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IDENTIFYING PATIENTS FOR BENLYSTA IN CLINICAL PRACTICE
SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) IS A CHRONIC, MULTISYSTEM AUTOIMMUNE DISEASE CHARACTERIZED BY
- Diverse clinical manifestations, which are the result of inflammation in multiple organ systems
- Waxing and waning disease activity, with signs of
active disease often appearing or disappearing despite standard therapy - Pathologic production of autoantibodies directed against self-antigens
- Antinuclear autoantibodies are
hallmark ofdisease - Abnormal activation of certain cells, including autoreactive B cells
- Antinuclear autoantibodies are
Several clinical tools have been developed to measure active SLE, including SELENA-SLEDAI, BILAG, and PGA.
- Diverse clinical manifestations, which are the result of inflammation in multiple organ systems
- Waxing and waning disease activity, with signs of
active disease often appearing or disappearing despite standard therapy - Pathologic production of autoantibodies directed against self-antigens
- Antinuclear autoantibodies are
hallmark ofdisease - Abnormal activation of certain cells, including autoreactive B cells
- Antinuclear autoantibodies are
Several clinical tools have been developed to measure active SLE, including SELENA-SLEDAI, BILAG, and PGA.
| SELENA-SLEDAI1,2 | BILAG3 | PGA |
|---|---|---|
|
|
|
Consider evaluating your patients for BENLYSTA if 4-7
- Patient is 18 years of age or older and has been diagnosed with SLE according to the American College of Rheumatology criteria
- Patient meets at least 1 of the following:
- Antinuclear antibody (ANA) titer ≥1:80
- Anti-dsDNA autoantibodies ≥30 IU/mL
- Patient is currently receiving any of the following types of standard therapy, alone or in combination, for ≥30 days:
- Antimalarial
- Immunosuppressive
- Corticosteroid
- NSAID
- Patient has active disease*
- SELENA-SLEDAI score ≥8 for BLISS-SC
- SELENA-SLEDAI score ≥6 for BLISS-52 and BLISS-76
*Can include both clinical† and serological‡ manifestations of SLE.
†eg, arthritis, rash, hair loss.
‡eg, decreased complement and anti-dsDNA.
- SELENA-SLEDAI score ≥8 for BLISS-SC
- Patient does not have severe active lupus nephritis
- Patient does not have severe active CNS lupus
- Patient is not using other biologics or IV cyclophosphamide
SELENA-SLEDAI = Safety of Estrogens in Lupus Erythematosus: National Assessment Version of the Systemic Lupus Erythematosus Disease Activity Index.
BILAG = British Isles Lupus Assessment Group.
PGA = Physician’s Global Assessment.
REFERENCES:
- Bombardier C, Gladman DD, Urowitz MB, Caron D, Chang CH. Derivation of the SLEDAI. A disease activity index for lupus patients. The Committee on Prognosis Studies in SLE. Arthritis Rheum. 1992;35(6):630-640.
- Petri M, Kim MY, Kalunian KC, et al. Combined oral contraceptives in women with systemic lupus erythematosus. N Engl J Med. 2005;353:2550-2558.
- Hay EM, Bacon PA, Gordon C, et al. The BILAG index: a reliable and valid instrument for measuring clinical disease activity in systemic lupus erythematosus. QJM. 1993;86(7):447-458.
- Data on file, Human Genome Sciences, Inc.
- 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.
- 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.
- 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.
Indication
BENLYSTA is indicated for the treatment of patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who receive standard therapy. BENLYSTA is approved as an intravenous infusion in patients 5 years and older and as a subcutaneous injection in patients 18 years and older.
Limitations of Use: The efficacy of BENLYSTA has not been evaluated and is not recommended in patients with severe active lupus nephritis, or severe active central nervous system lupus, or in combination with other biologics or intravenous cyclophosphamide.
How supplied: BENLYSTA for intravenous use (IV) is available as 120 mg in a 5-mL single-dose vial and 400 mg in a 20-mL single-dose vial. BENLYSTA for subcutaneous use (SC) is available as 200 mg in a 1-mL single-dose prefilled autoinjector and 200 mg in a 1-mL single-dose prefilled glass syringe.
Important Safety Information
CONTRAINDICATION
Previous anaphylaxis with BENLYSTA.
WARNINGS AND PRECAUTIONS
MORTALITY
In controlled clinical trials in adults (N=2,133), death occurred in 0.8% (11/1,458) of patients treated with BENLYSTA IV and in 0.4% (3/675) of patients receiving placebo. Etiologies included infection, cardiovascular disease, and suicide.
In the controlled trial in adults (N=836), death occurred in 0.5% (3/556) of patients receiving BENLYSTA SC and 0.7% (2/280) of patients receiving placebo. Infection was the most common cause of death.
SERIOUS INFECTIONS
Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents, including BENLYSTA. The most frequent serious infections in adults were pneumonia, including bacterial pneumonia, urinary tract infection, cellulitis, herpes zoster, and bronchitis. Use caution in patients with severe or chronic infections. Consider interrupting therapy with BENLYSTA in patients who develop a new infection.
