For patients with lupus nephritis, add BENLYSTA as part of initial therapy

See the effect of BENLYSTA + ST vs placebo + ST on renal response at Week 104.

See pivotal trial data

For patients with lupus nephritis, add BENLYSTA as part of initial therapy

See the effect of BENLYSTA + ST vs placebo + ST on renal response at Week 104.

See pivotal trial data

74%

more likely to achieve complete renal response (renal remission) with BENLYSTA1,2*

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

Renal remission is defined here as complete renal response (CRR) and was a secondary endpoint in the 104-week BLISS-LN study.

See renal remission data

55%

reduction in risk of renal flares3†

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

Post hoc analysis. Results are descriptive.

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.

See flares data

63%

less eGFR loss over time

3.61 eGFR slope difference vs ST alone3‡
(95% CI: 0.15, 7.06)

Post hoc analysis. Results are descriptive.

In patients treated with BENLYSTA + ST (n=196), the eGFR slope (mL/min/1.73 m2/year) was -2.12; in patients treated with placebo + ST (n=198), the eGFR slope was -5.72 from Week 24 to 104.‡

See eGFR data

* Complete renal response (renal remission) at Week 104: BENLYSTA + ST (n=223) = 30%; placebo + ST (n=223) = 20%.1,2

† 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.3

‡ On-study population: includes all available data for patients on treatment at Week 24 inclusive of those who discontinued treatment but remained enrolled.3

BLISS-LN = Belimumab International Study in Lupus Nephritis; CI = confidence interval; CRR = complete renal response; eGFR = estimated glomerular filtration rate; HR = hazard ratio; OR = odds ratio; ST = standard therapy.

Study design

Study design

Renal response

Renal remission

Preservation of kidney function

Steroid sparing

Renal-related events

Study design

Renal response

Renal remission

Preservation of kidney function

Steroid sparing

Renal-related events

Significantly more patients achieved renal response at Week 1041,2*

Greater odds of achieving response1,2

Greater odds of achieving response¹˒² graph
Greater odds of achieving response¹˒² graph

Renal response

Week 104

(Primary endpoint)

P=0.0311

Greater odds of achieving response¹˒² graph
Greater odds of achieving response¹˒² graph

* Results from the modified intention-to-treat population.
IV = intravenous.

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  • Renal response over 104 weeks

    Observed treatment differences as early as Week 241,2Renal response by visit1,2*

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

    From Furie R, et al. N Engl J Med. 2020;383(12):1117-1128. ©2020 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.

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

    RR = renal response; SE = standard error.

  • 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.

    * Results are descriptive. Other pre-specified endpoint.

    CI = confidence interval; HR = hazard ratio; RR = renal response; ST = standard therapy.

Significantly more patients achieved renal remission (CRR) at Week 1041,2*

In the BLISS-LN study, patients with Class III lupus nephritis treated with MMF or CYC were 74% more likely to achieve complete renal response (renal remission) at Week 104.

Complete renal response by visit²* graph
Complete renal response by visit²* graph

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

From Furie R, et al. N Engl J Med. 2020;383(12):1117-1128. ©2020 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.

  • Maintained renal remission response

    Patients on BENLYSTA had a
    58% increased likelihood of achieving complete renal response (renal remission) 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; ST = standard therapy.

The EULAR 2023 management of SLE recommendations and the 2024 KDIGO lupus nephritis treatment guidelines noted the findings from the secondary post hoc analysis of the BLISS-LN trial and the effect of BENLYSTA in the subgroup of patients with baseline proteinuria below 3 g/day.3-5

Complete renal response (renal remission) rates over 104 weeks by induction regimen and baseline uPCR level (mITT population)2*

Complete renal response (renal remisson) rates over 104 weeks (mITT population)* graph
Complete renal response (renal remisson) rates over 104 weeks (mITT population)* graph

Post hoc analysis by visit is descriptive. The same patient may not have responded at each time point.
Caution should be used when interpreting the data due to limitations such as small sample size and no adjustments for multiplicity.
The mITT subpopulation from the BLISS-LN trial was analyzed based on current treatment guidelines and expert opinion.3,4

  MMF CYC
  <3 g/g ≥3 g/g <3 g/g ≥3 g/g
BENLYSTA IV + ST 43.0% (n=100) 20.3% (n=64) 25.0% (n=32) 11.1% (n=27)
Placebo + ST 22.4% (n=98) 16.7% (n=66) 21.2% (n=33) 15.4% (n=26)

 

