Lupus Research

Research is the process scientists use to explain how our bodies work and why our bodies stop working well sometimes. Research eventually helps scientists understand enough about our bodies to treat or even cure what goes wrong.

History of lupus research

During World War II, the U.S. military wanted a drug to prevent and treat malaria. They discovered by accident that antimalarial drugs also helped control lupus inflammation. Thanks to this research, the antimalarial hydroxychloroquine remains one of the main drugs doctors prescribe for lupus.¹

Since then, new lupus drugs have been hard to find. This is because lupus symptoms can be so different from one person to another. This variety makes it hard to design studies to track whether a new treatment helps enough people to gain government approval. In 2011, Benlysta became the first new drug in 50 years to be approved for the treatment of lupus.

Current types of lupus research

Research helps build understanding into the causes of and treatments for lupus. Some current types of lupus research include:

• What causes lupus, how it progresses over time, and what role genes play in developing lupus
• Safety and effectiveness of new drugs for lupus and lupus nephritis
• Outcomes of pregnant women with lupus (PROMISSE)
• Safety of certain lupus drugs in pregnant women and their babies
• Potential of new imaging techniques to replace kidney biopsy (DIVINE)
• How well certain drugs work to control skin rashes, blood vessel inflammation, joint pain and more

Some studies are only available in a few locations, while others recruit patients all over the country. For the most part, clinical trials are located in major cities.

Today’s newer treatments, such as immunosuppressants, became available after hundreds of people volunteered to try a new drug. These volunteers had to meet certain requirements, then report any side effects and whether their symptoms got better or not.

Different types of research for different purposes

Different types of research provide different types of answers about a disease like lupus. The 3 main types of medical research are:

• Basic
• Population-based
• Clinical trials

Basic research

helps doctors better understand what causes a disease or why a particular drug works and another does not. It is sometimes called bench research because these scientists often work at a bench in a lab. Basic research for lupus may look at:

• Which antibodies are found in the blood of someone with joint pain or a malar rash
• Specific genes that may cause someone to develop lupus
• Whether a new chemical lowers the level of antibodies in someone with lupus

Clinical trials

answer specific questions about a new drug or medical device. When a drug company invents a new medicine, they need to know how well it works compared to older drugs. They also need to know how much of the new drug someone should take. Side effects are another important question that clinical trials answer.

Clinical trials run in 4 stages:

• Phase I – A very small group of people take the new drug for the first time to determine safety, dosage range, and side effects. Less than 25 people may be involved in a Phase I trial.
• Phase II – A larger group takes the drug to see how well it works and if it is still safe. It varies, but a phase II trial may have just 50 to 300 participants.
• Phase III – At this point, the drug is thought to be safe enough to give to large groups of people. Doctors continue to look for side effects, how well it works, and compare it to other drugs. Several hundred to a few thousand people may be taking the drug at this point.
• Phase IV – The drug is now marketed to the public and even larger groups of people are able to take the drug. The government and drug companies gather information about how the drug works in a larger, more diverse population. They also look for new or different side effects that happen with long-term use.

If a drug or device appears to be unsafe at any stage, the clinical trial is stopped. The researchers involved then issue an explanation of what they believe went wrong.

Population-based research

looks for patterns of health and illness across large groups of people. These studies identify how many and what type of people in a city, state or country has a disease like lupus. These type of studies are how we know that:

• About 1.5 million Americans have lupus.
• African American and Asian women get lupus more than Caucasian women.
• 90 percent of people with lupus are women.²

Is medical research safe?

All medical research on humans must be approved and monitored by a group of scientists and doctors called an institutional review board (IRB). IRBs must follow rules for human safety set out by the U.S. Food & Drug Administration (FDA). In the U.S., all IRBs that work on FDA-regulated studies must register with the FDA.³

Who pays for research?

There are 3 main sources of funding for research into diseases. The federal government, non-profits, universities, and pharmaceutical and medical device companies all fund lupus research. In the U.S., the Lupus Foundation of America and the Lupus Research Alliance fund several research studies.

How to get involved

Eventually, research will help scientists find a cure. Until then, joining a clinical trial lets you contribute to the lupus community by sharing your unique genes and responses to drugs. To find a study near you, talk to your doctor or visit Lupus Research Alliance or the government’s clinical trial registry.