Final efficacy and safety results from phase II continuation study
Madrid, June 17, 2017: GSK today announced results from a 10-year continuation study, which showed that Benlysta (belimumab) plus standard of care prolonged control of disease activity in patients with active systemic lupus erythematosus (SLE). Benlysta is a biologic medicine specifically developed and approved for SLE and this is the longest study to measure efficacy and safety of an SLE therapy.
The study, presented at the Annual European Congress of Rheumatology (EULAR) 2017, showed that the percentage of those responding to treatment with belimumab increased over time, with an overall response of 65.1% (n=126) at Year 10 as measured by SRI (SLE Responder Index), a composite efficacy measure in lupus. Overall, patients were able to decrease their corticosteroid dose over time from baseline to Year 10. Of patients receiving more than 7.5 mg/day baseline prednisone, 32.6% (14/43) decreased their dose to ≤7.5 mg/day by Year 10. 9.5% (9/95) of patients receiving baseline prednisone ≤7.5 mg/day had a dose increase to more than 7.5 mg/day. Corticosteroid use is associated with significant side effects, so reduction in dose is an important goal in SLE management.
David Roth, Medicines Development Leader, R&D Immuno-Inflammation at GSK, said “In lupus, the underlying disease is always present and symptoms can erupt, or flare, without warning, making it incredibly difficult to manage everyday life. Unlike most treatments used for SLE, belimumab has a specific mode of action that targets the underlying disease process. It has consistently proven its effectiveness, with four successful pivotal trials in SLE and data now shows that the disease control is sustained, helping to stabilise day-to-day symptoms and improve outcomes for patients in the longer-term.”
The prevalence rate of AEs and SAEs also remained relatively stable over time and consistent with the known profile for belimumab.
Corporate Comm India(CCI Newswire)
