Targeted mechanism of action

See how BENLYSTA works.

BENLYSTA is the only FDA-approved treatment designed to target BLyS/BAFF, an underlying cause of lupus and lupus nephritis1,2

BENLYSTA is designed to target BLyS/BAFF, one of the drivers of lupus and lupus nephritis within the immune system1,2

Diagram of how BENLYSTA targets BLyS/BAFF, an underlying cause of lupus and lupus nephritis

The clinical relevance of these results has not been definitively established.

* BENLYSTA does not directly bind to B cells or directly deplete B-cell population.
BAFF = B-cell activating factor; BLyS = B-lymphocyte stimulator protein.

BLyS/BAFF levels correlate with lupus disease activity and anti-dsDNA titers in many patients1,3

BLyS expression is elevated in the glomeruli of patients with lupus nephritis2,4

Increased serum and intra-renal BLyS levels may promote renal inflammation and flares5-7

The clinical relevance of these results has not been definitively established.

Anti-dsDNA = anti-double–stranded DNA.

Improvement in key serological markers

At Week 52, adult patients with lupus on BENLYSTA showed:

Reductions in:

• lgG

• Anti-dsDNA antibodies*

Increases in:

  • Complement (C3 and C4)†

Adult patients with lupus on BENLYSTA experienced a 41% reduction in anti-dsDNA levels over 52 weeks1

SEE THE DATA

The clinical relevance of these results has not been definitively established.

*In patients who were positive for anti-dsDNA ≥30 IU/mL.1
†In patients with low complement levels at baseline.
IgG = immunoglobulin G.

Reductions in B-cell populations

At Week 52, adult patients with lupus on BENLYSTA had significant reductions in B-cell subsets

Median change from baseline to Week 528

  BENLYSTA IV 10 mg/kg + ST Placebo + ST
  Baseline Week 52 Baseline Week 52
CD19+ B cells 94.50(n=260) -48.45(n=193) 93.00(n=262) -10.42(n=189)
CD20+ B cells 94.00(n=251) -37.00(n=173) 92.00(n=249) -4.00(n=172)
Naïve B cells 74.00(n=251) -44.00(n=173) 79.00(n=249) -3.00(n=172)
Activated B cells 2285.00(n=247) -827.00(n=173) 2044.00(n=247) -337.00(n=171)
Lupus B-cell subset 377.00(n=251) -77.50(n=176) 293.00(n=249) 17.00(n=173)

Data from the BLISS-76 study only. The clinical relevance of these results has not been definitively established.

Results of select biomarkers in patients treated with BENLYSTA as early as Week 81

Median change in biomarkers over time

Pooled data from BLISS-52 and BLISS-761

Immunoglobulin G (IgG)

Graph showing median change in immunoglobulin G (IgG) of -2.5 on placebo + ST versus -15.3 on BENLYSTA IV + ST

Anti-double-stranded DNA antibodies (anti-dsDNA)*

Graph showing median change in anti-double-stranded DNA antibodies (anti-dsDNA) of -10.2 on placebo + ST versus -40.8 on BENLYSTA IV + ST

Complement C3†

Graph showing median change in complement C3 of 2.2 on placebo + ST versus 17.0 on BENLYSTA IV + ST

Complement C4†

Graph showing median change in complement C4 of 12.9 on placebo + ST versus 50.0 on BENLYSTA IV + ST

The clinical relevance of these results has not been definitively established.

Pooled data from the BLISS-52 and BLISS-76 studies.
Used with permission from Stohl W, et al. Arthritis Rheum. 2012;64(7):2328-2337 ©2012 John Wiley and Sons.
*In patients who were positive for anti-dsDNA ≥30 IU/mL.1
†In patients with low complement levels at baseline.
IV = intravenous; ST = standard therapy.

Learn more

BENLYSTA for lupus

BENLYSTA improved key clinical outcomes for appropriate patients.

SEE EFFICACY DATA

Identifying the BENLYSTA patient

Patient profiles to help you determine which of your patients may benefit from BENLYSTA.

VIEW PATIENT PROFILES

Add BENLYSTA to target underlying disease

Indication & Safety Info

Indication

Important Safety Information

Indication

BENLYSTA is indicated for patients aged ≥5 with active systemic lupus erythematosus (SLE) or active lupus nephritis who are receiving standard therapy. BENLYSTA is not recommended in patients with severe active central nervous system lupus.

Important Safety Information

CONTRAINDICATION

Previous anaphylaxis with BENLYSTA.

WARNINGS AND PRECAUTIONS

Serious Infections: Serious and sometimes fatal infections have been reported and occurred more frequently with BENLYSTA. Use caution in patients with severe or chronic infections, and consider interrupting therapy in patients with a new infection.

