# Optimal Dosing for Biologic Agents in Obese Patients with Rheumatoid and Juvenile Arthritis

> **NIH NIH K23** · DUKE UNIVERSITY · 2021 · $165,187

## Abstract

PROJECT SUMMARY/ABSTRACT
Rheumatoid arthritis (RA) and Juvenile Idiopathic Arthritis (JIA) are leading causes of pain and disability. While
treatment with biologic agents may improve outcomes, treatment failure is common in patients who are obese.
Despite the significant impact of treatment failure, it is currently unknown if the poor drug response in obesity is
due to physiologic changes altering drug pharmacokinetics (PK)/Pharmacodynamics (PD), the underlying
inflammatory state, or both. Dr. Balevic proposes to respond to this need by 1) characterizing the effects of
obesity on disease activity and biomarkers of inflammation in a prospective observational study in RA and JIA;
2) using PK/PD modeling to investigate the effect of obesity on drug levels for a probe biologic agent, and
relate drug levels to disease activity; and 3) using the PK/PD model to evaluate an optimal dosing strategy in a
PK/PD clinical trial. This Mentored Career Development Award will provide a structured learning environment
and expert mentorship to enable Dr. Stephen Balevic to develop as an independent investigator and future
leader in the field of therapeutics for adults and children with rheumatic disease. Dr. Balevic’s overarching
career goal is to optimize the dosing, safety, and effectiveness of medications by integrating clinical
pharmacology and PK/PD modeling with drug trials. To achieve this goal, Dr. Balevic created a career
development plan that capitalizes on the longstanding collaboration between Duke University, where he is
junior faculty in the Divisions of Adult and Pediatric Rheumatology/Duke Clinical Research Institute, and the
University of North Carolina at Chapel Hill, where he is pursuing a PhD in Pharmaceutical Sciences. In
addition, Dr. Balevic will enhance his training in the regulatory conduct of clinical trials through a unique
training agreement with the FDA. His short-term goals for the K23 program are: 1) to acquire advanced
knowledge and skills in PK/PD modeling; 2) develop the professional skills and techniques to lead a clinical
trials team; and 3) generate a critical mass of preliminary data and publications to support an R01 grant
application. The mentorship team has a history of prior collaboration, a proven record of successful mentorship
of junior faculty, and has internationally recognized expertise in biomarkers of drug response, obesity, PK/PD
modeling, and clinical trials. Upon successful completion of this proposal, Dr. Balevic will have acquired the
necessary skillset to pursue a lifelong career in promoting safe and effective use of drugs in adults and children
with rheumatic disease.

## Key facts

- **NIH application ID:** 10247513
- **Project number:** 5K23AR075874-02
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** Stephen Joseph Balevic
- **Activity code:** K23 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $165,187
- **Award type:** 5
- **Project period:** 2020-08-26 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10247513

## Citation

> US National Institutes of Health, RePORTER application 10247513, Optimal Dosing for Biologic Agents in Obese Patients with Rheumatoid and Juvenile Arthritis (5K23AR075874-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10247513. Licensed CC0.

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