You are now leaving GSK’s website

This link will take you to a non-GSK website. GSK does not recommend, endorse or accept liability for sites controlled by third-parties.

Continue

Go back

Logo

Product menu

Consider Benlysta earlier to improve long-term treatment outcomes

Up to 50% of patients with SLE experience permanent organ damage within 5 years of diagnosis based on SDI. In a post hoc, propensity score-matched analysis, Benlysta + standard therapy was associated with reduced organ damage accrual.1 2

Organ damage accrual

Primary endpoint. Change in SDI from baseline to 5 years

Rate of organ damage accrual

Secondary endpoint. Time to first worsening in SDI score per year

Magnitude of year-to-year organ damage progression 

Secondary endpoint. Magnitude of SDI score increases from baseline to 5 years

SDI = SLICC/ACR Damage Index

Propensity score matching (PSM) is a post hoc analysis and the data should be viewed in the context of the following: 2

PSM can only match patients based on known variables.
Non-observable differences may cause some degree of residual confounding.
Patients could not be matched by year of entry.

Adding Benlysta IV reduced organ damage (SDI) at Year 5 vs. standard therapy 2

Primary endpoint 

* Includes HDA and non-HDA patients. High disease activity (HDA) 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).3

† The Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SLICC/ACR DI; SDI) is the only internationally agreed and validated measure of SLE damage. Features include: assesses 12 organ systems; descriptors within each organ system are scored independently; organ damage must be present for ≥6 months and considered irreversible; damage is recorded regardless of cause (SLE or medications); occurring since diagnosis of SLE; SDI can only increase over time.4-6

Magnitude of year-to-year organ damage progression 2

Secondary endpoint 

The proportion of SDI score increases ≥2 over any given year of follow-up was 30.56% (n=22/72) for standard therapy vs. 6.06% for Benlysta (n=2/33, P=0.006) among patients with SDI score increases.  

Difference in time to organ damage progression in patients with ≥1 year of follow-up 2

Secondary endpoint 

Patients receiving Benlysta were 61% less likely to progress their organ damage (SDI score) over any given year of follow-up vs. patients treated with standard therapy (HR 0.391 [95% CI: 0.253, 0.605] P<0.001). 2

HR = hazard ratio

Long-term data: Study design 2

Propensity score-matched analysis of organ damage in pooled BLISS-LTE trials vs. the Toronto Lupus Cohort

PSM identifies patients that are clinically and demographically comparable from two different studies over the same time period. 

Treatment groups 2

LTE = long-term extension; SLEDAI-2K = SLE Disease Activity Index-2000; SoC = standard of care

Propensity score matching

PSM is a method to pair similar patients from independent studies based on their propensity score. 2

Based on literature review, expert feedback and data availability, the following predictors of organ damage were used in the PSM analysis:

Demographics

  • Age
  • Age squared
  • Gender
  • Race/ethnicity
  • Current smoker

Clinical characteristics

  • Hypertension
  • Dyslipidemia
  • Proteinuria

SLE-specific characteristics

  • SLE duration
  • ACR criteria at diagnosis
  • Baseline SLEDAI score
  • Baseline SDI score = 1
  • Baseline SDI score ≥2

Medications

  • Steroids
  • Immunosuppressant
  • Antimalarials

Learn about the efficacy of Benlysta

EXPLORE THE RESULTS

Benlysta in renal involvement

EXPLORE THE RESULTS

Benlysta: Designed with your patients in mind

Dosing & Administration

Dosing options designed for your patients with SLE

Explore

Safety Profile

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

Explore

Mechanism of Action

Find out how Benlysta is designed for lupus

Explore

Benlysta IV:

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:

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
Consider adding Benlysta earlier for your appropriate patients with SLE
 
 

References

  1. Urowitz MB, Gladman DD, Ibañez D, et al. Evolution of disease burden over five years in a multicenter inception systemic lupus erythematosus cohort. Arth Care Res. 2012;64(1);132-37.
  2. Urowitz MB, Ohsfeldt RL, Wielage RC, et al. Organ damage in patients treated with belimumab versus standard of care: a propensity score-matched comparative analysis. Ann Rheum Dis. 2019;78(3):372-9.
  3. Benlysta Local prescribing information based on GDS16 & EMA_CPI0062
  4. Feld J, Isenberg D. Why and how should we measure disease activity and damage in lupus? Presse Med. 2014;43(6 Pt 2):e151-6.
  5. Gladman D, Ginzler E, Goldsmith C, et al. The development and initial validation of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index for systemic lupus erythematosus. Arthritis Rheum. 1996;39(3):363-9. 
  6. Bruce IN, O’Keeffe AG, Farewell V, et al. Factors associated with damage accrual in patients with systemic lupus erythematosus: results from the Systemic Lupus International Collaborating Clinics (SLICC) Inception Cohort. Ann Rheum Dis. 2015;74(9):1706-13.

Trade marks are owned by or licensed to the GSK group of companies.
©2020 GSK group of companies or its licensor.

PM-SA-BEL-WCNT-200006 Date of preparation: October 2020