Sanofi Launches Global Patient Registry to Advance Understanding About Cold Agglutinin Disease

  • The CADENCE (Cold Agglutinin Disease Real World EvidENCE) Registry Will Be the First Major Prospective Data Repository of Patients Living with CAD to Date

Cambridge, MA--(BUSINESS WIRE)--Cold agglutinin disease (CAD), is a rare blood disorder that results in the destruction of red blood cells (hemolysis) by the body’s immune system. This serious and chronic disease affects an estimated 16 per million people1, which is equivalent to approximately 12,000 patients in the United States, Europe and Japan. For those living with CAD, symptoms of anemia, for example severe fatigue, can be debilitating, and there is a risk of serious complications, such as acute hemolytic crisis, risk of thromboembolic events, and early mortality.

Better disease understanding, better support for patients worldwide

Despite the potential severity of CAD, to date, there is sparse information about the trajectory, diagnosis and long-term impact of this disease. Additional symptoms of CAD that can impact patients’ daily lives, include shortness of breath, irregular heartbeat and a bluish color or discomfort of their hands and feet. There are currently no approved treatments.

To advance understanding of CAD and better support patients globally impacted by this disease, Sanofi has launched the CADENCE (Cold Agglutinin Disease Real World EvidENCE) Registry. The registry will examine the natural history of CAD, the long-term impact of the comorbidities associated with the disease and the outcomes of various treatments, among other things.

“The CADENCE Registry is part of our ongoing commitment to generate evidence that can help improve the care of those with CAD. We believe that by improving understanding of this disease, we can help improve the treatment of those living with CAD,” said Mouhamed Gueye, PharmD, MBA, Head of Global Medical Affairs, Rare Blood Disorders, Sanofi Genzyme. “Thanks to ongoing research, our knowledge about the severity of CAD has increased. Our intention is that, by tracking the disease progression and management of hundreds of people with CAD in countries around the world, we will create a rich scientific repository of information that can inform how we understand this disease.”

Global insight into a complex rare blood disorder

The CADENCE registry is intended to advance the understanding of the disease and provide a resource to the scientific and medical community from around the world, that may ultimately improve the care of patients living with this rare condition. The registry will aim to enroll approximately 725 patients with CAD in 121 sites. The countries initially participating include the United States, Canada, France, United Kingdom, Germany, Italy, Spain, Austria, Norway, Japan and Australia.

We are learning that CAD is not just a simple anemia but a complex disease associated with systemic complications,” said Alexander Röth, M.D., Department of Hematology, University Hospital, University of Duisburg-Essen, Germany. “For patients and physicians alike, the availability of the CADENCE registry provides a meaningful step forward in our ability to capture the true impact of CAD on patients as a means to better inform treatment decisions and clinical management of the disease.”

About the CADENCE Registry

The CADENCE Registry is a global study intended to advance the understanding of CAD. The registry will follow patients in the real world and will gather their historical data as well as prospectively track their disease-related characteristics and complications, allowing for a better understanding of the natural history of this rare condition. As the data collection grows, it has the potential to better inform and describe the long-term clinical outcomes associated with various CAD treatments and provide insights into health-resource utilization and patient-reported outcomes. Any person 18 years of age or older with a diagnosis of CAD in the countries participating in the study, is eligible to enroll. To learn more, contact

About Cold Agglutinin Disease (CAD)

CAD is a serious, chronic rare blood disease in which a part of the body’s immune system called the complement system mistakenly attacks a person’s own healthy red blood cells. People with CAD suffer from chronic anemia, debilitating fatigue, acute hemolytic crisis and a poor quality of life. Retrospective analyses have also demonstrated other potential complications for CAD patients including an increased risk of thromboembolic events and early mortality. CAD occurs in approximately 16 people per millioni, including an estimated 12,000 people in the United States, Europe and Japan. There are currently no approved therapies for CAD.

i Berentsen S, et al. Haematologica. 2006;91(4):460-466


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