# Emulating hypothetical target trials to establish the comparative effectiveness of biologics in asthma

> **NIH HL R01** · BRIGHAM AND WOMEN'S HOSPITAL · 2026 · $819,020

## Abstract

PROJECT SUMMARY/ABSTRACT
Asthma is a leading cause of morbidity in the US and worldwide, affecting almost 10% of the US
population. Individuals with severe asthma, who are uncontrolled on conventional therapy,
account for a disproportionate share of asthma-related morbidity and mortality. For these
patients, the advent of multiple monoclonal antibodies “biologics” has provided additional
therapeutic options to improve outcomes in this potentially fatal disease. While these biologics
have helped to improved outcomes in many patients with asthma, there is considerable
uncertainty on the optimal choice of biologic in patients who meet criteria for two or more
biologics, a common occurrence. There are no head-to-head trials of these therapies and
results of indirect treatment comparisons have been limited or conflicting. Moreover, indirect
comparisons are fraught with multiple limitations, including that the populations recruited into
different trials for the therapies being compared may differ in ways which may influence the
outcome(s) of interest. Consequently, current asthma guidelines have limited evidence-based
guidance on how to approach biologic initiation in patients who are eligible for multiple biologics.
To optimize the value of these expensive biologics, data on their comparative effectiveness are
solely needed. In the absence of randomized trials, observational data can be used to generate
evidence on the comparative effectiveness of these biologics using ‘real-world’ data. However,
to mitigate biases in non-experimental research and to ensure sound conclusions are drawn
from the data, we need to leverage subject matter expertise with advanced and innovative
causal inference and pharmacoepidemiology techniques. This proposal leverages the PI and
study team’s clinical expertise in asthma and monoclonal antibody research with expertise in
causal inference and epidemiologic study design to emulate hypothetical randomized and
adaptive trials in answering questi

## Key facts

- **NIH application ID:** 11333320
- **Project number:** 5R01HL173055-02
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** Ayobami T Akenroye
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** HL
- **Fiscal year:** 2026
- **Award amount:** $819,020
- **Award type:** 5
- **Project period:** 2025-06-01T00:00:00 → 2030-03-31T00:00:00

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11333320

## Citation

> US National Institutes of Health, RePORTER application 11333320, Emulating hypothetical target trials to establish the comparative effectiveness of biologics in asthma (5R01HL173055-02). Retrieved via AI Analytics 2026-06-30 from https://api.ai-analytics.org/grant/nih/11333320. Licensed CC0.

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