About Lupus Nephritis | BENLYSTA (belimumab) for HCPs

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By the time lupus nephritis is diagnosed, kidney damage may already be severe¹

Up to 5 of the next 10 patients with lupus a doctor sees may develop lupus nephritis²

31%–48% of patients will develop lupus nephritis at some point after their initial lupus diagnosis.²*

Once diagnosed with lupus nephritis, patients are

45X

more likely to develop ESKD^3†

(HR=44.7; 95% CI, 6.1–329.7)

Progression to lupus nephritis increases patient risk of death by

3X^3†

(HR=3.2; 95% CI: 1.6–6.5)

* Data from a pragmatic review of 26 publications involving patients with lupus nephritis with or without a proven biopsy.

† Adjusted risk of kidney failure and death once diagnosed with lupus nephritis. Analysis of SLICC inception cohort of newly diagnosed patients enrolled between 1999 and 2012, and who were followed for a mean of 4.6 years. A total of 1827 patients were recruited, of whom 700 (38.3%) had lupus nephritis over the course of the follow-up. The estimated cumulative incidence of ESKD (as defined by the SDI) for the entire cohort at 10 years following enrollment was 4.3% (95% CI: 2.8%, 5.8%). For all patients with lupus nephritis, the [estimated] cumulative incidence of ESKD at 10 years after the diagnosis of lupus nephritis was 10.1% (95% CI: 6.6%, 13.6%). The estimated cumulative incidence of death from all causes for the entire cohort at 10 years after enrollment was 4.4% (95% CI: 2.7%, 6.1%). For patients with lupus nephritis, the [estimated] cumulative incidence of death at 10 years following the diagnosis of lupus nephritis was 5.9% (95% CI: 3.3%, 8.4%). Nephritis was identified by the renal disorder variable of the ACR classification criteria and/or biopsy evidence of nephritis as per the ISN/RPS criteria. Cox regression analysis that adjusted for gender, age at enrollment, and race/ethnicity.³

ACR = American College of Rheumatology; CI = confidence interval; ESKD = end-stage kidney disease; HR = hazard ratio; ISN/RPS = International Society of Nephrology/Renal Pathology Society; SDI = SLICC/ACR Damage Index; SLICC = Systemic Lupus International Collaborating Clinics.

Review the latest treatment recommendations for lupus nephritis

With each renal flare, there is irreversible nephron loss – shortening the kidney’s life span and increasing the risk of ESKD¹

Potential impact of lupus nephritis on kidney life span

Adapted from Anders HJ, et al. Nat Rev Dis Primers. 2020;6(1):7.

It is critical to reduce the number of renal flares to prevent progression to ESKD and the need for dialysis^1,5

45% of patients with lupus nephritis experience renal flares despite receiving immunosuppressive
therapy^1,6‡

‡ Renal flares are defined as a rise in serum creatinine level and/or proteinuria, abnormal urinary sediment, or reduction in creatinine clearance.^1,5

CKD = chronic kidney disease; GFR = glomerular filtration rate.

Is standard therapy alone enough?

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Mechanism of disease

Learn how lupus affects the body.

video transcript

NARRATOR:
Systemic lupus erythematosus, commonly referred to lupus or SLE, is the most common form of lupus.

REFERENCE: 1. Maidhof W, Hilas O. Lupus: An overview of the disease and management options. Pharm Ther. 2012;37(4):240.

NARRATOR:
Patients suffer from a range of debilitating effects of this autoimmune disease . . . each and every day.

REFERENCE: 1. Anders HJ, Saxena R, Zhao MH, et al. Lupus nephritis. Nat Rev Dis Primers. 2020;6(1):1- 25. 2. Cancro MP, D’Cruz DP, Khamashta MA. The role of B lymphocyte stimulator (BLyS) in systemic lupus erythematosus. J Clin Investig. 2009;119(5):1066-1073. 3. Maidhof W, Hilas O. Lupus: An overview of the disease and management options. Pharm Ther. 2012;37(4):240.

NARRATOR:
Lupus may manifest in 1 or multiple body systems, . . . such as the skin, . . . cardiovascular, pulmonary, . . . musculoskeletal, and renal systems, to name a few. Permanent organ damage can occur if lupus is not treated appropriately, which can have serious consequences for patients.

ON-SCREEN TEXT:
Skin
Cardiovascular
Pulmonary
Musculoskeletal
Renal

REFERENCE: 1. American College of Rheumatology Ad Hoc Committee on Systemic Lupus Erythematosus Guidelines. Guidelines for referral and management of systemic lupus erythematosus in adults. Arthritis Rheum. 1999;42(9):1785-1796. 2. Anders HJ, Saxena R, Zhao MH, et al. Lupus nephritis. Nat Rev Dis Primers. 2020;6(1):1-25. 3. Cancro MP, D’Cruz DP, Khamashta MA. The role of B lymphocyte stimulator (BLyS) in systemic lupus erythematosus. J Clin Investig. 2009;119(5):1066-1073. 4. Heinlen LD, McClain MT, Merrill J, et al. Clinical criteria for systemic lupus erythematosus precede diagnosis, an associated autoantibodies are present before clinical symptoms. Arthritis Rheum. 2007;56(7):2344-2351. 5. Lopez R, Davidson JE, Beeby MD, et al. Lupus disease activity and the risk of subsequent organ damage and mortality in a large lupus cohort. Rheumatol. 2012;51(3):491-498.

