The Steritas pediatric Glucocorticoid Toxicity Index (pGTI)^[1] provides a systematic approach to assessing steroid-toxicity in children between the ages of 2 and 18 years. It is used to measure and monitor steroid-toxicity in young patients.

The pGTI instrument provides weighted scores of steroid-toxicity that equip researchers, clinicians and regulators to evaluate the impact of steroid-sparing treatments. The pGTI is fast, accurate, and easy to implement.

Glucocorticoids can severely impact growth and development in children, lead to adverse events in puberty, and can affect overall wellness throughout adulthood. To fully address these impairments, the pGTI:

• Includes growth as an entirely new domain.
• Considers age-related references such as height, and gender-specific reference ranges for blood pressure and other parameters.
• Assesses neurological side effects unique to the pediatric population.
• Adjusts domain weights to score those steroid-toxicities that are specific to children.

The pGTI is a systematic approach to assessing steroid-toxicity and informing decision-making in the treatment of inflammatory diseases. The instrument provides weighted outcome scores of steroid-toxicity that equip clinicians and regulators to evaluate the impact of steroid-sparing treatments. The pGTI is fast, accurate and easy to implement.

The pGTI provides the only clinical outcome assessment (COA) that drug developers can rely on to demonstrate improved safety of their new treatment compared to steroids alone. When a new therapy is shown to be non-inferior to standard therapy with regard to efficacy, the safety of the new agent, as measured by the pGTI, becomes of paramount importance. 

The pGTI balances scientific rigor and data analytics with ease of use. In most cases, the STOX® Suite calculates steroid-toxicity using data that are collected routinely in clinical trial or in practice.

We welcome your interest in the STOX Suite. All uses of these instruments require a license, whether you are an academic researcher, biotech start-up, a large pharmaceutical company, or a clinical research organization.

Steritas will structure a use license to support the scope and design of your trial and the needs of your organization. 

1. Brogan P, Naden, R, Ardoin SP et. a.  The pediatric glucocorticoid toxicity index.  Seminars in Arthritis and Rheumatology. Vol 56 (2022) 152068 DOI: 10.1016/j.semarthrit.2022.152068
2. Jayne DRW, Merkel PA, Schall TJ, Bekker P; ADVOCATE Study Group. Avacopan for the Treatment of ANCA-Associated Vasculitis. N Engl J Med. 2021 Feb 18;384(7):599-609. DOI: 10.1056/NEJMoa2023386