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Organ involvement at baseline (% of patients) in Benlysta’s clinical trials1-5

Patients had a range of organ domain involvement, including renal, prior to Benlysta treatment.

Organ domain* BLISS-SC (N=836) %  BLISS-52 (N=865) %  BLISS-76 (N=819) %**

NE Asia 
(N=677) %**

PLUTO  (N=53) %
Mucocutaneous 88 59** 58 49 94
Immunology 76 85 N/A N/A 77
Musculoskeletal 79 59 67 27 66
Renal 12 20 7 25 19
CV and respiratory 6 3** 5 1 8
CNS 1 2 2 0.1 4
VascularVascular 8 7 9 13 4
Haematological and fever 8 7 13 21 6

These studies measured organ domain involvement differently as noted in the table (SELENA-SLEDAI vs. BILAG A or B).

Studies were designed to evaluate efficacy in overall disease activity and were not powered to evaluate efficacy in specific organ domains.6

Benlysta is not recommended in severe active lupus nephritis or severe CNS lupus.6

CV = cardiovascular; CNS = central nervous system; 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

* As defined by SELENA-SLEDAI.
** BILAG A or B organ domain scores at baseline.

Standard therapy at baseline in Benlysta’s clinical trials

BLISS-SC and BLISS-IV (52/76)1 7

More than 50% of patients were not receiving immunosuppressants at baseline1-3

NE Asia4

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

IV = intravenous; SC = subcutaneous

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 prescriing 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.

See the long-term data for Benlysta

 
 

EXPLORE THE RESULTS

Learn about the efficacy of Benlysta

 
 

EXPLORE THE RESULTS

Benlysta in renal involement

 
 

EXPLORE THE RESULTS

Resources for you and your patients

Dosing & Administration

Access & Support

Consider adding Benlysta for your appropriate patients with SLE

                

References

  1. 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.
  2. 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.
  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. Data on file. GlaxoSmithKline. REF-22180.
  6. Benlysta Local prescribing information based on GDS16 & EMA_CPI0062.
  7. Schwarting A, Dooley MA, Roth DA, et al. Impact of concomitant medication use on belimumab efficacy and safety in patients with systemic lupus erythematosus. Lupus. 2016;25:1587-96.

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PM-SA-BEL-WCNT-200005 Date of preparation: October 2020