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Benlysta is the only SLE treatment that met its primary endpoint in 4 pivotal clinical trials 1-4

The primary endpoint across trials was the SLE Responder Index (SRI-4), measured at 52 weeks.

All 4 studies were randomised, double-blind and placebo-controlled.

  • BLISS-SC [1] [5] [6]

    Treatment arms

    • BENLYSTA SC 200 mg + standard therapy (n=556)
    • Control arm: standard therapy + placebo (n=280)

    Regions

    177 centres throughout North America, South America, Europe, and Asia

  • BLISS-52 [2] [5] [6]

    Treatment arms

    • Experimental arm 1: BENLYSTA IV 1 mg/kg* + standard therapy (n=288)
    • Experimental arm 2: BENLYSTA IV 10 mg/kg + standard therapy (n=290)
    • Control arm: standard therapy + placebo (n=287)

    Regions

    90 centres throughout South America, Asia, Eastern Europe, and Australia

  • BLISS-76 [3] [5] [6]

    Treatment arms

    • Experimental arm 1: Benlysta IV 1 mg/kg* + standard therapy (n=271)
    • Experimental arm 2: Benlysta IV 10 mg/kg + standard therapy (n=273)
    • Control arm: standard therapy + placebo (n=275)

    Regions

    136 centres throughout North America and Europe

  • NE Asia [4]

    Treatment arms

    • Benlysta IV 10 mg/kg + standard therapy (n=451)
    • Control arm: standard therapy + placebo (n=226)

    Regions

    49 centres throughout China, Japan, and South Korea

SC = subcutaneous; IV = intravenous
* The 1-mg/kg dose is not recommended.

 

Inclusion criteria 1-4

In the Phase III clinical trials for Benlysta, patients:

  • Were ≥18 years of age
  • Were diagnosed with SLE according to the American College of Rheumatology criteria
  • Met ≥1 of the following:
    • ANA titre ≥1:80
    • Anti-dsDNA autoantibodies ≥30 IU/mL
  • Were receiving stable doses of any of the following, alone or in combination, for ≥30 days:
    • Antimalarial
    • Immunosuppressant
    • Corticosteroid
    • NSAID
  • Had active disease, including clinical (e.g., arthritis, rash, hair loss) or serological (e.g., decreased complement and anti-dsDNA) SLE manifestations:
    • SELENA-SLEDAI score ≥8 (BLISS-SC and NE Asia)
    • SELENA-SLEDAI score ≥6 (BLISS-52 and BLISS-76)

SLE patients with non-severe, active renal involvement (i.e., proteinuria <6 g/24 hours) were included in the BLISS trials.5 6

NSAID = nonsteroidal anti-inflammatory drug; dsDNA = double-stranded DNA; SELENA-SLEDAI = Safety of Estrogens in Lupus Erythematosus: National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index

Exclusion criteria 1-4

Patients were excluded from the Phase III clinical trials if they had:

  • Severe active lupus nephritis
    • Proteinuria >6 g over 24 hours or equivalent with spot urine protein:creatinine ratio (severe active lupus nephritis)
    • Serum creatinine >2.5 mg/dL
    • Required haemodialysis 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
  • Previous treatment
    • Any B-lymphocyte-targeted drug (including rituximab)
    • Intravenous cyclophosphamide within 6 months of enrolment, and
    • Intravenous immunoglobin or prednisone (>100 mg/day) within 3 months

Use of other biologics or IV cyclophosphamide was not permitted.
Use of Benlysta is not recommended in these situations.

CVA = cerebrovascular accident; CNS = central nervous system

Permitted changes to standard therapy in BENLYSTA’s clinical trials 2 3

* Prednisone or prednisone equivalent.
† At Week 24, daily corticosteroid dose (sum of all corticosteroid doses over 7 consecutive days divided by 7).
‡ Within 8 weeks before Week 52, daily corticosteroid dose could not be increased beyond the dose at Week 44 or at baseline, whichever was higher.

 

SRI-4: A composite measure designed for lupus

The SRI-4 is a validated, combined clinical endpoint mostly used in lupus clinical trials. It incorporates three assessment measures.7

In clinical trials, to be considered a responder, patients must meet ALL 3 components.5 6

SELENA-SLEDAI

  • Measurement: ≥4-point reduction
  • Rationale: Determines global improvement and measures disease activity

British Isles Lupus Assessment Group (BILAG)

  • Measurement: No new BILAG A or no more than 1 new BILAG B domain score
  • Rationale: Ensures no significant worsening in organ system involvement that wasn’t previously affected

Physician’s Global Assessment (PGA)

  • Measurement: No worsening of ≥0.3 points
  • Rationale: Ensures consistency with the physician’s personal evaluation

