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.
The risk of severe flare was significantly reduced in 2 of 3 trials1-4
Flare prevention (especially severe flares) is an important
How were severe flares defined?6
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
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.
831315R0 February 2018