Lupus trials offer hope
Three companies have recent news of clinical trials for the treatment of systemic lupus erythematosus (SLE). Pharmacists can help patients get into clinical trials by providing them and their physicians the appropriate information. Pharmacists can also participate in the trials themselves as dispensers of study medications.
Decision Resources, a company that provides strategic pharmaceutical information, has announced a forthcoming study that evaluates drug development opportunities for the treatment of the autoimmune diseases SLE, systemic sclerosis (SSc), and Sjogren’s syndrome (SS). Significant opportunity is now upon us as we learn more about the mechanisms of autoimmune diseases. Incentive for drug manufacturers to pursue treatment options is enhanced by fast-track designation for new drug applications (NDAs) from the FDA. Drugs developed for treatment of SLE can also be granted orphan drug status, giving the manufacturer a longer time of exclusivity. (For more details, see www. dresources.com.)
Genelabs Technologies announces the completion of its NDA for marketing approval from the FDA for its compound, GL701, for the treatment of SLE. The FDA granted fast-track designation for GL701. With a primary ingredient of prasterone, the drug has also been referred to as dehydroepiandrosterone. Aslera will be the trade name of the drug. Genelabs is seeking approval of Aslera for first-line treatment of women with mild to moderate SLE to improve disease activity and its symptoms, and to reduce the need for corticosteroids in these patients. The submission is based on two U.S. studies and one study from Taiwan for a total of more than 700 patients with SLE. (For more details, see www.genelabs.com.)
LaJolla Pharmaceutical Co. announces it has initiated a phase III clinical trial of its compound for the treatment of lupus, LJP394. The drug is designed to reduce levels of antibodies to double-stranded DNA, believed to be responsible for lupus nephritis. The company plans to enroll about 300 lupus patients to evaluate the potential of the compound to prevent or delay renal flares, reduce the need for treatment with high-dose corticosteroids or chemotherapy drugs, and improve patient quality of life. The trial has been named PEARL for Program Enabling Antibody Reduction in Lupus. Patients will be treated with weekly doses of 100 mg LJP394. Interested patients are encouraged to contact LJP at 888-30-LUPUS. (For more details, see www.ljpc.com.)
Approximately 200,000 people in the United States and more than 1,000,000 worldwide have lupus. Lupus causes the immune system to attack the body’s own tissue, causing inflammation, arthritis pain, tissue injury, and major organ damage. Typical signs and symptoms of SLE are listed in the box below. Lupus has few treatment options currently. It typically strikes women, usually during their childbearing years. Renal flares are life-threatening episodes during which renal tissue is damaged or destroyed. Current pharmacological treatment options include high doses of corticosteroids and chemotherapy agents that have increased patient survival rate, but also have strongly negative side effects representing the major cause of morbidity and mortality in lupus. (From www.ljpc.com and www.genelabs.com.)
| Signs and Symptoms of SLE | |
| • Fatigue | • Hair loss |
| • Arthritis | • Facial rash |
| • Fever | • Photosensitivity |
| • Seizures | • Depression |
| • Headache | • Lung inflammation |
| • Muscle weakness | • Heart and brain tissue damage |
| • Memory loss | • Organ damage, especially kidney |
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content