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Article ; Online: Precision Medicine: Towards Individualized Dosing in Pediatric Rheumatology.

Balevic, Stephen J / Sagcal-Gironella, Anna Carmela P

Rheumatic diseases clinics of North America

2021 Volume 48, Issue 1, Page(s) 305–330

Abstract: 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 ... ...

Abstract	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 wide between-patient variability in drug pharmacokinetics because of developmental changes or genetic polymorphisms that effect drug absorption, distribution, metabolism, and elimination. This review highlights several strategies to optimize dosing for biologic and nonbiologic disease-modifying antirheumatic drugs, including therapeutic drug monitoring, pharmacogenomics, and the use of pharmacokinetic/pharmacodynamic modeling.
MeSH term(s)	Antirheumatic Agents/therapeutic use ; Child ; Humans ; Pharmacogenetics ; Precision Medicine ; Rheumatic Diseases/drug therapy ; Rheumatology
Chemical Substances	Antirheumatic Agents
Language	English
Publishing date	2021-10-29
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	92118-x
ISSN	1558-3163 ; 0889-857X
ISSN (online)	1558-3163
ISSN	0889-857X
DOI	10.1016/j.rdc.2021.09.010
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Article ; Online: Islands of Inflammation: Neurosarcoidosis.

Balevic, Stephen J / Shah, Ankoor

The American journal of medicine

2017 Volume 130, Issue 2, Page(s) 157–160

Language	English
Publishing date	2017-02
Publishing country	United States
Document type	Journal Article
ZDB-ID	80015-6
ISSN	1555-7162 ; 1873-2178 ; 0002-9343 ; 1548-2766
ISSN (online)	1555-7162 ; 1873-2178
ISSN	0002-9343 ; 1548-2766
DOI	10.1016/j.amjmed.2016.09.009
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Article ; Online: Infliximab Concentrations in Participants with Moderate to Severe COVID-19.

Balevic, Stephen J / Dandachi, Dima / Dixon, Danielle / Hoetelmans, Richard M W / Bozzette, Sam / McCarthy, Matthew W

Journal of clinical pharmacology

2023 Volume 64, Issue 4, Page(s) 490–491

MeSH term(s)	Humans ; Infliximab ; COVID-19 ; Antibodies, Monoclonal ; Antirheumatic Agents ; Treatment Outcome
Chemical Substances	Infliximab (B72HH48FLU) ; Antibodies, Monoclonal ; Antirheumatic Agents
Language	English
Publishing date	2023-12-14
Publishing country	England
Document type	Letter ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	188980-1
ISSN	1552-4604 ; 0091-2700 ; 0021-9754
ISSN (online)	1552-4604
ISSN	0091-2700 ; 0021-9754
DOI	10.1002/jcph.2388
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Article: Low Etanercept Concentrations in Children With Obesity and Juvenile Idiopathic Arthritis.

Balevic, Stephen J / Becker, Mara L / Gonzalez, Daniel / Funk, Ryan S

The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG

2021 Volume 26, Issue 8, Page(s) 809–814

Abstract: 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 ... ...

Abstract	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 as standard of care from a single center. We analyzed the relationship between body size and ETN plasma concentrations, adjusting for dosage. Body size was analyzed as a continuous measure using weight and body mass index (BMI) percentiles and categorically using BMI percentile classifications according to the CDC guidelines. Results: We enrolled a total of 29 children. Each child provided one plasma sample for ETN concentration measurement, and all participants were receiving subcutaneous ETN dosed weekly. We observed that the ETN concentration normalized for dose decreased significantly as a function of weight (p = 0.004) and BMI percentile (p = 0.04). Similarly, we observed a progressive decline in mean and median dose-normalized concentrations across higher body size categories. Because of reaching maximum ETN dosage (50 mg), 7 of 8 children (87.5%) with obesity received a weight-based dosage < 0.8 mg/kg/dose. Conclusions: We found that higher body weight and BMI percentile are significantly and negatively associated with ETN drug serum concentration, accounting for differences in dosing. Our data suggest that children who are obese may be routinely under-dosed using current dosing strategies. Inadequate dosing may increase the risk for therapeutic failure and long-term morbidity in a developing child. As a result, characterizing adequate drug exposure in children of all sizes is an important step toward precision dosing.
Language	English
Publishing date	2021-11-10
Publishing country	United States
Document type	Journal Article
ZDB-ID	3028543-4
ISSN	1551-6776
ISSN	1551-6776
DOI	10.5863/1551-6776-26.8.809
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Article ; Online: The importance of pregnancy planning in lupus pregnancies.

