Teplizumab

Abstract

Generic name: Teplizumab-mzwv1US Food and Drug Administration (FDA). News Release: FDA Approves First Drug That Can Delay Onset of Type 1 Diabetes [FDA website]. 2022. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-can-delay-onset-type-1-diabetes. Accessed May 8, 2023.Google Scholar Brand name: Tzield Manufacturer: Provention Bio (Red Bank, New Jersey) Date of US Food and Drug Administration approval: November 17, 2022 Class: CD-3–directed monoclonal antibody2Teplizumab [Drugbank website]. Available at: https://go.drugbank.com/drugs/DB06606. Accessed May 8, 2023.Google Scholar Cost: 13,850 USD/vial; 14-day regimen, 193,900 USD3Mahobe R, Srinivasan N. Provention Bio diabetes drug to cost $13,850/vial [Reuters online]. Available at: https://www.nasdaq.com/articles/provention-bio-diabetes-drug-to-cost-$13850-vial. Accessed May 8, 2023.Google Scholar Teplizumab is indicated for the delay of the onset of type 1 diabetes mellitus (T1DM) stage 3 (ie, the presence of ≥2 autoantibodies, hyperglycemia, and symptoms of T1DM) in adults and children aged ≥8 years with T1DM stage 2 (ie, the presence of ≥2 autoantibodies, dysglycemia, with or without symptoms). T1DM is an autoimmune condition in which T cell–mediated destruction of pancreatic β cells leads to a loss of insulin production, impaired glycemic control, and a reliance on exogenous insulin.2Teplizumab [Drugbank website]. Available at: https://go.drugbank.com/drugs/DB06606. Accessed May 8, 2023.Google Scholar Teplizumab binds to certain immune cells and delays the progression to stage 3 T1DM. Teplizumab may deactivate the immune cells that attack insulin-producing cells, while increasing the percentage of cells that help to moderate the immune response.1US Food and Drug Administration (FDA). News Release: FDA Approves First Drug That Can Delay Onset of Type 1 Diabetes [FDA website]. 2022. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-can-delay-onset-type-1-diabetes. Accessed May 8, 2023.Google Scholar The most common adverse effects with teplizumab use include rash, headache, and decreased levels of certain white blood cells. Teplizumab should be used with caution; patients should undergo premedication and monitoring for cytokine-release syndrome, serious infections, decreased lymphocytes, and hypersensitivity reactions. All age-appropriate vaccinations should be administered prior to the initialization of teplizumab treatment, and the concurrent use of live, inactivated and mRNA vaccines should be avoided with teplizumab use.1US Food and Drug Administration (FDA). News Release: FDA Approves First Drug That Can Delay Onset of Type 1 Diabetes [FDA website]. 2022. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-can-delay-onset-type-1-diabetes. Accessed May 8, 2023.Google Scholar Teplizumab is administered by IV infusion once daily for 14 consecutive days. The safety and efficacy of teplizumab were evaluated in a randomized, double-blind, event-driven, placebo-controlled trial in 76 patients with stage 2 T1DM. Patients were randomly assigned to receive teplizumab (n = 44) or inactive vehicle (placebo; n = 32) via IV infusion, once daily for 14 days. The primary measure of efficacy was the time from randomization to a diagnosis of stage 3 T1DM. Over a median follow-up of 51 months, 45% of the patients who received teplizumab were later diagnosed with stage 3 T1DM, compared to 72% of the patients who received placebo. The mid-range times from randomization to the diagnosis of stage 3 T1DM were 50 months in the teplizumab group and 25 months in the placebo group. This finding represents a statistically significant delay in the development of stage 3 T1DM. T1DM occurs when the immune system attacks and destroys the cells that make insulin. In patients with T1DM, glucose is increased, necessitating both injectable insulin (or an insulin pump) for survival, and monitoring of blood sugar levels regularly throughout the day. Although it can develop at any age, T1DM is usually diagnosed in children and young adults. Patients are at higher risk for T1DM if they have a parent or sibling with T1DM, although most patients with T1DM do not have a family history. Teplizumab received Priority Review and Breakthrough Therapy designations for this indication.