Post hoc analysis by visit is descriptive. The same patient may not have responded at each time point. Caution should be used when interpreting the data due to limitations such as small sample size and no adjustments for multiplicity. The mITT subpopulation from the BLISS-LN trial was analyzed based on current treatment guidelines and expert opinion.3,4

  MMF
  <3 g/g ≥3 g/g
BENLYSTA IV + ST 43.0% (n=100) 20.3% (n=64)
Placebo + ST 22.4% (n=98) 16.7% (n=66)
  CYC
  <3 g/g ≥3 g/g
BENLYSTA IV + ST 25.0% (n=32) 11.1% (n=27)
Placebo + ST 21.2% (n=33) 15.4% (n=26)

* Complete renal response at Week 104 was a secondary endpoint and was defined as eGFR ≥90 mL/min/1.73 m2 or eGFR no worse than 10% below the preflare value; and uPCR <0.5; and not a treatment failure.1

CYC = cyclophosphamide; EULAR = European Alliance of Associations for Rheumatology; KDIGO = Kidney Disease Improving Global Outcomes; mITT = modified intention-to-treat; MMF = mycophenolate mofetil; SLE = systemic lupus erythematosus; uPCR = urine protein:creatinine ratio.

BENLYSTA: preservation of kidney function3

Icon: Flame

Just one renal flare could shorten a kidney’s life span by decades6-8

BENLYSTA reduced the risk of renal flare3*

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.

BENLYSTA reduced
eGFR loss3

63%

less eGFR loss over time

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

In patients treated with BENLYSTA + ST (n=196), the eGFR slope (mL/min/1.73 m2/year) was -2.12; in patients treated with placebo + ST (n=198), 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.3

† On-study population: includes all available data for patients on treatment at Week 24 inclusive of those who discontinued treatment but remained enrolled.3

BENLYSTA: steroid-sparing efficacy results for patients with lupus nephritis2

37%

of patients reduced their steroid dose to ≤5 mg/day at Week 104*

51%

more likely to reduce steroid
dose to ≤5 mg/day

(OR: 1.51; 95% CI: 1.01, 2.27)

Results are descriptive. Other efficacy endpoint.

* 37% of patients on BENLYSTA + ST (n=223) vs 28% of patients on placebo + ST (n=223) had ≤5 mg average daily steroid dose at Week 104.

Significantly reduced risk of renal-related events or death by approximately half1,2*

Percentage of patients with renal-related event infographic
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, 0.77).2

ESKD = end-stage kidney disease.

Icon: checkmark

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

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.

  • 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 preflare 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.

    Patients who discontinued BENLYSTA or placebo, had treatment failure, or withdrew from the trial were counted as not having had a response.

    Secondary endpoints1 
    Complete renal response (renal remission) at Week 104
    eGFR ≥90 mL/min/1.73 m2 or eGFR no worse than 10% below the preflare 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 preflare 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.‡

    Other endpoint
    Steroid use2
    Daily steroid use was converted to a prednisone-equivalent dose.

    * 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 24.1

    ‡ Treatment failures were defined as patients who received prohibited therapy due to inadequate lupus nephritis control or renal flare management.1

    BLISS-LN = Belimumab International Study in Lupus Nephritis; eGFR = estimated glomerular filtration rate; ESKD = end-stage kidney disease; uPCR = urine protein:creatinine ratio.

  • Key inclusion and exclusion criteria

    Inclusion criteria2

    • Adult ≥18 years old
    • SLE clinically diagnosed by ACR criteria
    • Autoantibody test: ANA+ and/or positive anti-dsDNA 
    • Active lupus nephritis: biopsy confirmed in the 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 criteria2

    • On dialysis within the past year or eGFR <30 mL/min/1.76 m2 at screening
    • Previous failures of both CYC and MMF induction
    • Received induction therapy with CYC within 3 months prior to induction therapy for BLISS-LN
    • Received B-cell–targeted therapy (eg, rituximab) 1 year before randomization
    • Severe active CNS lupus requiring intervention within 60 days of baseline
    • Required management of acute or chronic infections within 60 days of baseline 

    ACR = American College of Rheumatology; ANA = antinuclear antibodies; anti-dsDNA = anti-double–stranded DNA; BLISS-LN = Belimumab International Study in Lupus Nephritis; CNS = central nervous system; CYC = cyclophosphamide; eGFR = estimated glomerular filtration rate; MMF = mycophenolate mofetil; SLE = systemic lupus erythematosus.

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Real-world evidence

See the effect of BENLYSTA on organ damage progression.

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Safety profile

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

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Add BENLYSTA as part of initial and maintenance therapy for your patients with lupus nephritis

Add BENLYSTA as part of initial and maintenance therapy for your patients with lupus nephritis