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Benlysta is designed for lupus

Benlysta has been extensively studied in 4 pivotal trials of adults with lupus. With the aim of improving long-term outcomes, the trials assessed three main SLE treatment goals: reduction in disease activity, reduction in risk of severe flares and reduction in steroid dose.1 2 3

Compared to standard therapy alone, Benlysta:

Arrows pointing up and down
Reduced disease activity 1 2

Primary endpoint (statistically significant)

Figure with spots depicting flares
Reduced risk of severe flares 1 2

Secondary endpoint (statistically significant)

Prescription bottle
Reduced steroid dose 1 2

Secondary endpoint (numerical reduction, not statistically significant)

Disease activity reduction vs. standard therapy at 52 weeks 1 2 3

The primary efficacy endpoint for the Benlysta clinical trials was the change in disease activity at Week 52, as measured by the SLE Responder Index (SRI-4) response rate. 

In these two randomised, double-blind, placebo-controlled studies in a subset of adult patients with high disease activity (HDA), a significant reduction in disease activity was observed vs. standard therapy.  

HDA was defined as positive anti-dsDNA (≥30 IU/mL) and low C3 and/or C4 complement. 62% of patients had HDA at baseline in BLISS-SC and 52% in BLISS-IV (52/76 pooled data). 1 2

SC = subcutaneous; IV = intravenous; dsDNA = double-stranded DNA; C3 = complement 3; C4 = complement 4

* Patients were on SLE treatment (standard therapy) consisting of corticosteroids, antimalarials, nonsteroidal anti-inflammatory drugs (NSAIDs) or other immunosuppressives, alone or in combination. Patients were randomised to Benlysta SC 200 mg weekly or placebo in BLISS-SC and Benlysta IV 10 mg/kg or placebo in BLISS-52/76. 1 2

Benlysta was studied in two randomised, double-blind, placebo-controlled studies of adult patients (NE Asia trial) and paediatric patients (PLUTO trial) with active SLE disease. Active SLE was defined as a SELENA-SLEDAI score ≥8 (NE Asia) or ≥6 (PLUTO), and positive antinuclear antibody (ANA or anti-dsDNA) test results at screening. 1 2 3* 

In PLUTO, HDA was defined as positive anti-dsDNA (≥30 IU/mL) and low C3 and/or C4 complement. 69.9% of patients had positive anti-dsDNA (≥30 IU/mL) at baseline and complement levels (C3 and C4) were low in 34.4% and 38.7% of subjects, respectively. 4

SELENA-SLEDAI = Safety of Estrogens in Lupus Erythematosus: National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index

* A total of 677 adult patients in the NE Asia trial and 93 paediatric patients (5 to 17 years of age) in the PLUTO trial were randomised to receive placebo or Benlysta IV 10 mg/kg. Patients were on SLE treatment (standard therapy) consisting of corticosteroids, antimalarials, NSAIDs or other immunosuppressives, alone or in combination. 1 2 3

Reduction in risk of severe flares vs. standard therapy over 52 weeks 1 2 3 

Benlysta clinical trials measured the risk of severe flares at Week 52, as defined by the modified SELENA-SLEDAI SLE Flare Index. 1 2 3 5

A superior reduction in the risk of severe flares (by 40-60%) vs. standard therapy was observed in adult patients with active SLE disease. 1 2*

% of patients having ≥1 severe flare

A severe flare was defined by a change in SELENA-SLEDAI to >12, accompanied by at least one of the following: hospitalization for SLE activity; new or worse (requiring doubling of prednisone, or prednisone increase to >0.5 mg/kg/day, or hospitalization) CNS SLE, vasculitis, nephritis, myositis, platelets <60,000, or haemolytic anaemia (Hb <7 g/dL or decrease in Hb of >3 g/dL); increase in prednisone dose to >0.5 mg/kg/day; new immunosuppressant; increase in PGA score to >2.5.6

HR = hazard ratio; CNS = central nervous system; Hb = haemoglobin; PGA = Physician’s Global Assessment

* In two randomised, double-blind, placebo-controlled studies. Active SLE was defined as a SELENA-SLEDAI score ≥8 (BLISS-SC) or ≥6 (BLISS-52/76), and positive antinuclear antibody (ANA or anti-dsDNA) test results at screening.1 2 

