# Risk and impact of infection resulting from treatment with chronic glucocorticoids in patients with rheumatoid arthritis

> **NIH NIH K23** · UNIVERSITY OF PENNSYLVANIA · 2022 · $174,636

## Abstract

PROJECT SUMMARY
Rheumatoid arthritis (RA) is a common autoimmune condition affecting 1% of the population and is associated
with substantial morbidity and mortality. Treatment advances have improved disease control, but infections
remain a major complication of immunosuppressive treatment. Glucocorticoids are used as long-term therapy
in 30-60% of patients with RA and are potentially a major contributor to infection risk in RA. It is well known that
higher glucocorticoid doses carry very high infection risk, but risk with more commonly used low-dose therapy
remains unknown. Defining infection risk with low-dose glucocorticoids has been identified as a critical area for
research, needed to inform treatment strategies to improve outcomes in patients with RA.
The objective of this study is to determine whether low-dose glucocorticoids are associated with an increase in
the risk of 1) serious infections requiring hospitalization or 2) common infections that do not lead to
hospitalization. We will examine the risk of serious infections requiring hospitalization by applying advanced
pharmacoepidemiologic methods to two large claims databases and a longitudinal registry that includes
disease activity measures. By conducting a propensity-adjusted analysis and a novel instrumental variable
analysis based on the variability in the prescribing of glucocorticoids, we will provide the most comprehensive
evaluation of infection risk with glucocorticoids to date. A different approach is needed to study non-
hospitalized infections. These infections are more than 20 times more common than hospitalized infections but
cannot be accurately identified in existing data sources. We will conduct a prospective study with frequent
assessments to measure these infections, recruiting patients from a large online patient registry. An additional
key goal of this work will be to determine the impact of common infections on patients.
Dr. George's career goal is to become an independent investigator studying treatment safety and effectiveness
to improve outcomes in patients with rheumatic disease. He and his mentors have created a comprehensive
career development plan that takes advantage of the unique skills of his mentorship team and the resources
available at Penn. With formal coursework and hands-on experience guided by his mentorship team, he will
build on his current training in epidemiology and experience using administrative claims data. He will gain skills
in advanced pharmacoepidemiology including instrumental variable analysis, and he will develop new
expertise in prospective patient-oriented research, a critical skill needed to develop future interventional studies
to complement observational data. Through this work, and with the guidance of his mentorship team, he will
gain the skills and experience needed to launch a successful career as an independent physician scientist and
become a leader in rheumatoid arthritis research.

## Key facts

- **NIH application ID:** 10434713
- **Project number:** 5K23AR073931-05
- **Recipient organization:** UNIVERSITY OF PENNSYLVANIA
- **Principal Investigator:** Michael D. George
- **Activity code:** K23 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $174,636
- **Award type:** 5
- **Project period:** 2018-08-01 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10434713

## Citation

> US National Institutes of Health, RePORTER application 10434713, Risk and impact of infection resulting from treatment with chronic glucocorticoids in patients with rheumatoid arthritis (5K23AR073931-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10434713. Licensed CC0.

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