Lupus – Research Projects and Clinical Trials

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Lupus:  Research Projects and Clinical Trials




Guest:  Dr. Jim Oates – Rheumatology & Immunology

Host:  Dr. Linda Austin – Psychiatry


Dr. Linda Austin:  I’m Dr. Linda Austin.  I’m interviewing Dr. Jim Oates, who is Associate Professor of Rheumatology and an expert, at MUSC, in lupus.  Dr. Oates, I know you’re very active in research in this illness.  Can you tell us a little bit about some of the directions that research is taking, generally, in this illness?  And then I want to talk about what’s going on here, at MUSC.


Dr. Jim Oates:  This is an exciting time for research in lupus.  To give you a bit of a background, in 1950, all we had was prednisone, or drugs like prednisone, to treat this disease, an extremely effective drug but with many side effects, including loss of bone density, psychiatric problems, diabetes, obesity, high blood pressure, all the things we have problems with in this part of the country. 


Our current research is trying to test and discover pathways or drugs that allow us to target our therapy to specific abnormalities in lupus, rather than wiping out the whole immune system, which is what we’re currently doing with our immune-suppressing drugs.  Our goal is to have fewer side effects and more effective treatment for lupus. 


There are several things going on specifically at MUSC.  We have some studies that are what we call investigator initiated, where myself and my colleagues in the lupus research group come up with our own ideas and look for defining areas that may be useful to target with drugs in lupus, so that we can have a better impact, particularly among African-Americans, with lupus.  We have found that African-Americans tend to have the more severe disease than Caucasians.  Their outcome, when they get kidney disease, is much worse.  If you look at standard treatment, African-Americans tend to have a 50 percent kidney failure rate over five years, while Caucasians have about a 15 percent kidney failure rate over 10 years.  So, our goal, in our investigator initiated research, is try to discover pathways where we can bridge that disparity in treatment effectiveness.


We also have clinical trials here that are looking at specific drugs that are in development by pharmaceutical companies.  We have six of those trials going on now.  All of these are targeting specific pathways in lupus that we hope will; again, allow us to have more effective treatment and fewer side effects.


Dr. Linda Austin:  What is the advantage to a patient in participating in a clinical trial?


Dr. Jim Oates:  The direct benefit could, potentially, be nothing but knowing that they’re doing a good thing, because almost all clinical trials involve treatment with standard therapy and then adding what we call placebo, which is, essentially, an inactive drug, versus a study drug.  So, a patient could, potentially, be enrolled in a study where they take baseline therapy, perhaps a little bit more prednisone, and then an inactive drug.  There is a chance, however, it depends on the study, that they’ll actually get the active drug.  But we don’t like to promise that to patients because, again, a certain percentage don’t.  But, what they are doing is helping future lupus patients by helping us determine how effective a drug is at treating lupus and what the side effect profiles are. 


Dr. Linda Austin:  Are there any other potential benefits to a patient?  I would imagine, for example, that these patients are very carefully observed and monitored.


Dr. Jim Oates:  Absolutely.  Normally, in clinical practice, we may see a patient every three months, or every six months, if they’re doing very well.  In these studies, they’re monitored monthly, or more frequently than that, because the standard lupus disease activity measures occur every month.  So, they will get better monitoring and probably more insight into their disease.


Dr. Linda Austin:  And I would imagine, in the best case scenario, they may be lucky enough to be one of the first patients to get a new and very successful compound.


Dr. Jim Oates:  That’s true.  Often times, these studies will have what we call a randomized portion, where they get placebo or active drug.  Often times, the pharmaceutical company will give us the opportunity to give them the active drug at a later part in the study.


Dr. Linda Austin:  I remember in doing psychiatric research on obsessive-compulsive disorder, we got to use the first drug that was actually successful in that, and I saw a patient who’d suffered for 50 years have a complete reversal of symptoms.  And, of course, the medication wasn’t available to everyone else for several years after that.  So, you know, it’s a great success story for participation in clinical trials, that, if you get really lucky, you may be the person who really leads the vanguard in an effective new treatment.


Dr. Jim Oates:  That’s true.  We’ve seen a lot of very remarkable success stories in patients that have participated in these studies.  But, we often times don’t know whether they’ve received placebo or active drug yet.  But it’s exciting.


Dr. Linda Austin:  Good luck with that research.


Dr. Jim Oates:  Thank you very much.


Dr. Linda Austin:  Thanks a lot.


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