Access: Lupus Research -- Clinical Trials
Research Summaries from 2012
Rontalizumab: A Potential New Lupus Therapy
Rontalizumab is a potential new drug to treat lupus. It reduces the effects of the excessive interferon-alpha that is so characteristic of lupus. The researchers hoped to learn about the safety and tolerability of rontalizumab in people with mild lupus disease activity. The results suggest that rontalizumab is safe for use in people with lupus and effectively reduces levels of interferon-regulated genes, but not interferon-regulated proteins. Rontalizumab is now being tested in Phase II clinical trials, in people with more severe lupus disease activity, in order to further evaluate its effects on lupus.
Read more>> Long-Term Safety of Benlysta®
The U.S. Food and Drug Administration recommended belimumab (Benlysta®) for approval as a treatment for lupus in 2011 and the drug is now currently available for treatment of this disease. Belimumab has been tested for safety over a 72-week period. However, the safety of belimumab over a longer period is unknown. This study examined the long-term safety of belimumab over a 4-year period in people with lupus. The results of this study indicate that adverse events were similar for the placebo and belimumab groups in the initial portion of the study and either remained stable or declined over the 4-year belimumab exposure. Laboratory abnormalities were similar between placebo and belimumab groups in the initial study period but they were not required during the long-term continuation part of the study. The results highlight the long-term safety of belimumab over a 4-year period.
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Research Summaries from 2011
Belimumab Allows For Reduction in Steroid Use for People with Lupus
One way to test whether a new treatment for lupus is effective is to see whether it allows people to reduce the amount of steroids they are taking. In this study, the researchers hoped to learn whether treatment with belimumab could reduce the use of steroids in people with active lupus.
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Epratuzumab is Safe and Effective for Treatment of Lupus in Phase II Trials
Epratuzumab is an investigational agent for the treatment of lupus. It is an antibody that binds to a protein called CD22 on B cells, which are white blood cells known to be hyperactive in many people with lupus. The researchers hoped to learn whether epratuzumab could be a safe and effective treatment for people with moderate-to-severe lupus. They also wanted to find the best way to give the treatment (which dose and how often to give it) to get the best possible effects.
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Research Summaries from 2010
Belimumab Reduces Lupus Disease Activity After 76 Weeks
Benlysta™ (belimumab) is a treatment that has recently been studied for use in lupus and researchers hoped to learn about the safety and potential effectiveness of belimumab in the treatment of lupus. Belimumab is an antibody that binds to a protein of the immune system called B-lymphocyte stimulator (BLyS). BLyS helps one of the immune cells (white blood cells called “B cells”) to survive and trigger inflammation. By inhibiting BLyS, belimumab might help to inhibit inflammation.
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Successful Phase III Trial of CellCept® for Lupus Nephritis
Lupus nephritis, or inflammation of the kidney, is a somewhat common and potentially serious manifestation of lupus. There has not been a new FDA-approved treatment for lupus nephritis in over 50 years. In this study, the researchers wanted to compare the effectiveness of mycophenolate mofetil (CellCept) with that of azathioprine to prevent kidney flares after the initial treatment for nephritis was successful.
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An Early Study of a New Treatment (Tocilizumab) for Lupus
Interleukin-6 (IL-6) is a protein that helps to control inflammation in the body. Lupus patients sometimes have increased IL-6 in the blood, and some studies suggest that IL-6 might go up with lupus flares. If the activity of IL-6 could be blocked, it might help to decrease inflammation.
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Research Summaries from 2009
Belimumab Effectively Treats Lupus Flares Over a Four-Year Period
Belimumab (also known as Benlysta™) is currently being studied in Phase III clinical trials to determine whether or not it is effective for lupus. Belimumab specifically reduces the actions of a protein called “B lymphocyte stimulator,” or BLyS. BLyS is a protein that increases the lifespan and inflammatory potential of certain immune cells called B cells, which are known to be hyperactive in lupus patients. Belimumab, which interferes with BLyS, is a human antibody. This means that it looks a lot like the antibodies that the immune system makes to fight off viruses. But in this case, belimumab targets only the protein BLyS. Because it only has one target, it is called a "monoclonal" antibody.
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Belimumab Reduces Lupus Flares in a Phase III Clinical Trial
Belimumab (also known as Benlysta™) is being studied in Phase III clinical trials to see whether it might be effective for lupus. Belimumab specifically inhibits a protein called B lymphocyte stimulator, or BLyS, which increases the survival and activity of immune cells called B cells, which are known to be hyperactive in lupus. Belimumab is a human antibody, which looks very similar to the antibodies made by the immune system to protect people from infections. Most antibodies made during infections have varying structures so they can target different parts of a virus or bacteria. Belimumab only targets BLyS, so it is called a "monoclonal" antibody. Belimumab is in a class of treatments called monoclonal antibodies in which the cleverness of the human immune system has been used as the inspiration for the way a new biologic drug is constructed.
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Genentech’s Rontalizumab Is Well-Tolerated by Lupus Patients in a Phase I Clinical Trial
New treatments for lupus have to undergo a series of clinical trials to test whether they are safe and effective before the FDA can approve them for general use in patients. This trial was the first stage of testing for rontalizumab, which is a new treatment that interferes with an inflammatory protein called "interferon-alpha." Interferon-alpha is increased in many people with lupus, so it is thought that maybe this kind of treatment might work for lupus. The first stage of testing, called Phase I, is focused mostly on testing the safety of new treatments. Phase I studies are kind of like dipping your toe in the water and typically involve small numbers of patient volunteers. If the treatment seems safe enough after Phase I, then larger studies can be done to see if the treatment would help to treat the symptoms of lupus.
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Research Summaries from 2007
Rituxan® Being Studied as a Treatment of Lupus
Rituximab (brand name Rituxan®, a product of Genentech) is one of several new medications being studied to treat lupus that act by decreasing the number of specialized white blood cells called B cells. After the treatment and over time, new B cells are produced in the bone marrow. How those new B cells develop and whether they seem to be the same as they were before, having autoimmune activity, might determine if and how long the B-cell treatment would help keep the patient symptom-free.
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Small Study of Epratuzumab Shows Promise in Mild to Moderate Lupus
In a small preliminary study, a new treatment called epratuzumab that targets one protein in the immune system seemed to be well-tolerated by patients with mild to moderate active lupus.
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