De-risking CRS: Transforming care with digital technology

“I received a call at home from my nurse in the middle of the night concerned about my fever,” Michael said when explaining his experience with cytokine release syndrome (CRS) following CAR T-cell therapy, a type of immunotherapy used to treat cancer.

This was during a new pilot program, wherein Michael was able to be monitored for CRS in an outpatient setting from the comfort of his home. Despite the unpleasant symptoms for a couple of days, Michael expressed how this new program allowed him to be surrounded by his family for support and positioned him for returning to his busy life. His experience highlights the growing need for solutions that can make this kind of monitoring more common, ultimately supporting the broad use of immunotherapies like CAR T-cell therapy.

Monitoring CRS: Challenges and barriers

CRS is a severe immune response that can occur after treatments like CAR T-cell therapy and bispecific antibodies. While often mild, CRS can lead to severe complications, including organ failure or death in extreme cases. As these immunotherapies evolve and show promise in treating additional cancers and other diseases, effectively managing CRS becomes critical to improving patient safety and accessibility. However, managing CRS is no small task.

As the number of patients receiving CAR T-cells and other advanced therapies continues to rise, hospital resources are becoming increasingly stretched. Inpatient monitoring takes up valuable hospital beds, and healthcare providers are trying to keep up with the demands of managing more patients. Additionally, patients are often required to stay close to the hospital, adding logistical and financial burdens to their already difficult treatment journey.

At the same time, existing CRS monitoring practices fall short of what is needed. Vital signs are typically checked every 4-8 hours, which means early signs of CRS can be missed when timely intervention is most crucial. This infrequent monitoring doesn’t provide a continuous, real-time picture of a patient’s condition, making it harder for healthcare providers to detect CRS before it escalates. These gaps in care emphasize the urgent need for more innovative solutions to bridge the monitoring gap and improve outcomes.

Paving the way for better risk prediction

The pressing need for better CRS monitoring highlights a clear opportunity for innovation. This is where cutting-edge resources, like those provided by the Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe), come into play. A recent DATAcc project, Advancing digital capabilities to enable digital risk prediction for CRS, defined common elements of the digital measurement of CRS to advance CRS risk prediction products.

Through the DATAcc work, developers now have a set of key resources aimed at improving CRS detection. The resources include:

• Building CRS De-risking Products: A Practical Guide for Developers
  A guide offering recommendations and insights into the design and development of CRS de-risking products, including data harmonization and clinical evidence generation.
• Common Digital Clinical Measures for CRS
  A set of key measures for detecting early indicators of CRS, aimed at supporting high-frequency data collection and building data-driven CRS predictive models.
• CRS Innovation Roadmap
  A strategic resource for developers, outlining an iterative approach to building effective products for predicting CRS from current monitoring capabilities to the development of a digital diagnostic.

A vision for the future: Trustworthy de-risking CRS products and expanded access to immunotherapies

Advancing CRS risk prediction products requires addressing both operational needs and technological requirements. It is essential to build solutions that are not only clinically validated but also mitigate the clinical and financial burden. To maximize their impact, developers should focus on:

• Data harmonization: Enable standardized, robust, and high-frequency data collection during CRS monitoring.
• User-friendly products and operational efficiency: Design intuitive, low-touch interfaces that enhance patient responsibility and streamline operational resources.
• Robust data flow infrastructure: Build systems that support real-time data collection for high-acuity use.
• Compliance: Ensure adherence to regulatory and institutional standards for CRS risk management.

By addressing these priorities, developers can build products that are clinically robust and practical for real-world settings, expanding access to vital immunotherapies.

Together, we can innovate for better care

DATAcc’s work and resources laid the foundation for developing products to reduce the strain on healthcare systems, improve patient outcomes, and increase the accessibility of life-saving therapies. But there is still much work to be done. The future of de-risking CRS depends on continuous innovation and collaboration between developers, clinicians, and patients.

If you’re passionate about advancing healthcare through digital innovation, now is the time to get involved. DATAcc offers a platform for collaboration—where your expertise and ideas can help shape the future of digital health. Together, we can make a lasting impact. Join us today.