Innovation of TZIELD

NARRATOR: I’m Dr Diane Craig, a pediatric endocrinologist. I’ve managed hundreds of children living with type 1 diabetes, also known as T1D (tee-one-dee), many of them arriving at my office after being hospitalized with diabetic (di·​a·​bet·​ic) ketoacidosis (ke·​to·​ac·​i·​do·​sis), or DKA (dee-kay-ay); the entire family scared and trying to adapt quickly to the sudden and unexpected burdens of a T1D diagnosis.

NARRATOR: But the paradigm is evolving. Healthcare professionals, including endocrinologists, PCPs, and pediatricians can now test for pancreatic islet (eye-let) autoantibodies, identifying those with T1D earlier in the disease process, before visible signs and symptoms. Early identification allows for proactive monitoring, which can potentially reduce their risk of DKA.

NARRATOR: And, for the first time ever, Patients aged 8 years and older with Stage 2 T1D may be eligible for TZIELD (tee-zield), a treatment option that can potentially delay the onset of Stage 3 T1D, when insulin will be eventually required.

NARRATOR: Proactive T1D screening not only reduces the risk of DKA through continued monitoring, but is the first step to identifying patients who may be appropriate for TZIELD intervention.

NARRATOR: The American Diabetes Association (ADA) recommends screening those at risk of T1D for 4 available islet autoantibodies— GADA (Gad), ZnT8A (Zinc Transporter 8) , IA-2A (EYE-A-2), and IAA (Insulin Autoantibody)

NARRATOR: A fifth islet autoantibody, ICA (eye-see-A), is also available.

NARRATOR: Once a patient tests positive for 2 or more of these islet autoantibodies, it’s a signal that an autoimmune attack on the beta cells has begun.

NARRATOR: A positive T1D screening, along with glycemic testing, confirms T1D diagnosis and stage. Patients diagnosed with Stage 1 or 2 T1D will inevitably progress to Stage 3, requiring exogenous insulin for the remainder of their lives.

NARRATOR: According to the ADA, patients who screen positive for multiple islet autoantibodies should be evaluated and monitored further.

NARRATOR: By assessing patient glycemic levels, we can understand the metabolic impact of their beta-cell destruction and their disease between Stages 1, 2, or 3.

NARRATOR: Stage 1 patients are positive for 2 or more islet autoantibodies but are normoglycemic, with enough functional beta cells to maintain glucose homeostasis.

NARRATOR: As beta-cell destruction continues and T1D progresses, in addition to 2 or more autoantibodies being present, patients exhibit fasting plasma glucose levels between 100 and 125 milligrams per deciliter and are considered dysglycemic.

NARRATOR: These patients are in Stage 2. In both Stage 1 and Stage 2, there remains sufficient beta-cell function to produce enough insulin to maintain adequate blood glucose levels so that patients are without signs or symptoms.

NARRATOR: But by the time a patient progresses to Stage 3, their beta-cell function is insufficient to produce enough insulin for normal body function and patients present with clinical signs and symptoms indicative of overt hyperglycemia.

NARRATOR: Patients in Stage 3 T1D have lost the ability to naturally produce the amount of insulin that their body needs to maintain glucose homeostasis and inevitably require lifelong insulin replacement therapy.

NARRATOR: But if these patients are identified while in Stage 2 T1D, there is an opportunity to potentially delay the onset of Stage 3 with TZIELD.

NARRATOR: In patients aged 8 years and older with Stage 2 TID, TZIELD is designed to impact an underlying autoimmune process of T1D, and may delay the onset of Stage 3.

NARRATOR: It is believed that TZIELD may preserve some beta-cell function by binding with CD3 receptors on the surface of autoreactive T cells leading to deactivation. TZIELD is also believed to promote immune tolerance through the induction of regulatory and exhausted T cells and by reducing the expansion of antigen-specific memory T cells.

NARRATOR: The value TZIELD brings to people in Stage 2 is that it offers them the chance to delay disease progression to Stage 3 T1D. And in doing so, may give them more time for T1D education, support, and for future treatment options to emerge.

NARRATOR: TZIELD can have serious adverse reactions, including cytokine (cy-toe-kyne) release syndrome, serious infections, lymphopenia, hypersensitivity reactions.

NARRATOR: and interactions with some vaccinations and may affect how well they work.

NARRATOR: Most common adverse reactions (>10%) were lymphopenia, rash, leukopenia, and headache.

NARRATOR: There is currently no evidence that TZIELD will have any effect on burden of disease, outcomes, or life expectancy.

NARRATOR: The paradigm of T1D treatment is evolving. We’ve now entered an exciting era of what we’re able to offer patients so they can be proactive in their T1D management.

NARRATOR: If you want to learn more about the efficacy data and safety profile of TZIELD in patients aged 8 years and older with Stage 2 T1D, visit www.tzieldhcp.com