# New approaches to safety monitoring of novel systemic treatments for atopic dermatitis in clinical practice and underrepresented populations

> **NIH NIH R01** · BRIGHAM AND WOMEN'S HOSPITAL · 2024 · $636,546

## Abstract

Summary:
Severe treatment recalcitrant atopic dermatitis (AD) is a debilitating condition with substantial population
impact. Dermatology has experienced the emergence of targeted immuno-modulating drugs (IMDs) that have
unprecedented efficacy in treating AD. Their optimal use is still unknown because their safety remains
insufficiently characterized.
A range of serious side effects are conceivable based on the immunologic pathways although it is unlikely that
they will all play out in clinical practice. Quantifying or refuting these adverse effects is critical for a clinical
benefit-risk assessment and personalized treatment decisions. Existing trials have not answered these
questions and are unlikely to address them in the near future. The resulting uncertainty has led to both overly
restrictive but also aggressive prescribing of highly efficacious IMDs and this proposal aims to close this glaring
knowledge gap.
We propose a population-based prospective drug safety monitoring system leveraging existing data sources
that shortens the time to insights and provides high validity findings through advanced causal inference
methods. Analyses of longitudinal healthcare databases cover a source population of >78 million Americans
and include commercially insured and Medicaid beneficiaries. New and urgently needed safety insights will
reflect clinical practice, including populations typically excluded from RCTs, like children, women in
reproductive age, patients with complex diseases, minority populations, and patients with existing risk factors.
The size of the claims data source increases statistical power and the linkage to electronic health records in
subsets improves clinical depth. We use causal inference methods that demonstrated high validity in pilot data
and complement them with a novel data mining approach to identify unsuspected events. Analyses are done
with highest transparency and reproducibility to support clinical decision making. This project’s finding on the
optimal use of IMDs in clinical practice will lead to more targeted prescribing and benefit large patient groups,
including populations underrepresented in RCTs: children, older adults, pregnant women, racial minorities,
patients with pre-existing infections, cancers, VTE and others.
This project is highly innovative as it will generate directly applicable clinical insights on the safe and targeted
use of new immuno-modulating drugs (IMDs) to treat atopic dermatitis. Leveraging existing claims data
sources with added EHR data it builds on novel methods for causal inference to mitigate biases arising in real-
world data analyses in dermatology. The expedited evidence generation via the proposed prospective
monitoring system combined with our track record in pharmacoepidemiologic analyses, this research will
efficiently close knowledge gaps for optimal IMD use in many underrepresented and high-risk patients.

## Key facts

- **NIH application ID:** 10762447
- **Project number:** 5R01AR080194-03
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** Sebastian G. Schneeweiss
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $636,546
- **Award type:** 5
- **Project period:** 2022-02-01 → 2026-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10762447

## Citation

> US National Institutes of Health, RePORTER application 10762447, New approaches to safety monitoring of novel systemic treatments for atopic dermatitis in clinical practice and underrepresented populations (5R01AR080194-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10762447. Licensed CC0.

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