# Using SMART Design to Develop Dynamic Treatment Regimens for Glucocorticoid Tapering

> **NIH VA IK2** · VETERANS HEALTH ADMINISTRATION · 2022 · —

## Abstract

Background: Patients with rheumatoid arthritis (RA) commonly use glucocorticoids (GCs) despite their
toxicity and the risk of adverse symptoms when they are tapered. Such symptoms pose a major barrier to GC
tapering for many, but are minimal or well-tolerated by others. Clinicians cannot predict how a patient will
respond to GC dose reduction and rely on trial and error when tapering GCs, encouraging extended GC
exposure. Personalized medicine based on patient phenotyping is a cornerstone of RA management, yet
current GC tapering strategies remain “one size fits all”.
Significance/Impact: This application proposes a career development and research plan to characterize and
phenotype responses to GC dose reduction among Veterans with RA. This research agenda is well-aligned with
Clinical Science Research and Development priority research focus on individual treatment response and
treatment optimization. In the short-term, the results of this proposal will lead to a Merit award proposal to
test GC tapering protocols tailored to specific phenotypes, in a sequential multi-assignment randomized
clinical trial (SMART). Long-term, Dr. Wallace will expand this line of research to personalize a) GC tapering in
other conditions common among Veterans (e.g. chronic obstructive pulmonary disease, asthma, gout, etc). b)
other high-risk treatment regimens where data to guide optimization are limited (e.g. biologic drugs, opioids).
Dr. Wallace is a VHA rheumatologist and research investigator who is committed to improving treatment
outcomes for Veterans using high-risk medications Her long-term goal is to become an independent physician-
scientist focused on developing personalized sequential treatment strategies to optimize medication use in the
Veteran population.
Innovation: The proposed work will apply personalized medicine approaches to GC tapering to understand
why, and for whom, current GC tapering strategies fail. Short-term, this line of research will generate new
hypotheses surrounding etiology and management of GC taper-related symptoms in Veterans with RA, as well
as critical data on GC response phenotypes and associated effect sizes. Long-term, this work will inform other
innovative trials to guide optimization of high-risk medications across medical specialties within VHA.
Specific Aims: Focusing on Veterans with RA as a test case, this proposal aims to (1) Evaluate response to (a)
15-day and (b) 6-month GC dose reduction strategies; (2) Identify multi-dimensional phenotypes of patient
response to GC dose reduction, that can be used to develop tailored GC tapering strategies (SA2).
Training Aims: Dr. Wallace and her mentorship team have developed a program of targeted coursework,
seminars, directed readings, and mentored research that will provide her with necessary training in: a)
selecting and interpreting appropriate endpoints for measuring treatment change; b) quantitative methods
required for clinical phenotyping; c) clinical trial design and a...

## Key facts

- **NIH application ID:** 10367543
- **Project number:** 1IK2CX002430-01
- **Recipient organization:** VETERANS HEALTH ADMINISTRATION
- **Principal Investigator:** Beth Ilene Wallace
- **Activity code:** IK2 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2022
- **Award amount:** —
- **Award type:** 1
- **Project period:** 2022-03-01 → 2027-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10367543

## Citation

> US National Institutes of Health, RePORTER application 10367543, Using SMART Design to Develop Dynamic Treatment Regimens for Glucocorticoid Tapering (1IK2CX002430-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10367543. Licensed CC0.

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