 

Progressive Multifocal Leukoencephalopathy (PML): Cases of JC virus-associated PML resulting in neurological deficits, including fatal cases, have been reported. If PML is suspected, immunosuppressant therapy, including BENLYSTA, must be suspended until PML is excluded. If confirmed, stop immunosuppressant therapy, including BENLYSTA.

 

Hypersensitivity Reactions (Including Anaphylaxis): Acute hypersensitivity reactions, including anaphylaxis and death, and infusion-related reactions have been reported. Generally, reactions occurred within hours of the infusion but may occur later, including in patients who have previously tolerated BENLYSTA. Non-acute hypersensitivity reactions (eg, rash, nausea, fatigue, myalgia, headache, and facial edema) typically occurred up to a week after infusion. Monitor patients during and after treatment and be prepared to manage anaphylaxis and infusion-related reactions. Be aware of the risk of hypersensitivity reactions, which may present as infusion-related reactions. Discontinue immediately in the event of a serious reaction. With intravenous administration, if an infusion reaction develops, slow or interrupt the infusion.

 

Depression and Suicidality: Depression and suicidality were reported in patients receiving BENLYSTA. Before adding BENLYSTA, assess patients’ risk of depression and suicide and monitor them during treatment. Instruct patients/caregivers to contact their HCP if they experience new/worsening depression, suicidal thoughts/behavior, or other mood changes.

 

Malignancy: There is an increased risk of malignancies with the use of immunosuppressants. The impact of BENLYSTA on the development of malignancies is unknown.

 

Immunization: Live vaccines should not be given for 30 days before or concurrently with BENLYSTA as clinical safety has not been established.

 

Use With Biologic Therapies: Available data do not support the safety and efficacy of concomitant use of BENLYSTA with rituximab in patients with SLE. An increased incidence of serious infections and post-injection systemic reactions in patients receiving BENLYSTA concomitantly with rituximab compared to patients receiving BENLYSTA alone has been observed. The safety and efficacy of BENLYSTA concomitantly with other biologic therapies, including B-cell-targeted therapies, have not been established. Caution should be exercised if BENLYSTA is administered in combination with other biologic therapies.

 

ADVERSE REACTIONS

The most common serious adverse reactions in adult SLE clinical trials were serious infections; some were fatal. The most common adverse reactions (≥5%) were nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, pharyngitis, and injection site reactions (subcutaneous injection).

 

Adverse reactions reported in clinical trials with SLE pediatric patients (≥5 years) and adult patients with lupus nephritis were consistent with those observed in adult SLE trials.

 

USE IN SPECIFIC POPULATIONS

Pregnancy: There are insufficient data in pregnant women to establish whether there is drug-associated risk for major birth defects or miscarriage. After a risk/benefit assessment, if prevention is warranted, women of childbearing potential should use contraception during treatment and for ≥4 months after the final treatment.

 

Pregnancy Registry: HCPs are encouraged to refer patients and pregnant women are encouraged to enroll themselves by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/benlysta-belimumab/.

 

Please see full Prescribing Information and Medication Guide for BENLYSTA.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or 1-888-825-5249, or
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References

  1. Stohl W, Hiepe F, Latinis KM, et al. Belimumab reduces autoantibodies, normalizes low complement levels, and reduces select B cell populations in patients with systemic lupus erythematosus. Arthritis Rheum. 2012;64(7):2328-2337.

  2. Neusser MA, Lindenmeyer MT, Edenhofer I, et al. Intrarenal production of B-cell survival factors in human lupus nephritis. Mod Path. 2011;24(1):98-107.

  3. Petri M, Stohl W, Chatham W, et al. Association of plasma B lymphocyte stimulator levels and disease activity in systemic lupus erythematosus. Arthritis Rheum. 2008;58(8):2453-2459.

  4. Suso JP, Posso-Osorio I, Jiménez CA, et al. Profile of BAFF and its receptors’ expression in lupus nephritis is associated with pathological classes. Lupus. 2018;27(5):708-715.

  5. Kang S, Fedoriw Y, Brenneman EK, et al. BAFF induces tertiary lymphoid structures and positions T cells within the glomeruli during lupus nephritis. J Immunol. 2017;198(7):2602-2611.

  6. Schwarting A, Relle M, Meineck M, et al. Renal tubular epithelial cell-derived BAFF expression mediates kidney damage and correlates with activity of proliferative lupus nephritis in mouse and men. Lupus. 2018;27(2):243-256.

  7. Sun CY, Shen Y, Chen XW, et al. The characteristics and significance of locally infiltrating B cells in lupus nephritis and their association with local BAFF expression. Int J Rheumatol. 2013;2013:954292.

  8. Data on file, GSK.