Lurie Children’s Offers First Disease-Modifying Therapy for Newly Diagnosed Type 1 Diabetes Patients

FDA-approved therapy helps slow disease progression and expand treatment options for children and teens

Ann & Robert H. Lurie Children’s Hospital of Chicago is now offering Tzield (teplizumab-mzwv), the first disease-modifying therapy approved for children and adolescents newly diagnosed with type 1 diabetes. Following recent approval by the U.S. Food and Drug Administration (FDA) for use in stage 3 type 1 diabetes patients, Lurie Children’s is one of only a handful of hospitals in the Chicago area providing this groundbreaking treatment.

Stage 3 type 1 diabetes refers to new-onset diabetes, the point at which a person has developed symptoms and requires insulin treatment. Stage 1 disease is the presence of two or more autoantibodies (signs of immune system activation) with normal blood sugars, and Stage 2 disease is the presence of two or more autoantibodies and slight elevations in blood sugars.

Tzield is designed to slow the progression of type 1 diabetes by targeting the immune processes that damage insulin-producing cells. While not a cure, the therapy helps preserve remaining insulin production and can make the disease significantly easier to manage over time.

“This is an important milestone for families facing a new diagnosis of type 1 diabetes,” said Naomi Fogel, MD, Director of the Diabetes Program at Lurie Children’s and Assistant Professor of Pediatrics at Northwestern University Feinberg School of Medicine. “Tzield gives us an opportunity to intervene early in the disease process and help children maintain their body’s own insulin production for longer. That can translate into better blood sugar control, fewer complications, and an improved quality of life for the entire family.”

Tzield was previously approved to delay the onset of stage 3 type 1 diabetes in individuals with stage 2 disease who are 1 year or older. As such, Lurie Children’s has offered Tzield as a treatment option for this population of patients for the last two years at Central DuPage Hospital (CDH), as part of its clinical partnership with Northwestern Medicine. Mary McCauley, MD, Pediatric Endocrinologist at Lurie Children’s and Assistant Professor of Pediatrics at Northwestern University Feinberg School of Medicine, leads the diabetes program at this location. With its recent expanded approval, the therapy is now available to patients age 8 to 17 years who have been diagnosed with stage 3 type 1 diabetes within the past 8 weeks and show evidence of remaining insulin production.

The treatment for stage 3 type 1 diabetes consists of two 12-day outpatient intravenous infusion courses six months apart, with each session lasting approximately one to two hours.

“While Tzield is not a cure, it represents a major advance in how we care for children with type 1 diabetes,” said Dr. Fogel. “It changes the trajectory of the disease, and that is incredibly meaningful and potentially life changing for patients and families.”

Lurie Children’s treats more than 200 newly diagnosed type 1 diabetes patients each year and provides comprehensive, multidisciplinary care that includes medical management, education, nutrition support, and mental health services.

The hospital is now administering Tzield to eligible patients with stage 3 type 1 diabetes at its main campus in Streeterville and at CDH.

“Offering Tzield in-house allows us to provide seamless, coordinated care for our patients from diagnosis through long-term management,” said Laura Levin, DO, Pediatric Endocrinologist at Lurie Children’s and Assistant Professor of Pediatrics at Northwestern University Feinberg School of Medicine. “It reflects our commitment to bringing the most advanced, evidence-based treatments directly to the families we serve.”

Nine-year-old Karsyn was diagnosed with stage 3 type 1 diabetes in June, just days before she became eligible for Tzield under its expanded FDA approval. She is the first patient in this newly eligible population to receive the treatment at Lurie Children’s.

“After Karsyn’s diagnosis, we wanted to learn as much as we could about Tzield and understand what it could mean for her future. After we did the research, we knew it was a chance worth taking,” said Andra Hendricks, Karsyn’s mom. “What gives me the most hope is the possibility of giving Karsyn some normalcy back and letting her focus on being 9 years old, instead of diabetes being the center of her world. We wanted to give her every possible chance, and we’re grateful she had this treatment option so soon after her diagnosis. Karsyn has had hard days and easier ones, but she keeps pushing through with a strength that amazes me.”

More information and resources about Lurie Children’s Diabetes Program can be found at https://www.luriechildrens.org/en/specialties-conditions/juvenile-diabetes/.

About Ann & Robert H. Lurie Children’s Hospital of Chicago

Ann & Robert H. Lurie Children’s Hospital of Chicago is a nonprofit organization committed to providing access to exceptional care for every child. It is the only independent, research-driven children’s hospital in Illinois and one of less than 35 nationally. This is where the top doctors go to train, practice pediatric medicine, teach, advocate, research, and stay up to date on the latest treatments. Exclusively focused on children, all Lurie Children’s resources are devoted to serving their needs. Research at Lurie Children’s is conducted through Stanley Manne Children’s Research Institute, which is focused on improving child health, transforming pediatric medicine and ensuring healthier futures through the relentless pursuit of knowledge. Lurie Children’s is the pediatric training ground for Northwestern University Feinberg School of Medicine. It is ranked as one of the nation’s top children’s hospitals by U.S. News & World Report.