Established Efficacy in Patients with SLE

BENLYSTA IS THE FIRST BIOLOGIC APPROVED TO TREAT CLINICAL MANIFESTATIONS OF SLE WHEN ADDED TO STANDARD THERAPY  

Icon: Disease Activity

Superior disease activity reduction (SRI-4) vs standard therapy (ST) alone at Week 521-3

Primary endpoint
Graph: BLISS-SC SRI-4 Response Rate Shows 61% BENLYSTA + ST and 48% Placebo + ST.  BLISS-52 SRI-4 Response Rate Shows 58% BENLYSTA + ST and 44% Placebo + ST. BLISS-76 SRI-4 Response Rate Shows 43% BENLYSTA + ST and 34% Placebo + ST
Graph: BLISS-SC SRI-4 Response Rate Shows 61% BENLYSTA + ST and 48% Placebo + ST
Graph: BLISS-52 SRI-4 Response Rate Shows 58% BENLYSTA + ST and 44% Placebo + ST
Graph: BLISS-76 SRI-4 Response Rate Shows 43% BENLYSTA + ST and 34% Placebo + ST

SRI-4 achieved significant improvement

These reductions were primarily related to improvements in the mucocutaneous, musculoskeletal, and immunologic organ domains.

SRI = SLE Responder Index; SC = subcutaneous.

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

  • SLE RESPONDER INDEX (SRI-4):

    DESIGNED TO MEASURE RESPONSE TO LUPUS TREATMENT

    The SRI-4 is a combined clinical endpoint used in lupus trials

    The SRI-4 incorporates three assessment measures – to be considered a responder, patients must meet all 3 components.

    The primary endpoint, SRI-4, was defined as ≥4-point reduction in SELENA-SLEDAI score, and no new BILAG A or 2 new BILAG B organ domain scores, and <0.30-point increase in PGA score at Week 52.4

    Image: SRI-4
    SRI-4 Table

BENLYSTA REDUCED THE RISK OF SEVERE FLARE1-3Other secondary outcomes

Icon: Severe Flare
Icon: Reduction in Severe Flares Shows 49% for Bliss SC, 43% for Bliss 52, 28% for Bliss 76
Icon: Reduction in Severe Flares Shows 49% for Bliss SC, 43% for Bliss 52, 28% for Bliss 76

† As measured by the SELENA-SLEDAI Flare Index, 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.

  • DEFINITION OF SEVERE FLARE

    Severe flares were defined as at least one of the following:9

    • Hospitalization for SLE activity
    • New/worse (requiring doubling of prednisone, or prednisone increase to >0.5 mg/kg/day, or hospitalization) for at least one of the following:
      • CNS SLE
      • Vasculitis
      • Nephritis
      • Myositis
      • Platelets <60,000
      • Hemolytic anemia (Hb <7 g/dL or decrease in Hb >3 g/dL)
    • Increase in prednisone dose to >0.5 mg/kg/day, or
    • New immunosuppressant, or
    • Increase in PGA score to >2.5, or
    • Change in SELENA-SLEDAI to >12** accompanied by at least one of the items above

    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.

    ¶ As defined by a modified SELENA-SLEDAI Flare Index.

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

BENLYSTA REDUCED STEROID DOSE OVER TIME (40–52 WEEKS)1-3††Other secondary outcomes % of patients with a ≥25% reduction in steroid dose to ≤7.5 mg/day at Week 52‡‡

Icon: Steroid Dose
Adult SLE Chart
Adult SLE Chart

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.

  • BLISS-SC, BLISS-52, and BLISS-76 study designs

    Phase III trials in adults were randomized, double-blind, and placebo-controlled, and assessed intravenous and subcutaneous methods of administration1-3

    SRI-4 Table

    KEY INCLUSION CRITERIA1-3

    • Patients were ≥18 years of age
    • 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)
      • SELENA-SLEDAI score ≥6 (BLISS-52 and BLISS-76)

    KEY EXCLUSION CRITERIA10

    • 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

    ACR = American College of Rheumatology; ANA = antinuclear antibody; NSAID = non-steroidal anti-inflammatory drug; SELENA-SLEDAI = Safety of Estrogens in Lupus Erythematosus: National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index; CVA = cerebrovascular accident; CNS = central nervous system.

    §§ Not an approved dose.

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

Learn more about BENLYSTA for the treatment of patients with lupus nephritis.

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Learn about BENLYSTA and organ damage progression.

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Consider the efficacy of BENLYSTA when prescribing for your patients with SLE.