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Give your sponsor’s drug a competitive advantage with a precise measure of safety and efficacy

It’s time to get steroid-sparing in the label

In phase 2 and 3 clinical trials, the Steritas GTI can assess the efficacy of anti-inflammatory therapies to prevent, reduce, or reverse toxicities in patients taking high-dose or long-term steroids. Integrating the GTI into primary or secondary clinical trial endpoints confers competitive advantage for drug developers targeting steroid-sparing medications for patients with steroid-dependent diseases.


Quantitative measures that provide straightforward, reliable, and reproducible assessment of safety and efficacy endpoints have enabled significant strides in medical care. This is a critical advance for any clinical trial focused on alternative therapeutics for inflammatory diseases.

 

The GTI data were recently analyzed in a retrospective single-center study of patients with ANCA-associated vasculitis to assess treatment burden. Investigators reported results that support the value of steroid-sparing alternatives:

 

  • A statistically significant association of cumulative glucocorticoid doses and GTI scores.
  • Higher toxicity and adverse events associated with greater cumulative doses of glucocorticoids.

Distribution of AEs Related to Glucocorticoid Toxicity Over Time

The Figure shows the adverse events relating to each GTI domain over a 48-month period. Each discrete adverse event was scored once. This confirms the general decline in adverse events over time, as patients disease is brought under better control and glucocorticoids are tapered. GTI scores correspond well to widely acknowledged glucocorticoid related adverse events.

graph of AEs

ADVOCATE trial investigators reported the GTI as the most important secondary endpoint of efficacy

In the ADVOCATE trial of avacopan in ANCA associated vasculitis, demonstration of lower steroid-toxicity was a key differentiator between the two treatment approaches. The Steritas GTI made that possible.

The GTI, CWS, and AIS reveal lower steroid toxicity for avacopan vs. prednisone

cws - left AIS-right

For each trial participant, data were entered into the GTI to generate the Cumulative Worsening Score (CWS), and the Aggregate Improvement Score (AIS), at weeks 13 and 26. The lower scores in the avacopan group confirmed lower steroid-toxicity.

 

The mean CWS and AIS were both lower in the avacopan group. 

 

Find out more

“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

“Being able to show in a clinical trial that you can decrease the effects of glucocorticoid toxicity is a huge step on an additional end-point not only for drug approval, but making the benefits of that new drug more understandable as clinicians and physicians determine how and when to use it.”

Sudhakar Sridharan, MD
Vice President, Global Product Development, Imm/Rheum/Inflam/Clinical Research
PPD, part of ThermoFisher Scientific

“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

Could the Steritas GTI be a useful efficacy and safety outcome measure in your next clinical trial?
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