In a Phase 3 clinical trial, skin injections of a new drug therapy benefits patients with a form of lupus. Photo by Andrei Rahalski/Shutterstock
April 20 (UPI) -- Injections of a new drug therapy benefited patients with a form of lupus in a Phase 3 clinical trial, researchers report.
Belimumab was tested in patients with systemic lupus erythematosus, or SLE, a chronic inflammatory disease that can affect virtually any organ -- mainly in women. The findings were published this week in Arthritis & Rheumatology.
Belimumab, which has the brand name of Benlysta and is marketed by GlaxoSmithKline, has been approved in the United States, Canada and Europe for intravenous use in combination with other lupus medicines. The trial was conducted between 2011 and 2015.
"Intravenous administration of belimumab is an obstacle to treatment for many patients due to the need to go to the hospital for drug infusions. Thus, a higher number of patients could benefit from this treatment," Dr. Andrea Doria, a researcher at the University of Padova in Italy, said in a press release. "The self-administration of subcutaneous belimumab makes hospital access unnecessary, which leads to economic savings for patients and the community."
The Lupus Foundation of America estimates that 1.5 million Americans have some form of lupus, with 70 percent of the cases classified as systemic lupus. The Centers for Disease Control and Prevention said there is no cure for lupus treatment, but lifestyle changes can help control it.
While lupus is not in the CDC's annual selected list of causes of death for women, the foundation announced the results of a study this week revealing that there were 28,411 female deaths between 2008 and 2015 due to lupus, ranking it as the 10th leading cause of death for women ages 15-24. The data came from the CDC's Epidemiologic Research database.
In the clinical trial, 356 participants with characteristics of high disease activity received weekly skin injections of belimumab 200 mg, or a placebo, plus standard lupus therapy.
After 52 weeks, the researchers found the drug had reduced lupus disease activity -- 64.6 percent vs. 47.2 percent for a placebo. Participants also experienced fewer flares -- 14.1 percent for those taking belimumab, compared to 31.5 percent for the placebo.
Additionally, people taking the drug were more frequently able to reduce their need for steroids.
Both groups, however, experienced similar side effects.
Lupus deaths are often attributed to kidney failure and heart attacks, but Benlysta is not prescribed for people who have severe kidney problems caused by SLE or who have active SLE that affects the central nervous system.