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Let's face it

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Let's face it
steroid-toxicity

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Let's face it
steroid-toxicity
needs to be measured

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Let's face it
steroid-toxicity
needs to be measured

50 million people1

1% of the world's adult population is taking long-term glucocorticoids.

>60% of patients2

taking glucocorticoids are not monitored for steroid-toxicity.

40% of costs3

for patients on long-term glucocorticoids are linked to steroid-toxicity.

Glucocorticoids are overused and toxic: it’s time to quantify the problem.

For more than 70 years, steroids have been both panacea and poison.  The first report of steroid-toxicity came only three weeks after the first administration of cortisone in 1948. Steroids are now among the most widely prescribed drugs in the world, yet there is no international standard to measure their toxicity. The Steritas GTI (Glucocorticoid Toxicity Index) was developed to change that.

Glucocorticoid Toxicity Index
First-in-class clinical instrument to quantify steroid-toxicity

Steritas GTI

Validated clinical outcome assessment of steroid-toxicity

The Steritas GTI provides a systematic approach to assessing steroid-toxicity.  The instrument has been validated and is FDA 21 CFR Part 11 enabled4 to measure and monitor steroid-toxicity in clinical trials.

 

The GTI's weighted scores of steroid-toxicity equip clinicians and regulators to evaluate the impact of steroid-sparing treatments. The GTI is fast, accurate, and easy to implement.

Steritas_Core_Index_Damage_Checklist

Capture change in steroid-toxicity over time

The Steritas GTI is comprised of two components: the Core Index and the Damage Checklist. The Core Index is built on nine domains that are standardized and weighted to quantify and compare indicators of toxicity that may occur over the course of a clinical trial. The Damage Checklist is an inventory of steroid toxicities that are less common yet are often severe and generally reflect permanent damage from prior steroid use. The GTI merges these two components in an intuitive workflow that aligns with the normal course of data collection in a clinic visit.

Steritas_SteriToxProfile_CWS_AIS

Monitor your clinical trial patients with the SteriTox Profile

The Steritas GTI summarizes results in a SteriTox Profile for each patient. The Cumulative Worsening Score (CWS) and the Aggregate Improvement Score (AIS) provide nuanced interpretations of steroid-toxicity from the same dataset. Higher scores indicate higher toxicity (worsening); lower scores indicate lower toxicity (improvement). Therefore, if an investigational treatment is effective in decreasing steroid-toxicity, the CWS and AIS will be lower in the investigational arm of the trial.

HubSpot Video

“For inflammatory diseases, steroids remain - unfortunately - a necessary evil. Better steroid-sparing drugs are essential alternatives to the current standards of care for many conditions."

John H. Stone, M.D., M.P.H.
Professor of Medicine
Harvard Medical School
The Edward Fox Chair in Medicine
Massachusetts General Hospital

“If we had an instrument that could measure toxicity and show when a new drug works AND reduces toxicity that would be a really big deal.”

Paul Brunetta, MD
Head of Clinical & Translational Science, Sana Biotechnology
Adjunct Associate Professor, Pulmonary and Critical Care Division,
University of California, San Francisco

“What you gain by adding the Steritas GTI to a clinical trial is a systematic way of assessing steroid toxicity.”

David Jayne, MD
Professor of Clinical Autoimmunity,University of Cambridge
and Director, Vasculitis and Lupus Service, Addenbrooke’s Hospital

"Change in glucocorticoid toxicity does not have a significant linear correlation with a change in oral glucocorticoid dose. This indicates that if an important goal of a new therapy is to decrease glucocorticoid toxicity then glucocorticoid toxicity needs to be measured directly rather than relying upon milligrams of glucocorticoids administered."

Paul Brunetta, MD
Head of Clinical & Translational Science, Sana Biotechnology
Adjunct Associate Professor, Pulmonary and Critical Care Division,
University of California, San Francisco

“You always have your primary endpoint to address why you are doing the trial but then in your evaluation of benefit or cost, you want to evaluate activity, you want to evaluate damage, permanent damage, you want to evaluate quality of life. That’s where the GTI fits in as part of a holistic approach patient assessment.”

David Jayne, MD
Professor of Clinical Autoimmunity,University of Cambridge
and Director, Vasculitis and Lupus Service, Addenbrooke’s Hospital

“If the Glucocorticoid Toxicity Index were part of a Target Product Profile (TPP) in a clinical development program it could really help capture the benefit of a new therapy that reduces steroid-related toxicity as steroid dosage is also reduced. Again, the key elements of the TPP are efficacy, safety, dosage and administration."

Paul Brunetta, MD
Head of Clinical & Translational Science, Sana Biotechnology
Adjunct Associate Professor, Pulmonary and Critical Care Division,
University of California, San Francisco

Could the Steritas GTI provide valuable efficacy and safety data for your next clinical trial?
Register to attend our webinar.

Register today

The Steritas GTI in clinical trials

Steroid-toxicity is being measured in new drug trials in inflammatory diseases.

The Steritas GTI is being used in dozens of clinical trials worldwide. For example, the GTI was a key secondary endpoint in a trial that resulted in FDA approval of an adjunctive treatment to standard therapy for patients with active ANCA-associated vasculitis. The GTI supports primary and secondary safety endpoints in a growing list of clinical trials and real-world studies.

View a list of trials

 

References

1. Fardet L, Petersen I, Nazareth I. Prevalence of long-term oral glucocorticoid prescriptions in the UK over the past 20 years. Rheumatol Oxf Engl. 2011;50:1982–1990.

2. Laurence Fardet, MD, PhD, Irene Petersen, PhD, and Irwin Nazareth, MD, PhD Monitoring of Patients on Long-Term Glucocorticoid Therapy- A Population-Based Cohort Study. Medicine. Volume 94, Number 15, April 2015

3. Rice JB, White AG, Johnson M, Wagh A, Qin Y, Bartels-Peculis L, Ciepielewska G, Nelson WW. Healthcare resource use and cost associated with varying dosages of extended corticosteroid exposure in a US population. J Med Econ. 2018 Sep;21(9):846-852. 10.1080/13696998.2018.1474750. Epub 2018 May 23. PMID: 29741439.

4. FDA 21 CFR, Part 11 enabled tools. Software as a Medical Device (SaMD)