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Patients can’t wait
The drivers of organ damage
DR WELLS:
Hello! My name is Doctor Alvin Wells. I’m a practicing rheumatologist in Destin, Florida.
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Dr. Alvin Wells
Rheumatologist
Destin, Florida
Paid consultant to GSK at the time of filming.
DR WELLS:
Today we’ll discuss how key factors that drive organ damage impact patients with lupus and a treatment that may be able to help them.
These days, I find that I’m having more conversations about lupus-associated organ damage and the risk of organ damage progression.
DR WELLS:
It’s important to not only consider a patient’s current health and struggles with lupus. It’s crucial that we also look ahead to what health challenges they might face tomorrow.
I let the data be my guide—it helps me to decide when to intervene and make modifications to my treatment strategy.
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"It’s crucial that we also look ahead to what health challenges they might face tomorrow."
DR WELLS:
Data plays a critical role in enhancing the care of our patients with lupus. Through monitoring and testing, it helps us identify their risks. It helps us to see exactly how our patients are doing—and guides us to evaluate the efficacy and safety of treatments in our arsenal.
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"Data play a critical role in enhancing the care of our patients with lupus."
DR WELLS:
This evidence-based approach to medicine tells us when to rethink our current treatment strategy and make changes that can benefit our patients.
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"This evidence-based approach to medicine tells us when to rethink our current treatment strategy."
DR WELLS:
Let's see what the data can tell us about lupus-related organ damage.
DR WELLS:
We are learning that organ damage in patients with lupus can increase over time.
In fact, it may increase with every year following diagnosis. And by Year 5, nearly half of the patients diagnosed with lupus might experience irreversible organ damage.
This tells us that we need to focus more on monitoring our patients and learning more about lupus related organ damage. This irreversible damage may continue to progress—hidden in silence beneath the surface.
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32% of patients within the first year of diagnosis1,2*†
~50% of patients within 5 years2*†
* Damage in SLE is defined as an irreversible tissue injury occurring after diagnosis of SLE and lasting at least 6 months. SLICC/ACR Damage Index (SDI) is the internationally agreed and validated measure of organ damage.3,4
† Cohort analysis of 298 patients followed for a minimum of 5 years by the SLICC International Research Network, comprising 27 centers from 11 countries. Year 0 represents time of enrollment. Mean age at enrollment was 35.3 years. Fifty percent of patients acquired organ damage at Year 5. Retrospective analysis of records from 401 patients (232 patients with ≥10 years of consistent follow-up) attending the University College London Hospital SLE clinic between 1978–2004. Year 0 represents time of diagnosis. Mean age at diagnosis was 31.2 years. Thirty-three percent of patients acquired organ damage at Year 5.1,2
References: 1. Chambers SA, et al. Rheumatology (Oxford). 2009;48(6):673-675. 2. Urowitz MB, et al. Arth Care Res (Hoboken). 2012;64(1):132-137. 3. Doria A, et al. Autoimmun Rev. 2014;13(7):770-777. 4. Gladman D, et al. Arthritis Rheum. 1996;39(3):363-369
DR WELLS:
It’s time for us to dive deeper and uncover what may be causing this irreversible organ damage.
DR WELLS:
Lupus disease activity, flares and the chronic use of high-dose steroids are common drivers of organ damage.
It is vital for our patients that we identify a treatment that may impact these drivers of organ damage.
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Lupus disease activity1
Flares1
Chronic use of high-dose steroids1
Reference: 1. Doria A, et al. Autoimmune Rev. 2014;13(7):770-777.
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.
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How could treatment with BENLYSTA impact these drivers of organ damage?
DR WELLS:
Let’s discuss how BENLYSTA impacts these drivers of organ damage, starting with disease activity. In fact, BENLYSTA has been proven to reduce lupus symptoms across its pivotal trials. When BENLYSTA was added to standard therapy, up to 61% of patients significantly reduced lupus disease activity.
Data were derived from three Phase 3, double-blind, placebo-controlled studies conducted in over 2500 adult patients with active SLE and were randomized to BENLYSTA plus standard therapy or placebo plus standard therapy.
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Proven to reduce symptoms of lupus1-3*
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.
There were no statistically significant differences between treatment groups in any trial.
* 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).
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 WELLS:
The primary endpoint in these studies was the SRI-4 response rate at Week 52.
