"It's not the cumulative steroid dosage, but the toxicity the patients experience - that's what really matters."
Dr Ewa Olech's journey from medical student in Poland to Senior Medical Director at IQVIA began with a deeply personal observation. Three decades ago, accompanying her mother to a rheumatology appointment, she witnessed a waiting room full of patients bearing the visible toll of long-term steroid treatment. Every patient showed signs of steroid-toxicity: moon face, weight gain, the unmistakable physical markers of chronic exposure. The experience was so discouraging that rheumatology became the last specialty she wanted to pursue.
"Every patient in that waiting room had moon face. They were all cushingoid. I thought this would be the last specialty I would want to go to. They didn't have any alternatives to steroids, and the steroids gave them all these side effects."
Yet it was the introduction of biologics during her residency in the US that transformed her perspective entirely. These new therapies offered patients meaningful relief while enabling steroid tapers, dramatically improving both disease control and quality of life. The contrast was striking enough to draw her into the field she once avoided.
Today, Dr Olech holds a unique position in rheumatology. As Senior Medical Director at IQVIA, she leads the Rheumatology Center of Excellence and advises pharmaceutical companies on clinical trial strategy and protocol design. She also maintains a private practice in Las Vegas, treating patients with rheumatoid arthritis, lupus, and other autoimmune conditions. This dual perspective, spanning both the rigorous world of clinical development and the practical realities of patient care, gives her an unusually clear view of where steroid use still creates problems and where solutions are emerging.
The problem steroids create in clinical trials
Dr Olech is frank about the challenges steroids pose in drug development. They work quickly and effectively, making them a natural choice for bridge therapy. But that rapid symptom relief creates a significant problem: it masks the efficacy of investigational drugs.
"If you give patients a steroid, they feel great. And that's why so many trials have failed, especially in lupus. Patients were on steroids throughout the whole study without the proper taper. You couldn't see the difference between the drug and the placebo."
The result is a high placebo response rate driven not by the placebo, but by uncontrolled steroid use. For years, this confounding factor undermined lupus trials in particular. Only recently have protocols begun to require or at least encourage investigators to implement structured tapers, creating the conditions for true drug-placebo differentiation to emerge.
Dr Olech sees this as a turning point. Trials are now designed with steroid management as a core element of the protocol, not an afterthought. But she also recognizes that the shift isn't complete.
From dose to toxicity: why the GTI matters
While dose reduction has become a common endpoint in rheumatology trials, Dr Olech believes it misses the point. What matters isn't just how much steroid a patient takes, but the actual harm it causes.
"It's not the cumulative steroid dosage, but the toxicity the patients experience - that's what really matters."
That is the beauty and simplicity of The Glucocorticoid Toxicity Index (GTI): it quantifies what really matters. Direct measurement of patient harm across multiple domains captures effects that dose metrics miss entirely. IQVIA's recent acquisition of the STOX family of steroid-toxicity COAs, which includes the GTI, has given Dr Olech and her team direct access to these tools. For her, the value is clear: sponsors can now measure what truly impacts patients.
Avacopan's approval, supported by GTI data demonstrating steroid-toxicity reduction, marked the first time a drug secured regulatory approval based on this critical secondary endpoint. Dr Olech sees it as a proof of concept and a precedent that pharmaceutical companies are rapidly waking up to.
Despite the example of avacopan, Dr Olech is frustrated by how rarely the GTI appears in trial designs.
"The GTI is still underused. A lot of our rheumatology studies involve steroid use, and somehow, we're not incorporating the GTI in these trials. It's already validated. It's simple. There's room for a lot more drugs being approved with that true steroid-sparing label."
The tool has proven its value, supported a regulatory submission, and demonstrated clear patient benefit. While adoption was interrupted by the pandemic, several pivotal trial results are expected to report out this year.
Dr Olech hopes that IQVIA's integration of the STOX family will accelerate that, making the GTI a standard recommendation in protocols where steroid exposure is a factor.
The clinical practice perspective
In her private practice, Dr Olech would not use the GTI, which was developed for research settings. But simply knowing the tool exists has changed her prescribing behavior.
"In practice, you just write prescriptions for steroids. You don't think about long-term side effects. But having this tool, and knowing it, makes you think when you write that prescription: do we really need it? Can we use something else?"
She sees potential for the GTI-MD, a shorter version designed for clinical use, to bridge the gap between research and practice. Once integrated into electronic medical records, it could provide clinicians with a practical way to monitor steroid-toxicity without adding a significant workflow burden.
Dr Olech also values patient education tools like Sam (steroidsandme.com), which help patients understand the long-term risks of steroid therapy.
"Patients want to feel better right away. They don't know the long-term side effects. That responsibility ultimately rests with the physician. Deeper understanding of steroid-toxicity has changed how I think: can we modify the other immunomodulators in the treatment regimen so we can not only minimize but avoid using steroids altogether?"
The personal connection
Dr Olech's mother, now in her 80s, still lives with the effects of decades of steroid exposure. Even with modern biologics, the cumulative toxicity from years of treatment is evident. It's a reminder that progress has been real, but incomplete.
"When you look at my mother, she obviously still has effects from being on steroids. Even now."
That personal connection keeps the issue urgent for Dr Olech. Rheumatology has come far from the cushingoid waiting rooms of 1990s Poland, but steroid-toxicity remains a daily reality for patients and clinicians alike.
Looking ahead
Dr Olech is optimistic that the field is moving in the right direction. New therapies are entering the market. Protocols are better designed. Tools like the GTI are available. But she's also clear that adoption needs to accelerate.
For sponsors developing new therapies, the message is straightforward: steroid-sparing alone is no longer enough. Steroid-toxicity sparing is now an achievable aim. The regulatory pathway and the clinical value proposition both demand a focus on direct toxicity assessment. The GTI provides the means to demonstrate it.
Ewa Olech, MD is Senior Medical Director and Head of the Rheumatology Center of Excellence at IQVIA, where she leads clinical development strategy for rheumatology programs from early-stage trials through commercialization.
She is board-certified in Rheumatology and Internal Medicine and maintains a clinical practice in Las Vegas, Nevada, treating patients with rheumatoid arthritis, lupus, osteoarthritis, gout, and other autoimmune conditions.
Dr Olech received her medical degree from the Medical Academy in Lublin, Poland, completed her Internal Medicine residency at Lutheran General Hospital in Illinois, and her Rheumatology fellowship at the University of Arizona. She previously served as Associate Professor of Medicine and Section Chief of Rheumatology at the University of Nevada School of Medicine.
She has served as principal or sub-investigator in nearly 100 Phase I-IV rheumatology clinical trials and has published more than 80 articles, abstracts, and book chapters, with particular focus on musculoskeletal imaging as an outcome measure in clinical trials.
Dr Olech is the founder and past president of the Rheumatology Association of Nevada, a founding member of the International Society of Extremity MRI in Rheumatology, and a Fellow of the American College of Rheumatology.