Journal ArticleJ Clin Pharmacol · December 2024
Dexamethasone is a synthetic glucocorticoid approved for treating disorders of various organ systems in both adult and pediatric populations. Currently, approved pediatric dosing recommendations are weight-based, but it is unknown whether differences in de ...
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Journal ArticleArthritis Care Res (Hoboken) · September 29, 2024
OBJECTIVE: Differential disease control may contribute to racial disparities in outcomes of childhood-onset systemic lupus erythematosus (cSLE). We evaluated associations of race and individual- or neighborhood-level social determinants of health (SDoH) wi ...
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Journal ArticleJ Clin Pharmacol · August 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 ...
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Journal ArticleArthritis Care Res (Hoboken) · August 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 ( ...
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Journal ArticleCPT Pharmacometrics Syst Pharmacol · August 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 ...
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Journal ArticleJ 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 ...
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Journal ArticleLupus 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 ...
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Journal ArticleAntimicrob 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 ...
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Journal ArticleJAMA 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 ...
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Journal ArticleLupus 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 ...
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Journal ArticleArthritis 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 ...
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Journal ArticleClin 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 ...
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Journal ArticleJ 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). ...
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Journal ArticleArthritis 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 ...
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Journal ArticleRMD 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 ...
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Journal ArticleArthritis 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 ...
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Journal ArticleArthritis 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 ...
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Journal ArticleRheumatology (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 ...
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Journal ArticleJ 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 ...
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Journal ArticleClin 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 ...
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Journal ArticleJ 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 ...
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Journal ArticleClin 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 ...
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Journal ArticleCongenit 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 ...
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Journal ArticleAntimicrob 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 ...
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Journal ArticleAntimicrob 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 ...
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Journal ArticlePediatr 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 ...
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Journal ArticleLupus 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 ...
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Journal ArticlePediatr 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 ...
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Journal ArticleEarly 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 ...
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Journal ArticleCardiol 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 ...
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Journal ArticleClin 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 ...
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Journal ArticleInfect 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 ...
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Journal ArticlePediatr 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 ...
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Journal ArticleLupus 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 ...
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Journal ArticleRheum 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 ...
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Journal ArticleLupus 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 ...
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Journal ArticleFront 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 ...
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Journal ArticleFront 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 ...
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ConferenceArthritis 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 ...
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Journal ArticleJ 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 ...
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Journal ArticleJ 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 ...
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Journal ArticleArthritis 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 ...
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Journal ArticlePediatr 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 ...
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Journal ArticlePediatr 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 ...
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Journal ArticleJ 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 ...
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Journal ArticleArthritis 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 ...
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Journal ArticleLupus 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 ...
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Journal ArticleLupus · 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 ...
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Journal ArticleCurr 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 ...
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Journal ArticleJournal 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 ...
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Journal ArticleJAMA 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 ...
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Journal ArticleJ 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). ...
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Journal ArticleJ 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 ...
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Journal ArticleAntimicrob 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 ...
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Journal ArticleJ 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 ...
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Journal ArticleClin 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 ...
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Journal ArticleBr 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 ...
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Journal ArticleClin 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 ...
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Journal ArticleJ 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 ...
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Journal ArticleEarly 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 ...
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Journal ArticleJ 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 ...
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Journal ArticleArthritis 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 ...
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Journal ArticleBMJ 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 ...
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Journal ArticlePaediatr 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 ...
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Journal ArticleDrug 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 ...
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