DISEASE ACTIVITY REDUCTION
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.
The risk of severe flare was significantly reduced in 2 of 3 trials over 52 weeks1-4
Severe flares were defined as at least one of the following: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
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.
1009045R0 September 2018