveness of a Second Tumor Necrosis Factor Inhibitor Versus a Non-Tumor Necrosis Factor Biologic in the Treatment of Patients With Polyarticular-Course Juvenile Idiopathic Arthritis.

Journal Article Arthritis Care Res (Hoboken) · March 31, 2024 OBJECTIVE: The objective of this study was to compare the effectiveness of a second tumor necrosis factor inhibitor (TNFi) versus a non-TNFi biologic following discontinuation of a TNFi for patients with polyarticular-course juvenile idiopathic arthritis ( ... Full text Link to item Cite

Using Real-World Data to Externally Evaluate Population Pharmacokinetic Models of Dexmedetomidine in Children and Infants.

Journal Article J Clin Pharmacol · March 28, 2024 Dexmedetomidine is a sedative used in both adults and off-label in children with considerable reported pharmacokinetic (PK) interindividual variability affecting drug exposure across populations. Several published models describe the population PKs of dexm ... Full text Link to item Cite

Azathioprine metabolite levels and outcomes during pregnancies with rheumatic disease.

Journal Article Lupus Sci Med · January 3, 2024 OBJECTIVE: Despite widespread use of azathioprine (AZA) during pregnancy, no studies evaluated the impact of pregnancy on AZA metabolites 6-thioguanine nucleotide (6-TGN) and 6-methylmercaptopurine nucleotide (6-MMPN) disposition in rheumatic diseases. Thi ... Full text Link to item Cite

Health Equity Implications of Missing Data Among Youths With Childhood-Onset Systemic Lupus Erythematosus: A Proof-of-Concept Study in the Childhood Arthritis and Rheumatology Research Alliance Registry.

Journal Article Arthritis Care Res (Hoboken) · November 2023 OBJECTIVE: Health disparities in childhood-onset systemic lupus erythematosus (SLE) disproportionately impact marginalized populations. Socioeconomically patterned missing data can magnify existing health inequities by supporting inferences that may misrep ... Full text Link to item Cite

Pharmacokinetics of Oral Vitamin D in Children with Obesity and Asthma.

Journal Article Clin Pharmacokinet · November 2023 BACKGROUND AND OBJECTIVE: Vitamin D insufficiency is common in several pediatric diseases including obesity and asthma. Little data exist describing the pharmacokinetics of oral vitamin D in children or the optimal dosing to achieve therapeutic 25(OH)D tar ... Full text Link to item Cite

Insurance Status and Tumor Necrosis Factor Inhibitor Initiation Among Children With Juvenile Idiopathic Arthritis in the CARRA Registry.

Journal Article J Rheumatol · August 2023 OBJECTIVE: Prompt escalation to tumor necrosis factor inhibitors (TNFis) is recommended for children with juvenile idiopathic arthritis (JIA) and ongoing disease activity despite treatment with conventional disease-modifying antirheumatic drugs (cDMARDs). ... Full text Link to item Cite

Childhood-Onset Lupus Nephritis in the Childhood Arthritis and Rheumatology Research Alliance Registry: Short-Term Kidney Status and Variation in Care.

Journal Article Arthritis Care Res (Hoboken) · July 2023 OBJECTIVE: The goal was to characterize short-term kidney status and describe variation in early care utilization in a multicenter cohort of patients with childhood-onset systemic lupus erythematosus (cSLE) and nephritis. METHODS: We analyzed previously co ... Full text Link to item Cite

Occurrence of adverse events and change in disease activity after initiation of etanercept in paediatric patients with juvenile psoriatic arthritis in the CARRA Registry.

Journal Article RMD Open · May 2023 OBJECTIVE: Etanercept is commonly used to treat juvenile idiopathic arthritis, including juvenile psoriatic arthritis (JPsA); however, information on etanercept's safety and effectiveness in clinical practice is limited. We used data from the Childhood Art ... Full text Link to item Cite

Disease Recapture Rates After Medication Discontinuation and Flare in Juvenile Idiopathic Arthritis: An Observational Study Within the Childhood Arthritis and Rheumatology Research Alliance Registry.

