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|June 12, 2013 8:00 a.m.|
|Teva and Active Biotech Report Positive Results from Phase IIa Study of Laquinimod in Active Lupus Nephritis|
"The favorable trends towards laquinimod treatment in the renal end-points, coupled with the safety and tolerability profile, provide a rationale for further Phase III clinical studies,” said Principal Investigator Dr.
“The results from this clinical study further our understanding of how the immunomodulatory profile of laquinimod may benefit patients with lupus,” said Dr.
The clinical trial, NCT01085097, was a multicenter, double-blind, placebo-controlled, exploratory study of 46 patients with active lupus nephritis that evaluated oral laquinimod (0.5 and 1mg/day) versus placebo in combination with standard of care treatment. The study showed that at 24 weeks, 62.5% of patients with active lupus nephritis who received 0.5mg/day of laquinimod achieved renal response, compared to 33.3% of patients who were administered placebo. Renal response is a composite end point that measures several parameters of renal improvement.
Reported adverse events (AEs) were comparable in both the active treatment and placebo patient groups. Serious AEs were reported in 12 patients (four in each treatment group) and were attributed to infection, thromboembolic events or lupus-related complications. One death occurred in the active treatment arm due to pan-lobar pneumonia & sepsis in a patient with advanced disease. The death was not attributed to the study drug.
A larger clinical trial of laquinimod in combination with standard of care (mycophenolate mofetil and corticosteroids), compared to standard of care alone, is planned in patients with lupus nephritis to further evaluate the safety and efficacy profile observed in study NCT01085097.
Lupus is a chronic and often disabling autoimmune disease. An estimated five million people worldwide, including 1.5 million Americans, have a form of lupus.2 Most people who are affected by lupus are women of childbearing age, who suffer from symptoms including intense fatigue and exhaustion, joint pain, thinking and memory problems and skin rashes.3 Lupus is two to three times more common among people of African, Hispanic,
ABOUT SYSTEMIC LUPUS ERYTHEMATOSUS
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4. Study Protocol 201;
6. Bernatsky S, Bovin J-F, Joseph L, et al. Mortality in systemic lupus erythematosus. Arthritis Rheum 2006;54:2550-7.