About 1.5 million Americans live with some form of lupus, and 9 out of 10 are women.
Lupus is often difficult to diagnose because it shares symptoms with many other conditions and because it affects each person’s immune system differently. Lupus can also be difficult to treat, and medications traditionally used to manage the condition can have serious side effects.
One of the hardest things about lupus is that people who have it don’t always realize it: they know something is wrong, but often they aren’t sure what it is.
Researchers are working to learn more about lupus so they can develop new treatments, and clinical trials play an important role in that learning process.
HealthyWomen spoke with Anca Askanase, MDfounder and clinical director of the Columbia Lupus Center and director of Rheumatology Clinical Trials, about clinical trials for lupus and why they are so valuable.
What are clinical trials?
A clinical trial is a study of how a medication or other treatment works in people. Drugs must be shown in clinical trials to be safe and effective before they can be approved by the Food and Drug Administration (FDA).
Clinical trials are carried out in phases. Phase 1 focuses on safety, while Phase 2 looks at how safe the drug is but also how well it works. Phase 3 is the definitive test to determine whether the drug is safe and effective, and is the basis for applying for FDA approval. If there are more questions about a drug (for example, how it might affect certain groups of people who were not included in the first three phases), the trial may move to Phase 4.
Read: What you need to know about clinical trials >>
What are the different types of lupus clinical trials?
Some clinical trials for the treatment of lupus involve drugs that have been studied in people, but not in people with lupus. Others are for new treatments. In 2011, the FDA approved the first biologic drug for the treatment of lupus after two successful clinical trials involving more than 800 patients each. In recent years, there has been a lot of excitement because two new drugs were approved and another existing drug was recently approved to treat a specific type of lupus.
The work continues: It’s a constant struggle to find better drugs, better study designs, and better ways to test lupus medications.
What are some of the benefits of clinical trials for lupus?
Clinical trials offer benefits to both patients and researchers. For patients, it is an opportunity to be treated with a drug that may be very effective before it is available in the world. And, in a way, you are guaranteed the best possible treatment because you are constantly evaluated, observed and monitored.
Are there benefits to participating in a clinical trial for lupus that involves a placebo even if you receive the placebo and not the new treatment being studied?
Absolutely. Even for patients who do not receive the medication, the level of scrutiny at every step means they are being closely monitored and allows for the best possible care to be provided. And, if you need medical treatment, you will always receive the standard level of treatment in addition to the placebo if you participate in a clinical trial.
How can someone access a clinical trial for lupus or learn more information about it?
The Department of Health and Human Services has a campaign called Let’s take charge! which focuses on making lupus research more inclusive and diverse, and provides information on clinical trials. He Lupus Foundation of America and the Lupus Research Alliance They are also excellent resources. You should also talk to your rheumatologist.
If a woman is nervous about participating in a lupus clinical trial, what advice would you give her?
Most decisions in our lives involve pros and cons, so I would recommend that you speak with your healthcare provider to weigh the benefits and risks of participating in a clinical trial. And you should also talk to other people who have participated in clinical trials to get an idea of how they work.
a program called Patient Advocates for Lupus Studies (PALS) promotes clinical trial enrollment in diverse populations by connecting people living with lupus with peers who can offer first-hand experience of what it’s like to participate in a clinical trial.
Why are clinical trials important to advance research into diseases like lupus?
Some people think about clinical trials and worry about side effects or the drug not working. But it depends on your personality and how you think about the world.
I am a clinical researcher and clinical essayist, so for me the glass is always half full. This is how we move forward. This (people volunteering their bodies and time for drug development) is how we can have new therapeutic options for people with lupus.
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