74%

more likely to achieve complete renal response1,2*

OR=1.74 (95% CI: 1.11,
2.74)

 

 

SEE CRR DATA

49%

reduced risk of renal-related events or death1,2†

HR=0.51 (95% CI: 0.34,
0.77)

 

 

SEE RENAL-RELATED
EVENT DATA

63%

less eGFR loss over time with BENLYSTA3‡

3.61 eGFR slope difference vs ST alone
(95% CI: 0.15, 7.06)

Post hoc analysis. Results are descriptive.

SEE eGFR DATA

* Complete Renal Response (CRR) at Week 104: BENLYSTA + ST (n=223) = 30%, placebo + ST (n=223) = 20%.

† Proportion of patients experiencing a renal-related event or death: BENLYSTA + ST (n=223) = 16%, placebo + ST (n=223) = 28%.

‡ eGFR slope (mL/min/1.73 m2)/year from Week 24 to 104: BENLYSTA + ST (n=223) = -2.12, placebo + ST (n=223) = -5.72.

A lupus nephritis patient

See the patients with lupus nephritis who could benefit from BENLYSTA§

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§ Hypothetical patient profile. May not be representative of all patients.

SIGNIFICANTLY MORE PATIENTS ACHIEVED
RENAL RESPONSE AND COMPLETE RENAL
RESPONSE AT WEEK 1041

Greater odds of achieving response1,2

Greater odds of achieving response¹˒² chart

Renal response
Week 104
(Primary endpoint)
P=0.0311

Complete renal response
Week 104
(Secondary endpoint)
P=0.0167

Greater odds of achieving response¹˒² chart
Greater odds of achieving response¹˒² chart

Renal response

Week 104
(Primary endpoint)
P=0.0311

Greater odds of achieving response¹˒² chart
Greater odds of achieving response¹˒² chart

Complete renal response

Week 104
(Secondary endpoint)
P=0.0167

Greater odds of achieving response¹˒² chart

CI = confidence interval; IV = intravenous;
OR = odds ratio; ST = standard therapy.

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  • RENAL RESPONSE OVER 104 WEEKS

    Observed treatment differences as early as Week 24

    RENAL RESPONSE BY VISIT2*

    Observed treatment differences in renal response as early as Week 24 chart

    * RR analysis by visit is descriptive. The
    same patient may not have responded at
    each time point.

    eGFR = estimated glomerular filtration rate;
    IV = intravenous; RR = renal response; SE =
    standard error; ST = standard
    therapy.

  • COMPLETE RENAL RESPONSE OVER 104 WEEKS

    CRR: a more stringent measure of kidney function

    COMPLETE RENAL RESPONSE BY VISIT2*

    Complete renal response by visit²*chart

    From N Engl J Med, Furie R, et al., 2020;383:1117-1128. ©2020 Massachusetts Medical Society. Reprinted with permission
    from Massachusetts Medical Society.

    * CRR analysis by visit is descriptive. The
    same patient may not have responded at
    each time point.

    CRR = complete renal response; IV =
    intravenous; SE = standard error; ST =
    standard therapy.

  • MAINTAINED RESPONSE

    Patients on BENLYSTA had a

    46%

    increased likelihood of achieving RR that was maintained
    to Week 1041*

    HR=1.46 (95% CI: 1.07, 1.98)

    More patients on BENLYSTA + ST (n=223) vs placebo + ST (n=223)
    achieved RR at Week 104; 43% vs 32%, respectively.

     

     

    Patients on BENLYSTA had a

    58%

    increased likelihood of achieving CRR that was maintained
    to Week 1041*

    HR=1.58 (95% CI: 1.08, 2.31)

    More patients on BENLYSTA + ST (n=223) vs placebo + ST (n=223)
    achieved CRR at Week 104; 30% vs 20%, respectively.

     

    * Results are descriptive. Other pre-specified endpoint.

    CI = confidence interval; CRR = complete renal response; HR = hazard ratio; RR = renal response.

STEROID-SPARING EFFICACY FOR PATIENTS
WITH LUPUS NEPHRITIS2

Oral steroids icon

41%

of patients reduced their steroid dose
to ≤7.5 mg/day at Week 104

Results are descriptive. Other efficacy endpoint.

Results are descriptive. Other efficacy endpoint.

In patients on BENLYSTA + ST (n=223), 41% reduced their steroid dose to ≤7.5 mg/day at Week 104,
vs in patients on placebo + ST (n=223), 30% reduced their steroid dose to ≤7.5 mg/day at Week 104.

SIGNIFICANTLY REDUCED RISK OF RENAL-RELATED EVENTS OR DEATH BY APPROXIMATELY HALF1,2||

Percentage of patients with renal-related event infographic

Time to renal-related event or death was defined as first instance of ESKD, doubling of serum creatinine, renal worsening (increased proteinuria and/or impaired renal function), renal disease-related treatment failure, or death occurring after Day 1.

|| When excluding deaths (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).

