MONDAY, Oct. 23, 2023 (HealthDay News) -- For children and adolescents with newly diagnosed type 1 diabetes, two 12-day courses of teplizumab show benefit for preservation of beta (β)-cell function, according to a study published online Oct. 18 in the New England Journal of Medicine. The research was published to coincide with the annual meeting of the International Society for Pediatric and Adolescent Diabetes, held from Oct. 18 to 21 in Rotterdam, Netherlands.
Eleanor L. Ramos, M.D., from Provention Bio in Red Bank, New Jersey, and colleagues conducted a randomized, placebo-controlled trial to examine β-cell preservation, clinical end points, and safety in children and adolescents (aged 8 to 17 years) who were randomly assigned to receive two 12-day courses of teplizumab or placebo (217 and 111 patients, respectively).
The researchers found that at week 78, patients treated with teplizumab had significantly higher stimulated C-peptide levels than those receiving placebo (least-squares mean difference, 0.13 pmol/mL). Furthermore, 94.9 and 79.2 percent of patients treated with teplizumab and placebo, respectively, maintained a clinically meaningful peak C-peptide level of 0.2 pmol/mL or greater. With respect to key secondary end points, there was no significant difference observed between the groups. Adverse events, including headache, gastrointestinal symptoms, rash, lymphopenia, and mild cytokine release syndrome, occurred primarily in association with the administration of teplizumab or placebo.
"The present trial showed that two 12-day courses of intravenous teplizumab significantly improved stimulated C-peptide levels, as compared with placebo, at week 78 in patients with stage 3 type 1 diabetes who had enrolled in the trial within six weeks after diagnosis," the authors write.
Several authors disclosed ties to biopharmaceutical companies, including Provention Bio, a Sanofi company, which manufactures teplizumab and funded the study.
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