Key clinical outcomes in pediatric lupus1

BENLYSTA reduced disease activity and the risk of severe flare in pediatric patients with lupus aged 5 years and older.

53 percent

of patients had reduced disease activity (SRI-4) at Week 521

(Primary endpoint, numerical reduction)

SEE DISEASE ACTIVITY DATA
64 percent

reduction in risk of severe flare1

(HR=0.36; 95% CI: 0.15, 0.86) (Other efficacy endpoint, numerical reduction)

SEE FLARE DATA

BENLYSTA reduced disease activity in pediatric patients with lupus1

SRI-4 response rate at Week 52 (primary endpoint)

In the PLUTO study, a higher SRI-4 response rate was observed at Week 52 with BENLYSTA + ST vs placebo + ST in pediatric patients with lupus (53% vs 44%)

In patients on placebo + ST (n=40), the SRI-4 response rate at Week 52 was 44%.

  • *The PLUTO trial was not powered to show a statistical difference between treatment groups.

    IV = intravenous; PLUTO = Pediatric Lupus Trial of BENLYSTA; SRI = SLE Responder Index; ST = standard therapy.

BENLYSTA reduced the risk of severe flare1*†

64

%

reduction in risk of severe flare1

(HR=0.36‡; 95% CI: 0.15, 0.86)

Numerical reduction

In patients on BENLYSTA + ST (n=53), 17% had ≥1 severe flare over 52 weeks, vs patients on placebo + ST (n=40), 35% had ≥1 severe flare over 52 weeks

* As measured by the SELENA-SLEDAI Flare Index, modified to exclude the single criterion of increased SELENA-SLEDAI score to >12.

† The incidence of severe flare over 52 weeks was an other efficacy endpoint.

‡ The PLUTO trial was not powered to show a statistical difference between treatment groups.

CI = confidence interval; HR = hazard ratio; SELENA-SLEDAI = Safety of Estrogens in Lupus Erythematosus: National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index.

Additional information

Study design for the PLUTO trial

Definition of primary endpoint

Definition of severe flare

Definition of severe flare

Using a modified SELENA-SLEDAI Flare Index, severe flares were defined as at least one of the following2*:

  • Hospitalization for SLE activity
  • New/worse (requiring doubling of prednisone, or prednisone increase to >0.5 mg/kg/day, or hospitalization):
    • CNS SLE
    • Vasculitis
    • Nephritis
    • Myositis
  • Platelets <60,000
  • Hemolytic anemia (Hb <7 g/dL or decrease in Hb of >3 g/dL)
  • Any manifestation that required an increase in prednisone to >0.5 mg/kg/day or initiation of a new immunosuppressant
  • Increase in PGA score to >2.5

* The modified SELENA-SLEDAI excludes severe flares triggered only by an increase of the SELENA-SLEDAI score to >12.

CNS = central nervous system; Hb = hemoglobin; PGA = Physician’s Global Assessment.

Learn more

BENLYSTA Autoinjector

This option with at-home convenience is available for adult or pediatric patients with lupus or lupus nephritis.

LEARN ABOUT THE AUTOINJECTOR

Safety profile

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

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Choose BENLYSTA now for your pediatric patients with lupus

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. 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;79:1340-1348.

  2. Petri M, Kim M, Kalunian K, et al. Combined oral contraceptives in women with systemic lupus erythematosus. N Engl J Med. 2005;353:2550-2558.