Journal Article Arthritis Care Res (Hoboken) · April 2023 OBJECTIVE: Children with well-controlled juvenile idiopathic arthritis (JIA) frequently experience flares after medication discontinuation, but the outcomes of these flares have not been well described. The objective of this study was to characterize the r ... Full text Link to item Cite

Dosing Variation at Initiation of Adalimumab and Etanercept and Clinical Outcomes in Juvenile Idiopathic Arthritis: A Childhood Arthritis and Rheumatology Research Alliance Registry Study.

Journal Article Arthritis Care Res (Hoboken) · February 2023 OBJECTIVE: To determine the dose-response relationship of tumor necrosis factor (TNF) inhibition in the treatment of juvenile idiopathic arthritis (JIA). METHODS: Participants of the Childhood Arthritis and Rheumatology Research Alliance Registry were elig ... Full text Link to item Cite

Trajectories of disease activity in patients with JIA in the Childhood Arthritis and Rheumatology Research Alliance Registry.

Journal Article Rheumatology (Oxford) · February 1, 2023 OBJECTIVE: To describe 2-year trajectories of the clinical Juvenile Arthritis Disease Activity Score, 10 joints (cJADAS10) and associated baseline characteristics in patients with JIA. METHODS: JIA patients in the Childhood Arthritis and Rheumatology Resea ... Full text Link to item Cite

Extrapolation of Adult Efficacy Data to Pediatric Systemic Lupus Erythematosus: Evaluating Similarities in Exposure-Response.

Journal Article J Clin Pharmacol · January 2023 To streamline drug development, the United States Food and Drug Administration (FDA) can consider the extrapolation of adult efficacy data to children when the disease and drug effects are sufficiently similar. This study explored whether the relationship ... Full text Link to item Cite

Population Pharmacokinetics of Piperacillin/Tazobactam Across the Adult Lifespan.

Journal Article Clin Pharmacokinet · January 2023 BACKGROUND AND OBJECTIVE: Piperacillin/tazobactam is one of the most frequently used antimicrobials in older adults. Using an opportunistic study design, we evaluated the pharmacokinetics of piperacillin/tazobactam as a probe drug to evaluate changes in an ... Full text Link to item Cite

Patient-Reported Outcomes Among Transition-Age Young Adults With Juvenile Idiopathic Arthritis in the Childhood Arthritis and Rheumatology Research Alliance Registry.

Journal Article J Rheumatol · January 2023 OBJECTIVE: To evaluate patient-reported care utilization and outcomes among young adults with juvenile idiopathic arthritis (JIA), including factors associated with complete transfer to adult rheumatology. METHODS: We included young adults with JIA enrolle ... Full text Link to item Cite

Physiologically-based pharmacokinetic modeling of pantoprazole to evaluate the role of CYP2C19 genetic variation and obesity in the pediatric population.

Indomethacin Pharmacokinetics and Pharmacodynamics in Pregnancies With Preterm Labor: The Need for Dose-Ranging Trials.

Interpreting hydroxychloroquine blood levels for medication non-adherence: a pharmacokinetic study.

Opportunistic dried blood spot sampling validates and optimizes a pediatric population pharmacokinetic model of metronidazole.

Infliximab Concentrations in Participants with Moderate to Severe COVID-19.

Journal Article J Clin Pharmacol · April 2024 Full text Link to item Cite

Abatacept Pharmacokinetics and Exposure Response in Patients Hospitalized With COVID-19: A Secondary Analysis of the ACTIV-1 IM Randomized Clinical Trial.

Comparative Effectiveness of a Second Tumor Necrosis Factor Inhibitor Versus a Non-Tumor Necrosis Factor Biologic in the Treatment of Patients With Polyarticular-Course Juvenile Idiopathic Arthritis.

Using Real-World Data to Externally Evaluate Population Pharmacokinetic Models of Dexmedetomidine in Children and Infants.

Azathioprine metabolite levels and outcomes during pregnancies with rheumatic disease.

Health Equity Implications of Missing Data Among Youths With Childhood-Onset Systemic Lupus Erythematosus: A Proof-of-Concept Study in the Childhood Arthritis and Rheumatology Research Alliance Registry.

Pharmacokinetics of Oral Vitamin D in Children with Obesity and Asthma.

Insurance Status and Tumor Necrosis Factor Inhibitor Initiation Among Children With Juvenile Idiopathic Arthritis in the CARRA Registry.

