ON-SCREEN TEXT:
Patients can’t wait
The progression of lupus and lupus nephritis and role of treatment
DR SOLOMAN:
Hello! My name is Doctor Nehad Soloman. I’m a practicing rheumatologist in Phoenix, Arizona.
ON-SCREEN TEXT:
Dr. Nehad Soloman
Rheumatologist
Phoenix, Arizona
Paid consultant to GSK at the time of filming.
DR RASTOGI:
And I am Doctor Anjay Rastogi. I’m a practicing nephrologist in Los Angeles, California.
Today we will discuss the risks associated with the progression from lupus to lupus nephritis and highlight how treatment has helped patients in our practices.
ON-SCREEN TEXT:
Dr. Anjay Rastogi
Rheumatologist
Los Angeles, California
Paid consultant to GSK at the time of filming.
DR SOLOMAN:
In our practices, we have seen the impact of the development of lupus nephritis. The consequences can be devastating to a patient with lupus.
DR SOLOMAN:
In fact, studies have shown that nearly half of patients will develop lupus nephritis at some point after their initial lupus diagnosis.
ON-SCREEN TEXT:
Up to 5 in 10 patients with lupus will develop lupus nephritis at some point following their initial lupus diagnosis.1*
31%–48% of patients will develop lupus nephritis at some point after their initial lupus diagnosis.1*
* Data from a pragmatic review of 26 publications involving patients with lupus nephritis with or without a proven biopsy.1
Reference: 1. Mahajan A, et al. Lupus. 2020;29(9):1011-1020.
DR SOLOMAN:
Knowing that many of our patients are at risk of progressing to lupus nephritis, my priorities are regular monitoring for early detection and a rapid initiation of therapy. In my opinion, both rheumatologists and nephrologists need to be aggressive with the treatment approach to make sure we provide our patients with the best possible options.
DR SOLOMAN:
Communication and collaboration as a team is key. We can keep each other informed on a patient’s case—and align on how we can optimize their treatment and care.
ON-SCREEN TEXT:
“Communication and collaboration as a team is key.”
DR RASTOGI:
I completely agree with Dr. Soloman, collaboration and open communication is essential in helping our patients. I highly suggest continued monitoring of kidneys and kidney function. I also urge all healthcare professionals managing lupus and lupus nephritis—rheumatologists, nephrologists, and the patient’s primary care provider—to work together throughout the patient’s journey.
ON-SCREEN TEXT:
What are the associated risks following a diagnosis of lupus nephritis?
DR RASTOGI:
A single renal flare can shorten the life span of a kidney by decades.
Each flare causes irreversible nephron loss, which increases the risk of end-stage kidney disease.
It is important to reduce the number of renal flares to prevent progression to end-stage kidney disease and the need for dialysis.
ON-SCREEN TEXT:
Potential impact of lupus nephritis on kidney life span1
[ON-SCREEN VISUAL– GRAPH]
Normal aging
Potential nephron loss after one renal flare
Just one renal flare could shorten a kidney’s life span by decades1-3*
Adapted with permission from Anders HJ, et al., 2020.
* Renal flares are defined as a rise in serum creatinine level and/or proteinuria, abnormal urinary sediment, or reduction in creatinine clearance.
CKD = chronic kidney disease; GFR = glomerular filtration rate.
References: 1. Anders HJ, et al. Nat Rev Dis Primers. 2020;6(1):7. 2. Rijnink EC, et al. Clin J Am Soc Nephrol. 2017;12(5):734-743.
3. Sprangers B, et al. Nat Rev Nephrol. 2021;8(12):709-717.
DR RASTOGI:
Furthermore, patients with lupus nephritis are 45 times more likely to develop end-stage kidney disease and their risk of death is increased 3-fold.
Treatment is vital in managing lupus nephritis. As we evaluate our options, we should aim for the preservation of kidney function.
ON-SCREEN TEXT:
45x more likely to develop ESKD1*
(HR=44.7; 95% CI: 6.1-329.7)
3x increased risk of death1*
(HR=3.2; 95% CI: 1.6-6.5)
* 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.1
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/ACR = Systemic Lupus International Collaborating Clinics/American College of Rheumatology.
Reference: 1. Hanly JG, et al. Rheumatol. 2016;55(2):252-262.
NARRATOR:
BENLYSTA is indicated for patients aged 5 and older 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.
And now, Important Safety Information about BENLYSTA.
BENLYSTA should not be administered to patients with a history of previous anaphylaxis with BENLYSTA.
