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The first validated clinical outcome assessment of steroid-toxicity in children

Steritas pGTI

Validated clinical outcome assessment of steroid-toxicity in children

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.

Reduce steroid-toxicity in children

 

Regulatory agencies such as the U.S. Food & Drug Administration and European Medicines Agency view steroid reduction as a reflection of both efficacy and safety. 
 
Reduction in steroid-toxicity, as measured by the Steritas GTI, constituted the key secondary endpoint in the ADVOCATE trial.[2] The FDA granted approval to use avacopan for the treatment of ANCA-associated vasculitis. The GTI and pGTI now support a growing list of therapies in clinical trials and real-world studies.

First-in-class digital instrument validated to quantify steroid-toxicity in 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. 

"It's very clear that being able to measure things is essential if we want to change them. With the GTI, the pGTI and the GTI-MD, we can measure steroid-toxicity in both clinical trials and clinical practice."

John H. Stone, MD MPH

Professor of Medicine at Harvard Medical School, and the Edward A. Fox Chair in Medicine at the Massachusetts General Hospital

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"Steroid-toxicity is an even bigger problem for children than it is for adults. On top of the side effects experienced by adults, steroids can permanently impact a young person's growth and pubertal development."

Joyce Chang, MD MSCE

Pediatric rheumatologist at Boston Children's Hospital

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"Steroid use is prevalent among severe asthma patients, in part due to physician training that emphasizes the effectiveness of steroids rather than their potential dangers."

Jane McDowell, MBBS BSc PhD

Academic clinical lecturer at Queen's University Belfast in Northern Ireland

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Designed for ease-of-use, whatever your workflow

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.

 

Download the pGTI fact sheet

STOX Suite licenses are tailored to match your protocol

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. 

Measure efficacy and safety outcomes with the pGTI in your next clinical trial

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The STOX Suite in clinical trials

Steroid-toxicity is being measured in a growing list of clinical trials for inflammatory disease drug candidates.

The STOX Suite (GTI, pGTI and GTI-MD) has been licensed in 25+ disease indications, across 1100 sites in 80 countries across the world.

View a list of trials

 

Related Insights

References

  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