The CADENCE Registry

To advance understanding of cold agglutinin disease (CAD) and better support patients globally, Sanofi Genzyme has launched a global registry. The CADENCE (Cold Agglutinin Disease Real World Evidence) Registry is the first major prospective data repository for CAD patients. Following is information about the registry and its potential benefits.

About CAD

CAD is a rare autoimmune disorder in which exposure to cold temperatures, those between 32 to 50 F (zero and 10 C), causes autoantibodies called cold agglutinins to bind tightly to red blood cells, inducing their disintegration (lysis) and resulting in anemia.

The disease commonly affects adults who are of middle age and older. It may manifest as a primary disease, in which the underlying cause is not known, or as a secondary disease likely due to bacterial, viral, or parasitic infections, certain types of cancer, or another autoimmune disease.

About the registry

Sanofi launched the CADENCE Registry in late 2019 to help improve patient care through advanced CAD knowledge.

The observational, non-interventional registry aims to enroll about 725 CAD patients at 121 sites. It will run through 2024. Countries initially participating include the U.S., Canada, France, the U.K., Germany, Italy, Spain, Austria, Norway, Japan, and Australia.

The study will follow patients for three years in the real world, collect their historical data, and track their disease-related characteristics and complications. Its data will serve as a resource for the global scientific and medical community.

Upon enrollment, and every six months thereafter, patients will complete outcome questionnaires relating to their functional health and well-being, generic health, and fatigue severity.

Other data collected will include associated comorbidities (presence of other ailments), treatment regimens, transfusion history, relevant biomarkers, disease characteristics, clinical outcomes, and safety information. The data will be collected and analyzed at regional and global levels. Sites will submit data via electronic case report forms.

Registry goals

The goal of CADENCE is to better understand patient and clinical characteristics, patterns and use of CAD treatments, long-term clinical outcomes, patients’ health-related quality of life, and healthcare resource utilization.

Another intent is to gain more insight into the natural history of CAD, including complications and coexisting conditions. The registry also will seek to help raise awareness about CAD and its treatment.

Registry eligibility

The registry will include patients 18 and older with primary and secondary CAD, and mixed warm and cold autoimmune hemolytic anemia.

For more information, write to [email protected].

Last updated: Jan. 7, 2021

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