Extending Teplizumab treatment duration to delay progression of type 1 Diabetes
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Reviewed by Dat Tien Nguyen, B.A, ScM.
Translated by Nhi Phuong Quynh Le, B.A |
Posted on January 24th, 2024
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Type 1 diabetes manifests through an autoimmune attack on pancreatic beta cells responsible for insulin production. Thus, attenuating this immune response could potentially postpone the onset of diabetes. Teplizumab, an antibody capable of binding to CD3 T-cells and inhibiting their response, has received approval from the Food and Drug Administration for short-course treatment in type 1 diabetes. Consequently, the biopharmaceutical company Sanofi sponsored a study to explore the possibility of extending the treatment duration with Teplizumab for additional delays in the progression of type 1 diabetes.
The phase 3 clinical trial comprised 328 participants recently diagnosed with type 1 diabetes within 6 weeks of study enrollment. The average age of the cohort was 12.1 years, with an average body mass index of 18.9. Baseline measurements indicated an average C-peptide level of 0.738 pmol/mL and a glycated hemoglobin level of 9.0%. Random assignment led to participants receiving either Teplizumab or a placebo. Teplizumab, administered intravenously, was given daily in two 12-day courses separated by 26 weeks, with a total dosage of 9 mg per square meter per treatment course. After 78 weeks, Teplizumab-treated individuals exhibited a 0.13 pmol/mL higher C-peptide level compared to the control group. However, there were no significant differences in glycated hemoglobin levels and insulin dosage between the two groups. Notably, Teplizumab usage was associated with a higher incidence of adverse effects, specifically an increased risk of cytokine release syndrome and elevated liver enzymes.
The phase 3 clinical trial comprised 328 participants recently diagnosed with type 1 diabetes within 6 weeks of study enrollment. The average age of the cohort was 12.1 years, with an average body mass index of 18.9. Baseline measurements indicated an average C-peptide level of 0.738 pmol/mL and a glycated hemoglobin level of 9.0%. Random assignment led to participants receiving either Teplizumab or a placebo. Teplizumab, administered intravenously, was given daily in two 12-day courses separated by 26 weeks, with a total dosage of 9 mg per square meter per treatment course. After 78 weeks, Teplizumab-treated individuals exhibited a 0.13 pmol/mL higher C-peptide level compared to the control group. However, there were no significant differences in glycated hemoglobin levels and insulin dosage between the two groups. Notably, Teplizumab usage was associated with a higher incidence of adverse effects, specifically an increased risk of cytokine release syndrome and elevated liver enzymes.