Organ damage from lupus may be putting your patients at risk1,2

See how BENLYSTA + ST may impact organ damage progression.

DISCOVER HOW

In pivotal lupus trials, BENLYSTA demonstrated significant disease activity reduction (SRI-4) at Week 521-3

In pivotal Phase III lupus trials, the primary endpoint was defined as SRI-4 response rate at Week 52. The SRI-4 response rate at Week 52 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

VIEW EFFICACY DATA

For patients on BENLYSTA + ST

80%

had no change in organ damage score over 7-8 years

of treatment4

Post hoc analysis of pooled data from 3 open-label LTE studies (Phase II LTE, BLISS-76 LTE, and BLISS-52 + BLISS-76 LTE). Results are descriptive. See study design.

See data limitations.

See the impact of BENLYSTA on long-term organ damage progression.

For patients on BENLYSTA + ST, organ damage progression was

less than half

of that on ST alone5

Real-world, post hoc, propensity score-matched analysis. Results are descriptive. See study design.

See data limitations.

Learn more about reduction of organ damage progression.

BLISS = Belimumab International SLE Study; LTE = long-term extension; SC = subcutaneous; SLE = systemic lupus erythematosus; SRI = SLE Responder Index; ST = standard therapy.

The long-term impact of BENLYSTA + ST on organ damage progression over 7-8 years4

Patients with no change in SDI score from baseline

80% of patients were observed to have no change in organ damage score over 7-8 years of treatment with BENLYSTA + ST

Post hoc analysis of pooled data from 3 open-label LTE studies (Phase II LTE, BLISS-76 LTE, and BLISS-52 + BLISS-76 LTE). Results are descriptive. See study design.

See data limitations.

SDI = SLICC/ACR Damage Index; SLICC/ACR = Systemic Lupus International Collaborating Clinics/American College of Rheumatology.

Reduction of organ damage progression5

The impact of BENLYSTA was evaluated in a real-world analysis of organ damage progression.

Reduction of organ damage progression based on mean change in organ damage (SDI) from baseline to Year 5* (primary endpoint)

Real-world evidence: organ damage progression on BENLYSTA + ST was observed to be less than half of that on ST alone

Real-world, post hoc, propensity score-matched analysis. Results are descriptive. See study design.

See data limitations.

* Includes all patients with ≥5 years of follow-up.
TLC = Toronto Lupus Cohort.

Time to organ damage progression5

Patients treated with BENLYSTA + ST were less likely to progress to a higher organ damage score over any given year of follow-up5

Difference in time to organ damage progression*

Real-world evidence: as early as Year 1, more patients on BENLYSTA + ST were observed to have no change in their SDI score

Adapted from Urowitz MB et al. Ann Rheum Dis. 2019;78(3):372-379. © 2019 BMJ Publishing Group Ltd. Reprinted with permission from BMJ Publishing Group Ltd.

Real-world, post hoc, propensity score-matched analysis. Results are descriptive. See study design.

See data limitations.

* Time to organ damage progression was a secondary endpoint, assessed in patients with ≥1 year of follow-up.

† Years are 48 weeks in length.
CI = confidence interval; HR = hazard ratio; KM = Kaplan-Meier.

Reduction in rate of organ damage progression5

Annual probability of progression is based on the increase in SDI score per year (secondary endpoint)

Real-world evidence: patients on BENLYSTA + ST were observed to be 61% less likely to progress to a higher organ damage score (SDI) (HR=0.39; 95% CI: 0.25, 0.61)

Real-world, post hoc, propensity score-matched analysis. Results are descriptive. See study design.

See data limitations.

* Based on SDI score increases per year in patients with ≥1 year follow-up.