The SRI-4 has components that must be met for patients to be considered responders. These include at least 4-point reduction in the SELENA SLEDAI score, no new BILAG A or no more than 1 new BILAG B domain scores, and no worsening from baseline in Physician's Global Assessment by 0.3 points or more.
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SRI-4 at Week 521-3
To be considered responders, patients must meet all 3 components:
- SELENA-SLEDAI: ≥4-point reduction
- BILAG: No new BILAG A or <2 new BILAG B organ domain scores
- PGA: No worsening of ≥0.30 points
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 WELLS:
Lupus disease flares are also a key driver of organ damage.
We must consider treatment options that may provide protection against severe flares for your patients with lupus.
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Lupus disease flares are also a key driver of organ damage
DR WELLS:
Adding BENLYSTA to your patient's standard therapy may help reduce the risk of severe flares.
Data from the pivotal trials demonstrated that patients who received BENLYSTA plus standard therapy showed up to 49% reduction in the risk of severe flares over 52 weeks. Compared to standard therapy alone, fewer patients experienced severe flares when BENLYSTA was added to standard therapy.
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Up to 49% reduced risk of severe flares over 52 weeks1-3*†
Patients having ≥1 severe flare over 52 weeks1-3
[VISUAL: TABLE PATIENTS HAVING ≥1 SEVERE FLARES OVER 52 WEEKS]
Reduction of severe flares was not significant in BLISS-76.
* As measured by the SFI, modified to exclude the single criterion of increased SELENA-SLEDAI score to >12.
† The incidence of severe flare over 52 weeks was a secondary endpoint.
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. 4. Data on File, GSK.
DR WELLS:
We're also aware that the chronic use of high-dose steroids can cause organ damage. It’s important to look at ways to lower a patient’s steroid dose, without compromising on efficacy.
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Look at ways to lower a patient’s steroid dose
DR WELLS:
Adding BENLYSTA to a patient’s standard treatment has been shown to reduce the use of steroids. Approximately 1 in 5 patients were able to reduce their steroid dose by 25% or more to 7.5 mg/day or less at Week 52 in their lupus clinical trials.
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Proven to reduce steroid dose1-3*†
Approximately 1 in 5 patients reduced their steroid dose by ≥25% to ≤7.5 mg/day at Week 52
[ON-SCREEN VISUAL – TABLE]
There were no statistically significant differences between treatment groups in any trial.
* In patients who were receiving >7.5 mg/day at baseline. Overall, 60%, 69%, and 46% of patients were receiving doses >7.5 mg/day at baseline in BLISS-SC, BLISS-52, and BLISS-76, respectively.
† In BLISS-SC, BLISS-52, and BLISS-76, this was a secondary endpoint evaluating steroid dose reduction during Weeks 40–52.1-3
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 WELLS:
BENLYSTA plus standard therapy was assessed in a real-world study to measure the changes in steroid dose at 6-month intervals over a 24-month period.
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OBSErve real-world, observational cohort study1
2 years in US clinical practices1
Real-world, observational cohort study, results are descriptive.
Study Design: An observational cohort study assessed the effectiveness of BENLYSTA 10 mg/kg + ST (standard therapy) in adult patients with SLE over a 24-month period in US clinical practices across 27 states and included 92 rheumatologists (N=501). To qualify for enrollment, patients were required to have at least 8 infusions of BENLYSTA. The baseline was the date of first infusion. Physician-assessed clinical response was reviewed at 6-month intervals using medical charts and data collected using case report forms.1
Key Limitations: Lack of control group, risk of selection bias, validated disease assessment tool not consistently used, patient attrition, potential measurement error based on non-uniform categorization or interpretation of disease severity and treatment response, and reasons for change in steroid dose were not captured and may be unrelated to disease improvement/worsening.1
Reference: 1. Collins CE, et al. Lupus Sci Med. 2016;3(1):e000118.
DR WELLS:
The study showed that, by Week 26, 86% of patients who had received BENLYSTA had reduced or discontinued steroids.
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86% of patients reduced or discontinued steroids at Week 261,2*
Data from US patients prescribed steroids at baseline (n=386) ITT, LOCF†‡
[ON-SCREEN VISUAL – TABLE]
Real-world, observational cohort study, results are descriptive.
* Reasons for change in steroid dose were not captured and may be unrelated to disease improvement/worsening.
† Intent-to-treat (ITT) consisting of all patients enrolled at baseline followed through 24 months using the last observation carried forward (LOCF) method to account for patients who were lost to follow-up and/or discontinued BENLYSTA during follow-up.
