academia_top4

Steroid-toxicity
needs to be measured.

It’s time clinical trials were equipped with a standardized measure of efficacy and safety where steroids are concerned.

Among the multitude of steroid-toxicity metrics, which can you trust? It’s time to standardize steroid-sparing drug trial parameters.


The Steritas GTI provides a quantitative and systematic solution to assessing steroid-toxicity. It yields a precision outcome measure of efficacy and safety for clinical investigators to compare new drug protocols with conventional standards of care for steroid dependent patients.

 

The GTI data was 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 clinical trial of avacopan the primary efficacy endpoint at 26 weeks was non-inferiority comparing the two groups for remission induction. Avacopan was indeed non-inferior to standard of care. The secondary endpoint of lower steroid-toxicity proved to be the key differentiator for avacopan. The Steritas GTI made that possible.

 

The GTI reveals lower steroid toxicity for avacopan vs. prednisone

cws - left AIS-right

For each trial participant, patient data was entered into the GTI to generate the Cumulative Worsening Score (CWS), and the Aggregate Improvement Score (AIS),  for each participant at study weeks 13 and 26. A lower score corresponds to lower toxicity for both indices.

 

The mean CWS and AIS for all trial participants are both statistically significantly lower for avacopan than for prednisone. 

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?
Register to attend our webinar.

Register today