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 STOX® Suite is becoming an essential tool to help ease the regulatory journey by assessing steroid-toxicity to:
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 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:
The STOX Suite has been licensed in 25+ disease indications, across 1100 sites in 80 countries across the world.
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]
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.
Michelle Petri, MD MPH
Professor of Medicine at the Johns Hopkins University School of Medicine
David Jayne, MD
Clinical Nephrologist at Addenbrooke's Hospital, Cambridge UK
John H. Stone, MD MPH
Professor of Medicine at Harvard Medical School, and the Edward A. Fox Chair in Medicine at the Massachusetts General Hospital
Paul Brunetta, MD
Head of Clinical & Translational Science, Sana Biotechnology
Adjunct Associate Professor, Pulmonary and Critical Care Division,
University of California, San Francisco
Sudhakar Sridharan, MD
Vice President in Medical Science & Strategy Division at PPD/ThermoFisher