‡ Total percentage may not add up to 100% due to rounding.
References: 1. Data on File, GSK. 2. Collins CE, et al. Lupus Sci Med. 2016;3(1):e000118.
DR WELLS:
I had this patient in my practice, a 30-year-old woman who had just started a new job while battling lupus.
She came to me feeling overwhelmed, as she had been experiencing frequent flares and even ended up in the emergency room multiple times.
When I first saw her, it was clear that she needed a more aggressive treatment plan. She was already on hydroxychloroquine and steroids, but it was evident that, in her case, these were not enough to control her symptoms. It wasn't just the physical symptoms, like alopecia and sores in her nose and mouth, that concerned me. It was also her extreme fatigue and pain from recurring flares.
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30-year-old female
Frequent flares
Emergency room visits
Patient experience may not be representative of all BENLYSTA patients.
DR WELLS:
I knew that it was time to make a change for her and to try disrupt the cycle of frequent flares. Her risk of organ damage due to persistent disease activity and high-dose steroids were also top of mind.
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Potential organ damage
High steroid dose
Patient experience may not be representative of all BENLYSTA patients.
DR WELLS:
By starting her on BENLYSTA, we were able to effectively manage her symptoms and help her to experience fewer severe flares. I am proud to say that this patient is better now. Her primary focus now is succeeding in her job and remodeling her apartment, and not the burden of another flare.
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Patient experience may not be representative of all BENLYSTA patients.
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Can the impact of BENLYSTA on these drivers help to address the progression of organ damage?
DR WELLS:
Let’s take a look at BENLYSTA and its organ damage progression data. The results of a real-world post hoc analysis showed that organ damage progression with BENLYSTA plus standard therapy was less than half of standard therapy alone at Year 5. The effects of BENLYSTA, when added to standard therapy, may help to slow organ damage progression in patients with lupus.
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Reduction of organ damage progression based on mean change in organ damage (SDI) from baseline to Year 5* (primary endpoint)
[ON-SCREEN VISUAL – GRAPH]
For patients on BENLYSTA + ST, organ damage progression was less than half of ST alone1
Real-world, post hoc, propensity score-matched analysis. Results are descriptive.
Key limitations: Post hoc analysis, patients were matched based on known variables only, patients could not be matched by year of entry into the study, and differences in patient populations.1
* Includes all patients with ≥5 years of follow-up.
SDI = SLICC/ACR Damage Index; TLC = Toronto Lupus Cohort.
Reference: 1. Urowitz MB, et al. Ann Rheum Dis. 2019;78(3):372-379.
DR WELLS:
These results were from a post hoc, propensity score-matched comparative analysis performed to assess the difference in organ damage progression between patients in the BLISS-76 long-term extension trial and from the Toronto Lupus Cohort. Key limitations of this study are that it was a post hoc analysis, patients were matched based on known variables only, patients could not be matched by year of entry into the study, and there were differences in patient populations.
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Real-world analysis: study design1
A post hoc, propensity score-matched comparative analysis was performed to assess the difference in organ damage (SDI) progression between patients in BLISS-76 LTE* and from the TLC.†
[ON-SCREEN VISUAL – GRAPHIC]
Key limitations of this PSM study
- Post hoc analysis
- Patients matched based on known variables only
- Patients could not be matched by year of entry into the study
- Differences in patient populations
Results are descriptive.
* To be eligible, patients on BENLYSTA had to be in the United States; regimen was BENLYSTA IV 10 mg/kg + ST.
† Chosen based on its size, the extent of organ damage in patients and severity of disease activity. The regimen was ST alone.
LTE = long-term extension; PSM = propensity score matching.
Reference: 1. Urowitz MB, et al. Ann Rheum Dis. 2019;78(3):372-379.
DR WELLS:
When I think of what treatment regimen would benefit my patients for the long-term, I look at how that treatment can impact drivers of organ damage.
BENLYSTA is a proven treatment that impacts these drivers. That’s why, for my appropriate patients, I add BENLYSTA earlier to their treatment regimens. More specifically, after hydroxychloroquine and before immunosuppressants.
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"I add BENLYSTA earlier, after hydroxychloroquine and before immunosuppressants."
DR WELLS:
It’s important to remember that time is of the essence to help your patients with lupus in your practice. Patients and their organs 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 https://gsk.public.reportum.com 1-888-825-5249 or the 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-BELVID240025 January 2025
Produced in USA.
