During 2023, the Steritas team had the opportunity to speak with a range of inspiring clinical research leaders who shared their expertise with us and our colleagues. Every conversation underscored the steroid paradox: patients suffer long-term side effects well after the short-term benefits of glucocorticoids have faded.

The conversations also highlighted the hope that the ability to measure and monitor steroid-toxicity will finally shift prescribing patterns and improve patient care. 

The paradox of these powerful medications was highlighted by John H. Stone, MD MPH: “Steroids have a role in treating so many diseases - and yet, they do not cure any of them.”

The Steritas suite of clinical outcome assessment instruments is already providing researchers with objective measures of steroid-toxicity and is helping pharmaceutical companies demonstrate the steroid-sparing benefits of new therapies.

"Trial sponsors have a great opportunity and challenge to demonstrate what they mean by steroid-sparing and how that translates into healthcare benefits such as reduced hospitalizations, and improved quality of life,” states Sudhakar Sridharan, MD.

And Paul Brunetta, MD agrees, “Anywhere that steroids are being used in clinical studies, especially randomized controlled studies, there is a place for the Steritas GTI.”  

The instruments are also making their way from the researcher to the practicing clinician, with Michelle Petri, MD MPH stating, “I believe it's essential, that there be some stop sign in the electronic patient record that would force that conversation. Having a version of the Glucocorticoid Toxicity Index that could be built into the EMR and generate a big red pop-up that takes up the whole screen and urges providers to record data and to think differently about the prescription would provide the wake-up call that is so often needed.”

Lisa Christopher-Stine, MD MPH agrees, stating, “Steroids are often a necessary evil – they are phenomenally beneficial in the short term, but they're terrible in the long term. We probably underestimate the amount of suffering that patients tolerate from steroids.”

That’s because as Deborah Gelinas, MD reminds us: “The damage caused by steroid exposure is not surprising - it is expected.”

Long-term collaborator Frank Buttgereit, MD told Steritas: “Every milligram that helps control the disease is a good milligram, but every milligram we can spare is an even better one.” 

While the damage is predictable, each individual's response is unique, as highlighted by Joslin Johal, a medical student at the University of New South Wales in Sydney Australia:  “There are no obvious clinical factors that we have been able to pinpoint that predict how severe side effects may be - but there appears to be a resounding benefit of stopping the glucocorticoids entirely, as long as the disease symptoms are being controlled by other therapeutics.” 

Sadly, that suffering is not lost on the patients themselves. 

“We have a saying in China, ‘to turn pale at the mention of a tiger’, and this describes the fear many patients show when told they need to be prescribed steroids,” says Wen Zhang, MD PhD.

Pediatric lupus expert Joyce Chang, MD MSCE emphasized, “Infection is probably the biggest morbidity and mortality risk early on, and steroids dramatically increase the risk of infection." 

However, tapering in clinical practice is far more complex than in clinical trial settings, as David Jayne, MD opines: “We have a real problem in how we deliver steroid reduction, and that in part is due to the complexity of constantly changing doses.” 

“Steroid-toxicity is a huge problem amongst our patients…it sounds simple to just give people steroids, but the types of side effects they get when they have to be on these drugs for one to two years, sometimes many more years, to keep the disease suppressed produce many, many complicated side effects which can kill the patient,” discussed dermatology expert Dedee Murrell, MD DSc.

“Steroid use is prevalent among severe asthma patients, in part due to physician training that emphasizes the effectiveness of steroids rather than their potential dangers,” adds Jane McDowell, MBBS BSc PhD. 

Max Hamburger, MD remarks that while some of the damage can be mitigated by tapering, they still cause damage: “While some steroid-toxicities can be mitigated by tapering the drug, a lot of the side effects are very long-lasting. Steroids are like radiation, the best amount of exposure is no exposure.” 

We are honored to amplify discussions that address the all-too-real burdens of steroids and highlight the need to reshape the steroid paradox. As we look to 2024 and beyond, our focus on changing steroid prescribing patterns is sharper than ever, and we will introduce additions to our STOX® Suite of clinical outcome assessments, the new STOX Digital Platform and an educational companion for patients.