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Patients can’t wait
Treating today with tomorrow in mind
DR LAM:
Hello. My name is Dr. Gordon Lam and I’m a practicing rheumatologist in Charlotte, North Carolina.
Today, we’ll talk about the long-term efficacy data and safety profile of a biologic treatment for lupus.
ON-SCREEN TEXT:
Dr. Gordon Lam
Rheumatologist
Charlotte, North Carolina
Paid consultant to GSK at the time of filming.
DR LAM:
It’s common for a patient to feel like their lupus is out of their control. As healthcare professionals, we aim to give our patients the best chance possible to control their disease.
I factor in a patient’s future when I consider their treatment. I make treatment choices that are an investment today and may continue to deliver for patients over the long-term.
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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 LAM:
In my practice, when prescribing a biologic, I consider BENLYSTA to be my go-to for my patients with lupus.
If you think about our need to reduce disease activity early on and reduce organ damage progression, it becomes so obvious to use a proactive and appropriate approach to treatment. Adding a biologic before an immunosuppressant is supported by the guidelines and backed by the clinical evidence of BENLYSTA.
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Use a proactive and appropriate approach.
DR LAM:
The BLISS pivotal trials give us a window into the efficacy and safety of BENLYSTA. In these trials, BENLYSTA has been proven to reduce lupus symptoms. Up to 61% of patients achieved an SRI-4 response rate at Week 52.
Data derived from 3 Phase III, double-blinded studies conducted in more than 2500 adult patients with active SLE who were randomized to receive BENLYSTA plus standard therapy or placebo plus standard therapy.
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Up to 61% of patients had reduced lupus symptoms at Week 521*
The SRI-4 response rate at Week 52 (primary endpoint) for BENLYSTA + ST vs placebo + ST was 61% (n=554) vs 48% (n=279) for BLISS-SC, 58% (n=290) vs 44% (n=287) for BLISS-52, and 43% (n=273) vs 34% (n=275) for BLISS-76,† P<0.05 for each.1-3
*In the IV trials, BENLYSTA 10 mg/kg, BENLYSTA 1 mg/kg, or placebo was administered by IV infusion over 1 hour on Days 0, 14, and 28 and at 4-week intervals thereafter through Week 52 in BLISS-52 (N=839) or Week 76 in BLISS-76. In BLISS-SC (N=867), patients received weekly doses of subcutaneous BENLYSTA 200 mg or placebo for 52 weeks. BENLYSTA 1 mg/kg is not an approved dose and is not included in data shown.
† In BLISS-76 (N=819), the difference in SRI-4 response rates was not significantly different at Week 76 (secondary endpoint).
BLISS = Belimumab International SLE Study; IV = intravenous; SC = subcutaneous; SLE = systemic lupus erythematosus; SRI = SLE Responder Index; ST = standard therapy.
References: 1. Navarra SV, et al. Lancet. 2011;377(9767):721-731. 2. Furie R, et al. Arthritis Rheum. 2011;63(12):3918-3930. 3. Stohl W, et al. Arthritis Rheumatol. 2017;69(5):1016-1027.
DR LAM:
In the BLISS clinical trials, how early was a response seen with BENLYSTA?
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How early was a response seen with BENLYSTA?
DR LAM:
In a pooled post hoc analysis of 5 studies, 38% of patients had reduced lupus symptoms versus standard therapy as early as Week 8.
While some patients may see results after 8 weeks, they should plan to commit to treatment for 6 to 9 months to see the effect of BENLYSTA on their lupus. When I prescribe BENLYSTA for a patient I make sure that they keep this in mind.
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EARLY RESPONSE DATA
38% of patients had reduced lupus symptoms vs ST as early as Week 81*†
Be-SLE post hoc pooled analysis. Results are descriptive.
* Five randomized, controlled efficacy and safety studies included: BLISS-52, BLISS-76, NE Asia, BLISS-SC, EMBRACE. The primary endpoint (SRI-S2K at Week 52) was not met in EMBRACE.2
† Individual studies were not designed to establish onset of effect, and not all studies showed improvement at Week 8.
EMBRACE = Efficacy and Safety of Belimumab in Adult Subjects of Black Race;
NE = northeast; SRI-S2K = SLE Responder Index (SRI) response rate with the modified SLEDAI-2K (S2K) scoring for proteinuria.
References: 1. Data on File, GSK. 2. Ginzler E, et al. Arthritis Rheumatol. 2022;74(1):112-123.
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How has BENLYSTA demonstrated sustained response?
DR LAM:
We know lupus is a chronic disease, and for our patients, tomorrow is as important as today. Therefore, it’s important to see long-term data with our treatments.
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“Tomorrow is as important as today.”
DR LAM:
One of the things that has really become apparent across many diseases, not just lupus, is how treatment longevity is critical for our patients. Patients want to know the long-term results to feel confident with their medications.
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“Treatment longevity is critical for our patients.”
DR LAM:
Let’s see what the long-term data of BENLYSTA demonstrates.
DR LAM:
In the US open-label extension of the BLISS-76 study we saw the rate of SRI-4 responders over time; 76% of patients who continued on BENLYSTA were able to have a response at 7 years.
I see BENLYSTA as a key part of my therapeutic toolkit that I can utilize throughout various stages of my patients’ care.
