Efficacy for Patients With Lupus Nephritis
BENLYSTA met all primary and secondary endpoints
* Standard therapy was defined as:
- CYC with high-dose steroids for induction; followed by AZA with low-dose steroids for maintenance
- 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).
Analysis of the primary and secondary endpoints was performed in a hierarchical manner – if at any point statistical significance is not met, subsequent endpoints could not be considered significant.2
Renal Response (RR) at Week 104||
eGFR ≥60 mL/min/1.73m2 or eGFR no worse than 20% below the pre-flare value; and uPCR ≤0.7; and not a treatment failure.†
Renal response was determined by reproducible changes in proteinuria and renal function at Weeks 100 and 104.
Complete Renal Response (CRR) at Week 104
Renal Response (RR) at Week 52
Time to renal-related event or death
|| RR is equivalent to PERR (primary efficacy renal response).
¶ Treatment failures were defined as patients who received prohibited therapy due to inadequate lupus nephritis control or renal flare management.
SIGNIFICANTLY MORE PATIENTS ON BENLYSTA ACHIEVED RENAL RESPONSE VS ST ALONE AT WEEK 104Renal response observed numerical treatment differences as early as Week 24
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.