Efficacy in Pediatric Patients With SLE
BENLYSTA IS THE FIRST AND ONLY TREATMENT APPROVED SPECIFICALLY FOR SLE IN CHILDREN 5 YEARS AND OLDER*The Pediatric Lupus Trial of BENLYSTA (PLUTO) is the first Phase II, double-blind, placebo-controlled trial in children and adolescents with active SLE.1
Disease activity reduction (SRI-4) vs standard therapy (ST) alone at Week 52
Primary endpoint

Numerical Reduction
IV = intravenous; SRI = SLE Responder Index.
* The Pediatric Lupus Trial of BENLYSTA (PLUTO) trial was not powered to show a statistical difference between treatment groups.

SELENA-SLEDAI = Safety of Estrogens in Lupus Erythematosus: National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index; ST = Standard therapy.
† As measured by the SELENA-SLEDAI Flare Index, modified to exclude the single criterion of increased SELENA-SLEDAI score to >12.
‡ The incidence of severe flare over 52 weeks was a secondary endpoint.
§ PLUTO trial was not powered to show a statistical difference between treatment groups.