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Published on: February 17, 2022
Pediatric Endocrine Society Statement on Considerations for Use of Teplizumab (Tzield™) in Clinical Practice
Shilpa Mehta, Anna Ryabets-Lienhard1, Neha Patel2
1Division of Pediatric Endocrinology, Department of Pediatrics, New York Medical College, Valhalla, New York, USA.
Insights
Teplizumab is the first FDA-approved drug to delay type 1 diabetes progression. This guidance helps pediatric endocrinologists use this immunotherapy, covering administration, safety, and monitoring for optimal patient care.
Area of Science:
- Immunology
- Endocrinology
- Pharmacology
Background:
- Type 1 diabetes (T1D) is a chronic autoimmune disease.
- Progression from stage 2 to stage 3 T1D signifies significant beta-cell loss.
- Teplizumab is a novel immunotherapeutic agent targeting T-cell activation.
Purpose of the Study:
- To provide clinical guidance for pediatric endocrinologists on using teplizumab.
- To review evidence and expert recommendations for teplizumab administration.
- To address practical aspects of teplizumab use in clinical practice.
Main Methods:
- Systematic review of clinical trial data on teplizumab.
- Solicitation of expert recommendations from a task force.
- Development of practical guidelines for administration and monitoring.
Main Results:
- Teplizumab is the first FDA-approved therapy to delay T1D progression.
- Guidelines cover patient selection, prescreening, infusion protocols, and side effect management.
- Expert opinions address areas with limited evidence.
Conclusions:
- Teplizumab offers a new approach to delaying T1D progression.
- Standardized protocols are essential for safe and effective use.
- Further long-term surveillance studies are needed to evaluate efficacy and safety.
Abstract:
Teplizumab (TzieldTM, Provention Bio), a monoclonal antibody directed at T-cell marker CD3, is the first medication approved by the FDA to delay progression from stage 2 to stage 3 type 1 diabetes. To date, the overwhelming majority of pediatric endocrinologists do not have experience using immunotherapeutics and seek guidance on the use of teplizumab in clinical practice. To address this need, the Pediatric Endocrine Society (PES) Diabetes Special Interest Group (Diabetes SIG) and Drug and Therapeutics Committee assembled a task force to review clinical trial data and solicit expert recommendations on the approach to teplizumab infusions. We present considerations on all aspects of teplizumab administration, utilizing evidence where possible and providing a spectrum of expert opinions on unknown aspects. We discuss patient selection and prescreening, highlighting the safety and considerations for monitoring and treatment of side effects. We propose a schedule of events, a protocol for administration, and discuss practice management aspects. We advocate for the need for further long-term systematic surveillance studies to continue evaluating the efficacy and safety of teplizumab.
