Ten years ago, two clinical researchers walked into a bar and, over a beer, asked themselves whether the direct measurement of steroid-toxicity would ever be possible. Today, Steritas, in licensing these validated outcome measures, is leading conversations with researchers, clinicians, and patients worldwide about how to mitigate the risks associated with steroid use.
Martha Stone, CEO of Steritas, reflects on the progress over the past three years and her enthusiasm for what lies ahead.
“Three years ago, when I spoke about a worldwide steroid taper with senior staff at immunology companies and key opinion leaders in academia and clinical practice, most were cautious about whether the world was ready to take steroids head-on.
In the intervening years, those same voices are talking about a ‘tipping point’ away from steroids, where the world is now ready to investigate and discuss how damaging these medications are. We are in a unique position to support these efforts with our instruments and expertise in support of pivotal trials or HEOR studies, EMR integration in the clinic, or patient education and empowerment.
We are gratified that our clinical outcome assessments (COAs) of steroid-toxicity have been considered the most important secondary outcome measure for efficacy in clinical trials since 2021, and look forward to all the new trials that begin reporting results this year.”
Since its founding, the company has focused on scaling the use of the Steritas Glucocorticoid Toxicity Index (GTI) and the other COAs in the STOX® Suite.
“The idea for the first steroid-toxicity instrument was first discussed in 2015, and once the GTI had been validated and published, it became clear that the way to accelerate its use in research across the globe to serve patients was to create a company dedicated to the effort for direct measurement of steroid-toxicity anywhere steroids were being studied and prescribed. That was the enormous undertaking for which Steritas was founded.”
While much of the initial focus had been on clinical research applications of the STOX Suite, Steritas has played a pivotal part in educating and equipping all who are involved in treating some 50 million steroid-treated adults and children worldwide.
“In three years, the company has educated more than 26,000 individuals, whether practicing clinicians or data scientists studying large cohorts in EMR data, clinical developers in industry and academia, and more recently, patients.”
Steritas has addressed the complexities of measuring steroid-toxicity by developing a digitized suite of COAs for use in three channels: scientific research, clinical adoption, and patient education.
“Our first focus was proving the GTI’s utility in academic and industry research. And now, we’re seeing the results of those trials on nearly every continent.
The launch of the Steritas GTI-MD has meant that even if companies began their trials before the GTI was invented, they can now calculate steroid-toxicity scores from the patient data collected during those past trials and demonstrate that their new drugs enable meaningful reduction in steroid-toxicity.”
Beyond clinical trials, Steritas has also seen a significant uptake of the STOX Suite for health economics and outcomes research (HEOR) to assess the long-term economic impact of steroid-related complications.
“Data drives change, and we can now quantify the burden of steroid-toxicity across populations. Unmasking new insights in large datasets can influence prescribing patterns and even reimbursement policies.”
Real-world studies have shown that the GTI can determine prominent patient-specific differences in steroid-toxicities, and the GTI-MD can be used to detect, monitor, and manage glucocorticoid-related side effects in individual patients.
“We wanted to ensure that doctors could actually use this to monitor patients. Early pilot programs at medical centers in the US, UK, and EU are demonstrating how tracking steroid-toxicity can influence treatment decisions in clinical practice.”
One of the most exciting developments is the launch of Sam (steroidsandme.com), a free digital companion that educates patients and equips them to track and manage their lives with steroids.
"The idea that we can reach and support millions of steroid-treated patients and those who care for them is vital to our mission. While they wait for new treatments to be approved and for healthcare systems to evolve, Sam can provide the tools and guidance they need to navigate steroid use safely.
What’s truly exciting is that we are providing education and encouragement from world-renowned medical experts who drive scientific advancement–clinicians that most of us will never be able to see in person.
I am deeply grateful that these thinkers have given their time and expertise to speak to Sam users in plain language. They offer practical ways for patients to cope with steroids while they wait for the next miracle treatment for their condition.”
By offering personalized tracking tools, educational videos, and written insights, Sam changes how patients work with their doctors and healthcare providers.
“Patients don’t have to feel alone in this. Sam is there to help them navigate their journey and provide real-time insights into their health. The greatest initial engagement is, ‘How to Talk to My Doctor’ and ‘Why We Taper.’
When patients are activated and engaged in their care as partners with their providers, outcomes improve. Early feedback from patients, advocacy groups, clinicians, and pharma has been overwhelmingly positive, and Steritas is establishing new Sambassador partnerships every day.”
What began as an effort to share one clinical outcome assessment with the world has led to the development of a suite of COAs for use in clinical research and practice. Beyond that, the generosity of partners and a global network of experts make it possible to support patients directly with Sam.
With new research results on the horizon, expanding clinical applications in progress, and a growing patient community all working together to push away from steroids, small insights and big data will get us closer to realizing a worldwide steroid taper.
“We’re no longer just proving the concept - we’re embedding it into how medicine is practiced.”