Rajendran, Aardra / Eudy, Amanda M / Balevic, Stephen J / Clowse, Megan E B

Lupus

2021 Volume 30, Issue 5, Page(s) 741–751

Abstract: 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 ... ...

Abstract	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. Methods: Lupus pregnancies in a prospective registry (1/1/2018 to 4/1/2020) were classified as planned or not-planned using the patient-reported London Measure of Unplanned Pregnancy. These groups were compared for demographics, pre-pregnancy disease activity, pregnancy planning behaviors, and delivery outcomes. Results: Among 43 women with 43 singleton pregnancies the average age was 29.4 years and 42% were Black. Overall, 60% were planned pregnancies and 40% were not-planned (16 ambivalent, 1 unplanned). Women with not-planned pregnancies had lower age, income, and education, and more required Medicaid. Women with not-planned pregnancies were more likely to conceive when lupus activity was higher (p = 0.001), less likely to receive pre-pregnancy counseling with a rheumatologist (p = 0.02), and less likely to continue pregnancy-compatible medications (p = 0.03). Severe PROMISSE adverse pregnancy outcomes (APOs) and severe neonatal outcomes were higher among women with not-planned than planned pregnancies (43% vs 0% p = 0.003; 70% vs 30% p = 0.06). Conclusion: This study identifies pregnancy intention as a potentially modifiable risk factor for poor outcomes in women with lupus. It highlights a unique population of women with lupus at high risk for pregnancy and infant complications: those ambivalent about pregnancy. These women may not be effectively engaging in health behaviors that prevent pregnancy nor those that will prepare for a safe pregnancy. With effective pregnancy planning and contraception guidance, we may decrease their risk for maternal-fetal morbidity and mortality.
MeSH term(s)	Adult ; Age Factors ; Antiphospholipid Syndrome/complications ; Antiphospholipid Syndrome/epidemiology ; Antiphospholipid Syndrome/ethnology ; Contraception/standards ; Educational Status ; Family Planning Services/statistics & numerical data ; Female ; Health Behavior/physiology ; Humans ; Infant ; Infant Mortality/trends ; Infant, Newborn ; Lupus Erythematosus, Systemic/complications ; Lupus Erythematosus, Systemic/epidemiology ; Lupus Erythematosus, Systemic/ethnology ; Medicaid/statistics & numerical data ; Pregnancy ; Pregnancy Complications/epidemiology ; Pregnancy Complications/prevention & control ; Pregnancy Outcome/epidemiology ; Pregnancy Outcome/psychology ; Prospective Studies ; Registries ; Rheumatologists/ethics ; Risk Factors ; Severity of Illness Index ; Socioeconomic Factors ; United States
Language	English
Publishing date	2021-01-28
Publishing country	England
Document type	Journal Article
ZDB-ID	1154407-7
ISSN	1477-0962 ; 0961-2033
ISSN (online)	1477-0962
ISSN	0961-2033
DOI	10.1177/0961203321989803
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Article ; Online: Using Pharmacokinetic Modeling and Electronic Health Record Data to Predict Clinical and Safety Outcomes after Methylprednisolone Exposure during Cardiopulmonary Bypass in Neonates.

Foote, Henry P / Wu, Huali / Balevic, Stephen J / Thompson, Elizabeth J / Hill, Kevin D / Graham, Eric M / Hornik, Christoph P / Kumar, Karan R

Congenital heart disease

2023 Volume 18, Issue 3, Page(s) 295–313

Abstract: 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.: ... ...

