Rheumatic disease

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

Posted on by Kayla Korzekwinski

Journal of Clinical Pharmacology • January 2023

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Balevic SJ, Niu J, Chen J, Green D, McMahon A, Hornik CP, Schanberg L, Glaser R, Doddapaneni S, Gonzalez D, Burckart GJ

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 between drug exposure and response for selected drugs in systemic lupus erythematosus (SLE) was sufficiently similar to support a consideration of the extrapolation of adult efficacy data to children of ≥5 years of age.

Low Etanercept Concentrations in Children With Obesity and Juvenile Idiopathic Arthritis

Posted on by Kayla Korzekwinski

The Journal of Pediatric Pharmacology and Therapeutics • November 2021

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Balevic SJ, Becker ML, Gonzalez D, Funk RS

This study evaluated the impact of obesity on etanercept (ETN) drug exposure in children with juvenile idiopathic arthritis (JIA). The data suggest that children who are obese may be routinely under-dosed using current dosing strategies. As a result, characterizing adequate drug exposure in children of all sizes is an important step toward precision dosing.

Pharmacokinetics of Hydroxychloroquine in Pregnancies with Rheumatic Diseases

Posted on by Kayla Korzekwinski

Clinical Pharmacokinetics • April 2019

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Balevic SJ, Green TP, Clowse MEB, Eudy AM, Schanberg LE, Cohen-Wolkowiez M

 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 pregnancy on hydroxychloroquine disposition and the potential need for dose adjustment remains virtually unknown. This study developed a one-compartment population-pharmacokinetic model for hydroxychloroquine in pregnant women with rheumatic disease.