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Consider Benlysta for your patients with non-severe renal involvement 

Kidney involvement in SLE can range from mild to severe and occurs in 50%-70% of patients with lupus. 1 
Benlysta can be used in patients with renal involvement to treat SLE disease activity. It is not recommended in severe active lupus nephritis (proteinuria >6 mg over 24 hours and/or serum creatinine >2.5 mg/dL). 2

Patients with non-severe renal involvement 

In BLISS-IV (52/76) and BLISS-SC trials, 11% (n=1125) and 12% (n=836) of patients with SLE had renal involvement, respectively.  2

Patients were excluded from the BLISS trials if they had the following: 3-5

Severe active lupus nephritis

  • Proteinuria >6 g over 24 hours or equivalent with spot urine protein:creatinine ratio
  • Serum creatinine >2.5 mg/dL
  • Required haemodialysis or high-dose prednisone (>100 mg/day) within 90 days of study entry

Patients were included in the BLISS trials if they had the following: 3-5

Non-severe acute lupus nephritis

  • Proteinuria ≤6 mg over 24 hours
  • Serum creatinine ≤2.5 mg/dL
  • Haemodialysis or high-dose prednisone (>100 mg/day) >90 days before study entry
Review data from the Benlysta clinical trials

Study Design

Efficacy Profile

Adding Benlysta SC led to fewer patients experiencing renal flares vs. standard therapy 5*

Only statistically significant for patients with baseline proteinuria >0.5 g/24 hours

The BLISS trials excluded patients with severe active lupus nephritis (proteinuria >6 mg over 24 hours and/or serum creatinine >2.5 mg/dL), and the effect of Benlysta therapy on renal abnormalities was not a pre-specified endpoint of these studies. 2,6

Data is consistent with the results of the BLISS-52 trial, but not BLISS-76. 7-8

HDA = high disease activity; SC = subcutaneous; HR = hazard ratio
* A renal flare was defined as the reproducible development (i.e., confirmed at the subsequent clinical visit) of ≥1 of the following 3 features: 

An increase in 24-hour urinary protein to >1000 mg if baseline was <200 mg or to >2000 mg if baseline was 200-1000 mg or to more than twice a baseline value of >1000 mg

A decrease in the glomerular filtration rate of >20%, accompanied by proteinuria (>1000 mg/24 hours), haematuria (≥4 red blood cells [RBCs]/high-power field [hpf]), and/or cellular (RBC and white blood cell) casts

New haematuria (≥11-20 RBCs/hpf) or a 2-grade increase in haematuria compared with baseline, associated with >25% dysmorphic RBCs, glomerular in origin, and accompanied by an 800-mg increase in 24-hour urinary protein level or new RBC casts 5

Outcomes seen in patients with renal involvement treated with Benlysta 6*

Post hoc analysis of BLISS-52/76

Pooled data of 1684 patients enrolled in the BLISS-52/76 trials, including 267 (16%) with SELENA-SLEDAI renal involvement**

Compared to standard of care alone, adding Benlysta 10 mg/kg to treatment meant:6

Numerically, there were more patients who showed improvement in renal involvement in patients with renal involvement at baseline (54.1% vs. 44.6%, n=177), as measured by SELENA-SLEDAI (no statistical analysis performed)

In a subgroup of patients with a renal BILAG A or B, there were proportionately more patients with an improvement according to the BILAG scale (63.6% vs. 50.0%, n=44; no statistical analysis performed)

Numerically, there was a higher remission rate (70.5% vs. 58.7%, n=153), and the time to reach remission was numerically shorter (no statistical analysis performed) 

Numerically, there was a decrease in renal flares (1.1% vs. 3.0%, n=177; no statistical analysis performed)

In patients previously treated with mycophenolate mofetil (MMF), renal improvement with Benlysta was statistically significant (P=0.03) 6

SELENA-SLEDAI = Safety of Estrogens in Lupus Erythematosus: National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index; BILAG = British Isles Lupus Assessment Group

* Includes HDA and non-HDA patients.

** Renal involvement defined as including ≥1 of the following: proteinuria >0.5 g/24 hours, haematuria >5 RBCs/hpf, pyuria >5 white blood cells/hpf and heme granular/RBC casts).  6

Median percent reductions in proteinuria in patients with baseline proteinuria >0.2 g/24 hours (n=643) 6

The limitations of this analysis include the small numbers of patients with generally chronic stable baseline renal involvement and the smaller numbers with baseline renal involvement plus MMF use. Further, patients with severe active lupus nephritis were excluded from the BLISS trials. The post hoc nature of these analyses also limits extrapolation of the findings.6

The BLISS trials were not designed and not powered to detect a difference in renal outcomes between treatment groups for the base populations reported in this pooled analysis. The findings are, therefore, inconclusive.

Dosing guidance in renal impairment 2

Mild (CrCl ≥60 and <90 mL/min) and moderate (CrCl ≥30 and <60 mL/min) renal impairment

No dose adjustment required

Severe renal impairment (CrCl ≥15 and <30 mL/min)

No dose adjustment required
Caution recommended, due to lack of data

Severe active lupus nephritis
(Proteinuria >6 g/24 hours or equivalent using spot urine protein to creatinine ratio or serum creatinine >2.5 mg/dL)  3-5

Not recommended

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
Consider adding Benlysta earlier for your patients with non-severe renal involvement

                

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

References

  1. Bose B, Silverman ED, Bargman JM. Ten common mistakes in the management of lupus nephritis. Am J Kidney Dis. 2014;63(4):667-76.
  2. Benlysta Local prescribing information based on GDS16 & EMA_CPI0062
  3. 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.
  4. 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.
  5. 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.
  6. Dooley MA, Houssiau F, Aranow C, et al. Effect of belimumab treatment on renal outcomes: results from the phase 3 belimumab clinical trials in patients with SLE. Lupus. 2013;22:63-72.
  7. Data on file. GlaxoSmithKline. REF-5385.
  8. Data on file. GlaxoSmithKline. REF-5386.

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PM-SA-BEL-WCNT-200007 Date of preparation: October 2020