Up to

61%

of patients had reduced disease activity (SRI-4) at Week 521-3*

of patients had reduced disease activity (SRI-4) at Week 521-3*

SEE SRI-4 DATA

Patients had up to

60%

improvement in skin, joints, and kidneys at Week 524†

SEE ORGAN DOMAIN DATA

Real-world data

86%

of patients reduced or discontinued steroids at Week 267‡

of patients reduced or discontinued steroids at Week 267‡

SEE STEROID DATA

* SRI-4 response rate at Week 52 (primary endpoint).

* SRI-4 response rate at Week 52 (primary endpoint).

† Improvement in organ domain, as defined by SELENA-SLEDAI, at Week 52 among patients with organ involvement at baseline. Studies were designed to evaluate efficacy in overall disease activity and were not powered to evaluate efficacy in specific organ domains.

‡ Reasons for change in steroid dose were not captured and may be unrelated to disease improvement/worsening.

A lupus patient

Which patients are appropriate for BENLYSTA?

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

BENLYSTA: PROVEN TO REDUCE DISEASE ACTIVITY

SRI-4 response rate at
Week 52 (primary endpoint)1-3*

Graph: SRI-4 response rate at Week 52 (primary endpoint)¹¯³*
Graph: SRI-4 response rate at Week 52 (primary endpoint)¹¯³*

In patients on placebo + ST, the SRI-4 response rate at Week 52 was 48%, 44%, and 34% for BLISS-SC (n=279), BLISS-52 (n=287), and BLISS-76 (n=275), respectively.

* In BLISS-76, the difference in SRI-4 response rates was not significantly different at Week 76 (secondary endpoint).

BLISS = Belimumab International SLE Study; SRI = SLE Responder Index; ST = standard therapy.

IMPROVEMENT IN
ORGAN DOMAINS4*†

In a post hoc, pooled analysis
involving 5 SLE studies‡

Icon: Skin

59%

of patients on BENLYSTA + ST had improvements in skin

(n=1585)

vs 49% of patients on
ST alone (n=1039)

Icon: Joints

60%

of patients on BENLYSTA + ST had improvements in joints

(n=1180)

vs 50% of patients on
ST alone (n=780)

Icon: Kidneys

53%

of patients on BENLYSTA + ST had improvements in kidneys

(n=319)

vs 40% of patients on
ST alone (n=223)

* Results are descriptive. See individual study design.

† Improvement in organ domain, as defined by SELENA-SLEDAI, at Week 52 among patients with organ involvement at baseline. Studies were designed to evaluate efficacy in overall disease activity and were not powered to evaluate efficacy in specific organ domains.

‡ Five randomized, controlled efficacy and safety studies included: BLISS-52, BLISS-76, NE Asia, BLISS-SC, and EMBRACE. The primary endpoint (SRI-4 at Week 52) was not met in EMBRACE.

BLISS = Belimumab International SLE Study; EMBRACE = Efficacy and Safety of Belimumab in Adult Subjects of Black Race; NE = Northeast; SELENA-SLEDAI = Safety of Estrogens in Lupus Erythematosus: National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index; SLE = systemic lupus erythematosus; SRI = SLE Responder Index; ST = standard therapy.

MORE PATIENTS
REDUCED DISEASE
ACTIVITY
VS ST ALONE
BY WEEK 84

SRI-4 response by visit*

Graph: Reduced disease activity (SRI-4) by visit

38%

of patients had
reduced disease
activity vs ST as
early as Week 8

Graph: Reduced disease activity (SRI-4) by visit

In a post hoc, pooled analysis involving 5 SLE studies.*†‡ Results are descriptive.
See individual study design.

* The same patient may not have responded
at each visit.

† Five randomized, controlled efficacy and safety studies included: BLISS-52, BLISS-76, NE Asia, BLISS-SC, EMBRACE. The primary endpoint (SRI-4 at Week 52) was not met in EMBRACE.

‡ Individual studies were not designed to establish onset of effect, and not all studies showed improvement at Week 8.

BLISS = Belimumab International SLE Study; EMBRACE = Efficacy and Safety of Belimumab in Adult Subjects of Black Race; NE = Northeast; SLE = systemic lupus erythematosus; SRI = SLE Responder Index; ST = standard therapy.

REDUCED DISEASE ACTIVITY OVER 7 YEARS5

In the US open-label long-term extension trial of patients receiving
BENLYSTA + ST

SRI-4 responders over 7 years

Graph: Reduced disease activity (SRI-4) over 7 years

76%

of patients achieved SRI-4 at Year 7

Graph: Reduced disease activity (SRI-4) over 7 years

Used with permission from Furie RA, et al. Arthritis Rheumatol. 2018;70(6):868-877.
© 2018 John Wiley and Sons.

