About Lupus

Lupus Coping Corner

From the Lab to the Doctor’s Office: How Research Leads to Therapy

Jessica Rowshandel, M.S.W.
Amy Caron
Project Director
Lupus Research Institute

On October 20th, over 100 people, including patients, families and friends, came together to hear from leading scientists on the latest in lupus research funded by the Lupus Research Institute and the Alliance for Lupus Research. It’s an exciting event because only through research can we discover new, better treatments for lupus, and learn more about how the disease develops so we can find a cure. Here are the research questions these scientists are trying to answer:

  • Do certain bacteria in the gut react with male hormones to produce substances that protect males from lupus?
  • Do certain bacteria in the gut trigger antibodies that cause blood clots in patients with antiphospholipid antibody syndrome?
  • Can reducing salt in the diet reduce inflammation related to lupus?
  • What FDA approved drugs that are already available also be used as an effective treatment for lupus? For example, can a drug approved for plaque psoriasis and psoriatic arthritis be effective for active lupus?

Read more highlights from the Scientific Conference here.

While I’m excited about this research, and hope I can participate in one of the studies, when I put my patient hat on I ask, why does this matter? I spoke with a few patients after the event that had similar questions. To help us appreciate the connection between research and treatment for lupus patients, it’s helpful to take a look at the process of research and drug development. 

What does it take for a new drug to be approved?

The path from the laboratory to the doctor’s prescription pad can be long, about 12 years on average, and one path can be different from another. The Food and Drug Administration’s (FDA) drug approval process can be reviewed in detail in this infographic, so here’s a brief overview.

Step 1: Preclinical testing can take 1-6 years during which the sponsor, which is the company, research institution or other organization that is responsible for all parts of the drug approval process, tests the drug, sometimes in laboratory animals. The sponsor submits an Investigational New Drug (IND) Application to the FDA, which includes the testing results and what they plan to do for human testing. This is when the FDA will go through a strict and detailed evaluation to determine if the drug is reasonably safe for human trials in the Clinical Phase.

Animal research has played an important role in medical breakthroughs, from vaccines to antibiotics to anesthetics. Often times, mice are used in the testing phase because they are similar to humans in their genetics, anatomy and behavior. This means that results from testing in mice can be good indicators of the results that may be found in a test on human subjects. 

Step 2: Clinical research can take 6-11 years and each clinical trial is broken down into 3 phases. The trial will be reviewed by an Institutional Review Board (IRB) to assure that steps are taken to protect the rights and welfare of humans participating in the research. It’s important that we, as patients, participate in these trials to make sure potential new treatments can move through this phase. For more information about clinical trials in lupus and how to find a trial to participate in, visit LupusTrials.org.

Step 3: The approval process can take 6 months to a year and includes submission to and review of a New Drug Application by the FDA. This is when the sponsor formally asks the FDA to approve the drug for human use and the FDA carefully reviews the findings from the clinical trials.

Step 4: Post market evaluation lasts 11-14 years. This is when the FDA is carefully monitoring use by patients including any new side effects or adverse events.

Why is drug repositioning (or repurposing) important?

Sometimes drugs developed and approved to treat one disease can actually be used successfully to treat another. This is called drug repositioning. By looking to see if drugs that are already approved by the FDA for other purposes can work in lupus treatment, we can:

  • Reduce the time it takes for a new treatment to become available to patients by about 12 years, which is the time it takes for the FDA to approve a new drug
  • Reduce the amount of funding it takes to make a new treatment available

Sadly, only 1 in 5,000 potential treatments make it through the approval process and become available to patients for any disease. This project presents great opportunities to expand treatment options for lupus patients.  

Should I bring findings from the Scientific Conference to my doctor?

It’s good for your doctor to know about what’s going on in lupus research, but it’s important that you have the right expectations. At the conference what we learned about are the great questions the researchers are attempting to answer, and discoveries that need to be further explored. So while your doctor may be interested in hearing more about what you learned, chances are it may not make a difference in your treatment at this stage because these are early findings and the research is ongoing.

What you can ask your rheumatologist is if he or she knows about any trials that you might be a good match for and who to contact to enroll.

Final Thoughts

Before I changed my career to healthcare and worked in clinical practice management, I found myself frustrated when my rheumatologists weren’t aware of the latest research in lupus. But a doctor once told me, “Amy, you can’t expect your doctors to go home every night and read all of the latest journals. They want to cook dinner and watch TV with their families. Keep the focus on the things you can do.”

So what can we do?

  • Take good care of ourselves. This is always the first priority.
  • Become an Advocate. Our stories matter and our stories help get funding to find better treatments and a cure. When our legislators are considering an issue that affects lupus patients, hearing what it means to us, their constituents, can make a real difference.
  • Get involved. Fundraise, raise awareness, and participate in events with the Lupus Research Institute and the Alliance for Lupus Research

Participate in research that you qualify for and are comfortable with. This could mean participating in an observational study, in which you don’t take any drug or treatment, or a clinical trial, which is a critical part of the process to approve a drug for use by patients. You can also participate in genetics studies, in which you provide a sample that can be tested to see how our genes may have contributed to development of lupus. Patients are the key component to all research. So it’s important we do our part.

Lupus Coping Corner

Disclaimer: The information provided by the S.L.E Lupus Foundation is for educational purposes only and should not be used for diagnosing or treating a medical or mental illness, nor be a substitute for professional care. Consult your healthcare provider if you have or suspect you may have a medical or mental health problem.

Amy Caron, MPH is a lupus patient and Project Director of the Lupus Research Institute provider education initiative.  She is not a physician or counselor.  The suggestions shared in this column are strictly opinions from the perspective of a lay person with lupus. Lupus is a very individualized illness; consult a healthcare professional before making any decisions about your care.

The S.L.E. Lupus Foundation does not provide any direct medical or psychological services nor recommend or endorse any particular treatment or therapy. The S.L.E. Lupus Foundation employees, consultants, and agents shall not be liable for any claims or damages, and expressly disclaim all liability of any nature for any action or non-action taken as a result of the information generated by the S.L.E. Lupus Foundation programs and its website, as well as the S.L.E. Lupus Foundation Facebook and Twitter pages.