Childhood-Onset Lupus Nephritis in the Childhood Arthritis and Rheumatology Research Alliance Registry: Short-Term Kidney Status and Variation in Care.

Occurrence of adverse events and change in disease activity after initiation of etanercept in paediatric patients with juvenile psoriatic arthritis in the CARRA Registry.

Disease Recapture Rates After Medication Discontinuation and Flare in Juvenile Idiopathic Arthritis: An Observational Study Within the Childhood Arthritis and Rheumatology Research Alliance Registry.

Dosing Variation at Initiation of Adalimumab and Etanercept and Clinical Outcomes in Juvenile Idiopathic Arthritis: A Childhood Arthritis and Rheumatology Research Alliance Registry Study.

Trajectories of disease activity in patients with JIA in the Childhood Arthritis and Rheumatology Research Alliance Registry.

Extrapolation of Adult Efficacy Data to Pediatric Systemic Lupus Erythematosus: Evaluating Similarities in Exposure-Response.

Population Pharmacokinetics of Piperacillin/Tazobactam Across the Adult Lifespan.

Patient-Reported Outcomes Among Transition-Age Young Adults With Juvenile Idiopathic Arthritis in the Childhood Arthritis and Rheumatology Research Alliance Registry.

Race, ethnicity and patient-reported outcomes in childhood-onset systemic lupus erythematosus.

Journal Article Clin Exp Rheumatol · January 2023 OBJECTIVES: This study assesses the association of race/ethnicity with the Patient-Reported Outcomes Measurement Information System (PROMIS®) in childhood-onset systemic lupus erythematosus (cSLE) patients from the Childhood Arthritis and Rheumatology Rese ... Full text Link to item Cite

Using Pharmacokinetic Modeling and Electronic Health Record Data to Predict Clinical and Safety Outcomes after Methylprednisolone Exposure during Cardiopulmonary Bypass in Neonates.

Journal Article Congenit Heart Dis · 2023 BACKGROUND: Infants undergoing cardiac surgery with cardiopulmonary bypass (CPB) frequently receive intraoperative methylprednisolone (MP) to suppress CPB-related inflammation; however, the optimal dosing strategy and efficacy of MP remain unclear. METHODS ... Full text Link to item Cite

Pharmacokinetics of Ceftazidime-Avibactam in Combination with Aztreonam (COMBINE) in a Phase 1, Open-Label Study of Healthy Adults.

Journal Article Antimicrob Agents Chemother · December 20, 2022 Scant pharmacokinetic (PK) data are available on ceftazidime-avibactam (CZA) and aztreonam (ATM) in combination, and it is unknown if CZA-ATM exacerbates alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevations relative to ATM alone. This ... Full text Link to item Cite

Safety of Ceftazidime-Avibactam in Combination with Aztreonam (COMBINE) in a Phase I, Open-Label Study in Healthy Adult Volunteers.

Journal Article Antimicrob Agents Chemother · December 20, 2022 This phase I study evaluated the safety of the optimal ceftazidime-avibactam (CZA) with aztreonam (ATM) regimens identified in hollow fiber infection models of MBL-producing Enterobacterales. Eligible healthy subjects aged 18 to 45 years were assigned to o ... Full text Link to item Cite

Intraarticular steroids as DMARD-sparing agents for juvenile idiopathic arthritis flares: Analysis of the Childhood Arthritis and Rheumatology Research Alliance Registry.

Journal Article Pediatr Rheumatol Online J · November 25, 2022 BACKGROUND: Children with juvenile idiopathic arthritis (JIA) who achieve a drug free remission often experience a flare of their disease requiring either intraarticular steroids (IAS) or systemic treatment with disease modifying anti-rheumatic drugs (DMAR ... Full text Link to item Cite

Pharmacokinetics of hydroxychloroquine in paediatric lupus: data from a novel, direct-to-family clinical trial.

Journal Article Lupus Sci Med · November 2022 OBJECTIVE: Determine the pharmacokinetics (PK) and exposure-response of hydroxychloroquine (HCQ) and desethylhydroxychloroquine (DHCQ) in paediatric SLE (pSLE). METHODS: We conducted an exploratory phase 2, direct-to-family trial. Children enrolled in the ... Full text Link to item Cite

Baseline characteristics of children with juvenile dermatomyositis enrolled in the first year of the new Childhood Arthritis and Rheumatology Research Alliance registry.

