Seven year data shows benefits of Benlysta (belimumab) in autoantibody-positive systemic lupus erythematosus- GlaxoSmithKline

GlaxoSmithKline has announced results from a 7-year safety and efficacy continuation study for Benlysta (belimumab) in patients with active, autoantibody-positive systemic lupus erythematosus (SLE). Results indicate 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). The data were presented at the 2016 American College of Rheumatology/Association for Rheumatology Health Professionals Annual Meeting.