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Steroid-toxicity
is predictable; quantifying it is finally possible

Equip yourself for the regulatory journey with the STOX Suite: validated solutions for steroid-toxicity assessment

Modern medicine is increasingly setting its sights on steroid-sparing alternatives to minimize or avoid the adverse effects of long-term glucocorticoid therapy.

 

Rigorous safety and efficacy testing is crucial to demonstrate that next-generation treatment protocols and highly-targeted therapies are superior to glucocorticoids.

 

The use of a validated metric to quantify steroid-toxicity is of increasing importance as new therapies and drug candidates move through clinical development.

 

The STOXTM Suite is becoming an essential tool to help ease the regulatory journey by assessing steroid-toxicity to:

  • Demonstrate safety and efficacy of new inflammatory disease treatments
  • Aid timely progression through major development milestones
  • Support labeling claims
  • Conduct post-approval monitoring

Add the STOX Suite to your regulatory strategy

 

At Steritas, we’re paving the way for more efficient development and commercialization of safe and effective steroid-sparing therapies.  

 

he STOX Suite, our growing range of clinical outcome assessment instruments, includes:

  • The GTI: calculates change scores across nine health domains in adults
  • The GTI-MD: quantifies change across four metabolic domains in claims and EMR data
  • The pGTI: captures the change scores in nine health domains in children 

 

The STOX Suite is the first collection of validated clinical outcome assessments (COAs) of steroid-toxicity. Each COA can be licensed alone or as a bundle for both retrospective and prospective applications. These applications include:

  • Clinical trials
  • Academic studies
  • Health economics and outcomes research (HEOR)
  • Real-world experiences
  • Clinical practice


The STOX Suite has been licensed in 25+ disease indications, across 1100 sites in 80 countries across the world.

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

The GTI played a central role in the pivotal Phase 3 clinical trial (the ADVOCATE trial) to demonstrate that avacopan (Tavneos®) reduces glucocorticoid exposure and lowers glucocorticoid-induced side effects.  


This was the first demonstration in a worldwide randomized, double blind placebo controlled trial to show a clear clinical benefit of such a highly targeted therapy for the treatment of autoimmune and inflammatory disease.


Based on this evidence, the European Alliance of Associations for Rheumatology (EULAR) updated its recommendations in 2022 to propose avacopan as a steroid-sparing alternative for the management of ANCA-associated vasculitis (AAV).[1]

 

The GTI reveals lower steroid-toxicity for avacopan vs. prednisone

cws - left AIS-right

For each trial participant, patient data were 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

Steritas instruments can help you get steroid-sparing treatments to market

Find out more about licensing our world-class STOX Suite

Request today

References


  1. Hellmich B, Sanchez-Alamo B, Schirmer JH, et al. EULAR recommendations for the management of ANCA-associated vasculitis: 2022 update Annals of the Rheumatic Diseases, Published Online First: 16 March 2023. doi: 10.1136/ard-2022-223764