Journal Article Pediatr Rheumatol Online J · July 19, 2022 BACKGROUND: To report baseline characteristics, patient reported outcomes and treatment of children with Juvenile Dermatomyositis (JDM) in the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry. METHODS: Children newly diagnosed with J ... Full text Link to item Cite

Exposure-safety relationship for acyclovir in the treatment of neonatal herpes simplex virus disease.

Journal Article Early Hum Dev · July 2022 BACKGROUND: Neonatal herpes simplex virus (HSV) disease has been treated with high-dose (20 mg/kg/dose) acyclovir since 1991. AIMS: Determine the safety of acyclovir in infants with neonatal HSV treated with high-dose acyclovir; examine the association bet ... Full text Open Access Link to item Cite

The relationship between simulated milrinone exposure and hypotension in children.

Journal Article Cardiol Young · May 2022 INTRODUCTION: Hypotension is an adverse event that may be related to systemic exposure of milrinone; however, the true exposure-safety relationship is unknown. METHODS: Using the Pediatric Trials Network multicentre repository, we identified children ≤17 y ... Full text Link to item Cite

Development of a Generic Physiologically-Based Pharmacokinetic Model for Lactation and Prediction of Maternal and Infant Exposure to Ondansetron via Breast Milk.

Journal Article Clin Pharmacol Ther · May 2022 Ondansetron is commonly used in breastfeeding mothers to treat nausea and vomiting. There is limited information in humans regarding safety of ondansetron exposure to nursing infants and no adequate study looking at ondansetron pharmacokinetics during lact ... Full text Link to item Cite

Adverse Reactions in a Phase 1 Trial of the Anti-Malarial DM1157: An Example of Pharmacokinetic Modeling and Simulation Guiding Clinical Trial Decisions.

Journal Article Infect Dis Ther · April 2022 INTRODUCTION: There is an urgent need to develop new drugs to treat malaria due to increasing resistance to first-line therapeutics targeting the causative organism, Plasmodium falciparum (P. falciparum). One drug candidate is DM1157, a small molecule that ... Full text Link to item Cite

Social determinants of health influence disease activity and functional disability in Polyarticular Juvenile Idiopathic Arthritis.

Journal Article Pediatr Rheumatol Online J · March 7, 2022 BACKGROUND: Social determinants of health (SDH) greatly influence outcomes during the first year of treatment in rheumatoid arthritis, a disease similar to polyarticular juvenile idiopathic arthritis (pJIA). We investigated the correlation of community pov ... Full text Link to item Cite

Hydroxychloroquine in the pregnancies of women with lupus: a meta-analysis of individual participant data.

Journal Article Lupus Sci Med · March 2022 OBJECTIVE: Multiple guidelines recommend continuing hydroxychloroquine (HCQ) for SLE during pregnancy based on observational data. The goal of this individual patient data meta-analysis was to identify the potential benefits and harms of HCQ use within lup ... Full text Link to item Cite

Precision Medicine: Towards Individualized Dosing in Pediatric Rheumatology.

Journal Article Rheum Dis Clin North Am · February 2022 Despite an increase in the number of available therapeutics, many children with rheumatic disease continue to experience active inflammatory disease and treatment failure. One reason for treatment failure is the lack of dosing paradigms to account for the ... Full text Link to item Cite

Hydroxychloroquine PK and exposure-response in pregnancies with lupus: the importance of adherence for neonatal outcomes.

Journal Article Lupus Sci Med · January 2022 OBJECTIVE: Evaluate the impact of pregnancy physiology and medication non-adherence on serum hydroxychloroquine (HCQ) pharmacokinetics (PK) and exposure-response in SLE. METHODS: We conducted a PK analysis using data from two observational pregnancy regist ... Full text Link to item Cite

Characterizing Pharmacokinetics in Children With Obesity-Physiological, Drug, Patient, and Methodological Considerations.

