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

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, a secondary endpoint.

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.

These reductions were primarily related to improvements in the mucocutaneous, musculoskeletal, and immunologic organ domains.1
  • 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 patients1
  • 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
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.


The risk of severe flare was significantly reduced in 2 of 3 trials over 52 weeks1-4

(HR=0.51; 95% CI 0.35, 0.74),
(HR=0.57; 95% CI 0.39, 0.85),
(HR=0.72; 95% CI 0.49, 1.04),
P=0.081 (not statistically significant)

Severe flares were defined as at least one of the following:5

  • Hospitalization for SLE activity
  • New/worse (requiring doubling of prednisone, or prednisone increase to >0.5 mg/kg/day, or hospitalization):
  • CNS SLE, or
  • Vasculitis, or
  • Nephritis, or
  • Myositis, or
  • Platelet <60,000, or
  • 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
  • Increase in PGA score to >2.5
  • Change in SELENA-SLEDAI score to >12 accompanied by at least one of the items above

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.