BENLYSTA is the only FDA-approved treatment designed to target BLyS/BAFF, an underlying cause of lupus and lupus nephritis^1,2

NARRATOR:
BENLYSTA (belimumab) is designed for lupus. BENLYSTA is the only biologic with a mechanism of action that selectively targets the B-lymphocyte stimulator protein, or BLyS, a known underlying cause of systemic lupus erythematosus, or SLE, with or without lupus nephritis.

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BENLYSTA (belimumab)
BLyS

REFERENCES: 1. BENLYSTA [package insert]. Research Triangle Park, NC: GSK; 2021. 2. Neusser MA, Lindenmeyer MT, Edenhofer I, et al. Intrarenal production of B-cell survival factors in human lupus nephritis. Mod Pathol. 2011;24(1):98-107. 3. Stohl W, Hilbert DM. The discovery and development of belimumab: the anti-BLyS–lupus connection. Nat Biotechnol. 2012;30(1):69-77. 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.

NARRATOR:
BENLYSTA selectively blocks the binding of soluble BLyS to its receptor on B cells.

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B cell
B-cell membrane
BAFF-R
BAFF-R: B-cell activating factor receptor

REFERENCES: 1. BENLYSTA [package insert]. Research Triangle Park, NC: GSK; 2021. 2. Kim HM, Yu KS, Lee ME, et al. Crystal structure of the BAFF–BAFF-R complex and its implications for receptor activation. Nat Struct Mol Biol. 2003;10(5):342-348. 3. Shin W, Lee HT, Lim H, et al. BAFF-neutralizing interaction of belimumab related to its therapeutic efficacy for treating systemic lupus erythematosus. Nat Comm. 2018;9(1):1-11.

NARRATOR:
Although it does not bind to B cells directly, BENLYSTA inhibits the survival of autoreactive B cells and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. The clinical relevance of these effects on B cells has not been established.

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The clinical relevance of these effects on B cells has not been established.
B cell
Plasma cell
Hypothetical patient.

REFERENCE: 1. BENLYSTA [package insert]. Research Triangle Park, NC: GSK; 2021.

NARRATOR:
In patients with lupus who were positive for anti-double-stranded DNA, treatment with BENLYSTA resulted in a 41% reduction in anti-double-stranded DNA antibody levels over 52 weeks. Reductions were also seen in IgG CD19 positive, CD20 positive, naïve B cells, activated B cells, and the SLE B-cell subset at Week 52. Additionally increases in complement proteins C3 and C4 were also observed at Week 52 in patients with low complement levels at baseline.

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Overview of Pharmacodynamics for BENLYSTA
Hypothetical patient.
BENLYSTA resulted in a 41% reduction in anti-double-stranded DNA antibody levels over 52 weeks.
The clinical relevance of these results has not been fully established.
Reductions in: IgG, CD19+ B cells, CD20+ B cells, naïve B cells, activated B cells, B-cell subset
At Week 52
Increases in complement proteins C3 & C4 at Week 52

REFERENCES: 1. BENLYSTA [package insert]. Research Triangle Park, NC: GSK; 2021. 2. 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.

NARRATOR:
In patients with lupus nephritis, treatment with BENLYSTA led to a decrease in serum IgG as early as Week 4, and, subsequently, there was an increase in serum IgG levels, which was associated with decreased proteinuria. Reductions in autoantibodies, total circulating B cells, and B-cell subsets and increases in complement proteins were consistent with what was observed in SLE trials.

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Nephrons
IgG
Reductions in autoantibodies
Reductions in B cells
Increase in complement
The clinical relevance of these results has not been fully established.

REFERENCES: 1. BENLYSTA [package insert]. Research Triangle Park, NC: GSK; 2021. 2. Crow MK. Etiology and pathogenesis of systemic lupus erythematosus. Kelley and Firestein's Textbook of Rheumatology. Elsevier; 2017;1329-1344. 3. Marieb EN, Hoehn K, eds. Human Anatomy & Physiology. 11th ed. Pearson Education, Inc; 2019. 4. Davidson A, Berthier C, Kretzler M. Pathogenetic mechanisms in lupus nephritis. In: Dubois' Lupus Erythematosus and Related Syndromes. WB Saunders; 2013: 237-255.

NARRATOR:
BENLYSTA. An FDA-approved treatment option for patients with lupus or lupus nephritis.

ON-SCREEN TEXT:
Benlysta (belimumab) Intravenous Use 120 mg/vial Subcutaneous Use 200 mg/mL
©2022 GSK or licensor.
BELVID220007 April 2022
Produced in USA.
Trademarks owned by or licensed to the GSK group of companies.

REFERENCE: 1. BENLYSTA [package insert]. Research Triangle Park, NC: GSK; 2021.

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.^3,4

BAFF = B-cell activating factor; BLyS = B-lymphocyte stimulator protein.

BLyS/BAFF is elevated in patients with lupus nephritis^2,5

BLyS/BAFF expression is elevated in the glomeruli of patients with lupus nephritis^2,5

Increased serum and intra-renal BLyS/BAFF levels may promote renal inflammation and flares^6-8

In patients with active lupus nephritis, improvements were seen as early as Week 4

Decrease in serum IgG as early as Week 4

A subsequent increase in serum IgG levels was associated with decreased proteinuria

Reductions in autoantibodies* and increases in complement (C3 and C4)^† were consistent with those observed in patients with lupus

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

* In patients who were positive for anti-dsDNA ≥30 IU/mL.

†In patients with low complement levels at baseline.

Anti-dsDNA = anti-double-stranded DNA; IgG = immunoglobulin G.

Reductions in B-cell populations

In patients with active lupus nephritis, reductions in circulating total B-cells and B‑cell subsets observed were consistent with lupus studies.

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

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BENLYSTA for lupus nephritis

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INDICATION & IMPORTANT SAFETY INFO

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.

CONTRAINDICATION

Previous anaphylaxis with BENLYSTA.

WARNINGS AND PRECAUTIONS

Serious Infections: Serious and sometimes fatal infections have been reported and occurred more frequently with BENLYSTA.

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.

References

Stohl W, Hilbert DM. The discovery and development of belimumab: the anti-BLyS-lupus connection. Nat Biotechnol. 2012;30(1):69-77.

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

Baker KP, Edwards BM, Main SH, et al. Generation and characterization of LymphoStat-B, a human monoclonal antibody that antagonizes the bioactivities of B lymphocyte stimulator. Arthritis Rheum. 2003;48(11):3252-3265.

Do RKG, Hatada E, Lee H, et al. Attenuation of apoptosis underlies B lymphocyte stimulator enhancement of humoral immune response. J Exp Med. 2000;192(7):953-964.

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.

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.

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.

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.

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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 nephritis^1,2

BLyS/BAFF is elevated in patients with lupus nephritis^2,5

BLyS/BAFF expression is elevated in the glomeruli of patients with lupus nephritis^2,5

Increased serum and intra-renal BLyS/BAFF levels may promote renal inflammation and flares^6-8