NARRATOR:
Inside the body, . . . B cells produce antibodies to help fight off infection. In lupus, autoreactive B cells produce autoantibodies that attack and destroy healthy tissues and organs, causing widespread inflammation.

ON-SCREEN TEXT:
Pathogen
Antibodie
B cell
Inflammation
Autoantibodies
Autoreactive B Cell

REFERENCE: 1. Cancro MP, D’Cruz DP, Khamashta MA. The role of B lymphocyte stimulator (BLyS) in systemic lupus erythematosus. J Clin Investig. 2009;119(5):1066-1073. 2. Maidhof W, Hilas O. Lupus: An overview of the disease and management options. Pharm Ther. 2012;37(4):240. 3. Marieb EN, Hoehn K, eds. Human Anatomy & Physiology. 11th ed. Pearson Education, Inc; 2019. 4. Mok CC, Lau CS. Pathogenesis of systemic lupus erythematosus. J Clin Pathol. 2003;56(7):481-490. 5. Murphy K, Weaver C. Janeway's Immunobiology. 9th ed. Garland Science; 2008.

NARRATOR:
In lupus nephritis, the immune system attacks and damages nephrons. Let’s take a closer look at how this happens.

ON-SCREEN TEXT:
Nephrons

REFERENCE: 1. Anders HJ, Saxena R, Zhao MH, et al. Lupus nephritis. Nat Rev Dis Primers. 2020;6(1):1- 25.

NARRATOR:
In the blood, autoantibodies bind to anti-dsDNA and form immune complexes. One mechanism of tissue damage in lupus nephritis is the formation of immune complexes that accumulate and deposit in the filtration membrane formed by podocytes in the glomeruli, which impairs kidney function. The resulting inflammation leads to a buildup of waste in the blood and protein excreted in the urine (or proteinuria), which is a defining feature of lupus nephritis. This may ultimately lead to end-stage kidney disease that requires dialysis or kidney transplant. Low levels of complement proteins in lupus nephritis make it difficult to clear immune complex deposits.

ON-SCREEN TEXT:
Autoantibodies
Plasma cells
Immune complexes
Podocytes
Immune complex deposit
Damage
Complement

REFERENCE: 1. Almaani S, Meara A, Rovin BH. Update on lupus nephritis. Clin J Am Soc Nephrol. 2017;12(5):825-835. 2. Anders HJ, Saxena R, Zhao MH, et al. Lupus nephritis. Nat Rev Dis Primers. 2020;6(1):1-25. 3. Crow MK. Etiology and pathogenesis of systemic lupus erythematosus. Kelley and Firestein's Textbook of Rheumatology. Elsevier; 2017;1329-1344. 4. Davidson A, Berthier C, Kretzler M. Pathogenetic mechanisms in lupus nephritis. In: Dubois' Lupus Erythematosus and Related Syndromes. WB Saunders; 2013: 237-255. 5. Lech M, Anders HJ. The pathogenesis of lupus nephritis. J Am Soc Nephrol. 2013;24(9):1357-1366. 6. Marieb EN, Hoehn K, eds. Human Anatomy & Physiology. 11th ed. Pearson Education, Inc; 2019. 7. Song K, Liu L, Zhang X, Chen X. An update on genetic susceptibility in lupus nephritis. Clin Immunol. 2020;210:108272. 8. Toong C, Adelstein S, Phan TG. Clearing the complexity: immune complexes and their treatment in lupus nephritis. Int J Nephrol Renovasc Dis. 2011;4:17.

NARRATOR:
In treating lupus, with or without lupus nephritis, steroids can help control symptoms, but long-term use may also contribute to further organ damage. As a result, guideline and treatment recommendations suggest limiting their use or minimizing their dosage, leaving patients with few treatment options.

ON-SCREEN TEXT:
Continued damage

ON-SCREEN TEXT:
BENLYSTA (belimumab)
Intravenous Use 120 mg/via
Subcutaneous Use 200 mg/mL

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BENLYSTA for lupus nephritis

BENLYSTA improved key clinical outcomes for appropriate patients.

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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.

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

References

Anders HJ, Saxena R, Zhao MH, et al. Lupus nephritis. Nat Rev Dis Primers. 2020;6(1):7.
Mahajan A, Amelio J, Gairy K, et al. Systemic lupus erythematosus, lupus nephritis and end-stage renal disease: a pragmatic review mapping disease severity and progression. Lupus. 2020;29(9):1011-1020.
Hanly JG, O’Keeffe AG, Su L, et al. The frequency and outcome of lupus nephritis: results from an international inception cohort study. Rheumatology (Oxford). 2016;55(2):252-262.
Rijnink EC, Teng YKO, Wilhelmus S, et al. Clinical and histopathologic characteristics associated with renal outcomes in lupus nephritis. Clin J Am Soc Nephrol. 2017;12(5):734-743.
Sprangers B, Monahan M, Appel GB. Diagnosis and treatment of lupus nephritis flares—an update. Nat Rev Nephrol. 2021;8(12):709-717.
Illei GG, Takada K, Parkin D, et al. Renal flares are common in patients with severe proliferative lupus nephritis treated with pulse immunosuppressive therapy: long-term followup of a cohort of 145 patients participating in randomized controlled studies. Arthritis Rheum. 2002;46(4):995-1002.

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Characteristics of lupus nephritis

Lupus nephritis is a severe manifestation of lupus.¹

By the time lupus nephritis is diagnosed, kidney damage may already be severe¹