It’s been more than a half-century since the U.S. Food and Drug Administration approved a new treatment for the autoimmune disease lupus. So when news arrived this month that an experimental lupus drug had been shown effective in a large-scale clinical trial, patients and caregivers were understandably ecstatic.
“It’s the greatest thing in 50 years,” said Joan Merrill, M.D., of OMRF. Merrill heads OMRF’s Clinical Pharmacology Research Program, where Oklahoma lupus patients are participating in a second trial of the drug (known as Benlysta).
“Trial after trial has failed in lupus,” said Merrill, who also serves as the medical director of the Lupus Foundation of America. “This is the first one to work in a very, very long time.”
In the trial, which involved 865 patients, the drug improved the symptoms of more than half of the participants without worsening any other symptoms. This compared favorably with those receiving standard care and steroid treatment.
The current trial, which is taking place at OMRF and other sites in the U.S., is looking at how patients fare when treated with the drug for a slightly longer period of time. The results of that trial, which is in its final stages, are expected to be announced by year-end.
“It would probably require a positive result from this second trial before the drug could be considered for FDA approval,” said Merrill. “And that process can take many months, sometimes years.” Still, said Merrill, the new results are an important step in the right direction.
In lupus, the immune system loses its balance, leading to chronic and sometimes life-threatening inflammation. Lupus is unpredictable and can affect any part of the body—most commonly the skin, joints, blood and kidneys. The disease primarily strikes women and has no cure. The Lupus Foundation of America estimates that as many as 2 million Americans suffer from lupus.
At OMRF, Merrill is not alone in her quest to develop better treatments for lupus. The current issue of the scientific journal Genes and Immunity contains 10 papers about lupus authored or co-authored by OMRF lupus researchers. The issue is a product of an international lupus genetics conference held at OMRF and details how state-of-the-art genetic technology has advanced the study of lupus more in the last few years than in the 20 years preceding.
“OMRF probably has more people working in the field of lupus genetics than anywhere else in the world,” said OMRF’s Kathy Moser, Ph.D., who served as guest editor of the issue. “We’ve made a lot of progress, but there’s still so much more to discover.”
The issue includes papers by OMRF’s Moser, Merrill, John Harley, M.D., Ph.D., Patrick Gaffney, M.D., Judith James, M.D., Ph.D., Swapan Nath, Ph.D., Marta Alarcon-Riquelme, M.D., Ph.D., Courtney Gray-McGuire, Ph.D., and Igor Dozmorov, M.D., Ph.D.