DISEASE ACTIVITY REDUCTION

BENLYSTA is the only FDA-approved biologic to reduce clinical manifestations of SLE, when added to standard therapy1

These reductions were primarily related to improvements in the mucocutaneous,
musculoskeletal, and immunologic organ domains1

Percentage of patients meeting the SRI-4 response criteria over time

Phase III, multicenter, randomized, double-blind, placebo-controlled, 52-week study. Patients received weekly BENLYSTA 200 mg subcutaneously or placebo, in combination with standard therapy.

52-week, multicenter, phase III, randomized study evaluating the efficacy and safety of BENLYSTA administered intravenously + standard therapy vs placebo + standard therapy.

The difference in SRI-4 response rates was not significantly different at week 76.

76-week, multicenter, phase III, randomized, placebo-controlled trial assessing the efficacy and safety of BENLYSTA administered intravenously vs placebo, in combination with standard therapy.

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
  • Effect in black/African American Patients: In clinical studies, there have been mixed results regarding how well BENLYSTA works in black/African American patients. Consider the risks and benefits when prescribing BENLYSTA in black/African American patients.1
  • In BLISS-76, the SRI-4 response rate at Week 76 (a secondary endpoint) for BENLYSTA 10 mg/kg was not significantly different from that of placebo (39% and 32%, respectively)1
  • Inclusions: Diagnosis of SLE, ANA+ and/or anti-dsDNA+ at screening, SELENA-SLEDAI score ≥6 (≥8, BLISS-SC), stable standard therapy for ≥30 days.
    Exclusions: severe active lupus nephritis or severe active CNS lupus, other biologics or IV cyclophosphamide. The most common active organ systems at baseline were mucocutaneous, immune, and musculoskeletal.
  • In a Phase II trial, BENLYSTA did not meet its co-primary endpoints of percent reduction in SELENA-SLEDAI score at Week 24 and time to first flare over 52 weeks5
Setting expectations about when patients may see improvements can help them feel more in control of their treatment.6,7
Download a free copy of the BLISS SC clinical trial
Learn more about the clinical trials.
Discover how BENLYSTA works to lower disease activity.
Summary of the pivotal trials.

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 SV, Guzmán RM, Gallacher AE, 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.
  6. Karlson EW, Liang MH, Eaton H, et al. A randomized clinical trial of a psychoeducational intervention to improve outcomes in systemic lupus erythematosus. Arthritis Rheum. 2004;50(6):1832-1841.
  7. Knittle K, De Gucht V, Hurkmans E, Vlieland TV, Maes S. Explaining physical activity maintenance after a theory-based intervention among patients with rheumatoid arthritis: process evaluation of a randomized controlled trial. Arthritis Care Res. 2016;68(2):203-210.

SECONDARY OUTCOMES

The risk of severe flare was significantly reduced in 2 of 3 trials1-4

Flare prevention (especially severe flares) is an important
therapeutic goal5

11% vs 18%
(HR=0.51; 95% CI 0.35, 0.74),
P=0.0004
14% vs 23%
(HR=0.57; 95% CI 0.39, 0.85),
P=0.0055
18% vs 24%
(HR=0.72; 95% CI 0.49, 1.04),
P=0.081

How were severe flares defined?6

  • Change in SELENA-SLEDAI score to >12, or
  • New/worse (requiring doubling of prednisone, or prednisone increase to >0.5 mg/kg/day, or hospitalization):
  • CNS SLE
  • Vasculitis
  • Nephritis
  • Myositis
  • Platelet <60,000
  • Hemolytic anemia (Hb <7 g/dL or decrease in Hb >3 g/dL), or
  • Increase in prednisone to >0.5 mg/kg/day, or
  • New immunosuppressant, or
  • Hospitalization for SLE activity, or
  • Increase in PGA score to >2.5

Normalization of biomarkers as early as Week 81

16% of patients treated with BENLYSTA plus standard therapy converted from seropositive to seronegative for anti-dsDNA, compared to 6.8% of patients treated with placebo plus standard therapy at Week 52.7

Reduction in
anti-dsDNA and IgG levels
Increase in
C3 and C4 levels

Clinical relevance of normalizing these biomarkers has not been definitively established.

*As defined by a modified SELENA-SLEDAI SLE Flare Index.
In patients who were positive for anti-dsDNA ≥30 IU/mL.
In patients with low complement levels at baseline.

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 SV, Guzmán RM, Gallacher AE, 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. van Vollenhoven RF, Mosca M, Bertsias G, et al. Treat-to-target in systemic lupus erythematosus: recommendations from an international task force. Ann Rheum Dis. 2014;73(6):958-967.
  6. Data on file, Human Genome Sciences, Inc.
  7. Stohl W, Falk H, Latinis K, et al. Belimumab Reduces Autoantibodies, Normalizes Low Complement Levels, and Reduces Select B Cell Populations in Patients With Systemic Lupus Erythematosus. Arthritis Rheum. 2012;64:2‍328-2337.

831315R0 February 2018

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