Improved key clinical outcomes in pediatric lupus1

BENLYSTA reduced disease activity and the risk of severe flare in pediatric patients with lupus aged 5 years and older.

53

%

of patients had reduced disease activity (SRI-4) at Week 521 (Primary endpoint, numerical reduction)

See disease activity data

See disease activity data

64

%

reduction in risk of severe flare1
(HR=0.36; 95% CI: 0.15, 0.86)
(Other efficacy endpoint, numerical reduction)

See flare data

BENLYSTA: reduced disease activity in pediatric patients with lupus1

BENLYSTA: reduced disease activity in pediatric patients with lupus1

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

Bar graph: SRI-4 Response rate at Week 52 (primary endpoint) PLUTO
Bar graph: SRI-4 Response rate at Week 52 (primary endpoint) PLUTO

In patients on placebo + ST (n=40), the SRI-4 response rate at Week 52 was 44%.

* The PLUTO trial was not powered to show a statistical difference between treatment groups.

PLUTO = Pediatric Lupus Trial of BENLYSTA; SRI = SLE Responder Index; ST = standard therapy.

BENLYSTA reduced the risk of severe flare1*†

64

%

reduction in risk of severe flare1

(HR=0.36‡; 95% CI: 0.15, 0.86)

Numerical reduction

In patients on BENLYSTA + ST (n=53), 17% had ≥1 severe flare over 52 weeks, vs patients on placebo + ST (n=40), 35% had ≥1 severe flare over 52 weeks.

* 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 an other efficacy endpoint.

‡ The PLUTO trial was not powered to show a statistical difference between treatment groups.

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.

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  • Study design for the PLUTO trial

    Study design

    PLUTO is the first 52-week Phase II, double-blind, placebo-controlled trial in children and adolescents with active lupus, evaluating the efficacy, safety, and pharmacokinetics of BENLYSTA.1

    Treatment arms

    • BENLYSTA IV 10 mg/kg + ST (n=53)
    • Placebo + ST (n=40)     

    Primary endpoint

    • Disease activity reduction as measured by SRI-4 at Week 52

    Key inclusion criteria1,2

    • Patients were aged 5 to 17 years
    • Patients were diagnosed with SLE according to the ACR criteria
    • Patients had active disease*
      • SELENA-SLEDAI score ≥6 
    • 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
      • NSAID
      • Corticosteroids

    Key exclusion criteria1,2

    • Severe active CNS lupus
      • Patients required therapeutic intervention for any of the following CNS lupus symptoms within 60 days of study entry: seizures, psychosis, organic brain syndrome, CVA, cerebritis, or CNS vasculitis
    • Severe lupus kidney disease
    • Previous treatment with belimumab at any time
    • Treatment with B-cell–targeted therapy in the past year
    • Received high-dose prednisone or equivalent (>1.5 mg/kg/day) or IV cyclophosphamide or new immunosuppressive/ immunomodulatory or antimalarial agent within the past 60 days
    • Received high-dose prednisone or equivalent (>1.5 mg/kg/day) or IV cyclophosphamide or new immunosuppressive/immunomodulatory or antimalarial agent within the past 60 days

    * Can include clinical (eg, arthritis, rash, 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; CNS = central nervous system; CVA = cerebrovascular accident; IV = intravenous; NSAID = nonsteroidal anti-inflammatory drug; SLE = systemic lupus erythematosus; SRI = SLE Responder Index.

  • Definition of primary endpoint

    SRI-4 at Week 52 (primary endpoint)1

    To be considered a responder, patients must meet all 3 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.

  • Definition of severe flare

    Using a modified SELENA-SLEDAI Flare Index, severe flares were defined as at least one of the following3*:

    • 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.

    Hb = hemoglobin.

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BENLYSTA Autoinjector

This option with at-home convenience is available for adult patients with lupus or lupus nephritis.

Find out more

Safety profile

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

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Choose BENLYSTA now for your
pediatric patients with lupus

Choose BENLYSTA now for your pediatric patients with lupus