About 1.5 million Americans are living with some form of lupus — and 9 out of 10 of them are women.
Lupus is often hard to diagnose because it shares symptoms with so many other conditions, and because it affects the immune system of each person differently. Lupus can also be tough to treat, and the drugs traditionally used to manage the condition may come with serious side effects.
One of the most difficult things about lupus is that people who have it don’t always realize it — they know something’s not right, but they’re often not sure what it is.
Researchers are working to learn more about lupus so new treatments can be developed, and clinical trials play an important role in that learning process.
HealthyWomen spoke with Anca Askanase, M.D., the founder and clinical director of Columbia’s Lupus Center and the director of Rheumatology Clinical Trials, about clinical trials for lupus and why they’re so valuable.
What are clinical trials?
A clinical trial is a study of how a drug 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 happen 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 ultimate test of whether the drug is safe and effective, and is the basis for applying to the FDA for approval. If there are more questions about a drug — for example, how it might affect certain groups of people that weren’t included in the first three phases — the trial may move to Phase 4.
What are the different types of lupus clinical trials?
Some clinical trials for lupus treatment involve drugs that have been studied in people, but not in people with lupus. Others are for new treatments. In 2011, the first biologic drug for treatment of lupus was approved by the FDA after two successful clinical trials that each had over 800 patients. In the past few years, there has been a lot of excitement because two new drugs have been approved, and another drug that already existed was newly approved to treat a specific type of lupus.
The work is ongoing — it’s a constant struggle to come up with better drugs, better study designs and better ways to test drugs for lupus.
What are some of the benefits of clinical trials for lupus?
Clinical trials offer benefits to patients as well as to researchers. For patients, it’s an opportunity to be treated with a drug that may be highly effective before it’s available to the world. And, in a way, you’re guaranteed the best possible treatment because you’re constantly evaluated, constantly watched and constantly 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 don’t receive the drug, the level of scrutiny at every step means you’re being closely monitored and allows for the best care you could possibly get. And, if you need medical treatment, you will always get the standard level of treatment in addition to the placebo if you are participating in a clinical trial.
How can someone access a clinical trial for lupus or find out more information about it?
The Department of Health and Human Services has a campaign called Let’s Take Charge! that’s focused on making lupus research more inclusive and diverse, and it offers information about clinical trials. The Lupus Foundation of America and the Lupus Research Alliance are great resources as well. One should also talk to their rheumatologist.
If a woman is nervous about entering into a clinical trial for lupus, what advice would you give her?
Most decisions in our lives are about pros and cons, so I would recommend that she talk to her healthcare provider about weighing the benefits and risks of joining a clinical trial. And she should also talk to other people who have participated in clinical trials to get a sense 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 firsthand experience of what it’s like to participate in a clinical trial.
Why are clinical trials important to advance research in diseases such as 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 of the world.
I’m a clinical trialist and a clinical researcher, so to me, the glass is always half full. This is how we make progress. This — people volunteering their bodies and time for drug development — is how we are able to have new therapeutic options for people with lupus.
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