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SUSTAINED RESPONSE DATA
SRI-4 responders over 7 years1*
[ON-SCREEN VISUAL – GRAPH PRESENTING SRI-R RESPONDERS OVER 7 YEARS]
76% of patients achieved SRI-4 at Year 71*
Used with permission from Furie RA, et al. Arthritis Rheumatol. 2018;70(6):868-877.
© 2018 John Wiley and Sons.
Results are descriptive. Other efficacy endpoints. Exploratory results should be interpreted with additional care.
Key limitations:
- Open-label design with lack of comparator arm
- Pooled dosage groups
- Selection bias and response bias may be present
- Small group of patients at later time points
*US open-label extension of the BLISS-76 study that included 268 patients. Patients who received placebo in BLISS-76 received 10 mg/kg BENLYSTA in the LTE study, and patients who received BENLYSTA continued to receive the same dose (1 or 10 mg/kg IV every 28 days) plus standard therapy. Following a protocol amendment in March 2011, patients receiving 1 mg/kg BENLYSTA had their dose increased to 10 mg/kg.
Reference: 1. Furie RA,
et al. Arthritis Rheumatol. 2018;70(6):868-877.
DR LAM:
Safety profiles are important to me when I prescribe a treatment to my patients.
Some reasons I prescribe BENLYSTA are because it has the most comprehensive clinical trial program in lupus, was studied in a large number of patients, has multiple years of real-world clinical experience, and has a well-established safety profile.
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Most comprehensive clinical trial program in lupus1-7
7000+ patients1-7
11+ years1-7
Well-established safety profile1-7
References: 1. Brunner HI, et al. Ann Rheum Dis. 2020;79(10):1340-1348. 2. Furie R, et al. Arthritis Rheum. 2011;63(12):3918-3930. 3. Furie R, et al. N Engl J Med. 2020;383(12):1117-1128. 4. Ginzler E, et al. Arthritis Rheumatol. 2022;74(1):112-123. 5. Navarra SV, et al. Lancet. 2011;377(9767):721-731. 6. Sheikh SZ, et al. Lancet Rheumatol. 2021;3(2):E122-E130. 7. Stohl W, et al. Arthritis Rheumatol. 2017;69(5):1016-1027.
DR LAM:
In addition to that, BENLYSTA was also assessed in a long-term safety study where the rate of treatment-emergent adverse events remained stable over 7 years.
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Safety observed over 7 years
Primary endpoint safety results at any time post-baseline (N=268)1
In the pivotal trials of adult patients with SLE, the most common serious adverse reactions were serious infections; some were fatal. The most common adverse reactions (≥5%) were nausea (15% vs 12%), diarrhea (12% vs 9%), pyrexia (10% vs 8%), nasopharyngitis (9% vs 7%), bronchitis (9% vs 5%), insomnia (7% vs 5%), pain in extremity (6% vs 4%), depression (5% vs 4%), migraine (5% vs 4%), pharyngitis (5% vs 3%), and injection site reactions (6.1% vs 2.5% for the subcutaneous injection) for BENLYSTA vs placebo, respectively.
AE = adverse event; SAE = serious adverse event.
Reference: 1. Furie RA, et al. Arthritis Rheumatol. 2018;70(6):868-877.
DR LAM:
I started prescribing BENLYSTA as soon as it got approved. My first BENLYSTA patient has a remarkable story.
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Patient experience may not be representative of all BENLYSTA patients.
DR LAM:
When this woman came to us, she was 27 years old and she had been struggling with severe symptoms such as alopecia, oral ulcers, arthritis, and malar rash. Despite not having lupus nephritis, she was on an extensive multiple treatment regimen that included steroids, hydroxychloroquine, mycophenolate, azathioprine, and dapsone.
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27-year-old female
Severe symptoms
Multiple treatment regiment
Patient experience may not be representative of all BENLYSTA patients.
DR LAM:
I had heard about BENLYSTA and had seen the promising data and clinical evidence. I wanted to see if it could help her.
I added BENLYSTA to her treatment regimen and, over time, optimized her overall treatment. Thirteen years later, she is still doing very well. She is on a regimen of hydroxychloroquine and BENLYSTA, and is very adamant about staying on BENLYSTA because of how it has worked for her.
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“13 years later, she is still doing very well. She is on a regimen of hydroxychloroquine and BENLYSTA.”
Patient experience may not be representative of all BENLYSTA patients.
DR LAM:
This is just one of the many successes I’ve had over the years with BENLYSTA.
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Patient experience may not be representative of all BENLYSTA patients.
DR LAM:
The wealth of clinical and safety data of BENLYSTA over the long term has helped to make it a key part of my treatment toolkit.
We must remember that lupus is a lifelong disease. The time is now to offer your patients a treatment option that can help support their needs today and also in the future.
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“The wealth of clinical and safety data of BENLYSTA over the long term has helped to make it a key part of my treatment toolkit.”
DR LAM:
Your patients are not only facing a battle against lupus, they’re also facing a battle against time. Our goal is to help patients get in control of their disease activity as quickly as possible and to help them achieve sustained long-term results.
Choose BENLYSTA for your appropriate patients. Because patients can’t wait.
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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.
ON-SCREEN TEXT:
Benlysta
(belimumab)
GSK
Trademarks are owned by or licensed to the GSK group of companies.
©2025 GSK or licensor.
PMUS-BELVID240027 January 2025
Produced in USA.
