PROVEN EFFICACY

Proven efficacy in patients with SLE1-4

Response was defined as ≥4-point reduction in SELENA-SLEDAI score and 0 new BILAG A or ≤1 new BILAG B organ domain scores and <0.30-point increase in PGA score at Week 52

Superior disease activity reduction when added to standard therapy vs. standard therapy alone1-4

The difference in SRI-4 response rates did not reach statistical significance at Week 76.

These reductions were primarily related to improvements in the mucocutaneous, musculoskeletal, and immunologic organ domains.

In a Phase II trial, BENLYSTA did not meet the prespecified co-primary efficacy endpoints of percent change in SELENA-SLEDAI at Week 24 and time to first flare over 52 weeks (N=449).5

SELENA-SLEDAI - Safety of Estrogens in Lupus Erythematosus: National Assessment Version of the Systemic Lupus Erythematosus Disease Activity Index.
BILAG - British Isles Lupus Assessment Group.
PGA - Physician’s Global Assessment.

ADVERSE REACTIONS

BENLYSTA: 7 years in-market experience1

Adverse reactions in ≥3% of patients receiving BENLYSTA 10 mg/kg + standard therapy and ≥1% more frequently than in those receiving placebo + standard therapy in the 52-week Phase II trial, BLISS-52, and BLISS-76

  Preferred Term BENLYSTA 10 mg/kg +
Standard Therapy
(n=674)
%
Placebo + Standard Therapy
(n=675)
%
 
  Nausea 15 12  
  Diarrhea 12 9  
  Pyrexia 10 8  
  Nasopharyngitis 9 7  
  Bronchitis 9 5  
  Insomnia 7 5  
  Pain in extremity 6 4  
  Depression 5 4  
  Migraine 5 4  
  Pharyngitis 5 3  
  Cystitis 4 3  
  Leukopenia 4 2  
  Gastroenteritis viral 3 1  

The safety profile for BENLYSTA SC + standard therapy was consistent with that of BENLYSTA IV + standard therapy, with the exception of local injection site reactions.

DELIVERY OPTIONS

Multiple administration options to meet your patients’ needs1

Subcutaneous injection:
200 mg once-weekly
BENLYSTA SC is supplied as:

200 mg/mL single-dose
prefilled autoinjector

200 mg/mL single-dose
prefilled glass syringe

1-hour IV infusion: 10 mg/kg every 4 weeks after the first 3 doses (10 mg/kg every 2 weeks)
BENLYSTA IV is supplied as:

120 mg in a 5-mL single-dose vial
400 mg in a 20-mL single-dose vial

Useful tools to support your patients

Find the vial combination that
helps minimize product waste.

Calculate patients’
infusion dates.

REFERENCES:

  1. BENLYSTA [package insert]. Research Triangle Park, NC: GlaxoSmithKline, 2017.
  2. Stohl W, Schwarting A, Okada M, et al. Efficacy and safety of subcutaneous belimumab in systemic lupus erythematosus: a fifty-two–week randomized, double-blind, placebo-controlled study. Arthritis Rheumatol. 2017;69(5):1016-1027.
  3. Navarra S, Guzmán R, Gallacher A, et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet. 2011;377(9767):721-731.
  4. Furie R, Petri M, Zamani O, et al. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum. 2011;63(12):3‍918-3930.
  5. Wallace DJ, Stohl W, Furie RA, et al. A phase II, randomized, double-blind, placebo-controlled, dose-ranging study of belimumab in patients with active systemic lupus erythematosus. Arthritis Rheum. 2009;61(9):1168-1178.

831315R0 February 2018

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