"Nobody disputes the value of glucocorticoids, and while most clinicians recognize the damage they cause to patients, they don’t recognize the impact they have on clinical research.”
Andreas Reiff, MD is the senior vice president and global therapeutic area head for inflammation/immunology at Parexel. He is a board-certified rheumatologist and pediatrician, has extensive experience in drug development, and holds several academic and advisory roles.
He currently oversees drug development in the areas of rheumatology, allergy, dermatology, gastroenterology, and ophthalmology and leads a team of 32 subject matter experts. Before joining Parexel, Dr Reiff was the chief medical officer at TheraKine, specializing in innovative biodegradable polymer technology for drug delivery within the eye. He has held various academic clinical positions in the US and Europe.
One of the biggest frustrations Dr Reiff has faced throughout his career is the perception across the medical community that low doses of steroids are safe.
“The biggest challenge we face in autoimmunity is changing the culture of steroid prescribing. We need to instill in both the prescribers' and patients' minds that even in a low dose, glucocorticoids can do a lot of harm. The best steroid is no steroid.”
“Nobody disputes the value of glucocorticoids, and while most clinicians recognize the damage they cause to patients, they don’t recognize the impact they have on clinical research.”
Dr Reiff believes a lot of drugs die in the development process because they are given on top of a background complicated by steroids.
“Most patients entering clinical trials for new drugs treating autoimmune diseases have to take steroids to keep the disease stable enough to meet the entry criteria. But depending on the dose and because the steroids are so powerful, they do not allow us to show the difference between the effect of the background medication and the experimental drug.”
“We are now seeing a shift by regulators and innovators from trying to reduce the steroid burden through the introduction of new immunosuppressive or immunomodulatory therapies, towards eliminating the need for steroids entirely.”
“Clinical trial protocols for new drugs in autoimmunity now tend to mandate an aggressive steroid taper and the sustained discontinuation of steroids for a therapy to be considered successful.”
Dr Reiff explains that since the advent of steroids 75 years ago, there have been three major waves of innovation that have transformed the options available for many autoimmune diseases.
In the early 1990s, the first wave brought targeted biologic therapies such as TNF blockers, IL-6 blockers, and therapies targeting B cells and co-stimulatory molecules. These were very effective, but it was discovered that patients could develop tolerance over time.
The second wave introduced small molecule drugs that were easier for patients to take as pills rather than infusions or injections. However, these were later found to carry higher safety risks like infections and cancers. Of particular recent interest were the JAK inhibitors that have been approved for the treatment of rheumatoid arthritis, psoriatic arthritis, psoriasis, axial spondyloarthritis, inflammatory bowel disease (IBD), and atopic dermatitis.
The third and current wave is exploring the repurposing of targeted cancer drugs and their derivatives, including targeted cellular therapies, for autoimmune disease.
Dr Reiff continues by explaining one of the biggest challenges is changing the mindset of both the patients and prescribers.
“In routine clinical practice, achieving the elimination of steroids can be incredibly difficult, as many patients and clinicians cling to steroids as they would a parachute.”
“In the mindset of the prescriber or patient, they may only be taking a low dose, and think that it will still provide some benefits but be too low a dose for side effects to occur. I would like to challenge the latter because I doubt the low dose will have any major benefit for the patient, but the cumulative exposure to steroids will soon be a problem.”
“This is why I am so excited by the Steritas GTI. If we can show that even those low doses are having real side effects, then we will be better able to convince prescribers to remove them entirely.”
Andreas Reiff, MD is the senior vice president and global therapeutic area head for inflammation/immunology at Parexel International Global Medical Services, a global Contract Research Organization (CRO) based in Boston, MA.
He currently oversees drug development in the areas of rheumatology, allergy, dermatology, gastroenterology and ophthalmology and leads a team of 32 subject matter experts.
Before joining Parexel, Dr Reiff was the chief medical officer at TheraKine Inc., specializing in innovative biodegradable polymer technology for drug delivery within the eye. He is also an adjunct professor at the Oregon Health Science University, emeritus professor at the Keck School of Medicine at the University of Southern California, and the former division head of the Division of Rheumatology at Children's Hospital Los Angeles. He was also the director of the Pediatric Rheumatology Program at Miller Children’s Hospital in Long Beach, CA, and a visiting clinical associate professor at the University of Nevada School of Medicine’s Department of Pediatrics.
Dr Reiff's career began with a medical degree from the University Medical School in Freiburg, Germany, followed by various residencies and fellowships focused on internal medicine, surgery and pediatric rheumatology. He has led numerous clinical trials, acted as a consultant for pharmaceutical companies, and shared his expertise through publications and lectures worldwide on rheumatology and biologic drug development.
A member of various rheumatology societies and advisory boards, Dr Reiff is recognized internationally for his contributions to chronic inflammatory eye disease treatment. He is board-certified in pediatrics and pediatric rheumatology and has been honored with several awards for his work in the field.