Sustained Disease Control Seen With Long-Term Belimumab in SLE

Long-term safety and efficacy of Benlysta in patients with systemic lupus erythematosus has been released
Long-term safety and efficacy of Benlysta in patients with systemic lupus erythematosus has been released

WASHINGTON, DC—Long-term safety and efficacy data from a 7-year continuation study were announced at the 2016 ACR/ARHP Annual Meeting that evaluated Benlysta (belimumab; GlaxoSmithKline) for injection in patients with systemic lupus erythematosus (SLE).

The open-label extension study (n=268) included patients who completed the Phase 3 BLISS-76 study (n=819). Patients received the same dose of belilmumab as in BLISS-76 (1mg/kg or 10mg/kg IV every 28 days) plus standard of care (SoC). The SLE responder index (SRI) response rate was a composite measure that included: ≥4 point reduction from baseline in SELENA SLEDAI score and no worsening (increase of <0.30 points) in Physician's Global Assessment (PGA) and no worsening in disease activity as measured by British Isles Lupus Assessment Group of SLE Clinics (BILAG) organ domain score (No new A or 2 new BILAG B organ domain scores compared with baseline). 

The findings indicated that treatment with belimumab plus SoC led to long-term control of disease activity, including improvements in health-related quality of life (HRQoL), using SF-36, and fatigue. Long-term treatment with belimumab was generally well tolerated and resulted in effective control of patients' disease activity.  

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By Year 6, the mean change from baseline in the physical and mental component scores of the SF-36 surpassed the generally accepted minimum clinically important difference (MCID) for improvement (4.79 units and 2.71 units, respectively). Mean changes from baseline in SF-36 domain scores exceeded the MCID in 6 of the 8 domains, which include bodily pain, general health, physical functioning, role physical, social functioning, and vitality. 

By Year 7, three-quarters of study patients (75.6%) demonstrated a response to treatment, as measured by the Systemic Lupus Responder Index (SRI4). 

Improvements in fatigue were also reported by patients receiving long-term belimumab as seen with mean improvements of 3.70 units in FACIT-F score.

Benlysta, a BLyS-specific inhibitor, is a human monoclonal antibody that works by binding to soluble BLyS. This inhibits the survival of B cells, including autoreactive B cells, and decreases B-cell differentiation into immunoglobulin-producing plasma cells. It is FDA approved for SLE, in adults with active, autoantibody-positive SLE on standard therapy. 

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