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Be sure your research captures the full effects of steroids

Quantify steroid-toxicity in every study

As long as glucocorticoids remain the standard of care in inflammatory disease research, the ability to measure the impact of glucocorticoid-toxicity is essential to ensure robust study results.
 
Using the Steritas STOX® Suite in your studies enables the straightforward, reliable and reproducible assessment of steroid-toxicity and steroid-sparing alternatives. The STOX Suite enhances your data and strengthens your conclusions. 

Ultimately, research based on quantitative assessment of steroid-toxicity supports global efforts to get  “steroid-toxicity reduction”  on the label and change prescribing patterns.

Advance your research with the STOX Suite

 

The STOX Suite enables accurate measurement of steroid-toxicity. The STOX Suite includes four clinical outcome assessments (COA) optimized for different settings:

  • 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

Accelerate your research with steroid-toxicity scores

​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:

  • Anti-TNFs such as adalimumab: psoriasis, Crohn’s disease, ulcerative colitis, rheumatoid arthritis, non-infectious uveitis.
  • Cytotoxic agents including rituximab: rheumatoid arthritis, microscopic polyangiitis and granulomatosis with polyangiitis.
  • Small molecules exemplified by JAK-1 inhibitors: rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, ulcerative colitis, atopic dermatitis and alopecia areata.

 

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] 

 
When researchers use a validated assessment as a direct measure of steroid-toxicity, they can demonstrate when a new therapy reduces steroid- toxicity. This strengthens the likelihood of publication and a successful Investigational New Drug (IND) submission.

"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

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"Steroid-toxicity is a huge problem amongst our patients. When they have to be on these drugs for one or more years to keep the disease suppressed they experience many, many complicated side effects, some of which are life threatening."

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

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"Glucocorticoids cause many major side effects such as mental disturbance and gastric ulcers, but we also have to be conscious of the adverse effects - just one milligram of prednisone is harmful to the metabolism."

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

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"In recent years, we have seen more and more steroid-sparing therapies being developed - the GTI will help make more steroid-sparing therapies available to us, and give us even more options to reduce steroid-toxicity."

Wen Zhang, MD PhD

Professor Rheumatology at Peking Union Medical College Hospital (PUMCH), Beijing, China

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“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

The STOX Suite supports the development of new therapies across a growing range of inflammatory diseases

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.

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References


  1. Bridges SL.  Inflammatory Arthritis Treatment: What's Working, What's Coming.  HSS Health Connection, Living with Inflammatory Arthritis (2022) (https://www.hss.edu/conditions_inflammatory-arthritis-treatment-whats-working-whats-coming.asp)
  2. Zhang W and Stone JH. Management of IgG4-related disease.  The Lancet Rheumatology: 1(1):e55-e65 (2019) DOI: 10.1016/S2665-9913(19)30017-7
  3. Hamano H, Kawa s, Horiuchi a et al. High serum IgG4 concentrations in patients with sclerosing pancreatitis.  NEJM (2001), 366:732-738 (doi: 10.1056/NEJM200103083441005)
  4. Perugino CA, Wallace ZS, Zack DJ  et al., Evaluation of the safety, efficacy, and mechanism of action of obexelimab for the treatment of patients with IgG4-related disease: an open-label, single-arm, single centre, phase 2 pilot trial, Lancet Rheumatology, 2023, 5, e442-e450, DOI: 10.1016/S2665-9913(23)00157-1