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- STERITAS GTI
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In phase 2 and 3 clinical trials, the Steritas GTI can assess the efficacy of anti-inflammatory therapies to prevent, reduce, or reverse toxicities in patients taking high-dose or long-term steroids. Integrating the GTI into primary or secondary clinical trial endpoints confers competitive advantage for drug developers targeting steroid-sparing medications for patients with steroid-dependent diseases.
Quantitative measures that provide straightforward, reliable, and reproducible assessment of safety and efficacy endpoints have enabled significant strides in medical care. This is a critical advance for any clinical trial focused on alternative therapeutics for inflammatory diseases.
The GTI data was recently analyzed in a retrospective single-center study of patients with ANCA-associated vasculitis to assess treatment burden. Investigators reported results that support the value of steroid-sparing alternatives:
The Figure shows the adverse events relating to each GTI domain over a 48-month period. Each discrete adverse event was scored once. This confirms the general decline in adverse events over time, as patients disease is brought under better control and glucocorticoids are tapered. GTI scores correspond well to widely-acknowledged glucocorticoid-related adverse events.
In the ADVOCATE trial of avacopan in ANCA-associated vasculitis, demonstration of lower steroid-toxicity was a key differentiator between the two treatment approaches. The Steritas GTI made that possible.
For each trial participant, data were entered into the GTI to generate the Cumulative Worsening Score (CWS), and the Aggregate Improvement Score (AIS), at weeks 13 and 26. The lower scores in the avacopan group confirmed lower steroid-toxicity.
The mean CWS and AIS were both lower in the avacopan group.