The Food and Drug Administration (FDA) has approved Tzield (teplizumab-mzwv) injection, a new treatment that can delay the onset of stage 3 type 1 diabetes (T1D) in adults and pediatric patients eight years and older who have stage 2 T1D.
Tzield is the first disease-modifying therapy for T1D, a debilitating disease that occurs when the immune system attacks and destroys the body’s insulin-producing cells, leading to dependence on exogenous insulin therapy for survival.
Although Tzield does not prevent or cure T1D, the treatment can delay the need for exogenous insulin therapy and its associated risks and intensive regimen.
This delay is clinically meaningful, particularly because T1D often presents in patients younger than 10 years who may face challenges with complex disease management.
Diabetes is a non-communicable diseases that results when the levels of sugar in the blood remains persistently high due to the inability of the pancreas to produce insulin in sufficient quantities.
More than 3.6 million Nigerians or 11.2 million are estimated to be struggling with the disease, according to the Diabetes Association of Nigeria.
Smaller pockets of studies indicate that the prevalence could be roughly 5.8 percent of the adult population, many of which financial constraints prevent from beating the disease.
A 2016 data from the World Health Organization shows that a higher number of diabetes deaths (9,380) were recorded among women than among men (5780).
High sugar levels in the blood over a long period can cause serious damage to blood vessels and ultimately major organs in the body such as the heart, eyes, kidneys, and nerves.
If the blood sugar is not properly controlled, the organs become further damaged resulting in complications such as eye problems manifesting as blurry vision or outright blindness; and foot problems manifesting as numbness in the feet, foot infections, or wounds that are difficult to heal.
It could also result in heart attack and stroke; kidney disease, nerve damage, gum disease, and sexual dysfunction.
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Stage 1 occurs when a patient develops two or more auto-reactive antibodies to pancreatic islet cells. By stage 2, patients have lost enough insulin-producing cells to result in abnormal glucose levels (dysglycemia) but do not yet meet the criteria for diabetes.
Stage 2 T1D is associated with a 75 percent risk of progression to a T1D diagnosis (stage 3) within four to five years and a lifetime risk of nearly 100 percent, according to studies.
Stage 3 occurs when patients develop overt hyperglycemia, typically with signs and symptoms of diabetes including increased thirst, increased urination, blurred vision, weight loss, and fatigue.
While a family history of T1D substantially increases a patient’s risk, approximately 90 percent of patients with new-onset T1D do not have a family history of T1D.
Tzield is a CD3-directed antibody that binds to and may deactivate pancreatic beta cell auto-reactive T lymphocytes.
Tzield is administered by intravenous infusion once daily for 14 consecutive days.
Patients are eligible for Tzield when they have laboratory evidence of at least two positive pancreatic beta cell autoantibodies and dysglycemia.
As the gold standard in diabetes diagnosis, an oral glucose tolerance test is recommended to confirm presence of dysglycemia.
Tzield’s safety and efficacy were evaluated in a randomized, double-blind, event-driven, placebo-controlled trial with 76 patients with stage 2 T1D.
The primary measure of efficacy was the time from randomisation to stage 3 T1D diagnosis.
Over a median follow-up of 51 months, 45 percent of the 44 patients who received Tzield were diagnosed with stage 3 T1D compared to 72 percent of the 32 patients who received a placebo.
The mid-range time from randomisation to stage 3 T1D diagnosis was 50 months for patients who received Tzield and 25 months for those who received a placebo, representing a statistically significant delay in stage 3 T1D diagnosis of approximately two years.
Confirmatory evidence of effectiveness was provided by a meta-analysis of five trials that demonstrated a statistically significant reduction in the decline of C-peptide, a measure of endogenous insulin secretion when teplizumab was administered to patients with new or recent onset stage 3 T1D.
The most common side effects of Tzield include lymphopenia, rash, leukopenia and headache.
Use of Tzield comes with warnings and precautions about the risks of cytokine release syndrome, serious infections, lymphopenia and hypersensitivity reactions, as well as the need to administer age-appropriate vaccinations before starting Tzield and avoid concurrent use of live, inactivated, and mRNA vaccines.