CI = confidence interval; ESKD = end-stage
kidney disease; HR = hazard ratio;
ST = standard therapy.

PRESERVATION OF KIDNEY FUNCTION3

 

Reduced the risk of renal flare icon

BENLYSTA REDUCED THE RISK OF RENAL FLARE

55%

reduction in risk of renal flares

HR=0.45 (95% CI: 0.28, 0.72)

 

In patients treated with BENLYSTA + ST, 14% (28/194) had ≥1 renal flare from Week 24 to 104; in patients treated with placebo + ST, 26% (51/196) had ≥1 renal flare from Week 24 to 104.

Kidneys icon

BENLYSTA REDUCED eGFR LOSS3

63%

less eGFR loss over time

(3.61 eGFR slope difference vs ST alone; 95% CI: 0.15, 7.06)

(3.61 eGFR slope difference vs ST alone; 95% CI: 0.15, 7.06)

In patients treated with BENLYSTA + ST (n=223), the eGFR slope (mL/min/1.73 m2/year) was -2.12; in
patients treated with placebo + ST (n=223), the eGFR
slope was -5.72 from Week 24 to 104.#

Post hoc analysis. Results are descriptive.

Renal flares were defined as impaired kidney function accompanied by proteinuria and/or cellular casts, increase in proteinuria compared with Week 24, or treatment failure due to kidney disease-related intake of prohibited medications.

# On study population: includes all available data for patients on treatment at Week 24 inclusive of those who discontinued treatment but remained enrolled.

CI = confidence interval; eGFR = estimated glomerular filtration rate; HR = hazard ratio; ST = standard therapy.

BLISS-LN: THE LARGEST AND LONGEST TRIAL OF A BIOLOGIC IN LUPUS NEPHRITIS2

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  • STUDY DESIGN

    Study design

    BLISS-LN was a Phase III study of
    448 adult patients with active lupus nephritis* who were randomized to:

    • BENLYSTA + ST
    • OR
    • Placebo + ST

    BENLYSTA 10 mg/kg or placebo was administered by IV infusion on Days
    0, 14, and 28, and at 4-week intervals thereafter through Week 104.

    Standard therapy (ST) was defined as:

    • MMF + high-dose steroids,
      followed by MMF + low-dose
      steroids
    • OR
    • CYC + high-dose steroids,
      followed by AZA + low-dose
      steroids

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

    AZA = azathioprine; BLISS-LN = Belimumab International Study in Lupus Nephritis; CYC = cyclophosphamide; IV =
    intravenous; MMF = mycophenolate mofetil; ST = standard therapy.

Important icon

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

  • BLISS-LN PRIMARY AND SECONDARY ENDPOINTS

    Analysis of the primary and secondary endpoints was performed in a hierarchical manner –
    if at any point statistical significance was not met, subsequent endpoints could not be
    considered significant.1

    PRIMARY ENDPOINT1

    Renal Response (RR) at Week 104*
    eGFR ≥60 mL/min/1.73 m2 or eGFR
    no worse than 20% below the pre-
    flare value; and uPCR ≤0.7; and not a treatment failure.†    eGFR ≥60 mL/min/1.73 m2 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 ENDPOINTS1

    Complete Renal Response (CRR) at Week 104
    eGFR ≥90 mL/min/1.73 m2 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/1.73 m2 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.‡

    * RR is equivalent to PERR (primary efficacy renal response).

    † Treatment failures were defined as patients who received prohibited medications. For these endpoints, in order to be considered a responder, steroid dose had to be reduced to ≤10 mg/day from Week 24.

    ‡ Treatment failures were defined as patients who received prohibited therapy due to inadequate lupus nephritis control or renal flare management.

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

  • KEY INCLUSION AND EXCLUSION CRITERIA

    INCLUSION CRITERIA:2
    • 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 CRITERIA:2
    • On dialysis within the past year or eGFR <30 mL/min/1.76 m2 at screening
    • Received induction therapy with CYC 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 CYC and MMF induction

    ACR = American College of Rheumatology; ANA = anti-nuclear antibody; anti-dsDNA = anti-double-stranded DNA; CNS = central nervous system; CYC = cyclophosphamide; eGFR = estimated glomerular filtration rate; MMF = mycophenolate mofetil; SLE = systemic lupus erythematosus.

LEARN MORE

How BENLYSTA works Discover the mechanism of action of BENLYSTA, designed to target BLyS, an underlying cause of lupus.

Safety profile Well-established safety based on the
largest clinical trial program in lupus and
lupus nephritis.

Choose BENLYSTA now for your patients 
with lupus nephritis

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