Efficacy for Patients With Lupus Nephritis
BENLYSTA IS NOW APPROVED FOR MORE PATIENTS
BENLYSTA met all primary and secondary endpoints in Belimumab International SLE Study-LN (BLISS-LN)

Renal Response (RR) at Week 104 was defined as eGFR ≥60 mL/min/1.73m2 or eGFR no worse than 20% below the pre-flare value, and uPCR ≤0.7; and no treatment failure.†
Complete Renal Response (CRR) at Week 104 was defined as eGFR ≥90 mL/min/1.73m2 or no worse than 10% below the pre-flare value; and uPCR <0.5; and not a treatment failure.†
AZA = azathioprine; CI = confidence interval; CRR = complete renal response; CYC = cyclophosphamide; HR = hazard ratio; IV = intravenous; LN = lupus nephritis; MMF = mycophenolate mofetil; OR = odds ratio; RR = renal response; SLE = systemic lupus erythematosus; ST = standard therapy.
* Standard therapy was defined as:
- CYC with high-dose steroids for induction; followed by AZA with low-dose steroids for maintenance
OR - MMF with high-dose steroids for induction; followed by MMF with low-dose steroids for maintenance
† Treatment failures were defined as patients who received prohibited medications. For these endpoints, in order to be considered a responder, steroid use had to be reduced to ≤10 mg/day from Week 24.
‡ When excluding deaths from the analysis (BENLYSTA=1, ST=2), the percentage of patients with a renal-related event was 15% vs 27%, respectively (HR= 0.51; 95% CI: 0.34, 0.78).
SIGNIFICANTLY MORE PATIENTS ON BENLYSTA ACHIEVED RENAL RESPONSE VS ST ALONE AT WEEK 104
Maintained response2
Patients on BENLYSTA had a

INCREASED LIKELIHOOD OF ACHIEVING RR THAT WAS MAINTAINED TO WEEK 104
(HR=1.46, 95% CI: 1.07, 1.98)
Results are descriptive. Other pre-specified endpoint.
SIGNIFICANTLY MORE PATIENTS ON BENLYSTA ACHIEVED CRR (COMPLETE RENAL RESPONSE) VS ST ALONE Secondary endpoint: CRR included a more stringent measure of kidney function
Maintained response2
Patients on BENLYSTA had a

INCREASED LIKELIHOOD OF ACHIEVING CRR THAT WAS MAINTAINED TO WEEK 104
(HR=1.58, 95% CI: 1.08, 2.31)
Results are descriptive. Other pre-specified endpoint.

‡‡ When excluding deaths from the analysis (BENLYSTA=1, ST=2), the percentage of patients with a renal-related event was 15% vs. 27%, respectively (HR= 0.51; 95% CI: 0.34, 0.78).