Sanofi, Sema4 launch 5-year, real-world digital asthma study

Sanofi and Sema4 have launched a five-year longitudinal study of nearly 1,200 asthma patients, with plans to incorporate digital tools to develop a better understanding of the disease.

Alongside collections of clinical, genomic and environmental data, it will employ connected inhalers to track how the disease affects some individuals differently than others, in what Sanofi describes as one of the largest studies of its kind.

"Our goal is to develop a holistic view of each patient in the study, which is why we’re excited to add digital technology to the traditional types of medical examinations conducted in this study," said Sanofi’s Frank Nestle, global head of immunology and inflammation research and chief scientific officer of North America.

"It’s a new way to approach this enormous problem, connecting real world clinical and scientific data, that we hope will translate into new ways to treat asthma," Nestle said.

In conjunction with Mount Sinai Health System, which spun out the predictive health company Sema4 in June 2017, the researchers plan to use machine learning and other techniques to analyze the mechanisms of the disease and potential triggers of asthma attacks, as well as which patients are most likely to respond to certain therapies.

"We are big believers in applying digital technology across our entire business at Sanofi, starting with research," said Heather Bell, global head of digital and analytics at Sanofi, which expects the study will produce one of the richest data sets ever on asthma.

Using real-world patient experience and activity data gathered through digital sensors, researchers will have a view into each asthma attack placed in context with environmental factors such as pollen levels.

The researchers will then aim to identify new targets for drug development, as well as ways to translate their collected data into more effective treatment recommendations for patients.

"Asthma is an incredibly complex condition associated with genetics, environmental factors, activity levels, the immune system and more," said Sema4 CEO Eric Schadt. The disease affects about 235 million people globally, according to estimates from the World Health Organization, including 1 in every 13 individuals in the U.S.

"We believe the only way to fully understand asthma is by using sophisticated modeling tools to mine the rich, multi-dimensional data set we aim to generate in this study," Schadt said.

Connected inhaler developer Propeller Health, in collaboration with the University of Wisconsin-Madison and the University of California, Berkeley, recently completed a U.S. study showing an association between daily air pollution and rescue inhaler usage.

The study—conducted from 2012 to 2017 on more than 2,800 people with asthma and published in Proceedings of the National Academy of Sciences—used data from the former Fierce 15 winner’s digital medicine database to analyze levels of fine particulate matter at the time and location of rescue inhaler use, while previous studies have relied on hospitalization or mortality data to assess the impacts of pollution.

The study found that a 12% reduction in fine particulate matter concentration could generate about $350 million annually in economic benefits stemming from fewer asthma attacks.

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