WASHINGTON and LONDON, November 16, 2016 /PRNewswire/ -- Results from 7-year Phase III continuation study in US patients GSK today announced results from a 7-year safety and efficacy continuation study for Benlysta ® (belimumab) in patients with active, autoantibody-positive systemic lupus erythematosus (SLE). The data being presented at the 2016 American College of Rheumatology/Association for Rheumatology Health Professionals Annual Meeting (ACR/AHRP) indicates that the long-term control of disease activity seen in patients receiving belimumab plus standard of care (SoC), shows meaningful benefits in their daily lives, including improvements in health-related quality of life (HRQoL) and fatigue, a common and debilitating symptom of SLE. Results from the continuation study of patients who completed BLISS-76, one of the largest Phase III pivotal clinical trials conducted with intravenously administered belimumab in SLE, showed that long-term treatment with belimumab was generally well tolerated and provided effective control of patients' disease activity. By study Year 7, 75.6% of patients showed a response to treatment, as measured by the SRI4 (Systemic Lupus Responder Index). The study also assessed HRQoL using the SF-36, a measure commonly used to capture changes in quality of life across various domains of physical and mental health. By Study Year 6, the mean change from baseline in the physical (4.79 units) and mental component score (2.71 units) of the SF-36 exceeded the generally accepted minimum clinically important difference (MCID) for improvement. Furthermore, mean changes from baseline in SF-36 domain scores exceeded the MCID in 6 of the 8 domains: bodily pain, general health, physical functioning, role physical, social functioning, and vitality. Patients receiving long-term treatment with belimumab also reported continued benefits in fatigue (mean improvements of 3.70 units in FACIT-F score). Dr. Ravi Rao, Immuno-Inflammation Medical Head, GSK, said: "Persistent disease activity can have serious long-term consequences for lupus patients, greatly impacting their day-to-day lives and affecting both their ability to function physically and socially. We have known that Benlysta is effective in reducing disease activity, but until recently data for Benlysta in SLE studies exploring the longer-term effects of treatment has been limited. These data confirm that Benlysta provides continued control of disease activity over the long-term and that this translates into meaningful benefits experienced by patients living with this chronic condition." The incidence of adverse events remained stable or declined throughout the continuation study and were consistent with data from the Phase 2 extension study and the known profile of belimumab in patients with SLE.