Date: 2017-06-16
Type of
information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the Annual European Congress of Rheumatology (EULAR) 2017
Company: GSK (UK)
Product: Benlysta® (belimumab)
Action
mechanism: monoclonal antibody. Benlysta® (belimumab) is a fully human recombinant monoclonal antibody directed against BLyS (B-lymphocyte stimulator) . It prevents the interaction of BLys with its three receptors and indirectly decreases the B-cell survival and production of autoantibodies.
Disease: systemic lupus erythematosus (SLE)
Therapeutic
area: Autoimmune diseases
Country: Canada, USA
Trial
details:
- This was a multicentre, open-label, continuation trial (BEL 112626) of belimumab 10 mg/kg plus standard of care in patients who completed the phase II parent study – a double-blind, placebo-controlled, 52-week study of belimumab 1, 4 or 10 mg/kg and 24-week extension of belimumab (placebo switched to 10 mg/kg; belimumab same dose or switched to 10 mg/kg). Of 298 patients in the continuation trial, 131 (44%) remained at Year 10. Total belimumab exposure was 2,154 patient-years. Disease activity, defined by SELENA-SLEDAI score, was analysed in patients with active SLE at baseline of the initial study.
- The population that entered the long-term continuation study and continued throughout 10 years was potentially enriched with patients who responded to or tolerated belimumab [i.e. these were patients who had an improvement in Physician’s Global Assessment (PGA) compared with baseline or Week 52 and had no severe SLE flare in the last 30 days of the 24-week extension period]. (NCT00583362)
Latest
news:
- • On June 16, 2017, GSK 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. 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.
- The prevalence rate of AEs and SAEs also remained relatively stable over time and consistent with the known profile for belimumab.
Is
general: Yes
