The STOX Suite enables accurate measurement of steroid-toxicity. The STOX Suite includes four clinical outcome assessments (COA) optimized for different settings:
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 treatment of inflammatory diseases, such as rheumatoid arthritis, asthma, psoriasis and ulcerative colitis, has been transformed in recent years by the availability of new therapeutic agents:
Despite the impact of these new agents, glucocorticoids still play an outsized role in managing inflammatory conditions, and continue to serve as a benchmark in a majority of clinical trials. The ability to monitor both the efficacy and side-effects of steroids in such studies is fundamental to generating robust safety and efficacy data for new therapies. [1]
"If you ask the doctor and patient what they want most of all, their unanimous answer will be not to have to use steroids."
Murray Urowitz, MD FRCP(C)
Professor of Medicine at the University of Toronto
Senior Staff Rheumatologist at the Toronto Western Hospital
Senior Scientist at Krembil Research Institute
Clinical Director, Centre for Prognosis Studies in the Rheumatic Diseases, University Health Network
Dedee Murrell, MD DSc
Head of the Department of Dermatology and St George Hospital, University of New South Wales, Sydney, Australia
Professorial Fellow at The George Institute for Global Health
Yoshiya Tanaka, MD PhD
Professor and Chairman of the First Department of Internal Medicine, School of Medicine. Dean of Graduate School of Medical Science, University of Occupational and Environmental Health, Japan
Wen Zhang, MD PhD
Professor Rheumatology at Peking Union Medical College Hospital (PUMCH), Beijing, China
“My ultimate goal is to highlight the toxicity that we are exposing our patients to by prescribing them steroids, and to better understand the total cost to the patient.”
Neelam Goyal, MD
Clinical Associate Professor in Neurology and Neurological Sciences at Stanford
IgG4-related disease (IgG4-RD) was recognised as a single disease in 2003 with the discovery of elevated concentrations of serum concentrations of IgG4 across a range of inflammatory diseases that were considered separate conditions. [2,3]
The mainstay of the treatment of IgG4-RD diseases has been glucocorticoids.[2] However, new insights are driving the development of more focussed mechanism-based therapies. As is increasingly the case with most inflammatory diseases, the ability to measure glucocorticoid-toxicity directly is an important new opportunity in trial design, because the Glucocorticoid Toxicity Index has been short to play an important role in demonstrating not only safety but efficacy.
The study of obexelimab in lgG4-RD is a great example of how the STOX suite is supporting the development of new therapies across a breadth of inflammatory diseases.
lgG4-related disease (lgG4-RD) was recognised as a single disease in 2003 with the discovery of elevated concentrations of serum concentrations of lgG4 across a range of inflammatory diseases that were considered separate conditions. [2-3]
Improved understanding of the disease etiology is driving the development of mechanism-based therapies for IgG4-RD. [2] These targeted therapies aim to reduce the use of glucocorticoids which are still the standard of care for lgG4-RD. As such, the ability to quantify glucocorticoid toxicity is critically important.
Obexelimab reversibly inhibits B cells, by binding selectively to CD19 and Fe gamma receptor Ilb (FcyRllb), leading to the inhibition (not depletion) of B lymphocytes. Following promising results in a pilot study,[4] the drug is being studied in a Phase 3 trial (NCT05662241). The trial will examine the efficacy and safety of obexelimab for the prevention of disease flares. with the GTI measured toxicity as a key secondary endpoint for efficacy.