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The GTI

The assessment that changed the game

Steritas GTI

The first validated clinical outcome assessment of steroid-toxicity

The Steritas Glucocorticoid Toxicity Index (GTI) provides a systematic approach to assessing steroid-toxicity.[1] It has been validated and is FDA 21 CFR Part 11-enabled to demonstrate the steroid-sparing benefits of new drugs and treatment protocols.

The GTI provides weighted outcome scores of steroid-toxicity that enable clinicians and regulators to evaluate the impact of steroid-sparing treatments. The GTI is fast, accurate and easy to implement.

Get “steroid-toxicity reduction” in the label

 

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 now supports a growing list of therapies in clinical trials and real-world studies.
 
The GTI, its pediatric sibling the pGTI, and the point-of-care friendly GTI-MD have been used in more than 25 disease indications, across more than 1100 sites in 80 countries.

Evaluate the impact of steroid-sparing treatments

 

The GTI is  the one systematic assessment of steroid-toxicity that has been validated to inform decision making in the treatment of inflammatory diseases. The instrument provides weighted outcome scores of steroid-toxicity that enable clinicians and regulators to evaluate the impact of steroid-sparing treatments. The GTI is fast, accurate and easy to implement.
 
The GTI provides the only clinical outcome assessment (COA) that drug developers can rely on to demonstrate improved safety of their new treatments compared to steroids. 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 GTI, becomes of paramount importance. 

"While some steroid-toxicities can be mitigated by tapering the drug back, a lot of the side effects are very long lasting. Steroids are like radiation, the best amount of exposure is no exposure."

Max Hamburger, MD

Founder, United Rheumtaology

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"Steroid toxicity is rampant and it can be fatal -  bringing it onto the radar screen of the practicing physician is really, really important."

James T. Rosenbaum, MD

Chief of Ophthalmology emeritus at the Legacy Devers Eye Institute, Portland, Oregon

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"Steroid-toxicity is a huge problem amongst our patients. When they have to be on these drugs for one or more years to keep the disease suppressed they experience many, many complicated side effects, some of which are life threatening."

Dedee Murrell, MD DSc

Head of the Department of Dermatology and St George Hospital, University of New South Wales, Sydney, Australia

Professorial Fellow at The George Institute for Global Health

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"We know that it is not easy to taper patients safely. So if we find a patient's toxicity scores are worsening we can try an immunosuppressant or a biologic drug and then we need to track to see if we can taper the glucocorticoids safely."

Yoshiya Tanaka, MD PhD

Professor and Chairman of the First Department of Internal Medicine, School of Medicine. Dean of Graduate School of Medical Science, University of Occupational and Environmental Health, Japan

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Easy to use, whatever your workflow

 

The GTI 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 trials or in practice.

Download the GTI Factsheet

STOX Suite licenses are tailored to the design of your clinical trial

 

We welcome your interest in the Steritas GTI and related assessments. All uses of the GTI 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.

Contact Us 

Discover how the GTI demonstrates efficacy and safety in your next 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. Stone JH, McDowell, PJ, Jayne DRW et. al. The glucocorticoid toxicity index: Measuring change in glucocorticoid toxicity over time.   Seminars in Arthritis and Rheumatology. Vol 55 (2022): 152010 DOI: 10.1016/j.semarthrit.2022.152010
  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