Journal Article Front Pharmacol · 2022 Childhood obesity is an alarming public health problem. The pediatric obesity rate has quadrupled in the past 30 years, and currently nearly 20% of United States children and 9% of children worldwide are classified as obese. Drug distribution and eliminati ... Full text Link to item Cite

External Evaluation of Risperidone Population Pharmacokinetic Models Using Opportunistic Pediatric Data.

Journal Article Front Pharmacol · 2022 Risperidone is approved to treat schizophrenia in adolescents and autistic disorder and bipolar mania in children and adolescents. It is also used off-label in younger children for various psychiatric disorders. Several population pharmacokinetic models of ... Full text Link to item Cite

Down Syndrome-Associated Arthritis Cohort in the New Childhood Arthritis and Rheumatology Research Alliance Registry: Clinical Characteristics, Treatment, and Outcomes.

Conference Arthritis Care Res (Hoboken) · December 2021 OBJECTIVE: Down syndrome-associated arthritis (DA) is underrecognized, and current therapies used for juvenile idiopathic arthritis (JIA) appear to be poorly tolerated and less effective in patients with DA. The objective of this study was to characterize ... Full text Link to item Cite

Impact of the Season of Birth on the Development of Juvenile Idiopathic Arthritis in the United States: A Nationwide Registry-based Study.

Journal Article J Rheumatol · December 2021 OBJECTIVE: Autoimmune disorders result from the interplay of genetic and environmental factors. Many autoimmune disorders are associated with specific seasons of birth, implicating a role for environmental determinants in their etiopathology. We investigat ... Full text Link to item Cite

Comparative efficacy and safety of late surfactant preparations: a retrospective study.

Journal Article J Perinatol · November 2021 OBJECTIVE: Characterize the use, efficacy, and safety of poractant alfa and calfactant surfactants compared to beractant in preterm infants receiving late surfactant. STUDY DESIGN: We included infants <37 weeks gestational age (GA) discharged from Pediatri ... Full text Link to item Cite

Improved Disease Course Associated With Early Initiation of Biologics in Polyarticular Juvenile Idiopathic Arthritis: Trajectory Analysis of a Childhood Arthritis and Rheumatology Research Alliance Consensus Treatment Plans Study.

Journal Article Arthritis Rheumatol · October 2021 OBJECTIVE: To investigate the effects of early introduction of biologic disease-modifying antirheumatic drugs (bDMARDs) on the disease course in untreated polyarticular juvenile idiopathic arthritis (JIA). METHODS: We analyzed data on patients with polyart ... Full text Link to item Cite

Patterns of etanercept use in juvenile idiopathic arthritis in the Childhood Arthritis and Rheumatology Research Alliance Registry.

Journal Article Pediatr Rheumatol Online J · August 21, 2021 BACKGROUND: We aimed to characterize etanercept (ETN) use in juvenile idiopathic arthritis (JIA) patients enrolled in the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry. METHODS: The CARRA Registry is a convenience cohort of patien ... Full text Link to item Cite

Community poverty level influences time to first pediatric rheumatology appointment in Polyarticular Juvenile Idiopathic Arthritis.

Journal Article Pediatr Rheumatol Online J · August 14, 2021 BACKGROUND: The impact of social determinants of health on children with polyarticular juvenile idiopathic arthritis (pJIA) is poorly understood. Prompt initiation of treatment for pJIA is important to prevent disease morbidity; however, a potential barrie ... Full text Link to item Cite

Biologic Switching Among Nonsystemic Juvenile Idiopathic Arthritis Patients: A Cohort Study in the Childhood Arthritis and Rheumatology Research Alliance Registry.

Journal Article J Rheumatol · August 2021 OBJECTIVE: Biologic medications have significantly improved disease control and outcomes of patients with juvenile idiopathic arthritis (JIA). Current treatment recommendations suggest escalating therapy, including changing biologics if needed, when inacti ... Full text Link to item Cite

Juvenile Spondyloarthritis in the Childhood Arthritis and Rheumatology Research Alliance Registry: High Biologic Use, Low Prevalence of HLA-B27, and Equal Sex Representation in Sacroiliitis.

