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

See the effect of BENLYSTA + ST vs placebo + ST on renal response at Week 104.

SEE PIVOTAL TRIAL DATA

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

74% more likely to achieve complete renal response (renal remission) with BENLYSTA1,2*

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

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

SEE RENAL REMISSION DATA

55% reduction in risk of renal flares3†

HR=0.45 (95% CI: 0.28, 0.72)

Post hoc analysis. Results are descriptive.

In patients treated with BENLYSTA + ST, 14% (28/194) had ≥1 renal flare from Week 24 to 104; in patients treated with placebo + ST, 26% (51/196) had ≥1 renal flare from Week 24 to 104.

SEE FLARES DATA

63% less eGFR loss over time

3.61 eGFR slope difference vs ST alone3‡

(95% Cl: 0.15, 7.06)

Post hoc analysis. Results are descriptive.

In patients treated with BENLYSTA + ST (n=196), the eGFR slope (mL/min/1.73 m2/year) was -2.12; in patients treated with placebo + ST (n=198), the eGFR slope was -5.72 from Week 24 to 104.‡

SEE eGFR DATA
  • *

    Complete renal response (renal remission) at Week 104: BENLYSTA + ST (n=223) = 30%; placebo + ST (n=223) = 20%.1,2

  • †

    Renal flares were defined as impaired kidney function accompanied by proteinuria and/or cellular casts, increase in proteinuria compared with Week 24, or treatment failure due to kidney disease–related intake of prohibited medications.3

     

  • ‡

    On-study population: includes all available data for patients on treatment at Week 24 inclusive of those who discontinued treatment but remained enrolled.3

     

  • BLISS-LN = Belimumab International Study in Lupus Nephritis; CI = confidence interval; CRR = complete renal response; eGFR = estimated glomerular filtration rate; HR = hazard ratio; OR = odds ratio; ST = standard therapy.

Significantly more patients achieved renal response at Week 1041,2*

Greater odds of achieving response1,2

43% of responders on BENLYSTA IV + ST achieved renal response at Week 104 versus 32% on placebo + ST

* Results from the modified intention-to-treat population.

IV = intravenous.

    More likely to achieve renal remission (CRR) with BENLYSTA + ST compared to ST alone1,2*

    In the BLISS-LN study, patients with Class III lupus nephritis treated with MMF or CYC were 74% more likely to achieve complete renal response (renal remission) at Week 104.

     

    Complete renal response (renal remission) by visit1,2*

    Patients on BENLYSTA IV + ST were 74% more likely to achieve complete renal response (CRR; renal remission) at Week 104 vs placebo + ST

    * CRR analysis by visit is descriptive. The same patient may not have responded at each time point.

    From Furie R, et al. N Engl J Med. 2020;383(12):1117-1128. ©2020 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.

      More patients achieved CRR (renal remission) on BENLYSTA + ST + MMF (stratified by baseline proteinuria <3 g)2*

      BLISS-LN post hoc subgroup analysis of the secondary endpoint of complete renal response (renal remission) at Week 104†

      Approximately 2 times as many patients were observed to achieve CRR (renal remission) with BENLYSTA + ST + MMF vs placebo + ST + MMF at Week 104

      Post hoc, subgroup analysis. Results are descriptive.

      See study limitations.

      Complete renal response (renal remission) at Week 104 by induction regimen and baseline uPCR level (mITT population)2

        MMF CYC
        <3 g/g ≥3 g/g <3 g/g ≥3 g/g
      BENLYSTA + ST 43.0% (n=100) 20.3% (n=64) 25.0% (n=32) 11.1% (n=27)
      Placebo + ST 22.4% (n=98) 16.7% (n=66) 21.2% (n=33) 15.4% (n=26)

      • The mITT subpopulation from the BLISS-LN trial was analyzed based on current treatment guidelines and expert opinion.3,4

      • *

        The EULAR 2023 management of SLE recommendations and the 2024 KDIGO guidelines for the treatment of lupus nephritis cited findings from the secondary post hoc analysis of the BLISS-LN trial and the effect of BENLYSTA in the subgroup of patients with baseline proteinuria below 3 g/day. The results shown above are from a further post hoc analysis stratified by baseline proteinuria and induction regimen.3-5

      • †

        Complete renal response at Week 104 was defined as eGFR ≥90 mL/min/1.73 m2 or eGFR no worse than 10% below the preflare value; uPCR <0.5; and not a treatment failure.1

      • CYC = cyclophosphamide; EULAR = European Alliance of Associations for Rheumatology; KDIGO = Kidney Disease Improving Global Outcomes; mITT = modified intention-to-treat; MMF = mycophenolate mofetil; SLE = systemic lupus erythematosus; uPCR = urine protein:creatinine ratio.

