Efficacy in Pediatric Patients With SLE

BENLYSTA IS THE FIRST AND ONLY TREATMENT APPROVED SPECIFICALLY FOR SLE IN CHILDREN 5 YEARS AND OLDER*The Pediatric Lupus Trial of BENLYSTA (PLUTO) is the first Phase II, double-blind, placebo-controlled trial in children and adolescents with active SLE.1

Icon: Disease Activity

Disease activity reduction (SRI-4) vs standard therapy (ST) alone at Week 52

Primary endpoint
Graph: PLUTO SRI-4 Response Rate Showed 53% BENLYSTA IV + ST and 44% Placebo + ST
Graph: PLUTO SRI-4 Response Rate Showed 53% BENLYSTA IV + ST and 44% Placebo + ST

Numerical Reduction

IV = intravenous; SRI = SLE Responder Index.

* The Pediatric Lupus Trial of BENLYSTA (PLUTO) trial was not powered to show a statistical difference between treatment groups.

  • 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 52.2

    Image: SRI-4
    SRI-4 Table

BENLYSTA REDUCED THE RISK OF SEVERE FLARE7Other secondary outcomes

Icon: Severe Flare
Icon: PLUTO Shows 62% Decrease
Icon: PLUTO Shows 62% Decrease

SELENA-SLEDAI = Safety of Estrogens in Lupus Erythematosus: National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index; ST = Standard therapy.

 

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.

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

  • DEFINITION OF SEVERE FLARE

    Severe flares were defined as at least one of the following:8

    • 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.

  • PLUTO STUDY DESIGN

    BENLYSTA pediatric trial information1

    STUDY PARAMETERS

    PLUTO trial (pediatric)

    Pluto Table 2

    †† BENLYSTA administered subcutaneously is only approved in patients 18 years and older.

    PLUTO KEY INCLUSION CRITERIA

    • Patients were aged 5-17 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

    ACR = American College of Rheumatology; SELENA-SLEDAI = Safety of Estrogens in Lupus Erythematosus: National Assessment version of the Systemic Lupus

    Erythematosus Disease Activity Index; ANA = antinuclear antibody; NSAID = non-steroidal anti-inflammatory drug; CVA = cerebrovascular accident; CNS = central nervous system.

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

    PLUTO KEY EXCLUSION CRITERIA

    • 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

    Use of BENLYSTA is not recommended in these situations.

Consider BENLYSTA for your pediatric patients with lupus