Journal Article Arthritis Care Res (Hoboken) · July 2021 OBJECTIVE: To describe characteristics of children with enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (PsA) who were enrolled in the Childhood Arthritis and Rheumatology Research Alliance (CARRA) registry. METHODS: All children with E ... Full text Link to item Cite

Delivering clinical trials at home: protocol, design and implementation of a direct-to-family paediatric lupus trial.

Journal Article Lupus Sci Med · May 2021 INTRODUCTION: Direct-to-family clinical trials efficiently provide data while reducing the participation burden for children and their families. Although these trials can offer significant advantages over traditional clinical trials, the process of designi ... Full text Link to item Cite

The importance of pregnancy planning in lupus pregnancies.

Journal Article Lupus · April 2021 OBJECTIVE: In seeking new approaches to improve lupus pregnancy outcomes, we study the association between pregnancy planning, behaviors recommended by American College of Rheumatology's Reproductive Health Guideline 2020, and pregnancy and infant outcomes ... Full text Link to item Cite

Bringing research directly to families in the era of COVID-19.

Journal Article Pediatr Res · February 2021 Full text Link to item Cite

Hydroxychloroquine and COVID-19: a Rheumatologist's Take on the Lessons Learned.

Journal Article Curr Allergy Asthma Rep · January 21, 2021 PURPOSE OF REVIEW: Told from the viewpoint of rheumatologists, this review tells the story of hydroxychloroquine and its swift ascent to become a household name as a therapeutic strategy against the novel SARS-CoV-2 virus. This review describes the history ... Full text Link to item Cite

Low etanercept concentrations in children with obesity and juvenile idiopathic arthritis

Journal Article Journal of Pediatric Pharmacology and Therapeutics · January 1, 2021 OBJECTIVE To evaluate the impact of obesity on etanercept (ETN) drug exposure in children with juvenile idiopathic arthritis (JIA). METHODS We conducted a pilot, cross-sectional, observational study in a real-world cohort of children with JIA receiving ETN ... Full text Cite

Dr. Balevic, et al reply.

Journal Article J Rheumatol · October 1, 2020 Full text Link to item Cite

Simulated Assessment of Pharmacokinetically Guided Dosing for Investigational Treatments of Pediatric Patients With Coronavirus Disease 2019.

Journal Article JAMA Pediatr · October 1, 2020 IMPORTANCE: Children of all ages appear susceptible to severe acute respiratory syndrome coronavirus 2 infection. To support pediatric clinical studies for investigational treatments of coronavirus disease 2019 (COVID-19), pediatric-specific dosing is requ ... Full text Link to item Cite

Hydroxychloroquine in Patients with Rheumatic Disease Complicated by COVID-19: Clarifying Target Exposures and the Need for Clinical Trials.

Journal Article J Rheumatol · May 11, 2020 OBJECTIVE: To characterize hydroxychloroquine (HCQ) exposure in patients with rheumatic disease receiving longterm HCQ compared to target concentrations with reported antiviral activity against the coronavirus disease 2019 caused by SARS-CoV-2 (COVID-19). ... Full text Link to item Cite

Comparative safety profile of chloral hydrate versus other sedatives for procedural sedation in hospitalized infants.

Journal Article J Neonatal Perinatal Med · 2020 BACKGROUND: Given the limited available evidence on chloral hydrate safety in neonatal populations and the discrepancy in chloral hydrate acceptance between the US and other countries, we sought to clarify the safety profile of chloral hydrate compared to ... Full text Link to item Cite

Population Pharmacokinetics of Doxycycline in Children.

Journal Article Antimicrob Agents Chemother · September 9, 2019 Doxycycline is a tetracycline-class antimicrobial labeled by the United States (U.S.) Food and Drug Administration for children >8 years of age for many common childhood infections. Doxycycline is not labeled for children ≤8 years of age, due to the associ ... Full text Link to item Cite

Cefazolin pharmacokinetics in premature infants.

Journal Article J Perinatol · September 2019 OBJECTIVE: Pharmacokinetic (PK) data to guide cefazolin dosing in premature infants are virtually non-existent. Therefore, we aimed to characterize cefazolin PK in infants aged ≤32 weeks of gestation at birth. STUDY DESIGN: We conducted a prospective, open ... Full text Link to item Cite

Physiologically Based Pharmacokinetic Modeling for Trimethoprim and Sulfamethoxazole in Children.