Abstract	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: We retrospectively analyzed all infants under 90 days-old who received intra-operative MP for cardiac surgery with CPB from 2014-2017 at our institution. We combined real-world dosing data from the electronic health record (EHR) and two previously developed population pharmacokinetic/pharmacodynamic models to simulate peak concentration (Cmax) and area under the concentration-time curve for 24 h (AUC24) for MP and the inflammatory cytokines interleukin-6 (IL-6) and interleukin-10 (IL-10). We evaluated the relationships between post-operative, safety, and other clinical outcomes obtained from the EHR with each predicted exposure using non-parametric tests. Results: A total of 142 infants with median post-natal age 8 (interquartile range [IQR]: 5, 37) days received a total dose of 30 (19, 49) mg/kg of MP. Twelve (8%) died, 37 (26%) met the composite post-operative outcome, 114 (80%) met the composite safety outcome, and 23 (16%) had a major complication. Predicted median Cmax and AUC24 IL-6 exposure was significantly higher for infants meeting the composite post-operative outcome and those with major complications. Predicted median Cmax and AUC24 MP exposure was significantly higher for infants requiring insulin. No exposure was associated with death or other safety outcomes. Conclusions: Pro-inflammatory IL-6, but not MP exposure, was associated with post-operative organ dysfunction, suggesting current MP dosing may not adequately suppress IL-6 or increase IL-10 to impact clinical outcomes. Prospective study will be required to define the optimal exposure-efficacy and exposure-safety profiles in these infants.
Language	English
Publishing date	2023-06-09
Publishing country	United States
Document type	Journal Article
ZDB-ID	2274321-2
ISSN	1747-0803 ; 1747-079X
ISSN (online)	1747-0803
ISSN	1747-079X
DOI	10.32604/chd.2023.026262
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Article ; Online: Using Real-World Data to Externally Evaluate Population Pharmacokinetic Models of Dexmedetomidine in Children and Infants.

McCann, Sean / Helfer, Victória E / Balevic, Stephen J / Hornik, Chi D / Goldstein, Stuart L / Autmizguine, Julie / Meyer, Marisa / Al-Uzri, Amira / Anderson, Sarah G / Payne, Elizabeth H / Turdalieva, Sitora / Gonzalez, Daniel

Journal of clinical pharmacology

2024

Abstract: 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 ... ...

Abstract	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 dexmedetomidine in neonates, infants, children, and adolescents, though very few have been externally evaluated. A prospective PK dataset of dexmedetomidine plasma concentrations in children and young adults aged 0.01-19.9 years was collected as part of a multicenter opportunistic PK study. A PubMed search of studies reporting dexmedetomidine PK identified five population PK models developed with data from demographically similar children that were selected for external validation. A total of 168 plasma concentrations from 102 children were compared with both population (PRED) and individualized (IPRED) predicted values from each of the five published models by quantitative and visual analyses using NONMEM (v7.3) and R (v4.1.3). Mean percent prediction errors from observed values ranged from -1% to 120% for PRED, and -24% to 60% for IPRED. The model by James et al, which was developed using similar "real-world" data, nearly met the generalizability criteria from IPRED predictions. Other models developed using clinical trial data may have been limited by inclusion/exclusion criteria and a less racially diverse population than this study's opportunistic dataset. The James model may represent a useful, but limited tool for model-informed dosing of hospitalized children.
Language	English
Publishing date	2024-03-28
Publishing country	England
Document type	Journal Article
ZDB-ID	188980-1
ISSN	1552-4604 ; 0091-2700 ; 0021-9754
ISSN (online)	1552-4604
ISSN	0091-2700 ; 0021-9754
DOI	10.1002/jcph.2434
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Article ; Online: Occurrence of adverse events and change in disease activity after initiation of etanercept in paediatric patients with juvenile psoriatic arthritis in the CARRA Registry.

Correll, Colleen K / Stryker, Scott / Collier, David / Phillips, Thomas A / Dennos, Anne C / Balevic, Stephen J / Beukelman, Timothy

RMD open

2023 Volume 9, Issue 2

Abstract: 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 ... ...