† HDA was defined as positive anti-dsDNA (≥30 IU/mL) and low C3 and/or C4 complement.1 2

% of patients having ≥1 severe flare 1 2 3*

A severe flare was defined by a change in SELENA-SLEDAI to >12, accompanied by at least one of the following: hospitalization for SLE activity; new or worse (requiring doubling of prednisone, or prednisone increase to >0.5 mg/kg/day, or hospitalization) CNS SLE, vasculitis, nephritis, myositis, platelets <60,000, or haemolytic anaemia (Hb <7 g/dL or decrease in Hb of >3 g/dL); increase in prednisone dose to >0.5 mg/kg/day; new immunosuppressant; increase in PGA score to >2.5. 6

* A total of 677 adult patients (NE Asia) and 93 paediatric patients (PLUTO) were randomised to receive placebo or Benlysta IV 10 mg/kg. Patients had active SLE disease and were on treatment (standard therapy) consisting of corticosteroids, antimalarials, NSAIDs or other immunosuppressives, alone or in combination.1 2 3 

 † HDA was defined as positive anti-dsDNA (≥30 IU/mL) and low C3 and/or C4 complement. 4

EXPLORE RENAL FLARES

Reduction in steroid dose supported in clinical trials and real-world settings 1 2 3 5

Patients in the BLISS trials were on a stable SLE treatment regimen (standard therapy) consisting of any of the following: corticosteroids, antimalarials, NSAIDs or other immunosuppressives, alone or in combination. Compared with the placebo group, more patients taking Benlysta had a dose reduction in steroid use.1 2*

There were no statistically significant differences between treatment groups.1 2

% of patients with a ≥25% reduction in steroid dose to ≤7.5 mg/day
in patients who were receiving >7.5 mg/day at baseline

* In two randomised, double-blind, placebo-controlled studies of adult patients with active SLE, defined as a SELENA-SLEDAI score ≥8 (BLISS-SC) or ≥6 (BLISS-52/76), and positive antinuclear antibody (ANA or anti-dsDNA) test results at screening.1 2

‡ HDA was defined as positive anti-dsDNA (≥30 IU/mL) and low C3 and/or C4 complement.1 2

In the NE Asia trial, the reduction in steroid use was a pre-specified other endpoint. There were no statistically significant differences between treatment groups.3

% of patients with a ≥25% reduction in steroid dose to ≤7.5 mg/day
in patients who were receiving >7.5 mg/day at baseline

The use of Benlysta IV in routine clinical care was studied in a prospectively followed cohort of adult patients with SLE. All patients treated with Benlysta across 11 Italian SLE referral centres were included in the study. The mean follow-up was 17.5 months.

Causal inferences about the effect of Benlysta cannot be made, as the study did not have a control arm. 

Reduction in daily steroid dose

Discover more about the Benlysta clinical trials

Renal Involvement

Study Design

What are your long-term treatment goals?

Persistent disease activity is linked to increased organ damage which is predictive of more harm and early mortality. 7

LONG-TERM ORGAN DAMAGE

Resources for you and your patients

Patient Resources

Access & Support

Benlysta: Designed with your patients in mind

Dosing & Administration

Dosing options designed for your patients with SLE

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Safety Profile

Favourable risk:benefit profile from pivotal and follow-up trials

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Mechanism of Action

Find out how Benlysta is designed for lupus

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When standard therapy is not enough, why not choose Benlysta earlier?
 
 

 

 

Benlysta IV:1

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:2

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. Benlysta IV local prescribing information based on GDS 16.
  2. Benlysta SC local prescribing information based on EMA_CPI 0026.
  3. 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. 
  4. Data on file. GlaxoSmithKline. REF-22180.
  5. 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.
  6. Petri M, Kim M, Kalunian K, et al. Combined oral contraceptives in women with systemic lupus erythematosus. N Engl J Med. 2005;353:2550-8.
  7. Doria A, Gatto M, Zen M, et al. Optimizing outcome in SLE: treating-to-target and definition of treatment goals. Autoimmun Rev. 2014;13(7):770-7.

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PM-SA-BEL-WCNT-200003 Date of preparation: October 2020