Journal Article Clin Pharmacokinet · July 2019 OBJECTIVE: The aims of this study were to (1) determine whether opportunistically collected data can be used to develop physiologically based pharmacokinetic (PBPK) models in pediatric patients; and (2) characterize age-related maturational changes in drug ... Full text Link to item Cite

Pharmacokinetics of ticarcillin-clavulanate in premature infants.

Journal Article Br J Clin Pharmacol · May 2019 Ticarcillin-clavulanate covers a broad spectrum of pathogens that are common in premature infants. In infants <30 weeks gestational age, pharmacokinetic data to guide ticarcillin-clavulanate dosing are lacking. We enrolled 15 premature infants <30 weeks ge ... Full text Link to item Cite

Pharmacokinetics of Hydroxychloroquine in Pregnancies with Rheumatic Diseases.

Journal Article Clin Pharmacokinet · April 2019 BACKGROUND: Hydroxychloroquine is an oral drug prescribed to pregnant women with rheumatic disease to reduce disease activity and prevent flares. Physiologic changes during pregnancy may substantially alter drug pharmacokinetics. However, the effect of pre ... Full text Link to item Cite

Hydroxychloroquine Levels throughout Pregnancies Complicated by Rheumatic Disease: Implications for Maternal and Neonatal Outcomes.

Journal Article J Rheumatol · January 2019 OBJECTIVE: Pregnancies in women with active rheumatic disease often result in poor neonatal outcomes. Hydroxychloroquine (HCQ) reduces disease activity and flares; however, pregnancy causes significant physiologic changes that may alter HCQ levels and lead ... Full text Link to item Cite

Prolonged furosemide exposure and risk of abnormal newborn hearing screen in premature infants.

Journal Article Early Hum Dev · October 2018 BACKGROUND: At very high doses, furosemide is linked to ototoxicity in adults, but little is known about the risk of hearing loss in premature infants exposed to furosemide. AIMS: Evaluate the association between prolonged furosemide exposure and abnormal ... Full text Link to item Cite

Innovative Study Designs Optimizing Clinical Pharmacology Research in Infants and Children.

Journal Article J Clin Pharmacol · October 2018 Almost half of recent pediatric trials failed to achieve labeling indications, in large part because of inadequate study design. Therefore, innovative study methods are crucial to optimizing trial design while also reducing the potential harms inherent wit ... Full text Link to item Cite

Prescribing for Children With Rheumatic Disease: Perceived Treatment Approaches Between Pediatric and Adult Rheumatologists.

Journal Article Arthritis Care Res (Hoboken) · February 2018 OBJECTIVE: To compare practice patterns and prescribing differences for juvenile idiopathic arthritis (JIA) between adult rheumatologists (ARs) and pediatric rheumatologists (PRs), the perceived educational needs, and factors that enhance or impede co-mana ... Full text Link to item Cite

Increasing contraception use among women receiving teratogenic medications in a rheumatology clinic.

Journal Article BMJ Open Qual · 2018 Teratogenic medications are often prescribed to women of childbearing age with autoimmune diseases. Literature suggests that appropriate use of contraception among these women is low, potentially resulting in high-risk unintended pregnancies. Preliminary r ... Full text Open Access Link to item Cite

Clinical Trial Design in Juvenile Idiopathic Arthritis.

Journal Article Paediatr Drugs · October 2017 Randomized clinical trials provide the gold standard evidence base to guide clinical practice. Despite major advances in trial design, pediatric clinical trials are still difficult to perform and pose unique challenges, including the need to consider the i ... Full text Link to item Cite

Islands of Inflammation: Neurosarcoidosis.

Journal Article Am J Med · February 2017 Full text Link to item Cite

Profile of adalimumab and its potential in the treatment of uveitis.

Journal Article Drug Des Devel Ther · 2016 Uveitis refers to the presence of intraocular inflammation, and as a strict definition compromises the iris and ciliary body anteriorly and the choroid posteriorly (the uvea). Untreated, uveitis can lead to visual loss or blindness. The etiology of uveitis ... Full text Link to item Cite

Penile and scrotal swelling mimicking child abuse.

Journal Article Clin Pediatr (Phila) · October 2013 Full text Link to item Cite