      Just one renal flare could shorten a kidney’s lifespan by decades6-8

      BENLYSTA: preservation of kidney function3

      55%

      reduction in risk of renal flares*

      HR=0.45 (95% CI: 0.28, 0.72)

      In patients treated with BENLYSTA + ST, 14% (28/194) had ≥1 renal flare from Week 24 to 104; in patients treated with placebo + ST, 26% (51/196) had ≥1 renal flare from Week 24 to 104.

      See study limitations.

        

      63%

      less eGFR loss over time

      (3.61 eGFR slope difference vs ST alone; 95% CI: 0.15, 7.06)

      In patients treated with BENLYSTA + ST (n=196), the eGFR slope (mL/min/1.73 m2/year) was -2.12; in patients treated with placebo + ST (n=198), the eGFR slope was -5.72 from Week 24 to 104.†

      See study limitations.

      • Post hoc analysis. Results are descriptive.
      • *

        Renal flares were defined as impaired kidney function accompanied by proteinuria and/or cellular casts, increase in proteinuria compared with Week 24, or treatment failure due to kidney disease–related intake of prohibited medications.3

      • †

        On-study population: includes all available data for patients on treatment at Week 24 inclusive of those who discontinued treatment but remained enrolled.3

      BENLYSTA: steroid-sparing efficacy results for patients with lupus nephritis2

      37%

      of patients reduced their steroid dose to ≤5 mg/day at Week 104*

      51%

      more likely to reduce steroid dose to ≤5 mg/day

      (OR: 1.51; 95% CI: 1.01, 2.27)

      See study limitations.

      Results are descriptive.

      * 37% of patients on BENLYSTA + ST (n=223) vs 28% of patients on placebo + ST (n=223) had ≤5 mg average daily steroid dose at Week 104.

      Significantly reduced risk of renal-related events or death by approximately half1,2*

      49% reduction in risk of renal-related events or death in patients taking BENLYSTA + ST (16%) versus patients taking placebo + ST (28%)

      Time to renal-related event or death was a secondary endpoint defined as first instance of ESKD, doubling of serum creatinine, renal worsening (increased proteinuria and/or impaired renal function), renal disease–related treatment failure, or death occurring after Day 1.

      * When excluding deaths (BENLYSTA=1, ST=2), the percentage of patients with a renal-related event was 15% vs 27%, respectively (HR=0.51; 95% CI: 0.34, 0.77).2
      ESKD = end-stage kidney disease.

      BLISS-LN: the largest and longest trial of a biologic in lupus nephritis2

      SEE STUDY DESIGN

      BLISS-LN PRIMARY AND SECONDARY ENDPOINTS
      KEY INCLUSION AND EXCLUSION CRITERIA

      BENLYSTA is the first and only FDA-approved biologic for active lupus nephritis studied with both MMF and CYC.

      Learn more

      Real-world evidence

      See the effect of BENLYSTA on organ damage progression.

      LEARN ABOUT ORGAN DAMAGE

      Safety profile

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

      SEE SAFETY DATA

      Add BENLYSTA as part of initial and maintenance therapy for your patients with lupus nephritis

      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. 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.

      2. Data on file, GSK.

      3. Rovin BH, Furie R, Teng YKO, et al. A secondary analysis of the Belimumab International Study in Lupus Nephritis trial examined effects of belimumab on kidney outcomes and preservation of kidney function in patients with lupus nephritis. Kidney Int. 2022;101(2):403-413.

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

      6. Anders H-J, Saxena R, Zhao M-H, et al. Lupus nephritis. Nat Rev Dis Primers. 2020;6(1):7.

      7. Rijnink EC, Teng YKO, Wilhelmus S, et al. Clinical and histopathologic characteristics associated with renal outcomes in lupus nephritis. Clin J Am Soc Nephrol. 2017;12(5):734-743.

      8. Sprangers B, Monahan M, Appel GB. Diagnosis and treatment of lupus nephritis flares—an update. Nat Rev Nephrol. 2021;8(12):709-717.