Study Demonstrates Long-term Safety of Belimumab
In a Phase III study extension of the effects of belimumab (Benlysta®) on people with systemic lupus erythematosus (SLE), researchers found the treatment to be safe for long-term use. No new safety concerns were observed over the 8-year study period, and long-term use was associated with minimal organ damage progression, even in people with high disease activity.
In this multi-center long-term study, 735 participants with SLE were treated with intravenous (i.v.) belimumab in addition to standard drug therapy. Some people received the treatment just once, while others were regularly treated with the drug for multiple years. Throughout the eight-year study, researchers assessed for adverse events (AEs, unexpected medical problems that occur during treatment) as well as lab results indicating any potentially harmful effects caused by the drug. They also regularly monitored organ damage using the SLICC/ACR Damage Index.
While 9.4% of participants experienced an AE resulting in the discontinuation of the treatment or withdrawal from the study, overall annual incidence of AEs remained stable or declined over time, including serious and severe AEs. Similarly, lab values indicating drug safety and tolerability generally remained stable, and average SLICC/ACR Damage Index scores remained stable too, indicating low organ damage accrual over time.
Belimumab was approved by the FDA in 2011 and is the first and only drug specifically developed for and approved to treat lupus. Learn more about medications used to treat lupus.