Persistent disease activity, including flares and chronic high-dose steroid use, are some of the drivers of organ damage.1,2,6-10

SEE HOW BENLYSTA IMPACTS THESE DRIVERS

Did you know?
Organ damage in lupus can be severe and irreversible

1 in 3 patients

experience irreversible organ damage within 1 year of diagnosis6,9*†‡

1 in 2 patients

experience irreversible organ damage within 5 years of diagnosis6,9*†‡

  • *

    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.10,11

  • †

    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 5.6

  • ‡

    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. Nearly 50% of patients acquired organ damage at Year 5.9

Organ damage in patients with lupus can affect multiple organ systems12

Damage most commonly occurs in the mucocutaneous, musculoskeletal, and immune systems.

Constitutional

Respiratory

Hematological

Kidney

Dermatological

Musculoskeletal

Circulatory

Gastrointestinal

List of organ systems is not all inclusive.

Select overarching principle from the 2023 EULAR recommendations:

Assess lupus disease activity at each clinic visit and evaluate organ damage at least annually, using validated instruments (frequency for both at physician’s discretion).13

SEE EULAR RECOMMENDATION

EULAR = European Alliance of Associations for Rheumatology.

Hear the story of a patient experiencing organ damage*

* Hypothetical patient profile. Not representative of all BENLYSTA patients.

MEET MARIA

Learn more

BENLYSTA for lupus

BENLYSTA improved key clinical outcomes for appropriate patients.

SEE EFFICACY DATA

Safety profile

Well-established safety profile based on the largest clinical trial program in lupus and lupus nephritis.

SEE SAFETY DATA

Can the progression of organ damage be slowed in your patients with lupus?

SEE WHAT BENLYSTA COULD DO

Indication & Safety Info

Indication

Important Safety Information

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.

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 gsk.public.reportum.com or 1-888-825-5249, or
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References

  1. Navarra SV, Guzmán RM, Gallacher AE, et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet. 2011;377(9767):721-731.

  2. Furie R, Petri M, Zamani O, et al. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheumatol. 2011;63(12):3918-3930.

  3. Stohl W, Schwarting A, Okada M, et al. Efficacy and safety of subcutaneous belimumab in systemic lupus erythematosus: a fifty-two–week randomized, double-blind, placebo-controlled study. Arthritis Rheumatol. 2017;69(5):1016-1027.

  4. Touma Z, Arriens C, Henning C, et al. SLE medication usage and organ damage among adult SLE patients with SLE treated with belimumab (BEL): pooled data from three open-label extension studies over 11+ years [abstract]. Arthritis Rheumatol. 2023;75(Suppl 9).

  5. Urowitz MB, Oshfeldt RL, Wielage RC, et al. Organ damage in patients treated with belimumab versus standard of care: a propensity score-matched comparative analysis. Ann Rheum Dis. 2019;78(3):372-379.

  6. Chambers SA, Allen E, Rahman A, et al. Damage and mortality in a group of British patients with systemic lupus erythematosus followed up for over 10 years. Rheumatology (Oxford). 2009;48:673-675.

  7. 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. Rheum. 2012;51(3):491-498.

  8. Gladman DD, Urowitz MB, Rahman P, et al. Accrual of organ damage over time in patients with systemic lupus erythematosus. J Rheumatol. 2003;30(9):1955-1959.

  9. Urowitz MB, Gladman DD, Ibañez D, et al. Evolution of disease burden over five years in a multicenter inception systemic lupus erythematosus cohort. Arth Care Res. 2012;64(1):132-137.

  10. Doria A, Gatto M, Zen M, et al. Optimizing outcome in SLE: treating-to-target and definition of treatment goals. Autoimmun Rev. 2014;13(7):770-777.

  11. Gladman D, Ginzler E, Goldsmith C, et al. The development and initial validation of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index for systemic lupus erythematosus. Arthritis Rheumatol. 1996;39(3):363-369.

  12. Aringer M, Johnson SR. Classifying and diagnosing systemic lupus erythematosus in the 21st century. Rheumatology (Oxford). 2020;59(Suppl5):v4-v11.

  13. Fanouriakis A, Kostopoulou M, Andersen J, et al. EULAR recommendations for the management of systemic lupus erythematosus: 2023 update. Ann Rheum Dis. 2024;83(1):15-29.