79%
of patients did not have a severe flare during the 7-year follow-up (n/N=212/267)
of patients did not have a severe flare during the 7-year follow-up (n/N=212/267)

 

Results are descriptive. Other efficacy endpoints. Exploratory results should be interpreted with additional care. See study design for data limitations.

SRI = SLE Responder Index; ST = standard therapy.

BENLYSTA REDUCES DISEASE ACTIVITY WITH STEROIDS + ANTIMALARIAL6

SRI-4 response by baseline therapy6

Graph: Reduced disease activity (SRI-4) by visit

Did you know?

53%

of patients treated with BENLYSTA in three pivotal trials were not on an immunosuppressant1-3

Graph: Reduced disease activity (SRI-4) by visit

Results are descriptive. Post hoc, pooled analysis of BLISS-52 and BLISS-76. See study design and patient characteristics.

BLISS = Belimumab International SLE Study; SRI = SLE Responder Index.

POWERFUL PROTECTION AGAINST FLARES

BENLYSTA reduced the risk of severe flare1-3*†

Reduced risk of severe flare chart
Reduced risk of severe flare chart

* As measured by the SFI, modified to exclude the single criterion of increased SELENA-SLEDAI score to >12.

* As measured by the SFI, modified to exclude
the single criterion of increased SELENA-
SLEDAI score to >12.

† The incidence of severe flare over 52 weeks
was a secondary endpoint.

‡ Reduction of severe flare was not significant
in BLISS-76.

BLISS = Belimumab International SLE Study; CI = confidence interval; HR = hazard ratio; SELENA-SLEDAI = Safety of Estrogens in Lupus Erythematosus: National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index; SFI = SELENA-SLEDAI Flare Index; ST = standard therapy.

BENLYSTA: STEROID-SPARING EFFICACY

Across 3 pivotal studies:

Table: Reduction in steroid dose by ≥25% to ≤7.5 mg/day at Week 52
Table: Reduction in steroid dose by ≥25% to ≤7.5 mg/day at Week 52
Table: Reduction in steroid dose by ≥25% to ≤7.5 mg/day at Week 52
Table: Reduction in steroid dose by ≥25% to ≤7.5 mg/day at Week 52

There were no statistically significant differences between treatment groups in any trial.

* In patients who were receiving >7.5 mg/day at baseline. Overall, 60%, 69%, and 46% of patients were receiving doses >7.5 mg/day at baseline in BLISS-SC, BLISS-52, and BLISS-76, respectively.

† In BLISS-SC, BLISS-52, and BLISS-76, this was a secondary endpoint evaluating steroid dose reduction during Weeks 40-52.

BLISS = Belimumab International SLE Study; ST = standard therapy.

STEROID-SPARING EFFICACY IN A REAL-WORLD SETTING4,7*

AT WEEK 26

86%

OF PATIENTS REDUCED OR DISCONTINUED STEROIDS*

WITH A

MEAN REDUCTION IN DAILY DOSE* BY

58%

VS BASELINE

Table: Reduction in steroid dose by ≥25% to ≤7.5 mg/day at Week 52
Table: Reduction in steroid dose by ≥25% to ≤7.5 mg/day at Week 52

A real-world, observational cohort study. Results are descriptive. See study design for data limitations.

* Reasons for change in steroid dose were not captured and may be unrelated to disease improvement/worsening.

† Intent-to-treat (ITT) consisting of all patients enrolled at baseline followed through 24 months using the last observation carried forward (LOCF) method to account for patients who were lost to follow-up and/or discontinued BENLYSTA during follow-up.

THE MOST COMPREHENSIVE CLINICAL TRIAL
PROGRAM IN LUPUS TO DATE

Expand all       Collapse all

  • STUDY DESIGN FOR ADULT LUPUS TRIALS

    Study design

    Phase III trials in adults were randomized, double-blind, and placebo-controlled, and assessed intravenous and subcutaneous methods of administration

