Prolonged treatment with Benlysta (belimumab) offers safe and effective control of disease activity, improves life quality and eases fatigue in patients with active, autoantibody-positive systemic lupus erythematosus (SLE), according to seven-year clinical trial results released by GSK, the drug’s developer.
These findings come from a continuation study of patients who completed the Phase 3 trial BLISS-76 (NCT00410384), which evaluated the safety and efficacy profiles of intravenously administered Benlysta. The results were recently presented at the American College of Rheumatology/Association for Rheumatology Health Professionals Annual Meeting (ACR/AHRP).
Benlysta is a human antibody that selectively targets B-lymphocyte stimulator (BLyS), a key element for the survival of the B-cells of the immune system, which play a role in lupus development. Benlysta was approved as an intravenous (IV), one-hour infusion to be taken every 28 days in both Europe and the U.S. in 2011.
BLISS-76 followed 819 patients at several clinical sites across 19 countries, mainly in North America and Europe. Its objective was to assess patient response rate after 52 weeks of treatment using the SLE Responder Index (SRI), which measures decreases in disease activity.
The continuation study (GSK study 112233; NCT00724867) included 268 patients, of whom 140 completed the study and 128 did not. Discontinuation was due to patient request (about 24 percent) or to adverse side effects of the treatment (19.5 percent).
In this study, all patients, including those who had previously been on a placebo, received the same Benlysta treatment as in the BLISS-76 trial (1 or 10 mg/kg IV infusion every 28 days, plus standard of care). After Benlysta was approved, the lower dose was discontinued and only 10 mg/kg used.
Every 48 weeks (a study year), researchers assessed the treatment’s safety profile by analyzing the frequency of adverse effects and the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI). Other measures, such as the SRI, health-related quality of life (SF-36, which measures changes in the quality of life in several physical and mental health domains) and the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (which measures fatigue) were also assessed.
Results indicated that prolonged treatment with Benlysta was well-tolerated by patients and able to control disease activity. After six years of treatment, the mean change from baseline in the physical and mental components of the SF-36 were above what is considered an improvement, including measurements of bodily pain, general health, physical functioning, role physical, social functioning, and vitality. Patients also showed improvement in the FACIT-F score, showing that the treatment eased symptoms of fatigue.
By the continuation study’s end (year seven), 75.6 percent of patients showed a response to treatment, as measured by the SRI4 (Systemic Lupus Responder Index).
Also, the incidence of adverse events remained stable or declined throughout the study, and were consistent with the known profile of Benlysta in SLE patients.
Overall, these results indicate that prolonged treatment with Benlysta plus standard of care controls disease activity and improves health-related quality of life and fatigue in SLE patients.
“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,” said Ravi Rao, Immuno-Inflammation medical head at GSK, said in a company press release. “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.”