Clinical Science

Steritas GTI

Based on data-driven, peer-reviewed research.

Publications

From the first publication of the GTI in 2017 (“Development of the Glucocorticoid Toxicity Index (GTI 1.0) Using Multi-criteria Decision Analysis”), use of the GTI and study publications have continued to grow. The earliest adopters of the technology have begun to report their findings. The GTI has become an essential clinical outcome assessment in nearly 20 of the most common inflammatory diseases. 

 

The February 2021 New England Journal of Medicine article “Avacopan for the Treatment of ANCA-Associated Vasculitis” is a foundational study that describes the use of the GTI to demonstrate reduced toxicity of avacopan as an adjunct treatment with prednisone compared to prednisone alone.

The pediatric glucocorticoid toxicity index
Seminars in Arthritis and Rheumatism 56 (2022), 152068

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The glucocorticoid toxicity index: Measuring change in glucocorticoid toxicity over time
Seminars in Arthritis and Rheumatism 55 (2022) 152010

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Glucocorticoid Therapy in ANCA Vasculitis: Using the Glucocorticoid Toxicity Index as an Outcome Measure
Kidney360 June 2021, 2 (6) 1002-1010

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Glucocorticoid toxicity reduction with Mepolizumab using the glucocorticoid toxicity index

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Avacopan for the Treatment of ANCA-Associated Vasculitis.
The New England Journal of Medicine

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Clinical evidence demonstrates the value of the GTI for drug developers and for patients

For drug developers, the ADVOCATE trial that enabled FDA approval of avacopan to treat ANCA-associated vasculitis reported the GTI as a critical secondary endpoint in demonstrating avacopan efficacy. For patients, an asthma cohort study determined that measuring GC toxicity systematically with the GTI may help determine which patients would derive the most benefit from new steroid-sparing therapies

 

Avacopan Clinical Trial Data Real world study of Asthma

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Clinical Trials

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Polymyalgia Rheumatica

Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica

Phase 3 – A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica Recruitment Status: Terminated (Protracted recruitment timeline exacerbated by COVID-19 ...
Polymyalgia Rheumatica, Inflammatory Rheumatism, Giant Cell Arteritis, Idiopathic Inflammatory Myopathies, ANCA Associated Vasculitis, Systemic Autoimmune Disease

PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS (PRODIGIOUS)

Observational Cohort Prospective Recruitment Status: Not yet recruiting Sponsor: University Hospital, Brest Study Population: Patients usually treated with prolonged glucocorticoid therapy in the field of rheumatology.  Primary Outcome Measures: ...
Rheumatoid Arthritis, Vasculitis, Systemic Lupus Erythematosus

Monıtorıng Glucocortıcoıd Treatment In Patıents Followed In Rheumatology Clınıc.

Recruitment Status: Sponsor: Study Population:  Primary Outcome Measures: Secondary Primary Outcome Measures:
Polymyalgia Rheumatica, Giant Cell Arteritis

Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica

Recruitment Status: Terminated (Protracted recruitment timeline exacerbated by COVID-19 pandemic)  Sponsor: Sanofi  Study Population:  118 participants Primary Outcome Measures: To evaluate the efficacy of KEVZARA (sarilumab) in patients with ...
Giant Cell Arteritis

Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

Recruitment Status: Sponsor: Study Population:  Primary Outcome Measures: Secondary Primary Outcome Measures: