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Patients can’t wait
A discussion about the most recent treatment guidelines and recommendations
DR MIZELLE:
Hello! My name is Doctor Kristi Mizelle. I’m a practicing rheumatologist in Newport News, Virginia.
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Dr. Kristi Mizelle
Rheumatologist
Newport News, Virginia
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 how the treatment guidelines and recommendations support the early use of biologics.
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Dr. Anjay Rostogi
Nephrologist
Los Angeles, California
Paid consultant to GSK at the time of filming.
DR MIZELLE:
We are always looking for ways to improve the treatment and outcomes for patients with lupus and lupus nephritis.
DR MIZELLE:
Considering advances since the last EULAR recommendations in 2020 and KDIGO guidelines in 2021, the latest guidance can help you see treatment options for your patients in a new light.
Lupus is a chronic disease that can get away from you very quickly—becoming more severe over time.
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Help you to see treatment options for your patients in a new light.
DR MIZELLE:
I’m pleased to see the shift in the guidelines toward a more aggressive treatment approach for lupus, taking into account the risks patients face with irreversible organ damage and chronic kidney disease.
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“I’m pleased to see the shift in the guidelines toward a more aggressive treatment approach for lupus, taking into account the risks patients face with irreversible organ damage and chronic kidney disease.”
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Benlysta
(belimumab)
Intravenous Use 120 mg/vial
Subcutaneous Use 200 mg/mL
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.
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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 MIZELLE:
Let’s dive deeper into what the 2023 EULAR recommendations say and see how BENLYSTA may fit into your treatment strategy.
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Key takeaways from the 2023 EULAR recommendations
EULAR = European Alliance of Associations for Rheumatology.
DR MIZELLE:
The recommendations for the management of lupus support the use of biologics like BENLYSTA earlier in the treatment process. If your patient isn’t responding to hydroxychloroquine, alone or with steroids, or if it’s not possible to taper the steroid dose to an acceptable dose for chronic use, it’s time to consider adding a biologic, such as BENLYSTA.
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EULAR now supports the use of biologics, such as anifrolumab or BENLYSTA, right after HCQ1*:
- If not responding to HCQ (alone or with steroids)
- Or, if unable to taper steroid dose to an acceptable dose for chronic use
These are only select recommendations, not the complete EULAR recommendations.
* For patients with severe neuropsychiatric disease, anifrolumab and belimumab are not recommended.
HCQ = hydroxychloroquine.
Reference: 1. Fanouriakis A, et al. Ann Rheum Dis. 2024;83(1):15-29.
DR MIZELLE:
We all know how important it is to minimize a patient’s steroid dose when possible. The recommendations suggest maintaining your patients on a steroid dose no higher than 5 mg/day, and when it’s possible, aim for no steroids.
Keep in mind that chronic and long-term use of high-dose steroids is a key driver of organ damage in lupus.
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- Maintenance steroid dose should be ≤5 mg/day1
- And when possible, withdrawn1
These are only select recommendations, not the complete EULAR recommendations.
Reference: 1. Fanouriakis A, et al. Ann Rheum Dis. 2024;83(1):15-29.
DR MIZELLE:
Notably, the recommendations advise an annual assessment for organ damage…
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The 2023 EULAR recommendations advise an annual evaluation for organ damage1
Reference: 1. Fanouriakis A, et al. Ann Rheum Dis. 2024;83(1):15-29.
DR MIZELLE:
…and also recognized the extensive real-world clinical experience with BENLYSTA, spanning more than a decade.
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The 2023 EULAR recommendations acknowledge that1:
BENLYSTA has more than 10 years of real-life clinical experience in lupus
Reference: 1. Fanouriakis A, et al. Ann Rheum Dis. 2024;83(1):15-29.
DR MIZELLE:
Let’s have a look at the EULAR recommendations for lupus nephritis.
The key takeaway is that BENLYSTA should be considered as part of the initial treatment for all patients with active proliferative lupus nephritis.
Not only that, but patients should continue treatment for at least 3 years following renal response.
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For patients with active proliferative lupus nephritis1:
- Add BENLYSTA or CNIs as part of initial treatment*†
- Following renal response, continue this treatment for at least 3 years
These are only select recommendations, not the complete EULAR recommendations.
* BENLYSTA should always be given in combination with MMF or low-dose CYC and glucocorticoids.
† CNIs should be given in combination with MMF and glucocorticoids.
CNI = calcineurin inhibitor; CYC = cyclophosphamide; MMF = mycophenolate mofetil.
Reference: 1. Fanouriakis A, et al. Ann Rheum Dis. 2024;83(1):15-29.
DR MIZELLE:
Our approach to using BENLYSTA has evolved significantly over the years.
The use of BENLYSTA has shifted earlier and earlier—previously it would only be prescribed after immunosuppressant therapy. But today, we can prescribe BENLYSTA earlier, right after hydroxychloroquine.
As physicians, it’s important to embrace this change so that we can have the best possible regimen at our disposal for our patients.
DR MIZELLE:
I hope that more physicians align themselves to the latest guidelines and decide to adopt a more proactive approach to treatment.
DR MIZELLE:
We can’t wait around to see symptoms dramatically worsen or organ damage to occur before intervening.
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We can’t wait
DR RASTOGI:
Now, let’s look at the latest 2024 KDIGO guidelines for lupus nephritis and how they support early use of BENLYSTA in the treatment of lupus nephritis.
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What are the latest KDIGO guidelines for managing lupus nephritis?
KDIGO = Kidney Disease Improving Global Outcomes.
DR RASTOGI:
The guidelines included BENLYSTA as an option for initial treatment of lupus nephritis.
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2024 KDIGO guidelines1
Patients with active Class III or IV lupus nephritis, with or without a membranous component, be treated initially with glucocorticoids, plus either one of the following1:
MPAA (1B); or
Low-dose IV CYC (1B); or
BENLYSTA and either MPAA or low-dose IV CYC (1B); or
MPAA and a CNI when kidney function is not severely impaired (1B)*
These are only select recommendations, not the complete KDIGO guidelines.
* When eGFR is ≤45 mL/min/1.73 m2.
eGFR = estimated glomerular filtration rate; IV = intravenous.
Reference: 1. Kidney Disease: Improving Global Outcomes. Kidney Int. 2024;105(Suppl 1S):S1-S69.
DR RASTOGI:
When it comes to triple immunosuppressive regimens, the guidelines offer advice on how BENLYSTA can be included.
For patients with repeated kidney flares or who are at risk for progression to kidney failure due to severe chronic kidney disease, a triple immunosuppressive regimen including BENLYSTA is recommended.
Once on BENLYSTA or a CNI plus two other immunosuppressants, maintain this triple therapy for 2 to 3 years.
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Regarding triple immunosuppressive regimens1:
- BENLYSTA + glucocorticoids + MPAA or reduced-dose cyclophosphamide may be preferred in patients with repeated kidney flares or at high-risk for progression to kidney failure due to severe chronic kidney disease
- Patients treated with triple immunosuppressive regimens that include BENLYSTA or a CNI in addition to standard Immunosuppressive therapy can continue with a triple immunosuppressive regimen as maintenance therapy
These are only select recommendations, not the complete KDIGO guidelines.
Reference: 1. Kidney Disease: Improving Global Outcomes. Kidney Int. 2024;105(Suppl 1S):S1-S69.
DR RASTOGI:
I hope that physicians use these guidelines to move from a reactive to a proactive approach and act with more urgency.
DR MIZELLE:
These recommendations and guidelines clearly highlight the approach experts have taken with adding BENLYSTA earlier after hydroxychloroquine in lupus and as part of initial treatment in lupus nephritis.
One thing is clear.
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[CHECKMARK] Add BENLYSTA after HCQ in patients with lupus1*
[CHECKMARK] Add BENLYSTA as part of initial therapy in patients with lupus neprhitis1,2
These are only select recommendations, not the complete EULAR recommendations or KDIGO guidelines.
* As part of standard therapy.
References: 1. Fanouriakis A, et al. Ann Rheum Dis. 2024;83(1):15-29. 2. Kidney Disease: Improving Global Outcomes. Kidney Int. 2024;105(Suppl 1S):S1-S69.
DR RASTOGI:
For both lupus and lupus nephritis, treatment should not be delayed, due to the state of urgency.
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It’s time to act
DR RASTOGI:
Because patients can’t wait. Consider how you can enhance your treatment strategy now.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Benlysta
(belimumab)
GSK
Trademarks are owned by or licensed to the GSK group of companies.
©2025 GSK or licensor.
PMUS-BELVID240026 January 2025
Produced in USA.
