Digital Biomarkers of Cytokine Release Syndrome: Scoping Review and Ontology Development of the Role and Relevance of Digital Measures Using a Mixed Methods Approach.

Christopher J Medberry¹, Charlotte Zoe Angel², Ashita S Batavia¹, Sarah Bradley³, Nunzio Camerlingo⁴, Melinda Chen⁵, Mohamed Datoo¹, Premal Kamdar⁶, Erik Koenig⁵, Lieke Kusters⁷, Celine Marquez⁸, Ujwani Nukala⁹, Michael Pettinati¹⁰, Ruth Phillips³, Daniel P Sanchez¹, Nazila Shafagati¹¹, Jenifer Siegelman⁵, Mark Stewart¹², Cindy Varga¹³, Benjamin Vandendriessche^14,15, Matt Wilkes¹⁶, Dana L Wolff-Hughes¹⁷, David Zahavi¹⁷, Sylvain Zorman¹⁰, Samantha J McClenahan¹⁴

¹Johnson and Johnson Innovative Medicine, New Brunswick, NJ, United States.

²Fosanis GmbH, Berlin, Germany.

³Blue Spark Technologies, Inc, Westlake, OH, United States.

⁴Pfizer, Inc, Cambridge, MA, United States.

⁵Takeda (United States), Cambridge, MA, United States.

⁶Bristol Myers Squibb, Princeton, NJ, United States.

⁷Roche (Switzerland), Basel, Switzerland.

⁸Genentech, San Francisco, CA, United States.

⁹Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, United States.

¹⁰ActiGraph, Pensacola, FL, United States.

¹¹The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medicine, Baltimore, MD, United States.

¹²Friends of Cancer Research, Washington, DC, United States.

¹³Department of Hematologic Oncology and Blood Disorders, Levine Cancer Institute, Charlotte, NC, United States.

¹⁴Digital Medicine Society, 90 Canal Street, 4th Floor, Boston, MA, 02114, United States, 1 765-234-3463.

¹⁵Department of Electrical, Computer, and Systems Engineering, Case Western Reserve University, Cleveland, OH, United States.

¹⁶Current Health Inc, Dover, DE, United States.

¹⁷National Cancer Institute, Bethesda, MD, United States.

PubMed PMC DOI PDF

Abstract

BACKGROUND: Advancements in cancer-targeted immunotherapies have transformed care, yet these therapies present a high likelihood of cytokine release syndrome (CRS), a potentially severe immune-related adverse event. The ability to identify CRS earlier could improve care by mitigating risks, widening patient access, and reducing the burden on patients, caregivers, and health care providers. Digital…

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