    Study design for adult lupus trials
    Study design for adult lupus trials
    KEY INCLUSION CRITERIA1-4,8
    • Patients were ≥18 years of age
    • Patients were self-identified as Black race (EMBRACE)
    • Patients were diagnosed with SLE according to the ACR criteria
    • Patients met ≥1 of the following:
      • ANA titer ≥1:80
      • Anti-dsDNA autoantibodies
        ≥30 IU/mL
    • Patients were receiving stable
      doses of any of the following,
      alone or in combination,
      for
      ≥30 days:
      • Antimalarial
      • Immunosuppressant
      • Corticosteroid
      • NSAID
    • Patients had active disease†
      • SELENA-SLEDAI score ≥8
        (BLISS-SC, EMBRACE, NE Asia)
      • SELENA-SLEDAI score ≥6
        (BLISS-52 and BLISS-76)
    KEY EXCLUSION CRITERIA1-4
    • Severe active lupus nephritis
      • Proteinuria >6 g over 24 hours
        or equivalent with spot urine protein:creatinine ratio
      • Serum creatinine >2.5 mg/dL
      • Required hemodialysis within
        90 days of study entry
      • Required high-dose prednisone
        (>100 mg/day) within 90 days of study entry
    • Severe active CNS lupus
      • Patient required therapeutic intervention for any of the following within 60 days of study entry:
    • Seizures, psychosis, organic brain syndrome, CVA, cerebritis, or CNS vasculitis
    • Use of other biologics or IV cyclophosphamide was not permitted

    * The 1-mg/kg dose is not recommended.

    † Can include clinical (eg, arthritis, rash, and hair
    loss) and serological (eg, decreased
    complement and anti-dsDNA) SLE manifestations.

    ACR = American College of Rheumatology; ANA = antinuclear antibody; anti-dsDNA = anti-double-stranded DNA; BLISS = Belimumab International SLE Study; CNS = central nervous system; CVA = cerebrovascular accident; EMBRACE = Efficacy and Safety of Belimumab in Adult Subjects of Black Race; IV = intravenous; NE = Northeast; NSAID = nonsteroidal anti-inflammatory drug; SELENA-SLEDAI = Safety of Estrogens in Lupus Erythematosus: National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index; SC = subcutaneous; SLE = systemic lupus erythematosus; ST = standard therapy.

  • DEFINITION OF PRIMARY ENDPOINT

    SRI-4 at Week 52

    To be considered a responder,
    patients must meet all three components:

    • SELENA-SLEDAI: ≥4-point reduction
    • BILAG: No new BILAG A or 2 new
      BILAG B organ domain scores
    • PGA: No worsening of
      ≥0.30 points

    BILAG = British Isles Lupus Assessment Group;
    PGA = Physician’s Global Assessment;
    SELENA-SLEDAI = Safety of
    Estrogens in Lupus Erythematosus: National Assessment version of the Systemic Lupus Erythematosus Disease Activity
    Index; SRI = SLE Responder Index.

  • DEFINITION OF SEVERE FLARE

    Using a modified SELENA-SLEDAI Flare Index, severe flares were defined as at least one of the following:10*

    • Hospitalization for SLE activity
    • New/worse (requiring doubling of prednisone, or prednisone
      increase to >0.5 mg/kg/day,
      or
      hospitalization):
      • CNS SLE
      • Vasculitis
      • Nephritis
      • Myositis
      • Platelets <60,000
      • Hemolytic anemia (Hb <7 g/dL
        or decrease in Hb of >3 g/dL)
    • Any manifestation that required
      an increase in prednisone to
      >0.5 mg/kg/day or initiation
      of a new immunosuppressant
    • Increase in PGA score to >2.5

    * The modified SELENA-SLEDAI excludes
    severe flares triggered only by an increase of
    the SELENA-SLEDAI score to >12.

    CNS = central nervous system; Hb =
    hemoglobin; PGA = Physician’s Global
    Assessment; SELENA-SLEDAI = Safety of
    Estrogens in Lupus Erythematosus: National
    Assessment version of the Systemic Lupus
    Erythematosus Disease Activity
    Index; SLE =
    systemic lupus erythematosus.

  • STUDY PARAMETERS FOR Be-SLE4

    Post hoc pooled analysis of 5 double-blind placebo-controlled studies evaluating BENLYSTA

    Comparison for all efficacy endpoints:

    • Pooled BENLYSTA (10 mg/kg IV + 200 mg SC) vs pooled placebo (IV + SC)
    ANALYSIS PARAMETERS
    Study Parameters for Be-SLE
    Study Parameters for Be-SLE
    KEY LIMITATIONS:
    KEY LIMITATIONS:
    • Post hoc analysis
    • Pooled dosage groups
    • Results not adjusted for multiple comparisons
    • Individual endpoints may not have been achieved in all clinical studies pooled for this analysis

    * The primary endpoint (SRI-4 at Week 52) was not met in EMBRACE.