Please keep watching to see the complete Important Safety Information about BENLYSTA.
ON-SCREEN TEXT:
Benlysta
(belimumab)
Intravenous Use 120 mg/vial
Subcutaneous Use 200 mg/mL
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.
Please keep watching to see the complete Important Safety Information about BENLYSTA.
Please see full Prescribing Information, including Medication Guide, on this page.
DR RASTOGI:
Now, let’s explore how BENLYSTA may help your patients with lupus nephritis.
ON-SCREEN TEXT:
How may BENLYSTA help patients with lupus nephritis?
DR RASTOGI:
In the BLISS-LN study of nearly 450 patients, 43% of patients on BENLYSTA achieved the primary endpoint of renal response compared to 32% of patients who received placebo.
The BLISS-LN trial is the longest and largest phase 3 trial of a biologic in lupus nephritis, with a duration lasting 104 weeks. Patients were randomized 1:1 to receive BENLYSTA in addition to standard therapy or placebo in addition to standard therapy.
ON-SCREEN TEXT:
Renal response1*
43%
BENLYSTA IV + ST vs
32%
Placebo + ST
(Primary endpoint, P=0.0311)
Study design:
Patients were randomized to BENLYSTA 10 mg/kg + ST or placebo + ST administered by IV infusion on Days 0, 14, and 28, and at 4-week intervals thereafter through Week 104. ST was defined as MMF + high-dose steroids, followed by MMF + low-dose steroids or CYC + high-dose steroids, followed by AZA + low-dose steroids.
* Renal response defined as eGFR ≥60 mL/min/1.73 m2 or eGFR no worse than 20% below preflare value, uPCR ≤0.7, and not a treatment failure† at Week 104.
† Treatment failures were defined as patients who received prohibited medications. For these endpoints, in order to be considered a responder, steroid dose had to be reduced to ≤10 mg/day from Week 24.2
AZA = azathioprine; CYC = cyclophosphamide; eGFR = estimated glomerular filtration rate; MMF = mycophenolate mofetil; ST = standard therapy; uPCR = urine protein:creatinine ratio.
References: 1. Data on File, GSK. 2. Furie R, et al. N Engl J Med. 2020;383(12):1117-1128.
DR RASTOGI:
Timely treatment may help to make a difference for your patients with lupus nephritis—when every nephron matters.
ON-SCREEN TEXT:
Every nephron matters.
DR RASTOGI:
I do what I can for my patients to maintain their kidney function. From Day 1, I focus on reducing the risk of renal-related events, such as progression to end-stage kidney disease.
In the BLISS-LN trial, BENLYSTA significantly reduced the risk of renal-related events or death by nearly half.
ON-SCREEN TEXT:
Significantly reduced risk of renal-related events or death by approximately half1,2*
49% reduction in risk of renal-related events or death
Percentage of patients with an event
BENLYSTA + ST 16% (n=223)
Placebo + ST 28% (n=223)
(HR=0.51; 95% CI: 0.34, 0.77) P=0.001
Time to renal-related event or death (secondary endpoint) was defined as first instance of ESKD, doubling of serum creatinine, renal worsening (increased proteinuria and/or impaired real function), renal disease-related treatment failure, or death occurring after Day 1.
* When excluding deaths (BENLYSTA=1, ST=2), the percentage of patients with a renal–related event was 15% vs 27%, respectively (HR=0.51; 95% CI: 0.34, 0.77).2
References: 1. Furie R, et al. N Engl J Med. 2020;383(12):1117-1128. 2. Data on File, GSK.
DR RASTOGI:
In a post hoc analysis, BENLYSTA demonstrated how it can help with the preservation of kidney function by its effects on renal flares and eGFR loss.
BENLYSTA reduced the risk of renal flares by 55% and patients also experienced 63% less eGFR loss over time.
ON-SCREEN TEXT:
BENLYSTA and preservation of kidney function1
55% reduction in risk of renal flares
(HR=0.45; 95% CI: 0.28, 0.72)*
In patients treated with BENLYSTA + ST, 14% (28/194) had ≥1 renal flare from Week 24 to 104; in patients treated with placebo + ST, 26% (51/196) had ≥1 renal flare from Week 24 to 104.
63% less eGFR loss over time
(3.61 eGFR slope difference vs ST alone; 95% CI: 0.15, 7.06)
In patients treated with BENLYSTA + ST (n=196), the eGFR slope (mL/min/1.73 m2/year) was -2.12; in patients treated with placebo + ST (n=198), the eGFR slope was -5.72 from Week 24 to 104.†
Post hoc analysis. Results are descriptive.
