"Individual response is variable - 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.”
Conducting multi-site studies across multiple academic centers presents a number of challenges, such as consistency of data collection and analysis. Having clear measurement protocols and questionnaires is crucial, especially when trying to investigate the impact of steroid-toxicity on patients, and identifying the most common side effects patients experience from treatment of skin blistering diseases.
Joslin Johal, a fourth-year medical student at the University of New South Wales in Sydney Australia has been working with Professor Dedee Murrell MD, DSC to conduct a global multi-center study in patients with autoimmune blistering diseases to investigate the side effects patients face when they are prescribed glucocorticoids: “I've been using the Steritas glucocorticoid toxicity index (GTI) online platform for the past year and the GTI has been very, very useful for collecting all of the data and making sure it’s all analyzed in the same way.”
The aim of the study was to investigate the more common side effects, how long they last, and whether they go away when you take away glucocorticoids.
Johal continues: “We had centers all around the world - Japan, China, Iran, Turkey, Greece, and obviously our center in Australia. This was crucial to gain a broad demographic base – but obviously adds complexity to coordinating the centers. Having a standardized assessment tool like the Steritas GTI definitely made things easier as the protocols for measuring steroid-toxicity are all clearly explained.”
The team found the most common side effects were neuropsychiatric in nature – with many patients experiencing depression or insomnia.
“Fortunately, patients experiencing depression or insomnia find they resolve fairly soon after the glucocorticoids are stopped. We also frequently observed other side effects such as diabetes and obesity that are persistent toxicities that need to be accounted for before a physician prescribes steroids.”
One of the findings that most surprised Johal was how variable the responses were: “Some patients might be taking a very small dose, for a very short time and yet suffer massive side effects. Some of our international centers observed patients exhibiting steroid-induced violence or psychosis. The scary thing is that there doesn’t appear to be much correlation with dosage.”
She adds that while there is some early-stage research showing that there may be genetic markers that could help predict the severity of response, we are still a long way from a predictive pharmacogenomic model.
“The key thing that I took away is that the individual response is very variable - there are no obvious clinical factors that we have been able to pinpoint that would predict how severe side effects may be. The response seems to be ƒvariable and unpredictable. Still, there appears to be a resounding benefit of stopping the glucocorticoids entirely, as long as the disease symptoms are being controlled by other therapeutics.”