Because you know what is at stake

BENLYSTA EARLY*

*Add BENLYSTA to standard therapy—when HCQ alone isn’t enough in SLE and as part of initial therapy in LN.

See the effect of BENLYSTA + ST vs placebo + ST on SRI-4, severe flares, and steroid dose at Week 52. Effects on disease activity were primarily related to the most commonly involved organ systems. In the pivotal studies, there were no statistically significant differences in steroid dose reduction between groups.

HCQ = hydroxychloroquine; LN = lupus nephritis; SLE = systemic lupus erythematosus; SRI = SLE Responder Index; ST = standard therapy.

The only biologic in lupus and lupus nephritis backed by over a decade of comprehensive clinical and real-world evidence

In clinical trials, BENLYSTA was proven to reduce lupus symptoms in patients with lupus

Up to 61% of patients

had reduced disease activity (SRI-4) at Week 521-3†

See our primary endpoint

SEE LUPUS SYMPTOM DATA

Could BENLYSTA help your patients with lupus?

Organ damage

Can BENLYSTA help slow organ damage progression for your patients?

SEE ORGAN DAMAGE PROGRESSION DATA

Steroids

Can BENLYSTA help your patients with lupus reduce their steroid dose?

SEE LUPUS STEROID DATA

Backed by recommendations

BENLYSTA is recommended by EULAR as a treatment option for your patients with lupus.4

SEE THE RECOMMENDATIONS

For patients with lupus nephritis, add BENLYSTA as part of initial therapy

In a clinical trial, BENLYSTA was proven to improve complete renal response in patients with lupus nephritis

74% more likely

to achieve complete renal response (renal remission) (secondary endpoint)5,6

(OR=1.74; 95% CI: 1.11, 2.74; P=0.0167)

View details behind this data

SEE LUPUS NEPHRITIS DATA
  • †SRI-4 response rate at Week 52 (primary endpoint).
  • BLISS-LN = Belimumab International Study in Lupus Nephritis; BLISS-SC = Belimumab International SLE Study-Subcutaneous; CI = confidence interval; CRR = complete renal response; EULAR = European Alliance of Associations for Rheumatology; OR = odds ratio; SLE = systemic lupus erythematosus; SRI = SLE Responder Index; ST = standard therapy.

Is it time to rethink your lupus nephritis treatment goals?

Renal remission

Could BENLYSTA help patients achieve renal remission?

Renal remission is defined here as complete renal response (CRR) and was a secondary endpoint in the 104-week BLISS-LN study.5

SEE RENAL REMISSION DATA

Steroids

Is steroid reduction a priority for your patients with lupus nephritis?

SEE STEROID DATA

Supported by guidelines

Biologics, such as BENLYSTA, are included in the latest ACR and KDIGO lupus nephritis treatment guidelines.7,8

SEE THE RECOMMENDATIONS
  • ACR = American College of Rheumatology; KDIGO = Kidney Disease Improving Global Outcomes.

Hear from experts

The drivers of organ damage

Watch rheumatologist Dr. Alvin Wells discuss the drivers of organ damage and a treatment that may help your patients with lupus.

Paid consultant to GSK at the time of filming.

Early use of biologics

Hear nephrologist Dr. Anjay Rastogi and rheumatologist Dr. Kristi Mizelle discuss how treatment guidelines and recommendations support the early use of biologics.

Paid consultants to GSK at the time of filming.

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

More than 7,000 patients with lupus

have been included in trials of BENLYSTA, including a clinical trial in patients with lupus nephritis (N=448)1-3,5,9-11

SEE SAFETY DATA

Learn more

How to start a patient on BENLYSTA

Once you prescribe, Together with BENLYSTA can help your patients access BENLYSTA.

LEARN ABOUT PATIENT ACCESS

Peer perspectives

See what your peers have to say about their experience with BENLYSTA.

HEAR FROM OTHERS LIKE YOU

Add BENLYSTA for your patients with lupus

CONNECT WITH A REPRESENTATIVE

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, Guzman 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 Rheum. 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. 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.

  5. Furie R, Rovin BH, Houssiau F, et al. Two-year, randomized, controlled trial of belimumab in lupus nephritis. N Engl J Med. 2020;383(12):1117-1128.

  6. Data on file, GSK.

  7. Kidney Disease: Improving Global Outcomes. KDIGO 2024 clinical practice guideline for the management of lupus nephritis. Kidney Int. 2024;105(1S):S1-S69.

  8. Sammaritano LR, Askanase A, Bermas BL, et al. 2024 American College of Rheumatology (ACR) guideline for the screening, treatment, and management of lupus nephritis. Arthritis Rheumatol. 2025;77(9):1115-1135.

  9. Brunner HI, Abud-Mendoza C, Viola DO, et al. Safety and efficacy of intravenous belimumab in children with systemic lupus erythematosus: results from a randomised, placebo-controlled trial. Ann Rheum Dis. 2020;79(10):1340-1348.

  10. Ginzler E, Guedes Barbosa LS, D'Cruz D, et al. Phase III/IV, randomized, fifty-two-week study of the efficacy and safety of belimumab in patients of Black African ancestry with systemic lupus erythematosus. Arthritis Rheumatol. 2022;74(1):112-123.

  11. Sheikh SZ, Scheinberg MA, Wei JC, et al. Mortality and adverse events of special interest with intravenous belimumab for adults with active, autoantibody-positive systemic lupus erythematosus (BASE): a multicentre, double-blind, randomised, placebo-controlled, phase 4 trial. Lancet Rheumatol. 2021;3(2):E122-E130.