Abstract	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 Arthritis and Rheumatology Research Alliance (CARRA) Registry to evaluate etanercept's safety and effectiveness in JPsA in clinical practice. Methods: We analysed safety and effectiveness data for paediatric patients enrolled in the CARRA Registry who had a JPsA diagnosis and had used etanercept. Safety was assessed by calculating rates of prespecified adverse events of special interest (AESIs) and serious adverse events (SAEs). Effectiveness was assessed by a variety of disease activity measures. Results: Overall, 226 patients had JPsA and received etanercept; 191 met criteria for safety analysis and 43 met criteria for effectiveness analysis. AESI and SAE incidence rates were low. There were five events: three uveitis, one new-onset neuropathy and one malignancy. Incidence rates were 0.55 (95% CI: 0.18, 1.69), 0.18 (95% CI: 0.03, 1.29) and 0.13 (95% CI: 0.02, 0.09) per 100 patient-years for uveitis, neuropathy and malignancy, respectively. Etanercept showed effectiveness for JPsA treatment; 7 of 15 (46.7%) had an American College of Rheumatology-Pediatric Response 90, 9 of 25 (36.0%) had a clinical Juvenile Arthritis Disease Activity Score 10-joint ≤1.1 and 14 of 27 (51.9%) had clinically inactive disease at the 6-month follow-up. Conclusion: Data in the CARRA Registry showed that etanercept treatment was safe in treating children with JPsA, with low AESIs and SAEs. Etanercept was also effective, even when assessed in a small sample size.
MeSH term(s)	Humans ; Child ; United States ; Etanercept/adverse effects ; Arthritis, Juvenile/drug therapy ; Arthritis, Juvenile/epidemiology ; Arthritis, Juvenile/diagnosis ; Rheumatology ; Registries
Chemical Substances	Etanercept (OP401G7OJC)
Language	English
Publishing date	2023-05-25
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2812592-7
ISSN	2056-5933 ; 2056-5933
ISSN (online)	2056-5933
ISSN	2056-5933
DOI	10.1136/rmdopen-2022-002943
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Article ; Online: Indomethacin Pharmacokinetics and Pharmacodynamics in Pregnancies With Preterm Labor: The Need for Dose-Ranging Trials.

Balevic, Stephen J / Weiner, Daniel / Hornik, Christoph P / Cohen-Wolkowiez, Michael / Gonzalez, Daniel / Wang, Xiaoming / Xu, Meixiang / Abdel-Rahman, Sherif Z / Rytting, Erik

Journal of clinical pharmacology

2024

Abstract: 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 ...

Abstract	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 plasma disposition of indomethacin in pregnant women with PTL, and relate indomethacin exposure to delayed delivery and maternal/neonatal safety. We analyzed plasma and urine samples collected from a multicenter, prospective, opportunistic PK/PD study of indomethacin in pregnant women 12-32 weeks gestation admitted with PTL. Ninety-four participants with 639 plasma concentrations for indomethacin were included in the analysis. The final population PK (popPK) model for indomethacin was a 2-compartment structural model with first-order absorption and elimination and a covariate effect of body mass index on apparent oral clearance. We observed a 21%-60% increase in apparent oral clearance observed during pregnancy. There was no clear association between indomethacin exposure and maternal or neonatal safety outcomes, or with the magnitude of delayed delivery; however, 96.7% of women treated with indomethacin had a delivery that was delayed at least 48 hours. Given the changes to indomethacin apparent oral clearance during pregnancy, and the lack of relationship between indomethacin exposure and safety, dose-finding studies of indomethacin in pregnant women with PTL may help clarify the most safe and efficacious dosage and duration of indomethacin.
Language	English
Publishing date	2024-02-05
Publishing country	England
Document type	Journal Article
ZDB-ID	188980-1
ISSN	1552-4604 ; 0091-2700 ; 0021-9754
ISSN (online)	1552-4604
ISSN	0091-2700 ; 0021-9754
DOI	10.1002/jcph.2412
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Article ; Online: Profile of adalimumab and its potential in the treatment of uveitis.

Balevic, Stephen J / Rabinovich, C Egla

Drug design, development and therapy

2016 Volume 10, Page(s) 2997–3003

Abstract: 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 ... ...

Abstract	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 can include both infectious and noninfectious (usually immune-mediated) causes, the latter of which are often mediated predominantly by Th1 CD4
MeSH term(s)	Adalimumab/pharmacology ; Adalimumab/therapeutic use ; Antibodies, Monoclonal, Humanized/therapeutic use ; Arthritis, Juvenile/complications ; Arthritis, Juvenile/drug therapy ; Humans ; Immunoglobulin G/therapeutic use ; Methotrexate/chemistry ; Methotrexate/pharmacology ; Sarcoidosis/drug therapy ; Tumor Necrosis Factor-alpha/chemistry ; Tumor Necrosis Factor-alpha/immunology ; Tumor Necrosis Factor-alpha/metabolism ; Uveitis/drug therapy
Chemical Substances	Antibodies, Monoclonal, Humanized ; Immunoglobulin G ; Tumor Necrosis Factor-alpha ; Adalimumab (FYS6T7F842) ; Methotrexate (YL5FZ2Y5U1)
Language	English
Publishing date	2016
Publishing country	New Zealand
Document type	Journal Article ; Review
ZDB-ID	2451346-5
ISSN	1177-8881 ; 1177-8881
ISSN (online)	1177-8881
ISSN	1177-8881
DOI	10.2147/DDDT.S94188
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