PROVEN EFFICACY
Proven efficacy in patients with SLE1-4
Response was defined as ≥4-point reduction in SELENA-SLEDAI score and 0 new BILAG A or ≤1 new BILAG B organ domain scores and <0.30-point increase in PGA score at Week 52
Superior disease activity reduction when added to standard therapy vs. standard therapy alone1-4
The difference in SRI-4 response rates did not reach statistical significance at Week 76.
These reductions were primarily related to improvements in the mucocutaneous, musculoskeletal, and immunologic organ domains.
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
SELENA-SLEDAI - Safety of Estrogens in Lupus Erythematosus: National Assessment Version of the Systemic Lupus Erythematosus Disease Activity Index.
BILAG - British Isles Lupus Assessment Group.
PGA - Physician’s Global Assessment.
ADVERSE REACTIONS
BENLYSTA: 7 years in-market experience1
Adverse reactions in ≥3% of patients receiving BENLYSTA 10 mg/kg + standard therapy and ≥1% more frequently than in those receiving placebo + standard therapy in the 52-week Phase II trial, BLISS-52, and BLISS-76
Preferred Term | BENLYSTA 10 mg/kg + Standard Therapy (n=674) % |
Placebo + Standard Therapy (n=675) % |
||
Nausea | 15 | 12 | ||
Diarrhea | 12 | 9 | ||
Pyrexia | 10 | 8 | ||
Nasopharyngitis | 9 | 7 | ||
Bronchitis | 9 | 5 | ||
Insomnia | 7 | 5 | ||
Pain in extremity | 6 | 4 | ||
Depression | 5 | 4 | ||
Migraine | 5 | 4 | ||
Pharyngitis | 5 | 3 | ||
Cystitis | 4 | 3 | ||
Leukopenia | 4 | 2 | ||
Gastroenteritis viral | 3 | 1 |
The safety profile for BENLYSTA SC + standard therapy was consistent with that of BENLYSTA IV + standard therapy, with the exception of local injection site reactions.
DELIVERY OPTIONS
Multiple administration options to meet your patients’ needs1
Subcutaneous injection: 200 mg once-weekly |
BENLYSTA SC is supplied as:![]() 200 mg/mL single-dose ![]() 200 mg/mL single-dose |
1-hour IV infusion: 10 mg/kg every 4 weeks after the first 3 doses (10 mg/kg every 2 weeks) |
BENLYSTA IV is supplied as:![]() 120 mg in a 5-mL single-dose vial |
Useful tools to support your patients
Find the vial combination that
helps minimize product waste.
Calculate patients’
infusion dates.
REFERENCES:
831315R0 February 2018