Progressive Multifocal Leukoencephalopathy (PML): Cases of JC virus-associated PML resulting in neurological deficits, including fatal cases, have been reported in patients with SLE receiving immunosuppressants, including BENLYSTA. If PML is confirmed, consider stopping immunosuppressant therapy, including BENLYSTA.
HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS) AND INFUSION REACTIONS
Acute hypersensitivity reactions, including anaphylaxis and death, have been reported in association with infusions and injections of BENLYSTA, including in patients who have previously tolerated BENLYSTA. These events generally occurred within hours of the infusion; however, they may occur later. Non-acute hypersensitivity reactions including rash, nausea, fatigue, myalgia, headache, and facial edema, have been reported and typically occurred up to a week following the most recent infusion. Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk. Premedication may mitigate or mask an infusion reaction or hypersensitivity response. In the controlled trial of BENLYSTA SC in adults, systemic hypersensitivity reactions were similar to those observed in the IV clinical trials. Anaphylaxis was observed in 0.6% and 0.4% of adult patients receiving BENLYSTA IV and placebo, respectively. Manifestations included hypotension, angioedema, urticaria or other rash, pruritus, and dyspnea.
Serious infusion reactions in adults (excluding hypersensitivity reactions) were reported in 0.5% and 0.4% of patients receiving BENLYSTA and placebo, respectively and included bradycardia, myalgia, headache, rash, urticaria, and hypotension. BENLYSTA IV should be administered by healthcare providers prepared to manage infusion reactions and anaphylaxis. The infusion rate may be slowed or interrupted if the patient develops an infusion reaction. In the event of a serious reaction, administration of BENLYSTA must be discontinued immediately and appropriate medical therapy administered. Patients should be closely monitored during and for an appropriate period of time after IV administration of BENLYSTA. Patients receiving BENLYSTA should be informed of the signs and symptoms of hypersensitivity reactions and seek immediate medical care should a reaction occur.
DEPRESSION
In the controlled clinical trials of BENLYSTA IV in adults, psychiatric events were reported more frequently with BENLYSTA than with placebo, related primarily to depression-related events, insomnia and anxiety. Serious psychiatric events were reported in trials with BENLYSTA. Serious depression and suicidality (including two completed suicides) were reported in trials with BENLYSTA IV. There were no serious depression-related events or suicides reported in the BENLYSTA SC trial in adults. Instruct patients to contact their healthcare provider if they experience new or worsening depression, suicidal thoughts, or other mood changes.
MALIGNANCY
The impact of treatment with BENLYSTA on the development of malignancies is not known. The mechanism of action of BENLYSTA could increase the risk for the development of malignancies.
IMMUNIZATION
Live vaccines should not be given for 30 days before or concurrently with BENLYSTA. BENLYSTA may interfere with the response to immunizations.
USE WITH BIOLOGIC THERAPIES OR IV CYCLOPHOSPHAMIDE
BENLYSTA has not been studied in combination with other biologic therapies, including B-cell targeted therapies, or IV cyclophosphamide. Therefore, use of BENLYSTA is not recommended in combination with these therapies.
ADVERSE REACTIONS
The most common serious adverse reactions were serious infections (6.0% and 5.2% in adult patients receiving BENLYSTA IV and placebo, respectively), some of which were fatal. Adverse reactions, regardless of causality, occurring in at least 3% of adult patients with SLE who received BENLYSTA 10 mg/kg and placebo respectively and, at an incidence at least 1% greater than that observed with placebo in the 3 controlled studies, were: nausea 15% and 12%; diarrhea 12% and 9%; pyrexia 10% and 8%; nasopharyngitis 9% and 7%; bronchitis 9% and 5%; insomnia 7% and 5%; pain in extremity 6% and 4%; depression 5% and 4%; migraine 5% and 4%; pharyngitis 5% and 3%; cystitis 4% and 3%; leukopenia 4% and 2%; viral gastroenteritis 3% and 1%.
Adverse reactions in pediatric patients aged ≥5 years receiving BENLYSTA IV were consistent with those observed in adults.
The safety profile observed for BENLYSTA SC plus standard therapy in adults was consistent with the known safety profile of BENLYSTA IV plus standard therapy, with the exception of local injection site reactions.
OTHER IMPORTANT INFORMATION FOR BENLYSTA
USE IN SPECIFIC POPULATIONS
Pregnancy: There are insufficient data on use of BENLYSTA in pregnant women to establish whether there is drug-associated risk for major birth defects or miscarriage. Following an assessment of benefit versus risk, if prevention is warranted, women of childbearing potential should use effective contraception during treatment and for at least 4 months after the final treatment.
Pregnancy Registry: Healthcare professionals are encouraged to register patients and pregnant women are encouraged to enroll themselves by calling 1-877-681-6296.
Lactation: There is no information available on the presence of belimumab in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for BENLYSTA and any potential adverse effects on the breastfed child from BENLYSTA or from the underlying maternal condition.
Pediatric Use: The safety and effectiveness have not been established for BENLYSTA IV in patients younger than 5 years of age and for BENLYSTA SC in patients younger than 18 years of age.
Black/African American Patients: In clinical studies, there have been mixed results regarding how well BENLYSTA works in black/African American patients. Consider the risks and benefits when prescribing BENLYSTA in black/African American patients.
Please see full Prescribing Information and Medication Guide for BENLYSTA.
