The Oklahoma Medical Research Foundation has started the first-ever lupus prevention study.
The clinical trial, known as the SMILE trial, will seek to identify individuals at high risk for developing lupus and treat them with an immune-modifying medication before they ever transition into the disease. The goal is to delay the onset of lupus, lessen its symptoms and potentially prevent it altogether.
Lupus is caused when the immune system becomes unbalanced, leading to the development of antibodies and chronic inflammation that damage the body’s organs and tissues. According to the Lupus Foundation of America, an estimated 1.5 million people in the U.S. are living with lupus.
The disease also disproportionately affects healthy relatives of lupus patients.
For this reason, OMRF Vice President of Clinical Affairs Judith James, M.D., Ph.D., and a team of researchers launched a project where they looked at relatives of patients over an eight-year period to see if they could discover a way to identify those at high risk before the disease ever begins.
Once a person has a lupus diagnosis, many times the damage has already started, said James, chair of OMRF’s Arthritis and Clinical Immunology Research Program. “For some time, our lab has been interested in understanding the first things that go wrong in the body that lead to lupus. That fed into our work of trying to develop a better diagnostic test, as well as work in understanding how flares happen. Now we want to find ways to identify people at high risk so we can offer help before the damage starts.”
By studying relatives of lupus patients, James discovered that 89 percent of family members stayed healthy, while 11 percent developed the disease. Of those who transitioned to lupus, all displayed autoantibodies—inflammatory proteins that the body mistakenly unleashes against its own cells and tissues.
For the trial, James and her team will test participants for these specific autoantibodies in the blood and place them on a test medication.
The trial is still actively recruiting new participants who are at risk for developing lupus. In order to qualify, an individual must have a positive ANA test and at least one other lupus symptom. Symptoms of lupus include skin rashes, joint pain, joint swelling, anemia, extreme fatigue, mouth sores or sunlight sensitivity.
“As a physician, I find this trial incredibly important because I have seen the damage and destruction that happens with lupus,” said James. “Even when patients come to the doctor and get all the best medicines we currently have, the disease still leads to deformities, shortened lifespans and things we just can’t fix. Now, we may have the ability to dial this back and prevent people from moving into full-blown lupus.”
James said the ultimate goal is to prevent the disease altogether. But even if an individual still transitions into lupus, they would have had early intervention and therapy to allow doctors to get started on treatment much earlier to mitigate damage and improve outcomes.
A native of Pond Creek, Okla., James earned her M.D. and Ph.D. degrees from the University of Oklahoma Health Sciences Center and joined OMRF’s scientific staff in 1994. A pioneer in the field of autoimmune disease prediction, she holds the Lou C. Kerr Chair in Biomedical Research at OMRF.
To participate in the trial or receive more information, please call (405) 271-7221 or email Virginia-roberts@omrf.org.
“This is a trial of enormous importance that could prove life-changing for everyone involved,” said OMRF President Stephen Prescott, M.D. “This work is expansive, new and holds a great deal of hope. We are extremely proud of Dr. James’ brilliant work and excited for what lies ahead.”