Paediatric study design

The safety profile and efficacy of Benlysta was evaluated in a randomised, double-blind, placebo-controlled study in paediatric patients (PLUTO). This trial was not powered to show a statistical difference between treatment groups.5 6 8 9

Primary endpoint

SRI-4 response rate at Week 52

Secondary endpoints

  • % PRINTO/ACR responders, two definitions, at Week 52
  • % change in cSLE core response variables* at Week 52
  • Sustained SRI-4 response at Weeks 44-52
  • Sustained ParentGA response at Weeks 44-52

PRINTO = Pediatric Rheumatology International Trials Organization; ACR = American College of Rheumatology; cSLE = childhood-onset SLE; ParentGA = Parent Global Assessment

* Core response variables included: ParentGA, PGA, SELENA-SLEDAI score, Pediatric Quality of Life Inventory (PedsQL) physical functioning domain, proteinuria.

See the long-term data for Benlysta

 
 

EXPLORE THE RESULTS

Learn about the efficacy of Benlysta

 
 

EXPLORE THE RESULTS

See the baseline characteristics of the study population

 
 

EXPLORE THE RESULTS

Resources for you and your patients

Dosing & Administration

Access & Support

Consider adding Benlysta for your appropriate patients with SLE
 
 

Benlysta IV:5

Indications:

BENLYSTA IV is indicated for reducing disease activity in patients aged 5 years and older with active autoantibody positive systemic lupus erythematosus (SLE) who are receiving standard therapy.

Dosage:

Adults
The recommended dosage regimen is 10 mg/kg on Days 0, 14 and 28, and at 4-week intervals thereafter.

Children
The recommended dosage regimen for children aged 5 years and older is 10 mg/kg on Days 0, 14 and 28, and at 4-week intervals thereafter.

Safety:

BENLYSTA is contraindicated in patients who have demonstrated anaphylaxis to BENLYSTA. BENLYSTA has not been studied in combination with other B cell targeted therapy or intravenous cyclophosphamide. Caution should be exercised if BENLYSTA is co-administered with other B cell targeted therapy or cyclophosphamide. Administration of BENLYSTA may result in infusion-related systemic reactions and hypersensitivity reactions, which can be severe or fatal. In the event of a severe reaction, BENLYSTA administration must be interrupted and appropriate medical therapy administered. Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk.

Adverse Events

Very common: Infections.
Common: Hypersensitivity reaction, Depression, Pyrexia, Infusion related systemic reactions.

Benlysta SC:6

Indications:

Benlysta is indicated as add-on therapy in adult patients with active, autoantibodypositive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy.

Dosage:

Adults:
The recommended dose is 200 mg once weekly, administered subcutaneously. Dosing is not based on weight.

Safety:

Benlysta is contraindicated in patients with Hypersensitivity to the active substance or to any of the excipients listed in Prescribing information.

In order to improve traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded. Benlysta has not been studied in the following patient groups and is not recommended in:

  • severe active central nervous system lupus
  • severe active lupus nephritis
  • HIV
  • a history of, or current, hepatitis B or C
  • hypogammaglobulinaemia (IgG <400 mg/dl) or IgA deficiency (IgA <10 mg/dl)
  • a history of major organ transplant or hematopoietic stem cell/marrow transplant or renal transplant.

References

  1. Stohl W, Schwarting A, Okada M, et al. Efficacy and safety of subcutaneous belimumab in systemic lupus erythematosus: a fifty-two-week randomized, double-blind, placebo-controlled study. Arthritis Rheumatol. 2017;69(5):1016-27.
  2. Navarra SV, Guzman RM, Gallacher AE, et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomized, placebo-controlled, phase 3 trial. Lancet. 2011;377(9767):721-31.
  3. Furie R, Petri M, Zamani O, et al. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum. 2011;63(12):3918-30.
  4. Zhang F, Bae SC, Bass D, et al. A pivotal phase III, randomised, placebo-controlled study of belimumab in patients with systemic lupus erythematosus located in China, Japan and South Korea. Ann Rheum Dis. 2018;77:355-63.
  5. Benlysta IV local prescribing information based on GDS 16.
  6. Benlysta SC local prescribing information based on EMA_CPA 0026.
  7. Furie RA, Petri MA, Wallace DJ, et al. Novel evidence-based systemic lupus erythematosus responder index. Arthritis Rheum. 2009;61(9):1143-51.
  8. Brunner HI, Abud-Mendoza C, Viola D, et al. Efficacy and safety of intravenous belimumab in children with systemic lupus erythematosus. Presented at ACR/ARHP Annual Meeting, Chicago, Illinois, October 19-24, 2018.
  9. Data on file. GlaxoSmithKline. REF-22180.

 

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PM-SA-BEL-WCNT-200004 Date of preparation: December 2020