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Samisha Khangaonkar Pharma Analyst at GlobalData comments: “Approximately 85% of people with T1D have no family history of the disease and GlobalData expects T1D prevalence across the eight major markets (8MM*) to grow to 4.7 million by 2026 at an annual growth rate of 3.92% which emphasizes the need for expanded testing and greater population screening to optimize the impact of preventative or early-onset treatments.”
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Studies funded by JDRF such as FR1da TrialNet INNODIA and ASK found that T1D screening was able to reduce cases of diabetic ketoacidosis (DKA). In FR1da antibody screening signaled potential T1D and as a result families were able to catch typically overlooked symptoms and subsequently start insulin treatment earlier.
Khangaonkar continues: “Earlier symptoms of T1D such as extreme thirst frequent urination and vomiting are difficult to identify as T1D on their own. If untreated by exogenous insulin at this stage the patient is likely to develop DKA which can lead to death. DKA at diagnosis of T1D in children is predictive of poor long-term glycemic control and correlates to a greater risk of complications.”
Key opinion leaders (KOLs) interviewed by GlobalData had mixed feelings about early detection in T1D without an accessible preventative treatment. An EU KOL noted concerns over the ethics of screening if there is nothing to offer in terms of treatment as there is currently no approved disease-modifying therapeutic and treatment with exogenous insulin is not prescribed until the onset of symptoms. In addition as autoantibodies appear over time the cost of consistent testing may prove to be a burden unless accessible programs are consistently established and encouraged. Despite these concerns the clinical benefits to early screening are still quite important to consider.
Khangaonkar adds: “While KOLs have expressed some concerns they have also agreed that managing T1D complications is a high priority unmet need which can be addressed through treatment at earlier stages of the disease while patients are still able to produce some insulin and this is primarily determined through antibody screening.”
There are currently no disease-modifying therapeutics approved by the US Food and Drug Administration (FDA) but the late-stage pipeline has several promising therapeutics whose success depends on population screening as their greatest impact occurs in early stage patients whose beta cells can still produce some insulin. Recent clinical trials of Provention Bio’s Teplizumab Dompe Farmaceuiti’s ladarixin and Johnson & Johnson’s Ustekinmab have all shown some immune-modulatory success in early stage interventions which are dependent on population antibody screening.
*8MM: The US France Germany Italy Spain The UK Japan and Canada
