- Results from a seven-year continuation study assessing GlaxoSmithKline's (GSK -1%) Benlysta (belimumab) for the long-term treatment of patients with active autoantibody-positive systemic lupus erythematosus (SLE) showed treatment with belimumab plus standard-of-care (SOC) therapy delivered meaningful improvements in patients' daily lives, including quality-of-life and fatigue. The data were presented at the American College of Rheumatology and Association of Rheumatology Health Professionals Annual Meeting in Washington, D.C.
- The open-label extension study enrolled patients who completed the Phase 3 BLISS-76 trial which randomized 819 patients across 136 sites in 19 countries. The primary endpoint was the patient response rate at week 52 as measured by a composite measure of disease activity called the SLE Responder Index.
- The continuation phase enrolled 268 patients, comprising the modified intent-to-treat population. 140 (~48%) completed the study and 128 withdrew. There were no clinically significant trends associated with the withdrawals.
- Participants received the same dose of belimumab (1 or 10 mg/kg every 28 days) as BLISS-76 plus SOC. Following the regulatory approval of belimumab, the patients receiving the lower dose were increased to the higher dose.
- By year 7, 76.5% of patients showed a response to treatment as measured by a newer scale called SRI4 (Systemic Lupus Responder Index). In additional, quality of life measures of physical and mental health improved as well.
- The FDA approved Benlysta in March 2011 followed by approval in Europe in July 2011. It is the only drug approved in the last 50 years to treat SLE.
Original article