    BLISS = Belimumab International SLE Study; IV = intravenous; EMBRACE = Efficacy and Safety of Belimumab in Adult Subjects of Black Race; NE = Northeast; SRI = SLE Responder Index; SC = subcutaneous.

  • STUDY DESIGN FOR BLISS-76 LTE5

    US patients who completed the BLISS-76 Phase III trial were eligible for the
    BLISS-76 LTE open-label trial

    TRIAL PARAMETERS
    Study Design for BLISS-76 LTE
    Study Design for BLISS-76 LTE
    KEY LIMITATIONS:
    KEY LIMITATIONS:
    • Open-label design with lack of comparator arm
    • Selection bias and responder bias may be present
    • Pooled dosage groups
    • Small group of patients at later time points

    * Patients who received placebo in BLISS-76 received 10 mg/kg BENLYSTA in the LTE study, and patients who received BENLYSTA continued to receive the same dose (1 or 10 mg/kg IV every 28 days) plus standard therapy. Following a
    protocol amendment in March 2011, patients receiving 1 mg/kg BENLYSTA had their dose increased to 10 mg/kg.

    AE = adverse event; AESI = adverse events of special interest; BLISS = Belimumab International SLE Study; IV = intravenous; LTE = long-term extension; SDI = SLICC/ACR Damage Index; SRI = SLE Responder Index; ST = standard therapy.

  • POST HOC ANALYSIS (BLISS-52 AND BLISS-76)6

    • Post hoc, pooled analysis of efficacy and safety data from patients who received BENLYSTA IV + ST vs placebo + ST in BLISS-52 and BLISS-76
    • The primary endpoint was the SRI response at Week 52 by baseline concomitant medication group at study baseline: steroid only, antimalarial only, steroids + antimalarial, steroids + antimalarial + immunosuppressant
    • Analysis based on baseline use of concomitant medications
    • Antimalarial could be increased or added up to Week 16
    • Immunosuppressants could be modified up to Week 16 but with no new additions
    • Steroids could increase/add new up to Week 24 and changes within 25% or 5 mg more than baseline between Weeks 24-44 (in the BLISS studies; therefore, the subgroup classifications may not be fully reflective of concomitant standard therapy received throughout the entirety of the trial)
    KEY DATA LIMITATIONS:
    KEY DATA LIMITATIONS:
    • Not powered to detect differences between treatment groups
    • Potential imbalance between groups in baseline characteristics
    • No adjustments for multiplicity
    BASELINE CHARACTERISTICS6
    Study Design for BLISS-76 LTE
    Study Design for BLISS-76 LTE

    anti-dsDNA = anti-double-stranded DNA; BILAG = British Isles Lupus Assessment Group; BLISS = Belimumab International SLE Study; PGA = Physician’s Global Assessment; SD = standard deviation; SELENA-SLEDAI = Safety of Estrogens in Lupus Erythematosus: National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index.

  • OBSErve US: STUDY DESIGN7

    An observational cohort study assessed the effectiveness of BENLYSTA 10 mg/kg + ST in adult patients with SLE over a 24-month period in US clinical practices across 27 states and included 92 rheumatologists (N=501). To qualify for enrollment, patients were required to have at least 8 infusions of BENLYSTA. The baseline was the date of first infusion. Physician-assessed clinical response was reviewed at 6-month intervals using medical charts and data collected using case report forms.

    Primary objective: Physician-assessed clinical response to BENLYSTA at 6 months. Between baseline and Month 6, ≥50% improvement in overall clinical response was reported for 48.7% of participants.

    Selected other objective: Changes in steroid use at 6-month intervals over a 24-month period.

    Study discontinuation: During the 2-year observation, 45% (n=224) were lost to follow-up or discontinued use of BENLYSTA. Common reasons for discontinuing BENLYSTA (n=122; 22.5%) include: patient request (40.2%), medication not effective (29.5%), and adverse event (12.5%).

    KEY DATA LIMITATIONS:
    KEY DATA LIMITATIONS:
    • Lack of control group
    • Risk of selection bias
    • Validated disease assessment tool not consistently used
    • Patient attrition
    • Potential measurement error based on non-uniform categorization or interpretation of disease severity and treatment response
    • Reasons for change in steroid dose were not captured and may be unrelated to disease improvement/worsening

    SLE = systemic lupus erythematosus; ST = standard therapy.

LEARN MORE

Identifying the BENLYSTA patient Patient profiles to help you determine
which of your patients could benefit
from BENLYSTA.

Safety profile Well-established safety in lupus and
lupus nephritis.

Choose BENLYSTA now for your
patients
with lupus

Patient crossing her arms #2