Efficacy for Patients With Lupus Nephritis

BENLYSTA IS NOW APPROVED FOR MORE PATIENTS

Icon: Kidneys

BENLYSTA met all primary and secondary endpoints in Belimumab International SLE Study-LN (BLISS-LN)

Greater odds of achieving response1,2

Reduction in risk of events over 2 years1,2,‡

Graph: BLISS-LN Renal Response Rate Shows 43% BENLYSTA + ST and 32% Placebo + ST at Week 104; 47% BENLYSTA + ST and 35% Placebo + ST at Week 52; Complete Renal Response Shows 30% BENLYSTA + ST and 20% Placebo + ST at Week 104. Percent of Patients with a Renal Related Event or Death at Week 104 Shows 16% BENLYSTA + ST and 28% Placebo + ST
Graph: BLISS-LN Renal Response Rate Shows 43% BENLYSTA + ST and 32% Placebo + ST at Week 104; 47% BENLYSTA + ST and 35% Placebo + ST at Week 52; Complete Renal Response Shows 30% BENLYSTA + ST and 20% Placebo + ST at Week 104. Percent of Patients with a Renal Related Event or Death at Week 104 Shows 16% BENLYSTA + ST and 28% Placebo + ST
Graph: BLISS-LN Renal Response Rate Shows 43% BENLYSTA + ST and 32% Placebo + ST at Week 104; 47% BENLYSTA + ST and 35% Placebo + ST at Week 52; Complete Renal Response Shows 30% BENLYSTA + ST and 20% Placebo + ST at Week 104. Percent of Patients with a Renal Related Event or Death at Week 104 Shows 16% BENLYSTA + ST and 28% Placebo + ST

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).

  • Study design for BLISS-LN

    The largest and longest Phase III trial in LN: 2-year duration1

    Chart: BLISS LN Study Design
    Chart: BLISS LN Study Design
    Chart: BLISS LN Study Design

    BENLYSTA is the first and only FDA-approved treatment for lupus nephritis studied with both MMF and CYC.

    LN = lupus nephritis; ORR = overall response rate.

    § Confirmed biopsy-proven Class III, IV, V or V in combination with III or IV.

  • Primary and secondary endpoints

    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

    Primary endpoint

    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.

    Secondary endpoints

    Complete Renal Response (CRR) at Week 104

    eGFR ≥90 mL/min/1.73m2 or eGFR no worse than 10% below the pre-flare value; and uPCR <0.5; and not a treatment failure.

    Renal Response (RR) at Week 52

    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

    Time to renal-related event or death

    First instance of ESKD, doubling of serum creatinine, renal worsening (increased proteinuria and/or impaired renal function), renal disease-related treatment failure, or death.

    eGFR = estimated glomerular filtration rate; ESKD= end-stage kidney disease; uPCR = urinary protein creatinine ratio.

    || 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 104

Icon: Kidneys

Maintained response2

Patients on BENLYSTA had a
Icon: 46% Increased Likelihood of Achieving RR That Was Maintained to Week 104
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

Icon: Kidneys

Maintained response2

Patients on BENLYSTA had a
Icon: BLISS LN Shows 58% Increased Likelihood of Achieving CRR That Was Maintained to Week 104
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.

BENLYSTA REDUCED DISEASE WORSENING1,2,‡‡Reduced risk of renal-related events or death at any time up to Week 104

Icon: Kidneys
BENLYSTA REDUCED DISEASE WORSENING. Reduced risk of renal-related events or death at any time up to Week 104

‡‡ 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).

  • Key inclusion and exclusion criteria

    INCLUSION CRITERIA1

    • Adult ≥18 years old
    • SLE clinically diagnosed by ACR criteria
    • Autoantibody-positive: ANA+ and/or positive anti-dsDNA
    • Active lupus nephritis: biopsy confirmed in past 6 months (Class III, IV, and/or V)
    • Clinically active renal disease at screening requiring induction therapy with CYC + high-dose steroids or MMF + high-dose steroids

    EXCLUSION CRITERIA1

    • On dialysis within the past year or eGFR <30 mL/min/1.76m2 at screening
    • Received induction therapy with cyclophosphamide within 3 months prior to induction therapy for BLISS-LN
    • Received B-cell targeted therapy (eg, rituximab) within the past year
    • Severe active CNS lupus requiring intervention within 60 days of baseline
    • Required management of acute or chronic infections within the past 60 days
    • Previous failures of both cyclophosphamide and MMF induction

    ACR = American College of Rheumatology; ANA = anti-nuclear antibodies; CNS = central nervous system; CYC = cyclophosphamide; MMF = mycophenolate mofetil; SLE = systemic lupus erythematosus.

Additional Data

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