Long-term safety and efficacy data from a 7-year continuation study were announced at the 2016 ACR/ARHP Annual Meeting that evaluated belimumab (Benlysta®, GlaxoSmithKline) in patients with systemic lupus erythematosus (SLE).
The open-label extension study (n=268) included patients who completed the initial BLISS-76 phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT00410384, n=819). Patients received the same dose of belimumab 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 systemic lupus erythematosus disease activity index (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.
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 with high specificity for 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.
Furie RA, Wallace DJ, Aranow C, Fettiplace J, Wilson B, Mistry P, Roth DA, Gordon D. 7-Year safety and efficacy of belimumab in patients with systemic lupus erythematosus [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). http://acrabstracts.org/abstract/7-year-safety-and-efficacy-of-belimumab-in-patients-with-systemic-lupus-erythematosus/. Accessed November 23, 2016.
This article originally appeared on MPR