* Renal flares were defined as impaired kidney function accompanied by proteinuria and/or cellular casts, increase in proteinuria compared with Week 24, or treatment failure due to kidney disease–related intake of prohibited medications.
† On-study population: includes all available data for patients on treatment at Week 24 inclusive of those who discontinued treatment but remained enrolled.
Reference: 1. Rovin BH, et al. Kidney Int. 2022;101(2):403-413.
DR RASTOGI:
In addition to the clinical efficacy in the pivotal trials, I’ve seen these results first-hand. I would like to share a personal story about one of my BENLYSTA patients. Her story captures the difference a treatment can make.
DR RASTOGI:
This twenty-year-old Hispanic woman had experienced recurrent flares. She was in and out of the hospital, getting biopsies and treatments. Tests had shown that her kidney function was decreasing, and that’s when she was diagnosed with class four lupus nephritis. We had to take action.
ON-SCREEN TEXT:
20-year-old female
Recurrent flares
Declining kidney function
Patient experience may not be representative of all BENLYSTA patients.
DR RASTOGI:
Our team’s decision to prescribe BENLYSTA in addition to her current treatment proved to be a game changer. Her kidney function stabilized and she experienced fewer renal flares, only one over a two-year period. During our check-ins for monitoring, the results showed improvements and she shared she was feeling better.
ON-SCREEN TEXT:
Kidney function stabilized
Fewer renal flares
Patient experience may not be representative of all BENLYSTA patients.
DR RASTOGI:
By adding BENLYSTA to existing standard therapy for lupus nephritis treatment, we may be able to help our patients preserve their kidney function.
DR SOLOMAN:
Our armamentarium for the treatment of lupus and lupus nephritis has expanded now to include biologics like BENLYSTA, and I hope to see a paradigm shift in treating our patients.
ON-SCREEN TEXT:
“Our armamentarium for the treatment of lupus and lupus nephritis has expanded now to include biologics like BENLYSTA”
ON-SCREEN TEXT:
When should BENLYSTA be considered?
DR SOLOMAN:
When treating appropriate patients with lupus, I choose to prescribe BENLYSTA earlier, after hydroxychloroquine and before immunosuppressants.
DR RASTOGI:
When treating patients with lupus nephritis, I prescribe BENLYSTA earlier as part of initial treatment.
DR RASTOGI:
I do this because I know my patients can’t wait.
ON-SCREEN TEXT:
Patients can’t wait
NARRATOR:
And now, additional Important Safety Information about 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, or 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.
ON-SCREEN TEXT:
IMPORTANT SAFETY INFORMATION (CONT’D)
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.
NARRATOR:
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 (for example, 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.
ON-SCREEN TEXT:
IMPORTANT SAFETY INFORMATION (CONT’D)
WARNINGS AND PRECAUTIONS (CONT’D)
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.
NARRATOR:
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 or caregivers to contact their HCP if they experience new or worsening depression, suicidal thoughts or 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.
ON-SCREEN TEXT:
IMPORTANT SAFETY INFORMATION (CONT’D)
WARNINGS AND PRECAUTIONS (CONT’D)
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.
NARRATOR:
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.
ON-SCREEN TEXT:
IMPORTANT SAFETY INFORMATION (CONT’D)
WARNINGS AND PRECAUTIONS (CONT’D)
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.
NARRATOR:
ADVERSE REACTIONS
The most common serious adverse reactions in adult SLE clinical trials were serious infections; some were fatal. The most common adverse reactions (greater than or equal to 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 (aged 5 years or older) and adult patients with lupus nephritis were consistent with those observed in adult SLE trials.
ON-SCREEN TEXT:
IMPORTANT SAFETY INFORMATION (CONT’D)
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.
NARRATOR:
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 at least 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, including Medication Guide, on this page.
To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
ON-SCREEN TEXT:
IMPORTANT SAFETY INFORMATION (CONT’D)
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, including Medication Guide, on this page.
To report SUSPECTED ADVERSE REACTIONS, contact GSK at https://gsk.public.reportum.com or 1-888-825-5249 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
ON-SCREEN TEXT:
Benlysta
(belimumab)
GSK
Trademarks are owned by or licensed to the GSK group of companies.
©2025 GSK or licensor.
PMUS-BELVID240028 January 2025
Produced in USA.
