academia_top3

Can your research capture the full effects of steroids?

It’s time to get steroid-sparing into your studies.

Quantitative measures that provide straightforward, reliable, and reproducible assessments enable significant advances in clinical research. Integrating the Steritas GTI into your studies of steroid-sparing therapies provides valuable data and enhances the strength of your conclusions. Augmenting your protocols with the GTI helps measure and minimize the effects of steroid-toxicity in your patients.

 

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.  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 Steritas 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

Could the Steritas GTI be a useful efficacy and safety outcome measure in your next clinical trial?
Register to attend our webinar.

Register today